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Sample records for controlled intervention studies

  1. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  2. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    Science.gov (United States)

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  3. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  4. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control.

    Science.gov (United States)

    Quinn, Charlene C; Gruber-Baldini, Ann L; Shardell, Michelle; Weed, Kelly; Clough, Suzanne S; Peeples, Malinda; Terrin, Michael; Bronich-Hall, Lauren; Barr, Erik; Lender, Dan

    2009-07-01

    National data find glycemic control is within target (A1ccommunication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c> or =7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a year's supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period. Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

  5. Effect of Psychiatric Intervention in Attempted Suicide: A Controlled Study

    Science.gov (United States)

    Greer, Steven; Bagley, Christopher

    1971-01-01

    All patients presenting at the casualty department of King's College Hospital during the first six months of 1968 with deliberate self-poisoning or self-injury were followed up. Of 211 patients 204 (97%) were traced after a mean interval of 18 months (range one to two years). Despite official hospital policy, 22% had not been seen by a psychiatrist before discharge; these 44 untreated patients were compared with the remaining 160 who had received either brief (one or two interviews) or more prolonged psychiatric and social help. Subsequent suicidal attempts occurred significantly more often among untreated than among treated patients, prolonged treatment being associated with the best prognosis. The same trend was observed in respect of actual suicide, though the numbers were small and differences did not reach statistical significance. These findings held good when the untreated and treated groups were controlled for other variables which were found to be correlated with outcome. These results indicate that psychiatric intervention is associated with a significant reduction in subsequent suicidal behaviour. PMID:5100261

  6. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  7. A systematic review of studies evaluating diffusion and dissemination of selected cancer control interventions.

    Science.gov (United States)

    Ellis, Peter; Robinson, Paula; Ciliska, Donna; Armour, Tanya; Brouwers, Melissa; O'Brien, Mary Ann; Sussman, Jonathan; Raina, Parminder

    2005-09-01

    With this review, the authors sought to determine what strategies have been evaluated (including the outcomes assessed) to disseminate cancer control interventions that promote the uptake of behavior change. Five topic areas along the cancer care continuum (smoking cessation, healthy diet, mammography, cervical cancer screening, and control of cancer pain) were selected to be representative. A systematic review was conducted of primary studies evaluating dissemination of a cancer control intervention. Thirty-one studies were identified that evaluated dissemination strategies in the 5 topic areas. No strong evidence currently exists to recommend any one dissemination strategy as effective in promoting the uptake of cancer control interventions. The authors conclude that there is a strong need for more research into dissemination of cancer control interventions. Future research should consider methodological issues such as the most appropriate study design and outcomes to be evaluated. (c) 2005 APA, all rights reserved

  8. A controlled intervention study concerning the effect of intended temperature rise on house dust mite load

    DEFF Research Database (Denmark)

    Sidenius, Kirsten E; Hallas, Thorkil E; Poulsen, Lars K.

    2002-01-01

    In epidemiological studies, increased indoor temperature--producing a lower relative humidity--is associated with low house dust mite (HDM) load. Twenty-eight dwellings were allocated for either intervention (12/15 completed) or control (11/13 completed). In the intervention group, participants w...

  9. Reduction of Hospital Physicians' Workflow Interruptions: A Controlled Unit-Based Intervention Study

    Directory of Open Access Journals (Sweden)

    Matthias Weigl

    2012-01-01

    Full Text Available Highly interruptive clinical environments may cause work stress and suboptimal clinical care. This study features an intervention to reduce workflow interruptions by re-designing work and organizational practices in hospital physicians providing ward coverage. A prospective, controlled intervention was conducted in two surgical and two internal wards. The intervention was based on physician quality circles - a participative technique to involve employees in the development of solutions to overcome work-related stressors. Outcome measures were the frequency of observed workflow interruptions. Workflow interruptions by fellow physicians and nursing staff were significantly lower after the intervention. However, a similar decrease was also observed in control units. Additional interviews to explore process-related factors suggested that there might have been spill-over effects in the sense that solutions were not strictly confined to the intervention group. Recommendations for further research on the effectiveness and consequences of such interventions for professional communication and patient safety are discussed.

  10. Effects of pharmaceutical counselling on antimicrobial use in surgical wards: intervention study with historical control group.

    Science.gov (United States)

    Grill, Eva; Weber, Alexandra; Lohmann, Stefanie; Vetter-Kerkhoff, Cornelia; Strobl, Ralf; Jauch, Karl-Walter

    2011-07-01

    The objective of this study was to assess the impact of pharmaceutical consulting on the quality of antimicrobial use in a surgical hospital department in a prospective controlled intervention study. Patients receiving pharmaceutical intervention (intervention group, IG, n = 317) were compared with a historical control group (control group, CG, n = 321). During the control period, antimicrobial use was monitored without intervention. During the subsequent intervention period, a clinical pharmacist reviewed the prescriptions and gave advice on medication. Intervention reduced the length of antimicrobial courses (IG = 10 days, CG = 11 days, incidence rate ratio for i.v. versus o.p. = 0.88, 95% confidence interval 0.84 to 0.93) and shortened i.v. administration (IG = 8 days, CG = 10 days, hazard rate = 1.76 in favour of switch from i.v. to p.o., 95% confidence interval 1.23 to 2.52). Intervention also helped to avoid useless combination therapy and reduced total costs for antimicrobials. A clinical pharmacist who reviews prescriptions can promote an increase in efficiency, for example, by shortening the course of treatment. Counselling by ward-based clinical pharmacists was shown to be effective to streamline antimicrobial therapy in surgical units and to increase drug safety. Copyright © 2011 John Wiley & Sons, Ltd.

  11. Lay health workers perceptions of an anemia control intervention in Karnataka, India: a qualitative study.

    Science.gov (United States)

    Shet, Arun S; Rao, Abha; Jebaraj, Paul; Mascarenhas, Maya; Zwarenstein, Merrick; Galanti, Maria Rosaria; Atkins, Salla

    2017-09-18

    Lay health workers (LHWs) are increasingly used to complement health services internationally. Their perceptions of the interventions they implement and their experiences in delivering community based interventions in India have been infrequently studied. We developed a novel LHW led intervention to improve anemia cure rates in rural community dwelling children attending village day care centers in South India. Since the intervention is delivered by the village day care center LHW, we sought to understand participating LHWs' acceptance of and perspectives regarding the intervention, particularly in relation to factors affecting daily implementation. We conducted a qualitative study alongside a cluster randomized controlled trial evaluating a complex community intervention for childhood anemia control in Karnataka, South India. Focus group discussions (FGDs) were conducted with trained LHWs assigned to deliver the educational intervention. These were complemented by non-participant observations of LHWs delivering the intervention. Transcripts of the FGDs were translated and analyzed using the framework analysis method. Several factors made the intervention acceptable to the LHWs and facilitated its implementation including pre-implementation training modules, intervention simplicity, and ability to incorporate the intervention into the routine work schedule. LHWs felt that the intervention impacted negatively on their preexisting workload. Fluctuating relationships with mothers weakened the LHWs position as providers of the intervention and hampered efficient implementation, despite the LHWs' highly valued position in the community. Modifiable barriers to the successful implementation of this intervention were seen at two levels. At a broader contextual level, hindering factors included the LHW being overburdened, inadequately reimbursed, and receiving insufficient employer support. At the health system level, lack of streamlining of LHW duties, inability of LHWs to

  12. School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial.

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    Haugland, Bente Storm Mowatt; Raknes, Solfrid; Haaland, Aashild Tellefsen; Wergeland, Gro Janne; Bjaastad, Jon Fauskanger; Baste, Valborg; Himle, Joe; Rapee, Ron; Hoffart, Asle

    2017-03-04

    Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention. The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure. The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services. ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

  13. Khan Academy as Supplemental Instruction: A Controlled Study of a Computer-Based Mathematics Intervention

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    Kelly, Daniel P.; Rutherford, Teomara

    2017-01-01

    Khan Academy is a large and popular open educational resource (OER) with little empirical study into its impact on student achievement in mathematics when used in schools. In this study, we examined the use of Khan Academy as a mathematics intervention among seventh grade students over a 4-week period versus a control group. We also compared…

  14. Alcohol interventions for mandated students: behavioral outcomes from a randomized controlled pilot study.

    Science.gov (United States)

    Logan, Diane E; Kilmer, Jason R; King, Kevin M; Larimer, Mary E

    2015-01-01

    This study investigated the effectiveness of three single-session interventions with high-risk mandated students while considering the influence of motivational interviewing (MI) microskills. This randomized, controlled pilot trial evaluated single-session interventions: Alcohol Skills Training Program (ASTP), Brief Alcohol Screening and Intervention for College Students (BASICS) feedback sessions, and treatment-as-usual Alcohol Diversion Program (ADP) educational groups. Participants were 61 full-time undergraduates at a southern U.S. campus sanctioned to a clinical program following violation of an on-campus alcohol policy (Mage = 19.16 years; 42.6% female). RESULTS revealed a significant effect of time for reductions in estimated blood alcohol concentration (eBAC) and number of weekly drinks but not in alcohol-related consequences. Although ASTP and BASICS participants reported significant decreases in eBAC over time, ADP participant levels did not change (with no intervention effects on quantity or consequences). MI microskills were not related to outcomes. RESULTS from this study suggest equivalent behavioral impacts for the MI-based interventions, although individual differences in outcome trajectories suggest that research is needed to further customize mandated interventions. Given the overall decrease in eBAC following the sanction, the lack of reduction in the ADP condition warrants caution when using education-only interventions.

  15. Intervention effects on physical activity: the HEIA study - a cluster randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Although school-based interventions to promote physical activity in adolescents have been suggested in several recent reviews, questions have been raised regarding the effects of the strategies and the methodology applied and for whom the interventions are effective. The aim of the present study was to investigate effects of a school-based intervention program: the HEalth in Adolescents (HEIA) study, on change in physical activity, and furthermore, to explore whether potential effects varied by gender, weight status, initial physical activity level and parental education level. Methods This was a cluster randomized controlled 20 month intervention study which included 700 11-year-olds. Main outcome-variable was mean count per minute (cpm) derived from ActiGraph accelerometers (Model 7164/GT1M). Weight and height were measured objectively. Adolescents reported their pubertal status in a questionnaire and parents reported their education level on the consent form. Linear mixed models were used to test intervention effects and to account for the clustering effect of sampling by school. Results The present study showed an intervention effect on overall physical activity at the level of p = 0.05 with a net effect of 50 cpm increase from baseline to post intervention in favour of the intervention group (95% CI −0.4, 100). Subgroup analyses showed that the effect appeared to be more profound among girls (Est 65 cpm, CI 5, 124, p = 0.03) and among participants in the low-activity group (Est 92 cpm, CI 41, 142, p activity group, respectively. Furthermore, the intervention affected physical activity among the normal weight group more positively than among the overweight, and participants with parents having 13–16 years of education more positively than participants with parents having either a lower or higher number of years of education. The intervention seemed to succeed in reducing time spent sedentary among girls but not among boys. Conclusions A

  16. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

    Directory of Open Access Journals (Sweden)

    Jenkins William

    2007-05-01

    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  17. Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

    Science.gov (United States)

    Malmivaara, Antti

    2016-01-01

    Abstract Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. Aims: To create and pilot test a checklist for appraising methodological validity of a BCT. Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.Key messagesBenchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. PMID:27238631

  18. An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rachyla, Iryna; Pérez-Ara, Marian; Molés, Mar; Campos, Daniel; Mira, Adriana; Botella, Cristina; Quero, Soledad

    2018-05-31

    Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet

  19. Nutrition impact symptoms in advanced cancer patients: frequency and specific interventions, a case-control study.

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    Omlin, Aurelius; Blum, David; Wierecky, Jan; Haile, Sarah R; Ottery, Faith D; Strasser, Florian

    2013-03-01

    Involuntary weight loss (IWL) is frequent in advanced cancer patients causing compromised anticancer treatment outcomes and function. Cancer cachexia is influenced by nutrition impact symptoms (NIS). The aim of this study was to explore the frequency of NIS in advanced patients and to assess specific interventions guided by a 12-item NIS checklist. Consecutive patients from an outpatient nutrition-fatigue clinic completed the NIS checklist. The NIS checklist was developed based on literature review and multiprofessional clinical expert consensus. Chart review was performed to detect defined NIS typical interventions. Oncology outpatients not seen in the nutrition-fatigue clinic were matched for age, sex, and tumor to serve as controls. In 52 nutrition-fatigue clinic patients, a mixed cancer population [IWL in 2 months 5.96 % (mean)], the five most frequent NIS were taste and smell alterations 27 %, constipation 19 %, abdominal pain 14 %, dysphagia 12 %, and epigastric pain 10 %. A statistically significant difference for NIS typical interventions in patients with taste and smell alterations (p = 0.04), constipation (p = 0.01), pain (p = 0.0001), and fatigue (p = 0.0004) were found compared to the control population [mixed cancer, 3.53 % IWL in 2 months (mean)]. NIS are common in advanced cancer patients. The NIS checklist can guide therapeutic nutrition-targeted interventions. The awareness for NIS will likely evoke more research in assessment, impact, and treatment.

  20. Teaching Emotional Intelligence: A Control Group Study of a Brief Educational Intervention for Emergency Medicine Residents

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    Diane L. Gorgas

    2015-11-01

    Full Text Available Introduction: Emotional Intelligence (EI is defined as an ability to perceive another’s emotional state combined with an ability to modify one’s own. Physicians with this ability are at a distinct advantage, both in fostering teams and in making sound decisions. Studies have shown that higher physician EI’s are associated with lower incidence of burn-out, longer careers, more positive patient-physician interactions, increased empathy, and improved communication skills. We explored the potential for EI to be learned as a skill (as opposed to being an innate ability through a brief educational intervention with emergency medicine (EM residents. Methods: This study was conducted at a large urban EM residency program. Residents were randomized to either EI intervention or control groups. The intervention was a two-hour session focused on improving the skill of social perspective taking (SPT, a skill related to social awareness. Due to time limitations, we used a 10-item sample of the Hay 360 Emotional Competence Inventory to measure EI at three time points for the training group: before (pre and after (post training, and at six-months post training (follow up; and at two time points for the control group: pre- and follow up. The preliminary analysis was a four-way analysis of variance with one repeated measure: Group x Gender x Program Year over Time. We also completed post-hoc tests. Results: Thirty-three EM residents participated in the study (33 of 36, 92%, 19 in the EI intervention group and 14 in the control group. We found a significant interaction effect between Group and Time (p<0.05. Post-hoc tests revealed a significant increase in EI scores from Time 1 to 3 for the EI intervention group (62.6% to 74.2%, but no statistical change was observed for the controls (66.8% to 66.1%, p=0.77. We observed no main effects involving gender or level of training. Conclusion: Our brief EI training showed a delayed but statistically significant

  1. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol.

    Science.gov (United States)

    Chisholm, Katharine Elizabeth; Patterson, Paul; Torgerson, Carole; Turner, Erin; Birchwood, Max

    2012-03-22

    With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a

  2. Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

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    Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

    2014-11-20

    Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of

  3. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  4. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  5. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  6. Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

    2016-06-02

    The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

  7. A combined teamwork training and work standardisation intervention in operating theatres: controlled interrupted time series study.

    Science.gov (United States)

    Morgan, Lauren; Pickering, Sharon P; Hadi, Mohammed; Robertson, Eleanor; New, Steve; Griffin, Damian; Collins, Gary; Rivero-Arias, Oliver; Catchpole, Ken; McCulloch, Peter

    2015-02-01

    Teamwork training and system standardisation have both been proposed to reduce error and harm in surgery. Since the approaches differ markedly, there is potential for synergy between them. Controlled interrupted time series with a 3 month intervention and observation phases before and after. Operating theatres conducting elective orthopaedic surgery in a single hospital system (UK Hospital Trust). Teamwork training based on crew resource management plus training and follow-up support in developing standardised operating procedures. Focus of subsequent standardisation efforts decided by theatre staff. Paired observers watched whole procedures together. We assessed non-technical skills using NOTECHS II, technical performance using glitch rate and compliance with WHO checklist using a simple quality tool. We measured complication and readmission rates and hospital stay using hospital administrative records. Before/after change was compared in the active and control groups using two-way ANOVA and regression models. 1121 patients were operated on before and 1100 after intervention. 44 operations were observed before and 50 afterwards. Non-technical skills (p=0.002) and WHO compliance (pteamwork and system improvement causes marked improvements in team behaviour and WHO performance, but not technical performance or outcome. These findings are consistent with the synergistic hypothesis, but larger controlled studies with a strong implementation strategy are required to test potential outcome effects. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial.

    Science.gov (United States)

    Sorensen, Glorian; Pednekar, Mangesh; Cordeira, Laura Shulman; Pawar, Pratibha; Nagler, Eve M; Stoddard, Anne M; Kim, Hae-Young; Gupta, Prakash C

    2017-03-01

    We assessed a worksite intervention designed to promote tobacco control among workers in the manufacturing sector in Greater Mumbai, India. We used a cluster-randomised design to test an integrated health promotion/health protection intervention, the Healthy, Safe, and Tobacco-free Worksites programme. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014. The difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, p=0.03), although not for the overall sample (OR=1.70; p=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; p=0.07) and for the overall sample (OR=1.81; p=0.13), but the difference did not reach statistical significance. These findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites. NCT01841879. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  9. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Directory of Open Access Journals (Sweden)

    Chisholm Katharine

    2012-03-01

    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors

  10. Does periodontal treatment improve glycemic control in diabetic patients? A meta-analysis of intervention studies.

    Science.gov (United States)

    Janket, S-J; Wightman, A; Baird, A E; Van Dyke, T E; Jones, J A

    2005-12-01

    Previous analyses regarding effects of periodontal treatment on glycemic control included studies where causal association might not be assumed, or the results were reported non-quantitatively. We initiated this meta-analysis of 10 intervention studies to quantify the effects of periodontal treatment on HbA1c level among diabetic patients, to explore possible causes for the discrepant reports, and to make recommendations for future studies. Data sources were MEDLINE (January, 1980, to January, 2005), the EBMR, Cochrane Register, and bibliographies of the published articles. Three investigators extracted data regarding intervention, outcomes, and effect size. A total of 456 patients was included in this analysis, with periodontal treatment as predictor and the actual change in hemoglobin A1c level as the outcome. The weighted average decrease in actual HbA1c level was 0.38% for all studies, 0.66% when restricted to type 2 diabetic patients, and 0.71% if antibiotics were given to them. However, none was statistically significant.

  11. A Mediterranean Diet to Improve Cardiovascular and Cognitive Health: Protocol for a Randomised Controlled Intervention Study.

    Science.gov (United States)

    Wade, Alexandra T; Davis, Courtney R; Dyer, Kathryn A; Hodgson, Jonathan M; Woodman, Richard J; Keage, Hannah A D; Murphy, Karen J

    2017-02-16

    The Mediterranean diet has demonstrated efficacy for improving cardiovascular and cognitive health. However, a traditional Mediterranean diet delivers fewer serves of dairy and less dietary calcium than is currently recommended in Australia, which may limit long-term sustainability. The present study aims to evaluate whether a Mediterranean diet with adequate dairy and calcium can improve cardiovascular and cognitive function in an at-risk population, and thereby reduce risk of cardiovascular disease (CVD) and cognitive decline. A randomised, controlled, parallel, crossover design trial will compare a Mediterranean diet supplemented with dairy foods against a low-fat control diet. Forty participants with systolic blood pressure above 120 mmHg and at least two other risk factors of CVD will undertake each dietary intervention for eight weeks, with an eight-week washout period between interventions. Systolic blood pressure will be the primary measure of interest. Secondary outcomes will include measures of cardiometabolic health, dietary compliance, cognitive function, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), psychological well-being and dementia risk. This research will provide empirical evidence as to whether the Mediterranean diet can be modified to provide recommended dairy and calcium intakes while continuing to deliver positive effects for cardiovascular and cognitive health. The findings will hold relevance for the field of preventative healthcare and may contribute to revisions of national dietary guidelines.

  12. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  13. The effect of a structural intervention for syphilis control among 3597 female sex workers: a demonstration study in South China.

    Science.gov (United States)

    Wang, Baoxi; Wang, Qian-Qiu; Yin, Yue-Ping; Liang, Guo-Jun; Jiang, Ning; Gong, Xiang-Dong; Yang, Bin; Zhou, Yue-Jiao; Liu, Qiao; Huan, Xi-Ping; Yang, Li-Gang; Tan, Guang-Jie; Pei, Dong-Nu; Tucker, Joseph D; Chen, Xiang-Sheng

    2012-09-15

    Syphilis has made a rapid resurgence in China, especially among high-risk groups including female sex workers (FSWs). Two cities in each of 3 provinces in South China were chosen and allocated to intervention or control arms. The intervention consisted of enhancing community-based syphilis screening outreach intervention with comprehensive sexually transmitted infection services at designated clinics while the control maintained routine intervention activities. Generalized linear modeling was used to examine effect of the intervention on incident syphilis infection. A total of 8275 women were eligible, and 3597 women enrolled (n = 2011 in control arm, n = 1586 in intervention arm) in the study. The median follow-up duration was 375 days (interquartile range, 267–475). Syphilis incidence density in the intervention group was reduced by 70% (95% confidence interval, 53%–81%) compared with the incidence in the control arm. The syphilis prevention intervention benefits were robust among FSWs at low-tier venues, individuals with less than high school education, migrants, and women who did not report condom use during the last episode of sex. Integrated sexually transmitted infection and human immunodeficiency virus prevention strategies substantially reduce syphilis incidence among FSWs, especially among those at low-tier venues. This intervention suggests the need for scaling up comprehensive FSW programs in China.

  14. Community pharmacist intervention in depressed primary care patients (PRODEFAR study: randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Travé Pere

    2009-08-01

    Full Text Available Abstract Background Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75 diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain. Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9, anxiety (STAI-S, health-related quality of life (EuroQol-5D, satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI. Discussion This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical

  15. Development and evaluation of two web-based interventions for the promotion of physical activity in older adults: study protocol for a community-based controlled intervention trial.

    Science.gov (United States)

    Muellmann, Saskia; Bragina, Inna; Voelcker-Rehage, Claudia; Rost, Eric; Lippke, Sonia; Meyer, Jochen; Schnauber, Jochen; Wasmann, Merlin; Toborg, Merle; Koppelin, Frauke; Brand, Tilman; Zeeb, Hajo; Pischke, Claudia R

    2017-05-25

    Regular physical activity (PA) is a key contributor to healthy ageing. However, despite known health benefits, only one third of older adults in Germany reach the PA levels recommended for persons aged 65 years and above by the World Health Organization. The aim of the current study is to evaluate the effectiveness of two web-based interventions for the initiation and maintenance of regular PA (i.e., intervention groups 1 and 2) compared to a delayed intervention control group of older adults aged 65 to 75 years. Study participants will be randomly assigned to one of three study arms in five communities in the Bremen-Oldenburg metropolitan region: a) Participants in the first arm will receive access to a web-based intervention for 10 weeks allowing them to track their weekly PA (subjective self-monitoring, intervention group 1); b) participants in the second arm will receive access to the web-based intervention for 10 weeks and, in addition, track PA using Fitbit Zips (objective self-monitoring, intervention group 2); c) participants in the delayed intervention control group will receive access to the intervention implemented in the first study arm after completion of the 12-week follow-up in the other two groups within each community. In addition, weekly group meetings in the communities will be offered to study participants in the intervention groups providing the opportunity to address questions related to the use of the website and to practice PA in groups (e.g., neighborhood walks, strength and balance exercises). To evaluate short-term effects of the intervention on physical and psychological health, PA, physical fitness, and cognitive and psychological variables will be assessed at baseline and 12-week follow-up. This study will provide answers regarding acceptance and effectiveness of web-based interventions promoting uptake and maintenance of regular PA in persons aged 65-75 years. Study findings will contribute to a growing body of evidence in

  16. Weight change in control group participants in behavioural weight loss interventions: a systematic review and meta-regression study

    Directory of Open Access Journals (Sweden)

    Waters Lauren

    2012-08-01

    Full Text Available Abstract Background Unanticipated control group improvements have been observed in intervention trials targeting various health behaviours. This phenomenon has not been studied in the context of behavioural weight loss intervention trials. The purpose of this study is to conduct a systematic review and meta-regression of behavioural weight loss interventions to quantify control group weight change, and relate the size of this effect to specific trial and sample characteristics. Methods Database searches identified reports of intervention trials meeting the inclusion criteria. Data on control group weight change and possible explanatory factors were abstracted and analysed descriptively and quantitatively. Results 85 trials were reviewed and 72 were included in the meta-regression. While there was no change in control group weight, control groups receiving usual care lost 1 kg more than control groups that received no intervention, beyond measurement. Conclusions There are several possible explanations why control group changes occur in intervention trials targeting other behaviours, but not for weight loss. Control group participation may prevent weight gain, although more research is needed to confirm this hypothesis.

  17. Positive psychology interventions: A meta-analysis of randomized controlled studies

    NARCIS (Netherlands)

    Bolier, Linda; Haverman, M.; Westerhof, Gerben Johan; Riper, H.; Smit, F.; Bohlmeijer, Ernst Thomas

    2013-01-01

    Background The use of positive psychological interventions may be considered as a complementary strategy in mental health promotion and treatment. The present article constitutes a meta-analytical study of the effectiveness of positive psychology interventions for the general public and for

  18. Positive psychology interventions: a meta-analysis of randomized controlled studies

    NARCIS (Netherlands)

    Bolier, L.; Haverman, M.; Westerhof, G.J.; Riper, H.; Smit, H.F.E.; Bohlmeijer, E.

    2013-01-01

    Background: The use of positive psychological interventions may be considered as a complementary strategy in mental health promotion and treatment. The present article constitutes a meta-analytical study of the effectiveness of positive psychology interventions for the general public and for

  19. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

    Directory of Open Access Journals (Sweden)

    Xu Guifa

    2010-05-01

    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the

  20. Effect of a diet intervention during pregnancy on dietary behavior in the randomized controlled Norwegian Fit for Delivery study.

    Science.gov (United States)

    Hillesund, E R; Bere, E; Sagedal, L R; Vistad, I; Øverby, N C

    2016-10-01

    A mother's diet during pregnancy has the potential to influence both her own and her child's short- and long-term health. This paper reports the effects of a randomized controlled diet intervention during pregnancy on dietary behavior post-intervention as reported in late pregnancy. The diet intervention was part of a lifestyle intervention targeting both diet and physical activity behaviors among nulliparous women participating in the randomized controlled Norwegian Fit for Delivery study (NFFD). Eligible women were enrolled in early pregnancy from eight healthcare clinics in southern Norway between 2009 and 2013. The diet intervention was based on 10 dietary recommendations that were conveyed during two counseling sessions by phone and in a pamphlet describing the recommendations and their simplified rationale. A diet score was constructed from a 43-item food frequency questionnaire (FFQ) and used to assess intervention effect on dietary behavior (score range 0-10). Between-group dietary differences post-intervention were estimated with analysis of covariance, with adjustment for baseline diet. A total of 508 women completed the FFQ both at baseline and post-intervention. There were no between-group differences in diet score and subscales at baseline. Post-intervention, the intervention group had higher overall diet score (control: 4.61, intervention: 5.04, P=0.013) and favorable dietary behavior in seven of the 10 dietary domains: 'consumption of water relative to total beverage consumption' (P=0.002), 'having vegetables with dinner' (P=0.027), 'choosing fruits and vegetables for between-meal snacks' (P=0.023), 'buying small portion sizes of unhealthy foods' (P=0.010), 'limiting sugar intake' (P=0.005), 'avoiding eating beyond satiety' (P=0.009) and 'reading food labels' (P=0.011). The NFFD diet intervention improved dietary behavior. Potential long-term clinical influence in mother and child will be investigated in further studies.

  1. Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

    Science.gov (United States)

    Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

    2014-07-01

    Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

    Science.gov (United States)

    2013-01-01

    Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

  3. Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study.

    Science.gov (United States)

    Witvliet, Miranda; van Lier, Pol A C; Cuijpers, Pim; Koot, Hans M

    2009-10-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal classroom-based preventive intervention, or a control condition. Children's acceptance by peers, their number of mutual friends, and their proximity to others were assessed annually through peer ratings. Externalizing behavior was annually rated by teachers. Reductions in children's externalizing behavior and improvements in positive peer relations were found among GBG children, as compared with control-group children. Reductions in externalizing behavior appeared to be partly mediated by the improvements in peer acceptance. This mediating role of peer acceptance was found for boys only. The results suggest that positive peer relations are not just markers, but they are environmental mediators of boys' externalizing behavior development. Implications for research and prevention are discussed. (c) 2009 APA, all rights reserved.

  4. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study.

    Science.gov (United States)

    Gajecki, Mikael; Berman, Anne H; Sinadinovic, Kristina; Rosendahl, Ingvar; Andersson, Claes

    2014-07-02

    Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students. Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks. Among 28574 students offered participation, 4823 agreed to join; 415 were excluded due to incomplete data, and 1932 fulfilled eligibility criteria for randomization. Attrition was 22.7-39.3 percent, higher among heavier drinkers and highest in Group 2. Self-reported app use was higher in Group 1 (74%) compared to Group 2 (41%). Per-protocol analyses revealed only one significant time-by-group interaction, where Group 1 participants increased the frequency of their drinking occasions compared to controls (p = 0.001). Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week (p = 0.001), but not among women. Among all participants, 29 percent showed high-risk drinking, over the recommended weekly drinking levels of 9 (women) and 14 (men) standard glasses. Smartphone apps can make brief interventions available to large numbers of university students. The apps studied using eBAC calculation did not, however, seem to affect alcohol consumption among

  5. Perioperative Care and the Importance of Continuous Quality Improvement--A Controlled Intervention Study in Three Tanzanian Hospitals.

    Science.gov (United States)

    Bosse, Goetz; Abels, Wiltrud; Mtatifikolo, Ferdinand; Ngoli, Baltazar; Neuner, Bruno; Wernecke, Klaus-Dieter; Spies, Claudia

    2015-01-01

    Surgical services are increasingly seen to reduce death and disability in Sub-Saharan Africa, where hospital-based mortality remains alarmingly high. This study explores two implementation approaches to improve the quality of perioperative care in a Tanzanian hospital. Effects were compared to a control group of two other hospitals in the region without intervention. All hospitals conducted quality assessments with a Hospital Performance Assessment Tool. Changes in immediate outcome indicators after one and two years were compared to final outcome indicators such as Anaesthetic Complication Rate and Surgical Case Fatality Rate. Immediate outcome indicators for Preoperative Care in the intervention hospital improved (52.5% in 2009; 84.2% in 2011, pcontrol group, preoperative care declined from 50.8% (2009) to 32.8% (2011, p hospital declined (1.89% before intervention; 0.96% after intervention, p = 0.006). Surgical Case Fatality Rate in the intervention hospital declined from 5.67% before intervention to 2.93% after intervention (pcontrol group was 4% before intervention and 3.8% after intervention (p = 0.411). Anaesthetic Complication Rate in the control group was not available. Immediate outcome indicators initially improved, while at the same time final outcome declined (Surgical Case Fatality, Anaesthetic Complication Rate). Compared to the control group, final outcome improved more in the intervention hospital, although the effect was not significant over the whole study period. Documentation of final outcome indicators seemed inconsistent. Immediate outcome indicators seem more helpful to steer the Continuous Quality Improvement program. Specific interventions as part of Continuous Quality Improvement might lead to sustainable improvement of the quality of care, if embedded in a multi-faceted approach.

  6. Smoking cessation at the workplace. Results of a randomised controlled intervention study

    Science.gov (United States)

    Lang, T; Nicaud, V; Slama, K; Hirsch, A; Imbernon, E; Goldberg, M; Calvel, L; Desobry, P; Favre-Trosson, J; Lhopital, C; Mathevon, P; Miara, D; Miliani, A; Panthier, F; Pons, G; Roitg, C; Thoores, M; the, w

    2000-01-01

    OBJECTIVES—To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a "quit date" and extra support.
POPULATION—Employees of an electrical and gas company seen at the annual visit by their occupational physicians.
CRITERIA END POINTS—Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year. Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups.
METHODS—Randomised controlled trial. The unit of randomisation was the work site physician and a random sample of the employees of whom he or she was in charge. The length of the follow up was one year. Each of 30 work site physicians included in the study 100 to 150 employees.
RESULTS—Among 504 subjects classified as smokers at baseline receiving simple advice (group A) and 591 the more active programme (group B), 68 (13.5%) in group A and 109 (18.4%) were non-smokers one year later (p=0.03; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test). Twenty three subjects (4.6%) in group A and 36 (6.1%) in group B (p=0.26) declared abstinence of six months or more. Among non-smokers at baseline, 3.4% in both groups were smokers after one year follow up. The prevalence of smokers did not differ significantly at baseline (32.9% and 32.4%, p=0.75). After the intervention the prevalence of smoking was 30.8% in group A and 28.7% in group B (p=0.19). An increase of the mean symptoms score for depression in those who quit was observed during this period.
CONCLUSIONS—A simple cessation intervention strategy during a mandatory annual examination, targeting a population of smokers independently of their motivation to stop smoking or their health status, showed a 36% relative increase of the proportion of smokers who

  7. A randomized, controlled study of an online intervention to promote job satisfaction and well-being among physicians

    Directory of Open Access Journals (Sweden)

    Liselotte N. Dyrbye

    2016-09-01

    Full Text Available Although burnout, poor quality of life (QOL, depression, and other forms of psychological distress are common among physicians, few studies testing interventions to reduce distress have been reported. We conducted a randomized trial to determine the impact of a 10-week, individualized, online intervention on well-being among physicians (n = 290. Participants were randomized to either the intervention or control arm. Those in the intervention arm received a menu of self-directed micro-tasks once a week for 10 weeks, and were asked to select and complete one task weekly. Baseline and end-of-study questionnaires evaluating well-being (i.e., burnout, depression, QOL, fatigue and professional satisfaction (i.e., job satisfaction, work engagement, meaning in work, and satisfaction with work-life balance were administered to both arms. Overall quality of life and fatigue improved over the 10 weeks of the study for those in the intervention arm (both p < 0.01. When compared to the control arm, however, no statistically significant improvement in these dimensions of well-being was observed. At the completion of the study, those in the intervention arm were more likely to report participating in the study was worthwhile compared to those in the control arm. The findings suggest that although participants found the micro-tasks in the intervention arm worthwhile, they did not result in measurable improvements in well-being or professional satisfaction when compared to the control group. These results also highlight the critical importance of an appropriate control group in studies evaluating interventions to address physician burnout and distress.

  8. Yoga as a Therapeutic Intervention in the Management of Dysfunctional Uterine Bleeding: A Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Snehal Pankaj Nalgirkar

    2018-01-01

    Full Text Available Background: Dysfunctional uterine bleeding (DUB is one of the most common gynecological disorders encountered in women during the reproductive age. Yoga therapy has shown promising benefits in several gynecological disorders. Methods: Thirty women between the ages of 20 and 40 years with primary DUB were randomly assigned to a yoga (n = 15 and a waitlist control group (n = 15. Participants in the yoga group received a 3-month yoga module and were assessed for hemoglobin values, endometrial thickness (ET, pictorial blood loss assessment chart (PBAC, State-Trait Anxiety Inventory, perceived stress scale, and Pittsburgh Sleep Quality Index (PSQI before and after a 3-month follow-up period. Results: At the end of 3 months of intervention, the yoga group, unlike the control group, reported a significant reduction in the anxiety scores (P < 0.05 and perceived stress (P < 0.05. The PSQI scores indicated a reduction in sleep disturbances (P < 0.001 and the need for sleep medications (P < 0.01 and higher global scores (P < 0.001. However, there were no changes in PBAC and ET in both the groups. Conclusion: The results indicate that yoga therapy positively impacts the outcome of DUB by reducing the perceived stress and state anxiety and improving the quality of sleep. This warrants larger clinical trials to validate the findings of this pilot study.

  9. Promoting Active Transport in Older Adolescents Before They Obtain Their Driving Licence: A Matched Control Intervention Study.

    Science.gov (United States)

    Verhoeven, Hannah; Simons, Dorien; Van Cauwenberg, Jelle; Van Dyck, Delfien; Vandelanotte, Corneel; de Geus, Bas; De Bourdeaudhuij, Ilse; Clarys, Peter; Deforche, Benedicte

    2016-01-01

    Active transport has great potential to increase physical activity in older adolescents (17-18 years). Therefore, a theory- and evidence-based intervention was developed aiming to promote active transport among older adolescents. The intervention aimed to influence psychosocial factors of active transport since this is the first step in order to achieve a change in behaviour. The present study aimed to examine the effect of the intervention on the following psychosocial factors: intention to use active transport after obtaining a driving licence, perceived benefits, perceived barriers, subjective norm, self-efficacy, habit and awareness towards active transport. A matched control three-arm study was conducted and consisted of a pre-test post-test design with intervention and control schools in Flanders (northern part of Belgium). A lesson promoting active transport was implemented as the last lesson in the course 'Driving Licence at School' in intervention schools (intervention group 1). Individuals in intervention group 2 received this active transport lesson and, in addition, they were asked to become a member of a Facebook group on active transport. Individuals in the control group only attended the regular course 'Driving Licence at School'. Participants completed a questionnaire assessing socio-demographics and psychosocial variables at baseline, post (after one week) and follow-up (after eight weeks). To assess intervention effects, multilevel linear mixed models analyses were performed. A sample of 441 older adolescents (56.8% female; 17.4 (0.7) years) was analysed. For awareness regarding the existence of car sharing schemes, a significant increase in awareness from baseline to post measurement was found within intervention group 1 (p = 0.001) and intervention group 2 (p = 0.030) compared to the control group in which no change was found. In addition, a significant increase in awareness from baseline to follow-up measurement was found within intervention

  10. Promoting Active Transport in Older Adolescents Before They Obtain Their Driving Licence: A Matched Control Intervention Study.

    Directory of Open Access Journals (Sweden)

    Hannah Verhoeven

    Full Text Available Active transport has great potential to increase physical activity in older adolescents (17-18 years. Therefore, a theory- and evidence-based intervention was developed aiming to promote active transport among older adolescents. The intervention aimed to influence psychosocial factors of active transport since this is the first step in order to achieve a change in behaviour. The present study aimed to examine the effect of the intervention on the following psychosocial factors: intention to use active transport after obtaining a driving licence, perceived benefits, perceived barriers, subjective norm, self-efficacy, habit and awareness towards active transport.A matched control three-arm study was conducted and consisted of a pre-test post-test design with intervention and control schools in Flanders (northern part of Belgium. A lesson promoting active transport was implemented as the last lesson in the course 'Driving Licence at School' in intervention schools (intervention group 1. Individuals in intervention group 2 received this active transport lesson and, in addition, they were asked to become a member of a Facebook group on active transport. Individuals in the control group only attended the regular course 'Driving Licence at School'. Participants completed a questionnaire assessing socio-demographics and psychosocial variables at baseline, post (after one week and follow-up (after eight weeks. To assess intervention effects, multilevel linear mixed models analyses were performed.A sample of 441 older adolescents (56.8% female; 17.4 (0.7 years was analysed. For awareness regarding the existence of car sharing schemes, a significant increase in awareness from baseline to post measurement was found within intervention group 1 (p = 0.001 and intervention group 2 (p = 0.030 compared to the control group in which no change was found. In addition, a significant increase in awareness from baseline to follow-up measurement was found within

  11. Exploring Preschoolers' Engagement and Perceived Physical Competence in an Autonomy-Based Object Control Skill Intervention: A Preliminary Study

    Science.gov (United States)

    Logan, Samuel; Robinson, Leah; Webster, E. Kipling; Barber, Laura

    2013-01-01

    The purpose of this study was to describe children's engagement during two (high and low) autonomy-based climates. Twenty-five preschool children participated in a nine-week object control skill intervention. Children completed the object control subscale of the Test of Gross Motor Development 2nd Edition and the perceived physical competence…

  12. The study of patient controlled analgesia undergoing interventional therapy for gynecology and obstetrics ailment

    International Nuclear Information System (INIS)

    She Shouzhang

    2006-01-01

    Uterine artery embolism is widely used for interventional therapy of gynecology and obstetrics ailment, but immediate incidence of pain occurs in 90% to 100% after uterine artery embolism and postoperative incidence of pain takes place from 80% to 90%. Patient controlled epidural analgesia (PCEA) could be adopted to treat pain with obviously outweighed effects over the traditional drug regimen or patient intravenous analgesia during the period of interventional therapy of uterine artery embolization. PCEA possesses good effect of analgesia and less adverse reaction and furthermore could eliminate or lessen the sufferings of patient and thus improve rehabilitation quality. Adding droperidol (0.005%) into the preparation of PCEA could decrease adverse effect incidence of nausea and vomiting; so it deserves recommendation for extending application in clinical interventional therapy. (authors)

  13. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    Cleary, Cathy M; White, Katherine M; Young, Ross McD; Hawkes, Anna L; Leske, Stuart; Starfelt, Louise C; Wihardjo, Kylie

    2014-01-01

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  14. An internet-based intervention for people with psychosis (EviBaS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rüegg, Nina; Moritz, Steffen; Berger, Thomas; Lüdtke, Thies; Westermann, Stefan

    2018-04-13

    Evidence shows that internet-based self-help interventions are effective in reducing symptoms for a wide range of mental disorders. To date, online interventions treating psychotic disorders have been scarce, even though psychosis is among the most burdensome disorders worldwide. Furthermore, the implementation of cognitive-behavioral therapy (CBT) for psychosis in routine health care is challenging. Internet-based interventions could narrow this treatment gap. Thus, a comprehensive CBT-based online self-help intervention for people with psychosis has been developed. The aim of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting list control group. The intervention includes modules on delusion, voice hearing, social competence, mindfulness, and seven other domains. Participants are guided through the program by a personal moderator. Usage can be amended by an optional smartphone app. In this randomized controlled trial, participants are allocated to a waiting list or an intervention of eight weeks. Change in positive psychotic symptoms of both groups will be compared (primary outcome) and predictors of treatment effects will be assessed. To our knowledge, this project is one of the first large-scale investigations of an internet-based intervention for people with psychosis. It may thus be a further step to broaden treatment options for people suffering from this disorder. NCT02974400 (clinicaltrials.gov), date of registration: November 28th 2016.

  15. A Randomized Controlled Pilot Intervention Study of a Mindfulness-Based Self-Leadership Training (MBSLT) on Stress and Performance.

    Science.gov (United States)

    Sampl, Juliane; Maran, Thomas; Furtner, Marco R

    2017-01-01

    The present randomized pilot intervention study examines the effects of a mindfulness-based self-leadership training (MBSLT) specifically developed for academic achievement situations. Both mindfulness and self-leadership have a strong self-regulatory focus and are helpful in terms of stress resilience and performance enhancements. Based on several theoretical points of contact and a specific interplay between mindfulness and self-leadership, the authors developed an innovative intervention program that improves mood as well as performance in a real academic setting. The intervention was conducted as a randomized controlled study over 10 weeks. The purpose was to analyze the effects on perceived stress, test anxiety, academic self-efficacy, and the performance of students by comparing an intervention and control group ( n  = 109). Findings demonstrated significant effects on mindfulness, self-leadership, academic self-efficacy, and academic performance improvements in the intervention group. Results showed that the intervention group reached significantly better grade point averages than the control group. Moreover, the MBSLT over time led to a reduction of test anxiety in the intervention group compared to the control group. Furthermore, while participants of the control group showed an increase in stress over time, participants of the intervention group maintained constant stress levels over time. The combination of mindfulness and self-leadership addressed both positive effects on moods and on objective academic performance. The effects demonstrate the great potential of combining mindfulness with self-leadership to develop a healthy self-regulatory way of attaining achievement-related goals and succeeding in high-stress academic environments.

  16. SPACE for physical activity - a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kristensen Peter L

    2011-10-01

    Full Text Available Abstract Background The aim of the School site, Play Spot, Active transport, Club fitness and Environment (SPACE Study was to develop, document, and assess a comprehensive intervention in local school districts that promote everyday physical activity (PA among 11-15-year-old adolescents. The study is based on a social ecological framework, and is designed to implement organizational and structural changes in the physical environment. Methods/design The SPACE Study used a cluster randomized controlled study design. Twenty-one eligible schools in the Region of Southern Denmark were matched and randomized in seven pairs according to eight matching variables summarized in an audit tool (crow-fly distance from residence to school for 5-6th graders; area household income; area education level; area ethnicity distribution; school district urbanity; condition and characteristics of school outdoor areas; school health policy; and active transport in the local area. Baseline measurements with accelerometers, questionnaires, diaries, and physical fitness tests were obtained in Spring 2010 in 5-6th grade in 7 intervention and 7 control schools, with follow-up measurements to be taken in Spring 2012 in 7-8th grade. The primary outcome measure is objective average daily physical activity and will be supported by analyses of time spent in moderate to vigorous activity and time spent sedentary. Other secondary outcome measures will be obtained, such as, overweight, physical fitness, active commuting to/from school and physical activity in recess periods. Discussion A total of 1348 adolescents in 5-6th grade in the Region of Southern Denmark participated at baseline (n = 14 schools. The response rate was high in all type of measurements (72.6-97.4%. There were no significant differences between intervention and control groups at baseline according to selected background variables and outcome measures: gender (p = .54, age (p = .17, BMI (p = .59, waist

  17. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    Science.gov (United States)

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  18. Accuracy of self-reported intake of signature foods in a school meal intervention study: comparison between control and intervention period

    DEFF Research Database (Denmark)

    Biltoft-Jensen, Anja Pia; Damsgaard, Camilla Trab; Andersen, Rikke

    2015-01-01

    school meal study, 8- to 11-year-old children (n 834) were served the New Nordic Diet (NND) for lunch. The present study examined the accuracy of self-reported intake of signature foods (berries, cabbage, root vegetables, legumes, herbs, potatoes, wild plants, mushrooms, nuts and fish) characterising......Bias in self-reported dietary intake is important when evaluating the effect of dietary interventions, particularly for intervention foods. However, few have investigated this in children, and none have investigated the reporting accuracy of fish intake in children using biomarkers. In a Danish...... the NND. Children, assisted by parents, self-reported their diet in a Web-based Dietary Assessment Software for Children during the intervention and control (packed lunch) periods. The reported fish intake by children was compared with their ranking according to fasting whole-blood EPA and DHA...

  19. Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial.

    Science.gov (United States)

    Kandula, Namratha R; Dave, Swapna; De Chavez, Peter John; Bharucha, Himali; Patel, Yasin; Seguil, Paola; Kumar, Santosh; Baker, David W; Spring, Bonnie; Siddique, Juned

    2015-10-16

    South Asians (Asian Indians and Pakistanis) are the second fastest growing ethnic group in the United States (U.S.) and have an increased risk of atherosclerotic cardiovascular disease (ASCVD). This pilot study evaluated a culturally-salient, community-based healthy lifestyle intervention to reduce ASCVD risk among South Asians. Through an academic-community partnership, medically underserved South Asian immigrants at risk for ASCVD were randomized into the South Asian Heart Lifestyle Intervention (SAHELI) study. The intervention group attended 6 interactive group classes focused on increasing physical activity, healthful diet, weight, and stress management. They also received follow-up telephone support calls. The control group received translated print education materials about ASCVD and healthy behaviors. Primary outcomes were feasibility and initial efficacy, measured as change in moderate/vigorous physical activity and dietary saturated fat intake at 3- and 6-months. Secondary clinical and psychosocial outcomes were also measured. Participants' (n = 63) average age was 50 (SD = 8) years, 63 % were female, 27 % had less than or equal to a high school education, one-third were limited English proficient, and mean BMI was 30 kg/m2 (SD ± 5). There were no significant differences in change in physical activity or saturated fat intake between the intervention and control group. Compared to the control group, the intervention group showed significant weight loss (-1.5 kg, p-value = 0.04) and had a greater sex-adjusted decrease in hemoglobin A1C (-0.43 %, p-value culturally-salient, community-based lifestyle intervention was feasible for engaging medically underserved South Asian immigrants and more effective at addressing ASCVD risk factors than print health education materials. NCT01647438, Date of Trial Registration: July 19, 2012.

  20. A Technology-Mediated Behavioral Weight Gain Prevention Intervention for College Students: Controlled, Quasi-Experimental Study.

    Science.gov (United States)

    West, Delia Smith; Monroe, Courtney M; Turner-McGrievy, Gabrielle; Sundstrom, Beth; Larsen, Chelsea; Magradey, Karen; Wilcox, Sara; Brandt, Heather M

    2016-06-13

    Both men and women are vulnerable to weight gain during the college years, and this phenomenon is linked to an increased risk of several chronic diseases and mortality. Technology represents an attractive medium for the delivery of weight control interventions focused on college students, given its reach and appeal among this population. However, few technology-mediated weight gain prevention interventions have been evaluated for college students. This study examined a new technology-based, social media-facilitated weight gain prevention intervention for college students. Undergraduates (n =58) in two sections of a public university course were allocated to either a behavioral weight gain prevention intervention (Healthy Weight, HW; N=29) or a human papillomavirus (HPV) vaccination awareness intervention (control; N=29). All students were enrolled, regardless of initial body weight or expressed interest in weight management. The interventions delivered 8 lessons via electronic newsletters and Facebook postings over 9 weeks, which were designed to foster social support and introduce relevant educational content. The HW intervention targeted behavioral strategies to prevent weight gain and provided participants with a Wi-Fi-enabled scale and an electronic physical activity tracker to facilitate weight regulation. A repeated-measures analysis of variance was conducted to examine within- and between-group differences in measures of self-reported weight control practices and objectively measured weight. Use of each intervention medium and device was objectively tracked, and intervention satisfaction measures were obtained. Students remained weight stable (HW: -0.48+1.9 kg; control: -0.45+1.4 kg), with no significant difference between groups over 9 weeks (P =.94). However, HW students reported a significantly greater increase in the number of appropriate weight control strategies than did controls (2.1+4.5 vs -1.1+3.4, respectively; P =.003) and there was no increase in

  1. Parent-only Group Cognitive Behavioral Intervention for Children with Anxiety Disorders: A Control Group Study.

    Science.gov (United States)

    Salari, Elham; Shahrivar, Zahra; Mahmoudi-Gharaei, Javad; Shirazi, Elham; Sepasi, Mitra

    2018-04-01

    Parents play an important role in development and continuation of anxiety disorders in children. Yet the evidence on parent contribution in cognitive behavioral therapy (CBT) for childhood anxiety is limited. This open randomized trial examined the effectiveness of a parent-directed group CBT to manage children with anxiety disorders. Parents of 42 children aged 6-12 with primary anxiety disorders were allocated to a six, two-hour weekly intervention and a wait-list (WL) control. The Revised Children's Manifest Anxiety, Children's Depression Inventory, Strengths and Difficulties Questionnaire-Home Version, Depression-Anxiety-Stress Scale, Children Global Assessment Scale, and Global Relational Assessment of Functioning were used to assess children's and parents' functioning and emotional symptoms. Parents completed consumer satisfaction questionnaire. Parents in the CBT group reported significant improvement in their depressive symptoms (p=0.006) and the family functioning (p=0.04), as well as reduction in children's emotional symptoms (p=0.007). Clinician rating of children's functioning showed significant improvement in the CBT group(p=0.001). There was no significant difference in children rating of their anxiety within groups from pre- to post-intervention. Parents were satisfied mostly with the intervention. A brief parent-only CBT based intervention can be effective in the management of childhood anxiety.

  2. Effectiveness of a Randomized Controlled Lifestyle Intervention to Prevent Obesity among Chinese Primary School Students: CLICK-Obesity Study.

    Directory of Open Access Journals (Sweden)

    Fei Xu

    Full Text Available Childhood obesity has been increasing rapidly worldwide. There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide, especially in developing countries like China. The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program (the CLICK-Obesity study in Mainland China.A cluster randomized controlled trial was developed among grade 4 students from 8 urban primary schools (638 students in intervention, 544 as control in Nanjing City, China. Students were randomly allocated to the control or intervention group at school-level. A one-year multi-component intervention program (classroom curriculum, school environment support, family involvement and fun programs/events together with routine health education was provided to the intervention group, while the control group received routine health education only. The main outcome variables assessed were changes in body mass index, obesity occurrence, obesity-related lifestyle behaviors and knowledge.Overall, 1108 (93.7% of the 1182 enrolled students completed the intervention study. The intervention group had a larger marginal reduction than did the control group in overall mean BMI value (-0.32±1.36 vs. -0.29±1.40, p = 0.09, although this was not significant. Compared with the control group, the intervention group was more likely to decrease their BMI (OR = 1.44, 95%CI = 1.10, 1.87 by 0.5 kg/m2 or above, increase the frequency of jogging/running (OR = 1.55, 95%CI = 1.18, 2.02, decrease the frequency of TV/computer use (OR = 1.41, 95%CI = 1.09, 1.84 and of red meat consumption (OR = 1.50, 95%CI = 1.15, 1.95, change commuting mode to/from school from sedentary to active mode (OR = 2.24, 95%CI = 1.47, 3.40, and be aware of the harm of selected obesity risk factors.The school-based lifestyle intervention program was practical and effective in improving health behaviors and obesity

  3. MOVING: Motivation-Oriented interVention study for the elderly IN Greifswald: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kleinke, Fabian; Schwaneberg, Thea; Weymar, Franziska; Penndorf, Peter; Ulbricht, Sabina; Lehnert, Kristin; Dörr, Marcus; Hoffmann, Wolfgang; van den Berg, Neeltje

    2018-01-22

    Cardiovascular diseases (CVD) are the leading cause of mortality. In 2014, they were responsible for 38.9% of all causes of death in Germany. One major risk factor for CVD is a lack of physical activity (PA). A health-promoting lifestyle including regular PA and minimizing sitting time (ST) in daily life is a central preventive measure. Previous studies have shown that PA decreases in older age; 2.4-29% of the people aged over 60 years achieve the World Health Organization recommendations. This age group spends on average 9.4 h per day in sedentary activities. To increase PA and decrease ST, a low-threshold intervention, consisting of individualized feedback letters based on objectively measured data of PA and ST, was developed. The research question is: Do individual feedback letters, based on accelerometer data, have a positive effect on PA and ST? MOVING is a two-arm, randomized controlled trial. Inclusion criteria are age ≥ 65 years and the ability to be physically active. Exclusion criteria are the permanent use of a wheelchair and simultaneous participation in another study on PA. At baseline participants who give informed consent will receive general information and recommendations about the positive effects of regular PA and less ST. Participants of both groups will receive an accelerometer device, which records PA and ST over a period of seven consecutive days following by a randomization. Participants in the intervention group will receive automatically generated, individualized feedback letters by mail based on their PA and ST at baseline and at 3-month follow-up. Further follow-up examinations will be carried out at 6 and 12 months. The primary outcome is the increase of PA and the reduction of ST after 6 months in the intervention group compared to the control group. The goal of the study is to examine the effects of a simple feedback intervention on PA and ST in elderly people. We aim to achieve an effect of 20% increase in moderate

  4. Identification of biomarkers for intake of protein from meat, dairy products and grains: A controlled dietary intervention study

    NARCIS (Netherlands)

    Altorf-van der Kuil, W.; Brink, E.J.; Boetje, M.; Siebelink, E.; Bijlsma, S.; Engberink, M.F.; Veer, P.V.'.; Tomé, D.; Bakker, S.J.L.; Baak, M.A. van; Geleijnse, J.M.

    2013-01-01

    In the present controlled, randomised, multiple cross-over dietary intervention study, we aimed to identify potential biomarkers for dietary protein from dairy products, meat and grain, which could be useful to estimate intake of these protein types in epidemiological studies. After 9 d run-in,

  5. Identification of biomarkers for intake of protein from meat, dairy products and grains : a controlled dietary intervention study

    NARCIS (Netherlands)

    Altorf-van der Kuil, Wieke; Brink, Elizabeth J.; Boetje, Martine; Siebelink, Els; Bijlsma, Sabina; Engberink, Marielle F.; van 't Veer, Pieter; Tome, Daniel; Bakker, Stephan J. L.; van Baak, Marleen A.; Geleijnse, Johanna M.

    2013-01-01

    In the present controlled, randomised, multiple cross-over dietary intervention study, we aimed to identify potential biomarkers for dietary protein from dairy products, meat and grain, which could be useful to estimate intake of these protein types in epidemiological studies. After 9 d run-in,

  6. Comparative Effectiveness of Three Occupational Therapy Sleep Interventions: A Randomized Controlled Study.

    Science.gov (United States)

    Gutman, Sharon A; Gregory, Kristin A; Sadlier-Brown, Megan M; Schlissel, Marcy A; Schubert, Allison M; Westover, Lee Ann; Miller, Richard C

    2017-01-01

    Although sleep intervention is within the domain of occupational therapy, few studies exist supporting practice. Effectiveness of three sleep interventions was compared: Dreampad Pillow®, iRest® meditation, and sleep hygiene. Twenty-nine participants were randomly assigned to the Dreampad Pillow® ( n = 10), iRest® meditation ( n = 9), and sleep hygiene ( n = 10) groups. In Phase 1, all participants used a 7-day sleep hygiene regimen to reduce poor sleep habits. In Phase 2 (14 days), 10 participants used the Dreampad Pillow® and sleep hygiene, nine used the iRest meditation and sleep hygiene, and 10 continued sleep hygiene only. At intervention-end, the iRest meditation group experienced statistically greater time asleep than both the Dreampad Pillow® ( p meditation ( p occupational therapy's domain.

  7. A Controlled Study of an HIV/AIDS/STI/TB Intervention with Faith ...

    African Journals Online (AJOL)

    The aim of the study was to develop an HIV and AIDS training manual, and to evaluate the knowledge, attitudes and management of faith healers of Apostolic churches regarding HIV and AIDS, before and after they attended an HIV and AIDS training programme. A quasi-experimental intervention design was used with faith ...

  8. Paediatric Early Warning Score - A multi-center randomized controlled intervention study

    DEFF Research Database (Denmark)

    Jensen, Claus Sixtus; Aagaard, Hanne; Olesen, Hanne Vebert

    Paediatric Early Warning System on evolving critical illness and intervention in hospitalised children; a regional multicentre study on implementation of a Paediatric Early Warning System Background: Critical illness in the patient and death can potentially be predicted and prevented. Deterioration...... is critically ill are related to the child’s symptoms of serious illness often being uncharacteristic. Children can seem relatively unaffected until a short time before circulatory insufficiency and cardiac arrest. Thus, there is a need for developing and investigating if an Paediatric Early Warning System...... of the intervention and evaluation. The study involves all paediatric departments and some acute departments in Central Denmark Region. The project both includes quantitative studies and a qualitative evaluation study. The studies will have different designs: • Registry study - exploring and describing life...

  9. Use of prophylactic Saccharomyces boulardii to prevent Clostridium difficile infection in hospitalized patients: a controlled prospective intervention study.

    Science.gov (United States)

    Carstensen, Jeppe West; Chehri, Mahtab; Schønning, Kristian; Rasmussen, Steen Christian; Anhøj, Jacob; Godtfredsen, Nina Skavlan; Andersen, Christian Østergaard; Petersen, Andreas Munk

    2018-05-03

    Clostridium difficile infection (CDI) is a common complication to antibiotic use. Saccharomyces boulardii has shown effect as a prophylactic agent. We aimed to evaluate the efficacy of S. boulardii in preventing CDI in unselected hospitalized patients treated with antibiotics. We conducted a 1 year controlled prospective intervention study aiming to prescribe Sacchaflor (S. boulardii 5 × 10 9 , Pharmaforce ApS) twice daily to hospitalized patients treated with antibiotics. Comparable departments from three other hospitals in our region were included as controls. All occurrences of CDI in patients receiving antibiotics were reported and compared to a baseline period defined as 2 years prior to intervention. Results were analyzed using run chart tests for non-random variation in CDI rates. In addition, odds ratios for CDI were calculated. S. boulardii compliance reached 44% at the intervention hospital, and 1389 patients were treated with Sacchaflor. Monthly CDI rates dropped from a median of 3.6% in the baseline period to 1.5% in the intervention period. S. boulardii treatment was associated with a reduced risk of CDI at the intervention hospital: OR = 0.06 (95% CI 0.02-0.16). At two control hospitals, CDI rates did not change. At one control hospital, the median CDI rate dropped from 3.5 to 2.4%, possibly reflecting the effects of simultaneous multifaceted intervention against CDI at that hospital. The results from this controlled prospective interventional study indicate that S. boulardii is effective for the prevention of CDI in an unselected cohort of mainly elderly patients from departments of internal medicine.

  10. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G

    2012-01-01

    bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design...... characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes....

  11. Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Bell, Imogen H; Fielding-Smith, Sarah F; Hayward, Mark; Rossell, Susan L; Lim, Michelle H; Farhall, John; Thomas, Neil

    2018-05-02

    Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

  12. The MOVE study: a study protocol for a randomised controlled trial assessing interventions to maximise attendance at physical activity facilities.

    Science.gov (United States)

    Newton, Joshua D; Klein, Ruth; Bauman, Adrian; Newton, Fiona J; Mahal, Ajay; Gilbert, Kara; Piterman, Leon; Ewing, Michael T; Donovan, Robert J; Smith, Ben J

    2015-04-18

    Physical activity is associated with a host of health benefits, yet many individuals do not perform sufficient physical activity to realise these benefits. One approach to rectifying this situation is through modifying the built environment to make it more conducive to physical activity, such as by building walking tracks or recreational physical activity facilities. Often, however, modifications to the built environment are not connected to efforts aimed at encouraging their use. The purpose of the Monitoring and Observing the Value of Exercise (MOVE) study is to evaluate the effectiveness of two interventions designed to encourage the ongoing use of a new, multi-purpose, community-based physical activity facility. A two-year, randomised controlled trial with yearly survey points (baseline, 12 months follow-up, 24 months follow-up) will be conducted among 1,300 physically inactive adult participants aged 18-70 years. Participants will be randomly assigned to one of three groups: control, intervention 1 (attendance incentives), or intervention 2 (attendance incentives and tailored support following a model based on customer relationship management). Primary outcome measures will include facility usage, physical activity participation, mental and physical wellbeing, community connectedness, social capital, friendship, and social support. Secondary outcome measures will include stages of change for facility usage and social cognitive decision-making variables. This study will assess whether customer relationship management systems, a tool commonly used in commercial marketing settings, can encourage the ongoing use of a physical activity facility. Findings may also indicate the population segments among which the use of such systems are most effective, as well as their cost-effectiveness. Australian New Zealand Clinical Trials Registry: ACTRN12615000012572 (registered 9 January 2015).

  13. The impact of a microsavings intervention on reducing violence against women engaged in sex work: a randomized controlled study.

    Science.gov (United States)

    Tsai, Laura Cordisco; Carlson, Catherine E; Aira, Toivgoo; Norcini Pala, Andrea; Riedel, Marion; Witte, Susan S

    2016-10-28

    Women who engage in sex work are at risk for experiencing violence from numerous perpetrators, including paying partners. Empirical evidence has shown mixed results regarding the impact of participation in microfinance interventions on women's experiences of violence, with some studies demonstrating reductions in intimate partner violence (IPV) and others showing heightened risk for IPV. The current study reports on the impact of participation in a microsavings intervention on experiences of paying partner violence among women engaged in sex work in Mongolia. Between 2011 and 2013, we conducted a two-arm, non-blinded randomized controlled trial (RCT) comparing an HIV/STI risk reduction intervention (HIVSRR) (control condition) to a combined microsavings and HIVSRR intervention (treatment condition). Eligible women (aged 18 or older, reported having engaged in unprotected sex with paying partner in past 90 days, expressed interest in microsavings intervention) were invited to participate. One hundred seven were randomized, including 50 in the control and 57 in the treatment condition. Participants completed assessments at baseline, immediate post-test following HIVSRR, and at 3-months and 6-months after completion of the treatment group intervention. Outcomes for the current study include any violence (physical and/or sexual), sexual violence, and physical violence from paying partners in the past 90 days. An intention-to-treat approach was utilized. Linear growth models revealed significant reductions over time in both conditions for any violence (β = -0.867, p participation did not significantly impact women's risk for paying partner violence. Qualitative research is recommended to understand the cause for reductions in paying partner violence in both study conditions. Evaluating a Microfinance Intervention for High Risk Women in Mongolia; NCT01861431 ; May 20, 2013.

  14. Effect of individualized worksite exercise training on aerobic capacity and muscle strength among construction workers - a randomized controlled intervention study

    DEFF Research Database (Denmark)

    Gram, Bibi; Holtermann, Andreas; Søgaard, Karen

    2012-01-01

    OBJECTIVES: The combination of high physical work demands and low physical capacity has been shown to increase the risk for cardiovascular disease and musculoskeletal disorders. The aim of this study was to assess the physical capacity of construction workers and evaluate the effect of individually...... tailored exercise programs on their physical fitness and muscular capacity. METHOD: The study was a randomized controlled trial of male constructions workers allocated to either an exercise or control group. The intervention lasted 12 weeks, and the exercise group trained 3 x 20 minutes a week....... The participants completed health checks before and after the intervention period. Data from the first health check were used to tailor the exercise in the interventions. RESULTS: At baseline, participants had maximal oxygen consumption (VO (2max)) of 2.9 [standard deviation (SD) 0.7L/min] and body mass index (BMI...

  15. Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies

    DEFF Research Database (Denmark)

    Souverein, Olga W; de Vries, Jeanne H M; Freese, Riitta

    2015-01-01

    concentrations. Furthermore, a prediction model of fruit and vegetable intake based on these biomarkers and subject characteristics (i.e. age, sex, BMI and smoking status) was established. Data from twelve diet-controlled intervention studies were obtained to develop a prediction model for fruit and vegetable...

  16. Effects of a continuum of care intervention on frail older persons' life satisfaction: a randomized controlled study.

    Science.gov (United States)

    Berglund, Helene; Hasson, Henna; Kjellgren, Karin; Wilhelmson, Katarina

    2015-04-01

    The aim of this study was to analyse effects of a comprehensive continuum of care (intervention group) on frail older persons' life satisfaction, as compared to those receiving usual care (control group). The intervention included geriatric assessment, case management, interprofessional collaboration, support for relatives and organising of care-planning meetings in older persons' own homes. Improvements in older persons' subjective well-being have been shown in studies including care planning and coordination by a case manager. However, effects of more complex continuum of care interventions on frail older persons' life satisfaction are not well explored. Randomised controlled study. The validated LiSat-11 scale was used in face-to-face interviews to assess older persons' life satisfaction at baseline and at three, six and 12 months after the baseline. The odds ratio for improving or maintaining satisfaction was compared for intervention and control groups from baseline to three-month, three- to six-month as well as six- to 12-month follow-ups. Older persons who received the intervention were more likely to improve or maintain satisfaction than those who received usual care, between 6 and 12 month follow-ups, for satisfaction regarding functional capacity, psychological health and financial situation. A comprehensive continuum of care intervention comprising several components had a positive effect on frail older persons' satisfaction with functional capacity, psychological health and financial situation. Frail older persons represent a great proportion of the persons in need of support from the health care system. Health care professionals need to consider continuum of care interventions' impact on life satisfaction. As life satisfaction is an essential part of older persons' well-being, we propose that policy makers and managers promote comprehensive continuum of care solutions. © 2014 John Wiley & Sons Ltd.

  17. Community mobilization and household level waste management for dengue vector control in Gampaha district of Sri Lanka; an intervention study.

    Science.gov (United States)

    Abeyewickreme, W; Wickremasinghe, A R; Karunatilake, K; Sommerfeld, J; Axel, Kroeger

    2012-12-01

    Waste management through community mobilization to reduce breeding places at household level could be an effective and sustainable dengue vector control strategy in areas where vector breeding takes place in small discarded water containers. The objective of this study was to assess the validity of this assumption. An intervention study was conducted from February 2009 to February 2010 in the populous Gampaha District of Sri Lanka. Eight neighborhoods (clusters) with roughly 200 houses each were selected randomly from high and low dengue endemic areas; 4 of them were allocated to the intervention arm (2 in the high and 2 in the low endemicity areas) and in the same way 4 clusters to the control arm. A baseline household survey was conducted and entomological and sociological surveys were carried out simultaneously at baseline, at 3 months, at 9 months and at 15 months after the start of the intervention. The intervention programme in the treatment clusters consisted of building partnerships of local stakeholders, waste management at household level, the promotion of composting biodegradable household waste, raising awareness on the importance of solid waste management in dengue control and improving garbage collection with the assistance of local government authorities. The intervention and control clusters were very similar and there were no significant differences in pupal and larval indices of Aedes mosquitoes. The establishment of partnerships among local authorities was well accepted and sustainable; the involvement of communities and households was successful. Waste management with the elimination of the most productive water container types (bowls, tins, bottles) led to a significant reduction of pupal indices as a proxy for adult vector densities. The coordination of local authorities along with increased household responsibility for targeted vector interventions (in our case solid waste management due to the type of preferred vector breeding places) is

  18. Nutrition impact symptoms in advanced cancer patients: frequency and specific interventions, a case?control study

    OpenAIRE

    Omlin, Aurelius; Blum, David; Wierecky, Jan; Haile, Sarah R.; Ottery, Faith D.; Strasser, Florian

    2013-01-01

    Background Involuntary weight loss (IWL) is frequent in advanced cancer patients causing compromised anticancer treatment outcomes and function. Cancer cachexia is influenced by nutrition impact symptoms (NIS). The aim of this study was to explore the frequency of NIS in advanced patients and to assess specific interventions guided by a 12-item NIS checklist. Methods Consecutive patients from an outpatient nutrition-fatigue clinic completed the NIS checklist. The NIS checklist was developed b...

  19. A comprehensive intervention following the clinical pathway of eating and swallowing disorder in the elderly with dementia: historically controlled study.

    Science.gov (United States)

    Arahata, Masahisa; Oura, Makoto; Tomiyama, Yuka; Morikawa, Naoe; Fujii, Hatsue; Minani, Shinji; Shimizu, Yukihiro

    2017-07-14

    Eating problems in patients with advanced dementia are strongly associated with their deteriorating survival. Food and drink intake in people with dementia may be supported by specific interventions, but the effectiveness of such interventions is backed by almost no evidence. However, comprehensive geriatric assessment (CGA) might potentially clarify the etiology of decreased oral intake in people with dementia; thus improving their clinical outcomes. This study was a single-arm, non-randomized trial that included historically controlled patients for comparison. We defined elderly patients with both severely decreased oral intake depending on artificial hydration and/or nutrition (AHN) and dementia as "Eating and Swallowing Disorder of the Elderly with Dementia (ESDED)". In the intervention group, participants received CGA through the original clinical pathway with multidisciplinary interventions. This was followed by individualized therapeutic interventions according to assessment of the etiology of their eating problems. During the intervention period (between 1st April 2013 and 31st March 2015), 102 cases of ESDED were enrolled in the study and 90 patients had completed receiving CGA. Conversely, 124 ESDED patient controls were selected from the same hospital enrolled during the historical period (between 1st April 2011 and 31st March 2012). Most participants in both groups were bedridden with severe cognitive impairment. For the intervention group, an average of 4.3 interventional strategies was recommended per participant after CGA. Serological tests, diagnostic imaging and other diagnostic examinations were much more frequently performed in the intervention group. Recovery rate from ESDED in the intervention group was significantly higher than that in the historical group (51% v.s. 34%, respectively, P = 0.02). The 1-year AHN-free survival in the intervention group was significantly higher than that in the historical group (28% v.s. 15%, respectively, P

  20. Effects of Combining a Brief Cognitive Intervention with Transcranial Direct Current Stimulation on Pain Tolerance: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Powers, Abigail; Madan, Alok; Hilbert, Megan; Reeves, Scott T; George, Mark; Nash, Michael R; Borckardt, Jeffrey J

    2018-04-01

    Cognitive behavioral therapy has been shown to be effective for treating chronic pain, and a growing literature shows the potential analgesic effects of minimally invasive brain stimulation. However, few studies have systematically investigated the potential benefits associated with combining approaches. The goal of this pilot laboratory study was to investigate the combination of a brief cognitive restructuring intervention and transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in affecting pain tolerance. Randomized, double-blind, placebo-controlled laboratory pilot. Medical University of South Carolina. A total of 79 healthy adult volunteers. Subjects were randomized into one of six groups: 1) anodal tDCS plus a brief cognitive intervention (BCI); 2) anodal tDCS plus pain education; 3) cathodal tDCS plus BCI; 4) cathodal tDCS plus pain education; 5) sham tDCS plus BCI; and 6) sham tDCS plus pain education. Participants underwent thermal pain tolerance testing pre- and postintervention using the Method of Limits. A significant main effect for time (pre-post intervention) was found, as well as for baseline thermal pain tolerance (covariate) in the model. A significant time × group interaction effect was found on thermal pain tolerance. Each of the five groups that received at least one active intervention outperformed the group receiving sham tDCS and pain education only (i.e., control group), with the exception of the anodal tDCS + education-only group. Cathodal tDCS combined with the BCI produced the largest analgesic effect. Combining cathodal tDCS with BCI yielded the largest analgesic effect of all the conditions tested. Future research might find stronger interactive effects of combined tDCS and a cognitive intervention with larger doses of each intervention. Because this controlled laboratory pilot employed an acute pain analogue and the cognitive intervention did not authentically represent cognitive behavioral

  1. Evaluation of support group interventions for children in troubled families: study protocol for a quasi-experimental control group study.

    Science.gov (United States)

    Skerfving, Annemi; Johansson, Fredrik; Elgán, Tobias H

    2014-01-24

    Support groups for children in troubled families are available in a majority of Swedish municipalities. They are used as a preventive effort for children in families with different parental problems such as addiction to alcohol/other drugs, mental illness, domestic violence, divorce situations, or even imprisonment. Children from families with these problems are a well-known at-risk group for various mental health and social problems. Support groups aim at strengthening children's coping behaviour, to improve their mental health and to prevent a negative psycho-social development. To date, evaluations using a control-group study design are scarce. The aim of the current study is to evaluate the effects of support groups. This paper describes the design of an effectiveness study, initially intended as a randomized controlled trial, but instead is pursued as a quasi-experimental study using a non-randomized control group. The aim is to include 116 children, aged 7-13 years and one parent/another closely related adult, in the study. Participants are recruited via existing support groups in the Stockholm county district and are allocated either into an intervention group or a waiting list control group, representing care as usual. The assessment consists of questionnaires that are to be filled in at baseline and at four months following the baseline. Additionally, the intervention group completes a 12-month follow-up. The outcomes include the Strength and Difficulties Questionnaire (SDQ S11-16), the Kids Coping Scale, the "Ladder of life" which measures overall life satisfaction, and "Jag tycker jag är" (I think I am) which measures self-perception and self-esteem. The parents complete the SDQ P4-16 (parent-report version) and the Swedish scale "Familjeklimat" (Family Climate), which measures the emotional climate in the family. There is a need for evaluating the effects of support groups targeted to children from troubled families. This quasi-experimental study

  2. Effectiveness of interventions for hypertension care in the community – a meta-analysis of controlled studies in China

    Directory of Open Access Journals (Sweden)

    Lu Zuxun

    2012-07-01

    Full Text Available Abstract Background Hypertension is a serious public health problem in China and in other developing countries. Our aim is to conduct a systematic review of studies on the effectiveness of community interventions for hypertension management in China. Methods China National Knowledge Infrastructure, PubMed, and references of retrieved articles were searched to identify randomised or quasi-randomised controlled studies that evaluated community hypertension care in mainland China. One reviewer extracted and a second reviewer checked data from the included studies. Results We included 94 studies, 93 of which were in Chinese language, that evaluated the following interventions: health education, improved monitoring, family-support, self-management, healthcare management changes and training of providers. The study quality was generally poor, with high risk of biased outcome reporting and significant heterogeneity between studies. When reported, the vast majority of the included studies reported statistically significantly improved outcomes in the intervention group. By assuming zero treatment effects for missing outcomes, the weighted reduction in the intervention group was 6∙9 (95% CI: 4∙9 to 8∙9 mm Hg for systolic BP, and 3∙8 (95% CI: 2∙6 to 5∙0 mm Hg for diastolic BP. Exploratory subgroup analyses found no significant differences between different interventions. Conclusions After taking account of possible reporting biases, a wide range of community interventions for hypertension care remain effective. The findings have implications for China and other low and middle income countries facing similar challenges. Because of significant heterogeneity and high risk of bias in the available studies, further well designed studies should be conducted in China to provide high quality evidence to inform policy decisions on hypertension control.

  3. A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

    Science.gov (United States)

    Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

    2014-03-01

    India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

  4. Patients' communication with doctors: a randomized control study of a brief patient communication intervention.

    Science.gov (United States)

    Talen, Mary R; Muller-Held, Christine F; Eshleman, Kate Grampp; Stephens, Lorraine

    2011-09-01

    In research on doctor-patient communication, the patient role in the communication process has received little attention. The dynamic interactions of shared decision making and partnership styles which involve active patient communication are becoming a growing area of focus in doctor-patient communication. However, patients rarely know what makes "good communication" with medical providers and even fewer have received coaching in this type of communication. In this study, 180 patients were randomly assigned to either an intervention group using a written communication tool to facilitate doctor-patient communication or to standard care. The goal of this intervention was to assist patients in becoming more effective communicators with their physicians. The physicians and patients both rated the quality of the communication after the office visit based on the patients' knowledge of their health concerns, organizational skills and questions, and attitudes of ownership and partnership. The results supported that patients in the intervention group had significantly better communication with their doctors than patients in the standard care condition. Physicians also rated patients who were in the intervention group as having better overall communication and organizational skills, and a more positive attitude during the office visit. This study supports that helping patients structure their communication using a written format can facilitate doctor-patient communication. Patients can become more adept at describing their health concerns, organizing their needs and questions, and being proactive, which can have a positive effect on the quality of the doctor-patient communication during outpatient office visits. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

  5. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Tsai Midi

    2011-06-01

    Full Text Available Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33% do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention or control (no change. At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI and standardized body mass index (zBMI. Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous, Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight

  6. A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study.

    Science.gov (United States)

    Wong, Connie S

    2013-05-01

    The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.

  7. Assessing handwriting intervention effectiveness in elementary school students: a two-group controlled study.

    Science.gov (United States)

    Howe, Tsu-Hsin; Roston, Karen Laurie; Sheu, Ching-Fan; Hinojosa, Jim

    2013-01-01

    This study examined the effectiveness of two approaches used in elementary schools to improve children's handwriting. Participants were 72 New York City public school students from the first and second grades. A nonequivalent pretest-posttest group design was used in which students engaged in handwriting activities using two approaches: intensive handwriting practice and visual-perceptual-motor activities. Handwriting speed, legibility, and visual-motor skills were examined after a 12-wk Handwriting Club using multivariate analysis of variance. The results showed that students in the intensive handwriting practice group demonstrated significant improvements in handwriting legibility compared with students in the visual-perceptual-motor activity group. No significant effects in handwriting speed and visual-motor skills were found between the students in intensive handwriting practice group and the students in visual-perceptual-motor activities group. The Handwriting Club model is a natural intervention that fits easily into existing school curriculums and can be an effective short-term intervention (response to intervention Tier II). Copyright © 2013 by the American Occupational Therapy Association, Inc.

  8. A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol.

    Science.gov (United States)

    Ramsauer, Brigitte; Lotzin, Annett; Mühlhan, Christine; Romer, Georg; Nolte, Tobias; Fonagy, Peter; Powell, Bert

    2014-01-30

    Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention

  9. Perioperative Care and the Importance of Continuous Quality Improvement—A Controlled Intervention Study in Three Tanzanian Hospitals

    Science.gov (United States)

    Mtatifikolo, Ferdinand; Ngoli, Baltazar; Neuner, Bruno; Wernecke, Klaus–Dieter; Spies, Claudia

    2015-01-01

    Introduction Surgical services are increasingly seen to reduce death and disability in Sub-Saharan Africa, where hospital-based mortality remains alarmingly high. This study explores two implementation approaches to improve the quality of perioperative care in a Tanzanian hospital. Effects were compared to a control group of two other hospitals in the region without intervention. Methods All hospitals conducted quality assessments with a Hospital Performance Assessment Tool. Changes in immediate outcome indicators after one and two years were compared to final outcome indicators such as Anaesthetic Complication Rate and Surgical Case Fatality Rate. Results Immediate outcome indicators for Preoperative Care in the intervention hospital improved (52.5% in 2009; 84.2% in 2011, pimproved to then decline again (63.3% in 2009; 70% in 2010; 58.6% in 2011). In the control group, preoperative care declined from 50.8% (2009) to 32.8% (2011, p improved, while at the same time final outcome declined (Surgical Case Fatality, Anaesthetic Complication Rate). Compared to the control group, final outcome improved more in the intervention hospital, although the effect was not significant over the whole study period. Documentation of final outcome indicators seemed inconsistent. Immediate outcome indicators seem more helpful to steer the Continuous Quality Improvement program. Conclusion Specific interventions as part of Continuous Quality Improvement might lead to sustainable improvement of the quality of care, if embedded in a multi-faceted approach. PMID:26327392

  10. Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study.

    Science.gov (United States)

    Grossert, Astrid; Urech, Corinne; Alder, Judith; Gaab, Jens; Berger, Thomas; Hess, Viviane

    2016-11-03

    Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients. In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program. New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often

  11. Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Thomas, Kristin; Bendtsen, Marcus; Linderoth, Catharina; Karlsson, Nadine; Bendtsen, Preben; Müssener, Ulrika

    2017-04-04

    Despite significant health risks, heavy drinking of alcohol among university students is a widespread problem; excessive drinking is part of the social norm. A growing number of studies indicate that short message service (SMS)-based interventions are cost-effective, accessible, require limited effort by users, and can enable continuous, real-time, brief support in real-world settings. Although there is emerging evidence for the effect of SMS-based interventions in reducing alcohol consumption, more research is needed. This study aims to test the effectiveness of a newly developed SMS-based intervention targeting excessive alcohol consumption among university and college students in Sweden. The study is a two-arm randomized controlled trial with an intervention (SMS programme) and a control (treatment as usual) group. Outcome measures will be investigated at baseline and at 3-month follow up. The primary outcome is total weekly alcohol consumption. Secondary outcomes are frequency of heavy episodic drinking, highest estimated blood alcohol concentration and number of negative consequences due to excessive drinking. This study contributes knowledge on the effect of automatized SMS support to reduce excessive drinking among students compared with existing support such as Student Health Centres. ISRCTN.com, ISRCTN95054707 . Registered on 31 August 2016.

  12. Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar.

    Science.gov (United States)

    Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

    2012-12-01

    To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description: The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Pupae per person index (PPI) decreased at the last evaluation by 5·7% (0·35-0·33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63·6% (0·33-0·12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18·6% in evaluation 2 and 44·1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment.

  13. The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rodrigues, Marcela Perdomo; Dos Santos, Luciana Kaercher John; Fuchs, Flavio Danni; Fuchs, Sandra Costa; Moreira, Leila Beltrami

    2017-07-21

    The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control. Clinical

  14. “Active Team” a social and gamified app-based physical activity intervention: randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Sarah Edney

    2017-11-01

    Full Text Available Abstract Background Physical inactivity is a leading preventable cause of chronic disease and premature death globally, yet over half of the adult Australian population is inactive. To address this, web-based physical activity interventions, which have the potential to reach large numbers of users at low costs, have received considerable attention. To fully realise the potential of such interventions, there is a need to further increase their appeal to boost engagement and retention, and sustain intervention effects over longer periods of time. This randomised controlled trial aims to evaluate the efficacy of a gamified physical activity intervention that connects users to each other via Facebook and is delivered via a mobile app. Methods The study is a three-group, cluster-RCT. Four hundred and forty (440 inactive Australian adults who use Facebook at least weekly will be recruited in clusters of three to eight existing Facebook friends. Participant clusters will be randomly allocated to one of three conditions: (1 waitlist control condition, (2 basic experimental condition (pedometer plus basic app with no social and gamification features, or (3 socially-enhanced experimental condition (pedometer plus app with social and gamification features. Participants will undertake assessments at baseline, three and nine months. The primary outcome is change in total daily minutes of moderate-to-vigorous physical activity at three months measured objectively using GENEActive accelerometers [Activeinsights Ltd., UK]. Secondary outcomes include self-reported physical activity, depression and anxiety, wellbeing, quality of life, social-cognitive theory constructs and app usage and engagement. Discussion The current study will incorporate novel social and gamification elements in order to examine whether the inclusion of these components increases the efficacy of app-based physical activity interventions. The findings will be used to guide the development

  15. "Active Team" a social and gamified app-based physical activity intervention: randomised controlled trial study protocol.

    Science.gov (United States)

    Edney, Sarah; Plotnikoff, Ronald; Vandelanotte, Corneel; Olds, Tim; De Bourdeaudhuij, Ilse; Ryan, Jillian; Maher, Carol

    2017-11-02

    Physical inactivity is a leading preventable cause of chronic disease and premature death globally, yet over half of the adult Australian population is inactive. To address this, web-based physical activity interventions, which have the potential to reach large numbers of users at low costs, have received considerable attention. To fully realise the potential of such interventions, there is a need to further increase their appeal to boost engagement and retention, and sustain intervention effects over longer periods of time. This randomised controlled trial aims to evaluate the efficacy of a gamified physical activity intervention that connects users to each other via Facebook and is delivered via a mobile app. The study is a three-group, cluster-RCT. Four hundred and forty (440) inactive Australian adults who use Facebook at least weekly will be recruited in clusters of three to eight existing Facebook friends. Participant clusters will be randomly allocated to one of three conditions: (1) waitlist control condition, (2) basic experimental condition (pedometer plus basic app with no social and gamification features), or (3) socially-enhanced experimental condition (pedometer plus app with social and gamification features). Participants will undertake assessments at baseline, three and nine months. The primary outcome is change in total daily minutes of moderate-to-vigorous physical activity at three months measured objectively using GENEActive accelerometers [Activeinsights Ltd., UK]. Secondary outcomes include self-reported physical activity, depression and anxiety, wellbeing, quality of life, social-cognitive theory constructs and app usage and engagement. The current study will incorporate novel social and gamification elements in order to examine whether the inclusion of these components increases the efficacy of app-based physical activity interventions. The findings will be used to guide the development and increase the effectiveness of future health

  16. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  17. An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial.

    Science.gov (United States)

    Watson, Judith; Tober, Gillian; Raistrick, Duncan; Mdege, Noreen; Dale, Veronica; Crosby, Helen; Godfrey, Christine; Lloyd, Charlie; Toner, Paul; Parrott, Steve

    2013-04-30

    Alcohol misuse is a major cause of premature mortality and ill health. Although there is a high prevalence of alcohol problems among patients presenting to general hospital, many of these people are not help seekers and do not engage in specialist treatment. Hospital admission is an opportunity to steer people towards specialist treatment, which can reduce health-care utilization and costs to the public sector and produce substantial individual health and social benefits. Alcohol misuse is associated with other lifestyle problems, which are amenable to intervention. It has been suggested that the development of a healthy or balanced lifestyle is potentially beneficial for reducing or abstaining from alcohol use, and relapse prevention. The aim of the study is to test whether or not the offer of a choice of health-related lifestyle interventions is more acceptable, and therefore able to engage more problem drinkers in treatment, than an alcohol-focused intervention. This is a pragmatic, randomized, controlled, open pilot study in a UK general hospital setting with concurrent economic evaluation and a qualitative component. Potential participants are those admitted to hospital with a diagnosis likely to be responsive to addiction interventions who score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT). The main purpose of this pilot study is to evaluate the acceptability of two sorts of interventions (healthy living related versus alcohol focused) to the participants and to assess the components and processes of the design. Qualitative research will be undertaken to explore acceptability and the impact of the approach, assessment, recruitment and intervention on trial participants and non-participants. The effectiveness of the two treatments will be compared at 6 months using AUDIT scores as the primary outcome measure. There will be additional economic, qualitative and secondary outcome measurements. Development of the study was a

  18. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia.

    Directory of Open Access Journals (Sweden)

    Ruth M H Peters

    Full Text Available Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a 'contact intervention'.This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called 'contact events'. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event. The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p < 0.001, effect size = 0.75 compared to the score at baseline (n = 213; for the SDS this was 3.56 (p < 0.001, effect size = 0.81. About 75% of those attending a contact event said they shared the information with others (median 10 persons.The contact intervention was effective in increasing knowledge and improving public attitudes regarding leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to reduce stigma against other neglected tropical diseases

  19. A Controlled Quasi-Experimental Study of an Educational Intervention to Reduce the Unnecessary Use of Antimicrobials For Asymptomatic Bacteriuria

    OpenAIRE

    Irfan, Neal; Brooks, Annie; Mithoowani, Siraj; Celetti, Steve J.; Main, Cheryl; Mertz, Dominik

    2015-01-01

    Background Asymptomatic bacteriuria (ABU) should only be treated in cases of pregnancy or in-patients undergoing urologic procedures; however, unnecessary treatment of ABU is common in clinical practice. Objective To identify risk factors for unnecessary treatment and to assess the impact of an educational intervention focused on these risk factors on treatment of ABU. Design Quasi-experimental study with a control group. Setting Two tertiary teaching adult care hospitals. Participants Consec...

  20. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention - Project Tomato.

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-06-16

    The School Fruit and Vegetable Scheme (SFVS) is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3) their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group), consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET), and height and weight measurements collected, at baseline (Year 2) and 18 month follow-up (Year 4). The primary outcome will be the ability of the intervention (Project Tomato) to maintain consumption of fruit and vegetable portions compared to the control group. A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Medical Research Council Registry code G0501297.

  1. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-01-01

    Background The School Fruit and Vegetable Scheme (SFVS) is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3) their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group), consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET), and height and weight measurements collected, at baseline (Year 2) and 18 month follow-up (Year 4). The primary outcome will be the ability of the intervention (Project Tomato) to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297 PMID:19531246

  2. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

    Directory of Open Access Journals (Sweden)

    Conner Mark T

    2009-06-01

    Full Text Available Abstract Background The School Fruit and Vegetable Scheme (SFVS is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3 their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group, consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET, and height and weight measurements collected, at baseline (Year 2 and 18 month follow-up (Year 4. The primary outcome will be the ability of the intervention (Project Tomato to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297

  3. The proactive approach--is it worthwhile? A prospective controlled ergonomic intervention study in office workers.

    Science.gov (United States)

    Laestadius, Jasminka Goldoni; Ye, Jian; Cai, Xiaodong; Ross, Sandra; Dimberg, Lennart; Klekner, Meg

    2009-10-01

    Does proactive ergonomics program enhance office worker health and productivity? The investigation was conducted in connection with the move of 1500 office staff to a building with improved ergonomics. It was focused on associations between workstation features, working postures, musculoskeletal pain symptoms, and eye strain before and 18 months after implementation of a proactive ergonomic program. The outcomes were compared between the intervention and a similar reference group. Associations between improvement of postures and less musculoskeletal pain and eye strain were confirmed. A cross association between several features and postures and improved symptoms was noted, along with improved productivity. The study suggests that a proactive program adhering to the OSHA recommendations needs to include an individual workstation assessment to be effective in reducing symptoms and increasing productivity.

  4. Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

    Science.gov (United States)

    Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

    2014-01-01

    To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research

  5. Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Mary Leamy

    Full Text Available OBJECTIVE: To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. DESIGN: Process evaluation nested within a cluster randomised controlled trial (RCT. PARTICIPANTS: 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. SETTING: 14 community-based mental health teams in two UK sites (one urban, one semi-rural who received the intervention. RESULTS: The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. CONCLUSIONS: Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would

  6. Modifying Alcohol Consumption to Reduce Obesity: A Randomized Controlled Feasibility Study of a Complex Community-based Intervention for Men.

    Science.gov (United States)

    Irvine, Linda; Crombie, Iain K; Cunningham, Kathryn B; Williams, Brian; Sniehotta, Falko F; Norrie, John; Melson, Ambrose J; Jones, Claire; Rice, Peter; Slane, Peter W; Achison, Marcus; McKenzie, Andrew; Dimova, Elena D; Allan, Sheila

    2017-11-01

    Being obese and drinking more than 14 units of alcohol per week places men at very high risk of developing liver disease. This study assessed the feasibility of a trial to reduce alcohol consumption. It tested the recruitment strategy, engagement with the intervention, retention and study acceptability. Men aged 35-64 years who drank >21 units of alcohol per week and had a BMI > 30 were recruited by two methods: from GP patient registers and by community outreach. The intervention was delivered by a face to face session followed by a series of text messages. Trained lay people (Study Coordinators) delivered the face to face session. Participants were followed up for 5 months from baseline to measure weekly alcohol consumption and BMI. The recruitment target of 60 was exceeded, with 69 men recruited and randomized. At baseline, almost all the participants (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease. The intervention was delivered with high fidelity. A very high follow-up rate was achieved (98%) and the outcomes for the full trial were measured. Process evaluation showed that participants responded as intended to key steps in the behaviour change strategy. The acceptability of the study methods was high: e.g. 80% of men would recommend the study to others. This feasibility study identified a group at high risk of liver disease. It showed that a full trial could be conducted to test the effectiveness and cost-effectiveness of the intervention. Current controlled trials: ISRCTN55309164. National Institute for Health Research Health Technology Assessment (NIHR HTA). This feasibility study recruited 69 men at high risk of developing liver disease. The novel intervention, to reduce alcohol consumption through the motivation of weight loss, was well received. A very high follow-up rate was achieved. Process evaluation showed that participants engaged with key components of the behaviour change strategy. © The Author 2017

  7. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women

    DEFF Research Database (Denmark)

    Vinter, Christina Anne; Jensen, Dorte M; Ovesen, Per Glud

    2011-01-01

    To study the effects of lifestyle intervention on gestational weight gain (GWG) and obstetric outcomes.......To study the effects of lifestyle intervention on gestational weight gain (GWG) and obstetric outcomes....

  8. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    Science.gov (United States)

    Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-01-01

    Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial

  9. The associations between regional gray matter structural changes and changes of cognitive performance in control groups of intervention studies

    Directory of Open Access Journals (Sweden)

    Hikaru eTakeuchi

    2015-12-01

    Full Text Available In intervention studies of cognitive training, the challenging cognitive tests, which were used as outcome measures, are generally completed in more than a few hours. Here, utilizing the control groups’ data from three 1-week intervention studies in which young healthy adult subjects underwent a wide range of cognitive tests and T1-weighted magnetic resonance imaging (MRI before and after the intervention period, we investigated how regional gray matter (GM density (rGMD of the subjects changed through voxel-based morphometry (VBM. Statistically significant increases in rGMD were observed in the anatomical cluster that mainly spread around the bilateral dorsal anterior cingulate cortex (dACC and the right superior frontal gyrus (rSFG. Moreover, mean rGMD within this cluster changes were significantly and positively correlated with performance changes in the Stroop task, and tended to positively correlate with performance changes in a divergent thinking task. Affected regions are considered to be associated with performance monitoring (dACC and manipulation of the maintained information including generating associations (rSFG, and both are relevant to the cognitive functions measured in the cognitive tests. Thus, the results suggest that even in the groups of the typical control group in intervention studies including those of the passive one, experimental or non-experimental factors can result in an increase in the regional GM structure and form the association between such neural changes and improvements related to these cognitive tests. These results suggest caution toward the experimental study designs without control groups.

  10. Effects of sodium and potassium supplementation on endothelial function: a fully controlled dietary intervention study

    NARCIS (Netherlands)

    Gijsbers, L.; Dower, J.I.; Schalkwijk, C.G.; Kusters, Y.H.A.M.; Bakker, S.J.A.; Hollman, P.C.H.; Geleijnse, J.M.

    2015-01-01

    High Na and low K intakes have adverse effects on blood pressure, which increases the risk for CVD. The role of endothelial dysfunction and inflammation in this pathophysiological process is not yet clear. In a randomised placebo-controlled cross-over study in untreated (pre)hypertensives, we

  11. Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study

    NARCIS (Netherlands)

    Witvliet, M.; van Lier, P.A.C.; Cuijpers, P.; Koot, H.M.

    2009-01-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal

  12. A controlled study of an HIV/AIDS/STI/TB intervention with faith healers in Vhembe District, South Africa.

    Science.gov (United States)

    Mashamba, Tshilidzi; Peltzer, Karl; Maluleke, Thelma X; Sodi, Tholene

    2011-01-01

    The aim of the study was to develop an HIV and AIDS training manual, and to evaluate the knowledge, attitudes and management of faith healers of Apostolic churches regarding HIV and AIDS, before and after they attended an HIV and AIDS training programme. A quasi-experimental intervention design was used with faith healers affiliated with the United African Apostolic Church (UAAC) in the Thulamela and Musina municipalities of Vhembe District, Limpopo Province, South Africa. A total of 103 faith healers were included in this study, 58 were systematically assigned to an intervention and 45 to a control group. The intervention group received training for 2 days. At follow-up after 2 months, intervention effects were significant for HIV knowledge and to a lesser extent TB knowledge. No significant improvement was found in HIV/STI (sexually transmitted infection) management strategies such as HIV/STI risk behaviour counselling, referral of clients for HIV testing, keeping condoms at stock in church, and church community HIV/AIDS/STI education. It is important to note that faith healers address some of the major known behavioural risk and protective factors such as partner reduction and condom use. Therefore, faith healers could be more widely utilized in HIV prevention programmes as risk reduction counsellors, in particular on matters of community-level education.

  13. Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Dray, Julia; Bowman, Jenny; Freund, Megan; Campbell, Elizabeth; Wolfenden, Luke; Hodder, Rebecca K; Wiggers, John

    2014-07-18

    Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited. Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health. The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas. A cluster randomised control trial will be conducted, with schools as the unit of randomisation. Initially, 32 secondary schools will be randomly allocated to a control or intervention group (12 control and 20 intervention). An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools. A survey of students in Grade 7 in both intervention and control schools will be conducted (baseline) and repeated three years later when the students are in Grade 10. The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems. At follow-up, the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness. The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools. The outcomes of the trial are of importance to youth, schools, mental health clinicians and policymakers. Australian New Zealand Clinical Trials Registry, ACTRN12611000606987, registered 14 June 2011.

  14. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia.

    Science.gov (United States)

    Peters, Ruth M H; Dadun; Zweekhorst, Marjolein B M; Bunders, Joske F G; Irwanto; van Brakel, Wim H

    2015-01-01

    Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a 'contact intervention'. This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called 'contact events'. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p stigma against other neglected tropical diseases and conditions should be evaluated.

  15. Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

    Science.gov (United States)

    Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

    2011-01-01

    Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in

  16. A Controlled Quasi-Experimental Study of an Educational Intervention to Reduce the Unnecessary Use of Antimicrobials For Asymptomatic Bacteriuria.

    Science.gov (United States)

    Irfan, Neal; Brooks, Annie; Mithoowani, Siraj; Celetti, Steve J; Main, Cheryl; Mertz, Dominik

    2015-01-01

    Asymptomatic bacteriuria (ABU) should only be treated in cases of pregnancy or in-patients undergoing urologic procedures; however, unnecessary treatment of ABU is common in clinical practice. To identify risk factors for unnecessary treatment and to assess the impact of an educational intervention focused on these risk factors on treatment of ABU. Quasi-experimental study with a control group. Two tertiary teaching adult care hospitals. Consecutive patients with positive urine cultures between January 30th and April 17th, 2012 (baseline) and January 30th and April 30th, 2013 (intervention). In January 2013, a multifaceted educational intervention based on risk factors identified during the baseline period was provided to medical residents (monthly) on one clinical teaching unit (CTU) at one hospital site, with the CTU of the other hospital serving as the control. During the baseline period, 160/341 (46.9%) positive urine cultures were obtained from asymptomatic patients at the two hospitals, and 94/160 (58.8%) were inappropriately treated with antibiotics. Risk factors for inappropriate use included: female gender (OR 2.1, 95% CI 1.1-4.3), absence of a catheter (OR 2.5, 1.2-5), bacteriuria versus candiduria (OR 10.6, 3.8-29.4), pyuria (OR 2.0, 1.1-3.8), and positive nitrites (OR 2.2, 1.1-4.5). In 2013, only 2/24 (8%) of ABU patients were inappropriately treated on the intervention CTU as compared to 14/29 (52%) on the control CTU (OR 0.10; 95% CI 0.02-0.49). A reduction was also observed as compared to baseline on the intervention CTU (OR 0.1, 0.02-0.7) with no significant change noted on the control CTU (OR 0.47, 0.13-1.7). A multifaceted educational intervention geared towards medical residents with a focus on identified risk factors for inappropriate management of ABU was effective in reducing unnecessary antibiotic use.

  17. A Controlled Quasi-Experimental Study of an Educational Intervention to Reduce the Unnecessary Use of Antimicrobials For Asymptomatic Bacteriuria.

    Directory of Open Access Journals (Sweden)

    Neal Irfan

    Full Text Available Asymptomatic bacteriuria (ABU should only be treated in cases of pregnancy or in-patients undergoing urologic procedures; however, unnecessary treatment of ABU is common in clinical practice.To identify risk factors for unnecessary treatment and to assess the impact of an educational intervention focused on these risk factors on treatment of ABU.Quasi-experimental study with a control group.Two tertiary teaching adult care hospitals.Consecutive patients with positive urine cultures between January 30th and April 17th, 2012 (baseline and January 30th and April 30th, 2013 (intervention.In January 2013, a multifaceted educational intervention based on risk factors identified during the baseline period was provided to medical residents (monthly on one clinical teaching unit (CTU at one hospital site, with the CTU of the other hospital serving as the control.During the baseline period, 160/341 (46.9% positive urine cultures were obtained from asymptomatic patients at the two hospitals, and 94/160 (58.8% were inappropriately treated with antibiotics. Risk factors for inappropriate use included: female gender (OR 2.1, 95% CI 1.1-4.3, absence of a catheter (OR 2.5, 1.2-5, bacteriuria versus candiduria (OR 10.6, 3.8-29.4, pyuria (OR 2.0, 1.1-3.8, and positive nitrites (OR 2.2, 1.1-4.5. In 2013, only 2/24 (8% of ABU patients were inappropriately treated on the intervention CTU as compared to 14/29 (52% on the control CTU (OR 0.10; 95% CI 0.02-0.49. A reduction was also observed as compared to baseline on the intervention CTU (OR 0.1, 0.02-0.7 with no significant change noted on the control CTU (OR 0.47, 0.13-1.7.A multifaceted educational intervention geared towards medical residents with a focus on identified risk factors for inappropriate management of ABU was effective in reducing unnecessary antibiotic use.

  18. Cluster randomised controlled trial of a consumer behaviour intervention to improve healthy food purchases from online canteens: study protocol.

    Science.gov (United States)

    Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris; Wolfenden, Luke

    2017-04-17

    School canteens represent an opportune setting in which to deliver public health nutrition strategies given their wide reach, and frequent use by children. Online school canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer behaviour strategies that impact on purchasing decisions. The aim of this study is to assess the efficacy of a consumer behaviour intervention implemented in an online school canteen ordering system in reducing the kilojoule, saturated fat, sugar and sodium content of primary student lunch orders. The study will employ a cluster randomised controlled trial design. Approximately 1040 students (aged 5-12 years) from 10 primary schools in New South Wales, Australia, currently using an online canteen ordering system will be invited to participate. Schools will be randomised in a 1:1 ratio to receive either the intervention (enhanced system) or control (standard online ordering only). The intervention will include evidence-based strategies shown to influence healthy food purchasing (strategies targeting availability, menu labelling, placement and prompting). The primary outcomes of the trial will be the mean content per student online lunch order of (1) energy (kJ), (2) saturated fat (g), (3) sugar (g) and (4) sodium (mg). The impact of the intervention will be determined by between-group assessment of the nutritional content of lunch purchases over a 2-month period postintervention initiation. The study was approved by the Hunter New England Human Research Ethics Committee, University of Newcastle Human Research Ethics Committee and New South Wales Department of Education and School Communities. Study findings will be disseminated widely through peer-reviewed publications and relevant presentations in international conferences and to stakeholders. ACTRN12616000499482. Published by the BMJ Publishing Group Limited. For permission to

  19. Study protocol: pragmatic randomized control trial of an internet-based intervention (My tools 4 care) for family carers.

    Science.gov (United States)

    Duggleby, Wendy; Ploeg, Jenny; McAiney, Carrie; Fisher, Kathryn; Swindle, Jenny; Chambers, Tracey; Ghosh, Sunita; Peacock, Shelley; Markle-Reid, Maureen; Triscott, Jean; Williams, Allison; Forbes, Dorothy; Pollard, Lori

    2017-08-14

    Family carers of older persons with Alzheimer's' disease and related dementia (ADRD) and multiple chronic conditions (MCC) experience significant, complex, and distressing transitions such as changes to their environment, roles and relationships, physical health, and mental health. An online intervention (My Tools 4 Care) was developed for family carers of persons with ADRD and MCC living at home, with the aim of supporting these carers through transitions and increasing their self-efficacy, hope, and health related quality of life (HRQoL). This study will evaluate My Tools 4 Care (MT4C) by asking the following research questions: 1. Does use of MT4C result in a 3 month (immediately post intervention) and 6-month (3 months after intervention) increase in HRQoL, self-efficacy, and hope, in carers of persons with ADRD and MCC compared to an educational control group? 2. Does use of MT4C help carers of community-dwelling older adults with ADRD and MCC deal with significant changes they experience as carers? and 3. Are the effects/benefits of the MT4C intervention achieved at no additional cost compared to an educational control group? Using a pragmatic mixed methods randomized controlled trial design, 180 family carers of community dwelling older persons (65 years of age and older) with ADRD and MCC will participate in the study. Data will be collected from the intervention and an educational control group at four time points: baseline, 1 month, 3 and 6 months. We expect to find that family carers using MT4C will show greater improvement in hope, self-efficacy and HRQoL, at no additional cost from a societal perspective, compared to those in the educational control group. General estimating equations will be used to determine differences between groups and over time. Data collection began in Ontario and Alberta Canada in June 2015 and is expected to be completed in June 2017. The results will inform policy and practice as MT4C can be easily revised for local

  20. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study.

    Science.gov (United States)

    Jouen, Anne-Lise; Narzisi, Antonio; Xavier, Jean; Tilmont, Elodie; Bodeau, Nicolas; Bono, Valentina; Ketem-Premel, Nabila; Anzalone, Salvatore; Maharatna, Koushik; Chetouani, Mohamed; Muratori, Filippo; Cohen, David

    2017-01-01

    To meet the required hours of intensive intervention for treating children with autism spectrum disorder (ASD), we developed an automated serious gaming platform (11 games) to deliver intervention at home (GOLIAH) by mapping the imitation and joint attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. Here, we report the results of a 6-month matched controlled exploratory study. From two specialized clinics, we included 14 children (age range 5-8 years) with ASD and 10 controls matched for gender, age, sites, and treatment as usual (TAU). Participants from the experimental group received in addition to TAU four 30-min sessions with GOLIAH per week at home and one at hospital for 6 months. Statistics were performed using Linear Mixed Models. Children and parents participated in 40% of the planned sessions. They were able to use the 11 games, and participants trained with GOLIAH improved time to perform the task in most JA games and imitation scores in most imitation games. GOLIAH intervention did not affect Parental Stress Index scores. At end-point, we found in both groups a significant improvement for Autism Diagnostic Observation Schedule scores, Vineland socialization score, Parental Stress Index total score, and Child Behavior Checklist internalizing, externalizing and total problems. However, we found no significant change for by time × group interaction. Despite the lack of superiority of TAU + GOLIAH versus TAU, the results are interesting both in terms of changes by using the gaming platform and lack of parental stress increase. A large randomized controlled trial with younger participants (who are the core target of ESDM model) is now discussed. This should be facilitated by computing GOLIAH for a web platform. Trial registration Clinicaltrials.gov NCT02560415.

  1. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

  2. Enhancing Buruli ulcer control in Ghana through social interventions: a case study from the Obom sub-district

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    Ahorlu Collins K

    2013-01-01

    Full Text Available Abstract Background Buruli ulcer is considered a re-emerging disease in West Africa where it has suffered neglect over the years, though children below the age of 16 years are the worst affected in most endemic regions. Due to delayed health seeking, the disease leads to disabilities resulting from amputation and loss of vital organs like the eye leading to school dropout and other social and economic consequences for the affected family. Early treatment with antibiotics is effective; however, this involves daily oral and intramuscular injection at distant health facilities for 56 days making it a challenge among poor rural folks living on daily subsistence work. The mode of transmission of Buruli ulcer is not known and there is no effective preventive vaccine for Buruli ulcer. Thus the only effective control tool is early case detection and treatment to reduce morbidity and associated disabilities that occurs as a result of late treatment. It is therefore essential to implement interventions that remove impediments that limit early case detection; access to early effective treatment and this paper reports one such effort where the feasibility of social interventions to enhance Buruli ulcer control was assessed. Methods This was a qualitative study using in-depth interviews to generate information to ascertain the benefit or otherwise of the intervention implemented. Clinical records of patients to generate data to determine the feasibility and effectiveness of social interventions in the fight against Buruli ulcer was examined. In all, 56 in-depth interviews (28 at baseline and 28 at evaluation were conducted for this report. Results At full implementation, treatment default and dropout reduced significantly from 58.8% and 52.9% at baseline to 1.5% and 1.5% respectively. The number of early case detection went up significantly. Affected families were happy with social interventions such as provision of transportation and breakfast to patients

  3. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Earhart, Gammon M; Duncan, Ryan P; Huang, John L; Perlmutter, Joel S; Pickett, Kristen A

    2015-02-05

    Effective treatment of locomotor dysfunction in Parkinson disease (PD) is essential, as gait difficulty is an early and major contributor to disability. Exercise is recommended as an adjunct to traditional treatments for improving gait, balance, and quality of life. Among the exercise approaches known to improve walking, tango and treadmill training have recently emerged as two promising therapies for improving gait, disease severity and quality of life, yet these two interventions have not been directly compared to each other. Prior studies have been helpful in identifying interventions effective in improving gait function, but have done little to elucidate the neural mechanisms underlying functional improvements. The primary objective of the proposed work is to compare the effects of three community-based exercise programs, tango, treadmill training and stretching, on locomotor function in individuals with PD. In addition, we aim to determine whether and how these interventions alter functional connectivity of locomotor control networks in the brain. One hundred and twenty right-handed individuals with idiopathic PD who are at least 30 years of age will be assigned in successive waves to one of three community-based exercise groups: tango dancing, treadmill training or stretching (control). Each group will receive three months of exercise training with twice weekly one-hour group classes. Each participant will be evaluated at three time points: pre-intervention (baseline), post-intervention (3 months), and follow-up (6 months). All evaluations will include assessment of gait, balance, disease severity, and quality of life. Baseline and post-intervention evaluations will also include task-based functional magnetic resonance imaging (fMRI) and resting state functional connectivity MRI. All MRI and behavioral measures will be conducted with participants OFF anti-Parkinson medication, with behavioral measures also assessed ON medication. This study will provide

  4. A qualitative study of successful adolescent and young adult weight losers: implications for weight control intervention.

    Science.gov (United States)

    Jensen, Chad D; Duraccio, Kara M; Hunsaker, Sanita L; Rancourt, Diana; Kuhl, Elizabeth S; Jelalian, Elissa; Wing, Rena R

    2014-12-01

    Our study aims to provide an in-depth analysis of behavioral strategies, psychological factors, and social contributors to adolescent weight loss and weight loss maintenance among participants in the Adolescent Weight Control Registry (AWCR). Qualitative analyses were conducted using semi-structured interview data from 40 participants from the AWCR who successfully lost ≥10 lbs and maintained their weight loss for at least one year. In contrast to existing literature, our findings suggest that primary motivating factors for adolescent weight loss may be intrinsic (e.g., desire for better health, desire to improve self-worth) rather than extrinsic. In addition, life transitions (e.g., transition to high school) were identified as substantial motivators for weight-related behavior change. Peer and parental encouragement and instrumental support were widely endorsed as central to success. The most commonly endorsed weight loss maintenance strategies included attending to dietary intake and physical activity levels, and making self-corrections when necessary. Results from this study highlight considerations for future adolescent weight control treatment development.

  5. Lifestyle intervention using an internet-based curriculum with cell phone reminders for obese Chinese teens: a randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Anisha A Abraham

    Full Text Available Obesity is an increasing public health problem affecting young people. The causes of obesity are multi-factorial among Chinese youth including lack of physical activity and poor eating habits. The use of an internet curriculum and cell phone reminders and texting may be an innovative means of increasing follow up and compliance with obese teens. The objectives of this study were to determine the feasibility of using an adapted internet curriculum and existing nutritional program along with cell phone follow up for obese Chinese teens.This was a randomized controlled study involving obese teens receiving care at a paediatric obesity clinic of a tertiary care hospital in Hong Kong. Forty-eight subjects aged 12 to 18 years were randomized into three groups. The control group received usual care visits with a physician in the obesity clinic every three months. The first intervention (IT group received usual care visits every three months plus a 12-week internet-based curriculum with cell phone calls/texts reminders. The second intervention group received usual care visits every three months plus four nutritional counselling sessions.The use of the internet-based curriculum was shown to be feasible as evidenced by the high recruitment rate, internet log-in rate, compliance with completing the curriculum and responses to phone reminders. No significant differences in weight were found between IT, sLMP and control groups.An internet-based curriculum with cell phone reminders as a supplement to usual care of obesity is feasible. Further study is required to determine whether an internet plus text intervention can be both an effective and a cost-effective adjunct to changing weight in obese youth.Chinese Clinical Trial Registry ChiCTR-TRC-12002624.

  6. Immediate outcome indicators in perioperative care: a controlled intervention study on quality improvement in hospitals in Tanzania.

    Science.gov (United States)

    Bosse, Goetz; Mtatifikolo, Ferdinand; Abels, Wiltrud; Strosing, Christian; Breuer, Jan-Philipp; Spies, Claudia

    2013-01-01

    Outcome assessment is the standard for evaluating the quality of health services worldwide. In this study, outcome has been divided into immediate and final outcome. Aim was to compare an intervention hospital with a Continuous Quality Improvement approach to a control group using benchmark assessments of immediate outcome indicators in surgical care. Results were compared to final outcome indicators. Surgical care quality in six hospitals in Tanzania was assessed from 2006-2011, using the Hospital Performance Assessment Tool. Independent observers assessed structural, process and outcome quality using checklists based on evidence-based guidelines. The number of surgical key procedures over the benchmark of 80% was compared between the intervention hospital and the control group. Results were compared to Case Fatality Rates. In the intervention hospital, in 2006, two of nine key procedures reached the benchmark, one in 2009, and four in 2011. In the control group, one of nine key procedures reached the benchmark in 2006, one in 2009, and none in 2011. Case Fatality Rate for all in-patients in the intervention hospital was 5.5% (n = 12,530) in 2006, 3.5% (n = 21,114) in 2009 and 4.6% (n = 18,840) in 2011. In the control group it was 3.1% (n = 17,827) in 2006, 4.2% (n = 13,632) in 2009 and 3.8% (n = 17,059) in 2011. Results demonstrated that quality assurance improved performance levels in both groups. After the introduction of Continuous Quality Improvement, performance levels improved further in the intervention hospital while quality in the district hospital did not. Immediate outcome indicators appeared to be a better steering tool for quality improvement compared to final outcome indicators. Immediate outcome indicators revealed a need for improvement in pre- and postoperative care. Quality assurance programs based on immediate outcome indicators can be effective if embedded in Continuous Quality Improvement. Nevertheless, final outcome

  7. Preventing academic difficulties in preterm children: a randomised controlled trial of an adaptive working memory training intervention - IMPRINT study.

    Science.gov (United States)

    Pascoe, Leona; Roberts, Gehan; Doyle, Lex W; Lee, Katherine J; Thompson, Deanne K; Seal, Marc L; Josev, Elisha K; Nosarti, Chiara; Gathercole, Susan; Anderson, Peter J

    2013-09-16

    Very preterm children exhibit difficulties in working memory, a key cognitive ability vital to learning information and the development of academic skills. Previous research suggests that an adaptive working memory training intervention (Cogmed) may improve working memory and other cognitive and behavioural domains, although further randomised controlled trials employing long-term outcomes are needed, and with populations at risk for working memory deficits, such as children born preterm.In a cohort of extremely preterm (memory and attention 2 weeks', 12 months' and 24 months' post-intervention, and to investigate training related neuroplasticity in working memory neural networks 2 weeks' post-intervention. This double-blind, placebo-controlled, randomised controlled trial aims to recruit 126 extremely preterm/extremely low birthweight 7-year-old children. Children attending mainstream school without major intellectual, sensory or physical impairments will be eligible. Participating children will undergo an extensive baseline cognitive assessment before being randomised to either an adaptive or placebo (non-adaptive) version of Cogmed. Cogmed is a computerised working memory training program consisting of 25 sessions completed over a 5 to 7 week period. Each training session takes approximately 35 minutes and will be completed in the child's home. Structural, diffusion and functional Magnetic Resonance Imaging, which is optional for participants, will be completed prior to and 2 weeks following the training period. Follow-up assessments focusing on academic skills (primary outcome), working memory and attention (secondary outcomes) will be conducted at 2 weeks', 12 months' and 24 months' post-intervention. To our knowledge, this study will be the first randomised controlled trial to (a) assess the effectiveness of Cogmed in school-aged extremely preterm/extremely low birthweight children, while incorporating advanced imaging techniques to investigate neural changes

  8. Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

    Science.gov (United States)

    Wong, Virginia C. N.; Kwan, Queenie K.

    2010-01-01

    We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

  9. A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

    Science.gov (United States)

    Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

    2015-01-01

    For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  10. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

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    Sanatinia Rahil

    2012-08-01

    Full Text Available Abstract Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention or control treatment (a leaflet on healthy living. Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic

  11. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    OpenAIRE

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-01-01

    Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Obj...

  12. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study.

    Science.gov (United States)

    Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

    2017-01-01

    Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes

  13. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study

    Directory of Open Access Journals (Sweden)

    Marcelo Demarzo

    2017-08-01

    Full Text Available Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population.Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively. Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed.Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience.Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both

  14. Multisystemic engagement & nephrology based educational intervention: a randomized controlled trial protocol on the kidney team at home-study

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    Ismail Sohal Y

    2012-07-01

    Full Text Available Abstract Background Living donor kidney transplantation (LDKT is the most successful form of renal replacement therapy in terms of wait time and survival rates. However, we observed a significant inequality in the number of LDKT performed between the Dutch and the non-Dutch patients. The objective of this study is to adapt, implement and test an educational home-based intervention to contribute to the reduction of this inequality. Our aim is to establish this through guided communication together with the social network of the patients in an attempt that well-informed decisions regarding renal replacement therapy can be made: Multisystemic Engagement & Nephrology. This manuscript is a detailed description of the Kidney Team At Home-study protocol. Methods and design All patients (>18 yrs that are referred to the pre-transplantation outpatient clinic are eligible to participate in the study. Patients will be randomly assigned to either an experimental or a control group. The control group will continue to receive standard care. The experimental group will receive standard care plus a home-based educational intervention. The intervention consists of two sessions at the patient’s home, an initial session with the patient and a second session for which individuals from their social network are invited to take part. Based on the literature and behavioural change theories we hypothesize that reducing hurdles in knowledge, risk perception, subjective norm, self-efficacy, and communication contribute to well-informed decision making and reducing inequality in accessing LDKT programs. A change in these factors is consequently our primary outcome-measure. Based on power calculations, we aim to include 160 patients over a period of two years. Discussion If we are able to show that this home-based group educational intervention contributes to 1 achieving well-informed decision regarding treatment and 2 reducing the inequality in LDKT, the quality of life

  15. Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study.

    Science.gov (United States)

    Dunleavy, K; Kava, K; Goldberg, A; Malek, M H; Talley, S A; Tutag-Lehr, V; Hildreth, J

    2016-09-01

    To determine the effectiveness of Pilates and yoga group exercise interventions for individuals with chronic neck pain (CNP). Quasi-randomised parallel controlled study. Community, university and private practice settings in four locations. Fifty-six individuals with CNP scoring ≥3/10 on the numeric pain rating scale for >3 months (controls n=17, Pilates n=20, yoga n=19). Exercise participants completed 12 small-group sessions with modifications and progressions supervised by a physiotherapist. The primary outcome measure was the Neck Disability Index (NDI). Secondary outcomes were pain ratings, range of movement and postural measurements collected at baseline, 6 weeks and 12 weeks. Follow-up was performed 6 weeks after completion of the exercise classes (Week 18). NDI decreased significantly in the Pilates {baseline: 11.1 [standard deviation (SD) 4.3] vs Week 12: 6.8 (SD 4.3); mean difference -4.3 (95% confidence interval -1.64 to -6.7); PPilates and yoga group exercise interventions with appropriate modifications and supervision were safe and equally effective for decreasing disability and pain compared with the control group for individuals with mild-to-moderate CNP. Physiotherapists may consider including these approaches in a plan of care. ClinicalTrials.gov NCT01999283. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  16. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia

    Science.gov (United States)

    Peters, Ruth M. H.; Dadun; Zweekhorst, Marjolein B. M.; Bunders, Joske F. G.; Irwanto; van Brakel, Wim H.

    2015-01-01

    Background Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’. Methods/Principal Findings This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called ‘contact events’. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to reduce stigma against other neglected tropical diseases and conditions should be evaluated. PMID:26485128

  17. Randomized controlled trial of a self-management intervention in persons with spinal cord injury : design of the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

    NARCIS (Netherlands)

    Kooijmans, H.; Post, M. W. M.; van der Woude, L. H. V.; de Groot, S.; Stam, H. J.; Bussmann, J. B. J.

    2013-01-01

    Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty

  18. Effects of a tailored lifestyle self-management intervention (TALENT) study on weight reduction: a randomized controlled trial.

    Science.gov (United States)

    Melchart, Dieter; Löw, Peter; Wühr, Erich; Kehl, Victoria; Weidenhammer, Wolfgang

    2017-01-01

    Overweight and obesity are globally increasing risk factors for diseases in the context of metabolic syndrome. A randomized controlled trial was conducted to investigate whether there are any existing differences between two lifestyle intervention strategies with respect to weight reduction after 1 year. A total of 166 subjects with a body mass index of 28-35 kg/m 2 were enrolled in this trial at seven study centers; 109 were randomly allocated to the intervention group (comprehensive lifestyle modification program: web-based Individual Health Management [IHM]) with 3-month reduction phase plus 9-month maintenance phase, and 57 were allocated to the control group (written information with advice for healthy food habits: usual care [UC]). Body weight, waist circumference, blood pressure, laboratory findings, and bioimpedance analysis used to determine body composition were measured at baseline and after 3, 6, 9, and 12 months. The primary outcome parameter was body weight at month 12 compared to baseline. With respect to baseline status there were no statistically significant differences between the groups. Based on the intent-to-treat population, body weight showed a mean decrease of 8.7 kg (SD 6.1) in the intervention group (IHM) and 4.2 kg (SD 5) in the control group (UC) at month 12. This statistically significant difference ( P <0.001) was confirmed by various sensitivity analyses. Body mass index, waist circumference, high-density lipid cholesterol, body fat, and the ratio of fat and body cell mass improved to a significantly higher degree in the IHM group. IHM proved to be superior to UC in weight reduction after 1 year. With a mean loss of about 10% of the baseline weight, a clinically high relevant risk reduction for cardio-metabolic diseases is achievable.

  19. Efficacy of a biobehavioral intervention for hot flashes: a randomized controlled pilot study.

    Science.gov (United States)

    Barton, Debra L; Schroeder, Kelliann C Fee; Banerjee, Tanima; Wolf, Sherry; Keith, Timothy Z; Elkins, Gary

    2017-07-01

    The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction. Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes. The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study. Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.

  20. Community Water Improvement, Household Water Insecurity, and Women’s Psychological Distress: An Intervention and Control Study in Ethiopia

    Science.gov (United States)

    Stevenson, E. G. J.; Ambelu, A.; Caruso, B. A.; Tesfaye, Y.; Freeman, M. C.

    2016-01-01

    Background Over 650 million people worldwide lack access to safe water supplies, and even among those who have gained access to ‘improved’ sources, water may be seasonally unreliable, far from homes, expensive, and provide insufficient quantity. Measurement of water access at the level of communities and households remains crude, and better measures of household water insecurity are urgently needed to inform needs assessments and monitoring and evaluation. We set out to assess the validity of a quantitative scale of household water insecurity, and to investigate (1) whether improvements to community water supply reduce water insecurity, (2) whether water interventions affect women’s psychological distress, and (3) the impacts of water insecurity on psychological distress, independent of socio-economic status, food security, and harvest quality. Methods and Findings Measures were taken before and one to six months after a community water supply improvement in three villages in rural northern Ethiopia. Villages similar in size and access to water sources and other amenities did not receive interventions, and served as controls. Household water insecurity was assessed using a 21-item scale based on prior qualitative work in Ethiopia. Women’s psychological distress was assessed using the WHO Self-Reporting Questionnaire (SRQ-20). Respondents were either female heads of household or wives of the heads of household (n = 247 at baseline, n = 223 at endline); 123 households provided data at both rounds. The intervention was associated with a decline of approximately 2 points on the water insecurity scale between baseline and endline compared to the control (beta -1.99; 95% CI’s -3.15, -0.84). We did not find evidence of impact of the intervention on women’s psychological distress. Water insecurity was, however, predictive of psychological distress (p insecurity scale, and establish our approach to measuring water insecurity as a plausible means of evaluating

  1. Radon balneotherapy and physical activity for osteoporosis prevention: a randomized, placebo-controlled intervention study.

    Science.gov (United States)

    Winklmayr, Martina; Kluge, Christian; Winklmayr, Wolfgang; Küchenhoff, Helmut; Steiner, Martina; Ritter, Markus; Hartl, Arnulf

    2015-03-01

    Low-dose radon hyperthermia balneo treatment (LDRnHBT) is applied as a traditional measure in the non-pharmacological treatment of rheumatic diseases in Europe. During the last decades, the main approach of LDRnHBT was focused on the treatment of musculoskeletal disorders, but scientific evidence for the biological background of LDRnHBT is weak. Recently, evidence emerged that LDRnHBT influences bone metabolism. We investigated, whether combined LDRnHBT and exercise treatment has an impact on bone metabolism and quality of life in a study population in an age group at risk for developing osteoporosis. This randomized, double-blind, placebo-controlled trial comprised guided hiking tours and hyperthermia treatment in either radon thermal water (LDRnHBT) or radon-free thermal water (PlaceboHBT). Markers of bone metabolism, quality of life and somatic complaints were evaluated. Statistics was performed by linear regression and a linear mixed model analysis. Significant changes over time were observed for most analytes investigated as well as an improvement in self-assessed health in both groups. No significant impact from the LDRnHBT could be observed. After 6 months, the LDRnHBT group showed a slightly stronger reduction of the osteoclast stimulating protein receptor activator of nuclear kB-ligand compared to the PlaceboHBT group, indicating a possible trend. A combined hyperthermia balneo and exercise treatment has significant immediate and long-term effects on regulators of bone metabolism as well as somatic complaints. LDRnHBT and placeboHBT yielded statistically equal outcomes.

  2. Memory-focused interventions for people with cognitive disorders: A systematic review and meta-analysis of randomized controlled studies.

    Science.gov (United States)

    Yang, Hui-Ling; Chan, Pi-Tuan; Chang, Pi-Chen; Chiu, Huei-Ling; Sheen Hsiao, Shu-Tai; Chu, Hsin; Chou, Kuei-Ru

    2018-02-01

    A better understanding of people with cognitive disorders improves performance on memory tasks through memory-focused interventions are needed. The purpose of this study was to assess the effect of memoryfocused interventions on cognitive disorders through a meta-analysis. Systematic review and meta-analysis. The online electronic databases PubMed, the Cochrane Library, Ovid-Medline, CINHAL, PsycINFO, Ageline, and Embase (up to May 2017) were used in this study. No language restriction was applied to the search. Objective memory (learning and memory function, immediate recall, delayed recall, and recognition) was the primary indicator and subjective memory performance, global cognitive function, and depression were the secondary indicators. The Hedges' g of change, subgroup analyses, and meta-regression were analyzed on the basis of the characteristics of people with cognitive disorders. A total of 27 studies (2177 participants, mean age=75.80) reporting RCTs were included in the meta-analysis. The results indicated a medium-to-large effect of memory-focused interventions on learning and memory function (Hedges' g=0.62) and subjective memory performance (Hedges' g=0.67), a small-to-medium effect on delayed recall and depression, and a small effect on immediate recall and global cognitive function (all pmemory function were more profound in the format of memory training, individual training, shorter treatment duration, and more than eight treatment sessions, and the effect size indicated the MMSE score was the most crucial indicator (β=-0.06, p=0.04). This is first comprehensive meta-analysis of special memory domains in people with cognitive disorders. The results revealed that memory-focused interventions effectively improved memory-related performance in people with cognitive disorders. An appropriately designed intervention can effectively improve memory function, reduce disability progression, and improve mood state in people with cognitive disorders

  3. An interdisciplinary knowledge translation intervention in long-term care: Study protocol for the vitamin D and osteoporosis study (ViDOS pilot cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kennedy Courtney C

    2012-05-01

    Full Text Available Abstract Background Knowledge translation (KT research in long-term care (LTC is still in its early stages. This protocol describes the evaluation of a multifaceted, interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes. Methods and design The Vitamin D and Osteoporosis Study (ViDOS is underway in 40 LTC homes (n = 19 intervention, n = 21 control across Ontario, Canada. The primary objectives of this study are to assess the feasibility of delivering the KT intervention, and clinically, to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily. Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician. The target audience within each LTC home is the Professional Advisory Committee (PAC, an interdisciplinary team who meets quarterly. The key elements of the intervention are three interactive educational sessions led by an expert opinion leader, action planning using a quality improvement cycle, audit and feedback reports, nominated internal champions, and reminders/point-of-care tools. Control homes do not receive any intervention, however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy. Primary outcomes are feasibility measures (recruitment, retention, attendance at educational sessions, action plan items identified and initiated, internal champions identified, performance reports provided and reviewed, and vitamin D (≥800 IU/daily prescribing at 6 and 12 months. Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications, and falls and fractures. Qualitative methods will examine the experience of the LTC team with the KT intervention. Homes are centrally randomized to intervention and control groups in blocks of variable size using

  4. A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions.

    Science.gov (United States)

    McNulty, Cliodna; Ricketts, Ellie J; Rugman, Claire; Hogan, Angela; Charlett, Andre; Campbell, Rona

    2015-11-17

    Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants' behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development. We undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT. We reached data saturation and found five main themes; Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings. Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty-Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable. Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that

  5. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

    Directory of Open Access Journals (Sweden)

    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  6. A cluster randomised controlled trial to investigate the effectiveness and cost effectiveness of the 'Girls Active' intervention: a study protocol.

    Science.gov (United States)

    Edwardson, C L; Harrington, D M; Yates, T; Bodicoat, D H; Khunti, K; Gorely, T; Sherar, L B; Edwards, R T; Wright, C; Harrington, K; Davies, M J

    2015-06-04

    Despite the health benefits of physical activity, data from the UK suggest that a large proportion of adolescents do not meet the recommended levels of moderate-to-vigorous physical activity (MVPA). This is particularly evident in girls, who are less active than boys across all ages and may display a faster rate of decline in physical activity throughout adolescence. The 'Girls Active' intervention has been designed by the Youth Sport Trust to target the lower participation rates observed in adolescent girls. 'Girls Active' uses peer leadership and marketing to empower girls to influence decision making in their school, develop as role models and promote physical activity to other girls. Schools are provided with training and resources to review their physical activity, sport and PE provision, culture and practices to ensure they are relevant and attractive to adolescent girls. This study is a two-arm cluster randomised controlled trial (RCT) aiming to recruit 20 secondary schools. Clusters will be randomised at the school level (stratified by school size and proportion of Black and Minority Ethnic (BME) pupils) to receive either the 'Girls Active' intervention or carry on with usual practice (1:1). The 20 secondary schools will be recruited from state secondary schools within the Midlands area. We aim to recruit 80 girls aged 11-14 years in each school. Data will be collected at three time points; baseline and seven and 14 months after baseline. Our primary aim is to investigate whether 'Girls Active' leads to higher objectively measured (GENEActiv) moderate-to-vigorous physical activity in adolescent girls at 14 months after baseline assessment compared to the control group. Secondary outcomes include other objectively measured physical activity variables, adiposity, physical activity-related psychological factors and the cost-effectiveness of the 'Girls Active' intervention. A thorough process evaluation will be conducted during the course of the intervention

  7. SIRT1 genetic variants associate with the metabolic response of Caucasians to a controlled lifestyle intervention – the TULIP Study

    Directory of Open Access Journals (Sweden)

    Stefan Norbert

    2008-11-01

    Full Text Available Abstract Background Sirtuin1 (SIRT1 regulates gene expression in distinct metabolic pathways and mediates beneficial effects of caloric restriction in animal models. In humans, SIRT1 genetic variants associate with fasting energy expenditure. To investigate the relevance of SIRT1 for human metabolism and caloric restriction, we analyzed SIRT1 genetic variants in respect to the outcome of a controlled lifestyle intervention in Caucasians at risk for type 2 diabetes. Methods A total of 1013 non-diabetic Caucasians from the Tuebingen Family Study (TUEF were genotyped for four tagging SIRT1 SNPs (rs730821, rs12413112, rs7069102, rs2273773 for cross-sectional association analyses with prediabetic traits. SNPs that associated with basal energy expenditure in the TUEF cohort were additionally analyzed in 196 individuals who underwent a controlled lifestyle intervention (Tuebingen Lifestyle Intervention Program; TULIP. Multivariate regressions analyses with adjustment for relevant covariates were performed to detect associations of SIRT1 variants with the changes in anthropometrics, weight, body fat or metabolic characteristics (blood glucose, insulin sensitivity, insulin secretion and liver fat, measured by magnetic resonance techniques after the 9-month follow-up test in the TULIP study. Results Minor allele (X/A carriers of rs12413112 (G/A had a significantly lower basal energy expenditure (p = 0.04 and an increased respiratory quotient (p = 0.02. This group (rs12413112: X/A was resistant against lifestyle-induced improvement of fasting plasma glucose (GG: -2.01%, X/A: 0.53%; p = 0.04, had less increase in insulin sensitivity (GG: 17.3%, X/A: 9.6%; p = 0.05 and an attenuated decline in liver fat (GG: -38.4%, X/A: -7.5%; p = 0.01. Conclusion SIRT1 plays a role for the individual lifestyle intervention response, possibly owing to decreased basal energy expenditure and a lower lipid-oxidation rate in rs12413112 X/A allele carriers. SIRT1 genetic

  8. Diffusion of an evidence-based smoking cessation intervention through Facebook: a randomised controlled trial study protocol.

    Science.gov (United States)

    Cobb, Nathan K; Jacobs, Megan A; Saul, Jessie; Wileyto, E Paul; Graham, Amanda L

    2014-01-21

    Online social networks represent a potential mechanism for the dissemination of health interventions including smoking cessation; however, which elements of an intervention determine diffusion between participants is unclear. Diffusion is frequently measured using R, the reproductive rate, which is determined by the duration of use (t), the 'contagiousness' of an intervention (β) and a participant's total contacts (z). We have developed a Facebook 'app' that allows us to enable or disable various components designed to impact the duration of use (expanded content, proactive contact), contagiousness (active and passive sharing) and number of contacts (use by non-smoker supporters). We hypothesised that these elements would be synergistic in their impact on R, while including non-smokers would induce a 'carrier' state allowing the app to bridge clusters of smokers. This study is a fractional factorial, randomised control trial of the diffusion of a Facebook application for smoking cessation. Participants recruited through online advertising are randomised to 1 of 12 cells and serve as 'seed' users. All user interactions are tracked, including social interactions with friends. Individuals installing the application that can be traced back to a seed participant are deemed 'descendants' and form the outcome of interest. Analysis will be conducted using Poisson regression, with event count as the outcome and the number of seeds in the cell as the exposure. The results will be reported as a baseline R0 for the reference group, and incidence rate ratio for the remainder of predictors. This study uses an abbreviated consent process designed to minimise barriers to adoption and was deemed to be minimal risk by the Institutional Review Board (IRB). Results will be disseminated through traditional academic literature as well as social media. If feasible, anonymised data and underlying source code are intended to be made available under an open source license. NCT01746472.

  9. Diffusion of an evidence-based smoking cessation intervention through Facebook: a randomised controlled trial study protocol

    Science.gov (United States)

    Cobb, Nathan K; Jacobs, Megan A; Saul, Jessie; Wileyto, E Paul; Graham, Amanda L

    2014-01-01

    Introduction Online social networks represent a potential mechanism for the dissemination of health interventions including smoking cessation; however, which elements of an intervention determine diffusion between participants is unclear. Diffusion is frequently measured using R, the reproductive rate, which is determined by the duration of use (t), the ‘contagiousness’ of an intervention (β) and a participant's total contacts (z). We have developed a Facebook ‘app’ that allows us to enable or disable various components designed to impact the duration of use (expanded content, proactive contact), contagiousness (active and passive sharing) and number of contacts (use by non-smoker supporters). We hypothesised that these elements would be synergistic in their impact on R, while including non-smokers would induce a ‘carrier’ state allowing the app to bridge clusters of smokers. Methods and analysis This study is a fractional factorial, randomised control trial of the diffusion of a Facebook application for smoking cessation. Participants recruited through online advertising are randomised to 1 of 12 cells and serve as ‘seed’ users. All user interactions are tracked, including social interactions with friends. Individuals installing the application that can be traced back to a seed participant are deemed ‘descendants’ and form the outcome of interest. Analysis will be conducted using Poisson regression, with event count as the outcome and the number of seeds in the cell as the exposure. Results The results will be reported as a baseline R0 for the reference group, and incidence rate ratio for the remainder of predictors. Ethics and Dissemination This study uses an abbreviated consent process designed to minimise barriers to adoption and was deemed to be minimal risk by the Institutional Review Board (IRB). Results will be disseminated through traditional academic literature as well as social media. If feasible, anonymised data and underlying

  10. TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes

    Directory of Open Access Journals (Sweden)

    Tuzzi Cristina

    2010-04-01

    Full Text Available Abstract Background Obesity is one of the most important medical and public health problems of our time: it increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Methods/Design TECNOB (TEChnology for OBesity is a comprehensive two-phase stepped down program enhanced by telemedicine for the long-term treatment of obese people with type 2 diabetes seeking intervention for weight loss. Its core features are the hospital-based intensive treatment (1-month, that consists of diet therapy, physical training and psychological counseling, and the continuity of care at home using new information and communication technologies (ICT such as internet and mobile phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only will be evaluated in a randomized controlled trial (RCT with a 12-month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. Furthermore, the study will explore what behavioral and psychological variables are predictive of treatment success among those we have considered. Discussion The TECNOB study aims to inform the evidence-based knowledge of how telemedicine may enhance the effectiveness of clinical interventions for weight loss and related type-2 diabetes, and which type of obese patients may benefit the most from such interventions. Broadly, the study aims also to have a effect on

  11. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study

    DEFF Research Database (Denmark)

    Wood, L.; Egger, M.; Gluud, L.L.

    2008-01-01

    OBJECTIVE: To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome. DESIGN: Combined analysis of data from three meta-epidemiological studies based o...

  12. Randomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol.

    Science.gov (United States)

    Granich, Joanna; Dass, Alena; Busacca, Margherita; Moore, Dennis; Anderson, Angelika; Venkatesh, Svetha; Duong, Thi; Vellanki, Pratibha; Richdale, Amanda; Trembath, David; Cairns, Darin; Marshall, Wendy; Rodwell, Tania; Rayner, Madeleine; Whitehouse, Andrew J O

    2016-10-19

    Evidence for early intensive behavioural interventions (EIBI) by therapists as an effective treatment for children with an Autism Spectrum Disorder (ASD) is growing. High-intensity and sustained delivery of quality EIBI is expensive. The TOBY (Therapy Outcomes by You) Playpad is an App-based platform delivering EIBI to facilitate learning for young children with ASD, while enabling parents to become co-therapists. Intervention targets include increasing joint attention, imitation and communication of children with ASD. The primary aim of the study presented in this protocol is to determine the effectiveness of the TOBY App in reducing ASD symptoms when used as a complement to conventional EIBI. The secondary aim is to examine parental attributes as a result of TOBY App use. Children aged less than 4;3 years diagnosed with ASD and parents will be recruited into this single-blind, randomised controlled trial using a pragmatic approach. Eligible participants will be randomised to the treatment group 'TOBY therapy + therapy as usual' or, the control group 'therapy as usual' for six months. The treatment will be provided by the TOBY App and parent where a combination of learning environments such as on-iPad child only (solo), partner (with parent) and off-iPad - Natural Environment (with parent) Tasks will be implemented. Parents in the treatment group will participate in a TOBY training workshop. Treatment fidelity will be monitored via an App-based reporting system and parent diaries. The primary outcome measure is the Autism Treatment Evaluation Checklist. The secondary outcome measures involve diagnostics, functional and developmental assessments, including parent questionnaires at baseline (T0), three months (T1) and six months (T2). This trial will determine the effectiveness of the TOBY App as a therapeutic complement to other early interventions children with ASD receive. The trial will also determine the feasibility of a parent delivered early intervention

  13. School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cova Felix

    2011-02-01

    Full Text Available Abstract Background Depression is common and can have devastating effects on the life of adolescents. Psychological interventions are the first-line for treating or preventing depression among adolescents. This proposal aims to evaluate a school-based, universal psychological intervention to reduce depressive symptoms among student's aged 13-14 attending municipal state secondary schools in Santiago, Chile. Study design This is a cluster randomised controlled trial with schools as the main clusters. We compared this intervention with a control group in a study involving 22 schools, 66 classes and approximately 2,600 students. Students in the active schools attended 11 weekly and 3 booster sessions of an intervention based on cognitive-behavioural models. The control schools received their usual but enhanced counselling sessions currently included in their curriculum. Mean depression scores and indicators of levels of functioning were assessed at 3 and 12 months after the completion of the intervention in order to assess the effectiveness of the intervention. Direct and indirect costs were measured in both groups to assess the cost-effectiveness of this intervention. Discussion As far as we are aware this is the first cluster randomised controlled trial of a school intervention for depression among adolescents outside the Western world. Trial Registration ISRCTN19466209

  14. MP-AzeFlu provides rapid and effective allergic rhinitis control: results of a non-interventional study in Romania.

    Science.gov (United States)

    Agache, I; Doros, I C; Leru, P M; Bucur, I; Poenaru, M; Sarafoleanu, C

    2018-03-01

    Allergic Rhinitis and its Impact on Asthma (ARIA) and the European Union (EU) recommend a shift to guide allergic rhinitis (AR) treatment decisions from symptom severity to disease control, using a simple visual analogue scale (VAS). Using this VAS we assessed, in a real-life study in Romania, the effectiveness of MP-AzeFlu nasal spray. In this multi-centre, prospective, non-interventional study, 253 patients (over 11 years old) with moderate-to-severe AR were prescribed MP-AzeFlu and assessed their symptoms on a VAS (0 (not at all bothersome) to 100 mm (very bothersome)) on Days 0, 1, 3, 7 and 14. The proportion of patients who achieved a defined VAS score cut-off for well-controlled (38 mm) AR were also calculated. Patients perception of disease control was assessed on Day 3. MP-AzeFlu use was associated with a mean (standard deviation) VAS score reduction from 78.4 (15.1) mm at baseline to 14.7 (15.1) mm on the last day. Effectiveness was consistent irrespective of disease severity, phenotype or patient age. 83.4% of patients achieved the smaller than 39 mm well-controlled VAS score cut-off by last day and 95.2% considered their symptoms to be well- or partly controlled at Day 3. MP-AzeFlu provided rapid, effective and sustained AR symptom control in a real-life setting in Romania, irrespective of severity, phenotype or patient age, aligning with ARIA and EU recommendations and supporting the position of MP-AzeFlu as the drug of choice for the treatment of moderate-to-severe AR.

  15. A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol.

    Science.gov (United States)

    Bukhsh, Allah; Nawaz, Muhammad Sarfraz; Ahmed, Hafiz Sajjad; Khan, Tahir Mehmood

    2018-03-01

    Diabetes self-care activities, like, healthy diet, regular exercise, self-monitoring of blood glucose, and rational use of medicines are considered to play a vital role in establishing euglycemia. Health literacy among type 2 diabetes mellitus (T2DM) patients in Pakistan is very low, which is the most likely cause for poor clinical outcomes. This study is designed to investigate the impact of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among T2DM patients in Pakistan. In this randomized controlled trail, effectiveness of a 6-month pharmacist-led educational intervention will be examined on glycemic control, diabetes self-care activities and disease knowledge of 80 adult T2DM patients (age >30 years) with poorly controlled T2DM (HbA1c> 7%), after randomizing them into intervention and control groups, at diabetes care clinic of Capital Hospital Islamabad, Pakistan. The primary outcome is change in patients' HbA1c, whereas, changes in self-care activities and patients' disease knowledge are the secondary outcomes. After baseline assessment of their self-care activities and disease knowledge by using validated Urdu versions of Diabetes Self-management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively, interventional group patients will be supplemented with a face-to-face pharmacist-led educational intervention, whereas, the control group will receive usual care. Intervention arm patients will be educated successively at their first follow-up visit (12th week) and telephonically after every 4 weeks. All assessments will be made at baseline and end of trail for both intervention and control groups. Multivariate general linear model will be applied to analyze the effects of the intervention. Glycemic control in T2DM patients requires optimum self-care activities. This study is an attempt to improve self-care behaviors among poorly controlled T2DM patients who are at higher risk of

  16. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Costello Anthony

    2011-06-01

    Full Text Available Abstract Background Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen. Methods/Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers. MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design. MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs are supported in convening monthly women's groups. Nine groups per cluster (270 in total work through two action research cycles in which they (i identify local issues around maternity, newborn health and nutrition, (ii prioritise key problems, (iii develop strategies to address them, (iv implement the strategies, and (v evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i identify local births, (ii identify low birth weight infants, (iii identify possible newborn infection, (iv manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v follow up infants and support families. Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal

  17. Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study).

    Science.gov (United States)

    Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui

    2017-07-12

    Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised

  18. Control-Group Study of an Intervention Training Program for Youth Suicide Prevention

    Science.gov (United States)

    Chagnon, Francois; Houle, Janie; Marcoux, Isabelle; Renaud, Johanne

    2007-01-01

    Few studies have examined whether training can improve competency in intervening with suicidal youths. In this study we attempted to verify the effectiveness of such a training program on helper competency. Forty-three helpers who received the training were compared with 28 helpers who did not. Participants who received the training improved in…

  19. Municipal return to work management in cancer survivors undergoing cancer treatment: a protocol on a controlled intervention study.

    Science.gov (United States)

    Stapelfeldt, Christina M; Labriola, Merete; Jensen, Anders Bonde; Andersen, Niels Trolle; Momsen, Anne-Mette H; Nielsen, Claus Vinther

    2015-07-29

    Cancer survivors are often left on their own to deal with the challenges of resuming work during or after cancer treatment, mainly due to unclear agreements between stakeholders responsible for occupational rehabilitation. Social inequality exists in cancer risk, survival probability and continues with regard to the chance of being able to return to work. The aim is to apply an early, individually tailored occupational rehabilitation intervention to cancer survivors in two municipalities parallel with cancer treatment focusing on enhancing readiness for return to work. In a controlled trial municipal job consultants use acceptance and commitment therapy dialogue and individual-placement-and-support-inspired tools with cancer survivors to engage them in behaviour changes toward readiness for return to work. The workplace is involved in the return to work process. Patients referred to surgery, radiotherapy or chemotherapy at the Oncology Department, Aarhus University Hospital, Denmark for the diagnoses; breast, colon-rectal, head and neck, thyroid gland, testicular, ovarian or cervix cancer are eligible for the study. Patients must be residents in the municipalities of Silkeborg or Randers, 18-60 years of age and have a permanent or temporary employment (with at least 6 months left of their contract) at inclusion. Patients, for whom the treating physician considers occupational rehabilitation to be unethical, or who are not reading or talking Danish are excluded. The control group has identical inclusion and exclusion criteria except for municipality of residence. Return to work is the primary outcome and is indentified in a social transfer payment register. Effect is assessed as relative cumulative incidences within 52 weeks and will be analysed in generalised linear regression models using the pseudo values method. As a secondary outcome; co-morbidity and socio-economic status is analysed as effect modifiers of the intervention effect on return to work. The

  20. Teacher-Implemented Joint Attention Intervention: Pilot Randomized Controlled Study for Preschoolers with Autism

    Science.gov (United States)

    Lawton, Kathy; Kasari, Connie

    2012-01-01

    Objective: The vast majority of children with an autism spectrum disorder (ASD) attend public preschools at some point in their childhood. Community preschool practices often are not evidence based, and almost none target the prelinguistic core deficits of ASD. This study investigated the effectiveness of public preschool teachers implementing a…

  1. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study

    Directory of Open Access Journals (Sweden)

    Nada AM

    2017-07-01

    insignificant (P=0.069, 0.376, 0.058, respectively. FI decreased by 22%, HOMA-IR by 27.6%, and c-peptide by 1.83%. Total cholesterol, low-density lipoprotein cholesterol, parathyroid hormone, alkaline phosphatase, serum creatinine, and pulse rate significantly decreased (4.3±0.9 vs 4.0±0.9 mmol/L, P=0.036; 2.5±0.8 vs 2.2±0.8 mmol/L, P=0.018; 4.6±2.1 vs 3.5±1.8 pmol/L, P=0.001; 82.1±26.2 vs 66.2±19.5 U/L, P<0.001; 74.6±15.6 vs 70.7±14.7 µmol/L, P=0.047; and 81.6±11.9 vs 77.5±12.0 bpm, P=0.045, respectively. Triglycerides and high-density lipoprotein cholesterol, both systolic and diastolic BP, and BMI did not show significant change.Conclusion: Cholecalciferol helps improve blood glucose control and cholesterol profile in vitamin D3-deficient type 2 diabetic patients. Keywords: vitamin D, type 2 diabetes, HbA1c, cholesterol, creatinine, parathyroid hormone

  2. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study.

    Directory of Open Access Journals (Sweden)

    Maria Rubio-Valera

    Full Text Available Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care.Patients were recruited by general practitioners and randomized to community pharmacist intervention (87 that received an educational intervention and usual care (92. Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs, use of healthcare services and productivity losses were measured at baseline, 3 and 6 months.There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective. From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000.A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended.ClinicalTrials.gov NCT

  3. The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial.

    Science.gov (United States)

    Wykes, Til; Joyce, Eileen; Velikonja, Tjasa; Watson, Andrew; Aarons, Gregory; Birchwood, Max; Cella, Matteo; Dopson, Sue; Fowler, David; Greenwood, Kathy; Johnson, Sonia; McCrone, Paul; Perez, Jesus; Pickles, Andrew; Reeder, Clare; Rose, Diana; Singh, Swaran; Stringer, Dominic; Taylor, Matthew; Taylor, Rumina; Upthegrove, Rachel

    2018-03-15

    Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT. This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms. It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience

  4. Training intervention for health care staff in the provision of existential support to patients with cancer: a randomized, controlled study.

    Science.gov (United States)

    Henoch, Ingela; Danielson, Ella; Strang, Susann; Browall, Maria; Melin-Johansson, Christina

    2013-12-01

    When a patient receives a cancer diagnosis, existential issues become more compelling. Throughout the illness trajectory, patients with cancer are cared for in oncology wards, by home care teams or in hospices. Nurses working with these patients are sometimes aware of the patients' existential needs but do not feel confident when discussing these issues. To determine the effects of a training intervention, where the focus is on existential issues and nurses' perceived confidence in communication and their attitude toward caring for dying patients. This was a randomized, controlled trial with a training intervention comprising theoretical training in existential issues combined with individual and group reflection. In total, 102 nurses in oncology and hospice wards and in palliative home care teams were randomized to a training or non-training group. Primary outcomes, confidence in communication, and attitude toward the care of dying patients were measured at baseline, immediately after the training, and five to six months later. Confidence in communication improved significantly in the training group from baseline (before the training) to both the first and second follow-up, that is, immediately after the training and five months later. The attitude toward caring for the dying did not improve in the training group. This study shows that short-term training with reflection improves the confidence of health care staff when communicating, which is important for health care managers with limited resources. Further studies are needed to explore how patients experience the communication skills of health care staff after such training. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  5. A Randomized Controlled Pilot Intervention Study of a Mindfulness-Based Self-Leadership Training (MBSLT) on Stress and Performance

    OpenAIRE

    Sampl, Juliane; Maran, Thomas; Furtner, Marco R.

    2017-01-01

    The present randomized pilot intervention study examines the effects of a mindfulness-based self-leadership training (MBSLT) specifically developed for academic achievement situations. Both mindfulness and self-leadership have a strong self-regulatory focus and are helpful in terms of stress resilience and performance enhancements. Based on several theoretical points of contact and a specific interplay between mindfulness and self-leadership, the authors developed an innovative intervention p...

  6. Cognitive Flexibility Training: A Large-Scale Multimodal Adaptive Active-Control Intervention Study in Healthy Older Adults

    Directory of Open Access Journals (Sweden)

    Jessika I. V. Buitenweg

    2017-11-01

    Full Text Available As aging is associated with cognitive decline, particularly in the executive functions, it is essential to effectively improve cognition in older adults. Online cognitive training is currently a popular, though controversial method. Although some changes seem possible in older adults through training, far transfer, and longitudinal maintenance are rarely seen. Based on previous literature we created a unique, state-of-the-art intervention study by incorporating frequent sessions and flexible, novel, adaptive training tasks, along with an active control group. We created a program called TAPASS (Training Project Amsterdam Seniors and Stroke, a randomized controlled trial. Healthy older adults (60–80 y.o. were assigned to a frequent- (FS or infrequent switching (IS experimental condition or to the active control group and performed 58 half-hour sessions over the course of 12 weeks. Effects on executive functioning, processing- and psychomotor speed, planning, verbal long term memory, verbal fluency, and reasoning were measured on four time points before, during and after the training. Additionally, we examined the explorative question which individual aspects added to training benefit. Besides improvements on the training, we found significant time effects on multiple transfer tasks in all three groups that likely reflected retest effects. No training-specific improvements were detected, and we did not find evidence of additional benefits of individual characteristics. Judging from these results, the therapeutic value of using commercially available training games to train the aging brain is modest, though any apparent effects should be ascribed more to expectancy and motivation than to the elements in our training protocol. Our results emphasize the importance of using parallel tests as outcome measures for transfer and including both active and passive control conditions. Further investigation into different training methods is advised

  7. Feasibility of a Psychosocial Rehabilitation Intervention to Enhance the Involvement of Relatives in Cancer Rehabilitation: Pilot Study for a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    L, Ledderer; KI, Cour; O, Mogensen

    2013-01-01

    . We developed an innovative rehabilitation program to be offered to the patient and a relative as a pair. Objective The aim of the present pilot study was to examine the feasibility of the intervention in a randomized controlled trial (RCT) and to evaluate the impact on quality of life. Methods...... significant difference was observed between the intervention and the control group. Pairs reported that the time of inclusion was inconvenient and that rehabilitation ought to meet their changing needs. Conclusions The pilot study showed that it may be difficult to conduct an RCT of a psychosocial...... rehabilitation intervention for pairs, and difficulties with inclusion and drop out have to be addressed. Interventions need to be carefully developed and tested before evaluating an effect in a large-scale study....

  8. A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students

    Directory of Open Access Journals (Sweden)

    Coumaravelou Saravanan

    2014-01-01

    Full Text Available Background: Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Materials and Methods: Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1 st year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. Results: After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P < 0.01 and high intrinsic and extrinsic motivation (P < 0.01 in the postassessment compared with their preassessment scores. Conclusion: Overall psychological intervention is effective to reduce anxiety scores and its related variables.

  9. A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students.

    Science.gov (United States)

    Saravanan, Coumaravelou; Kingston, Rajiah

    2014-05-01

    Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1(st) year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P < 0.01) and high intrinsic and extrinsic motivation (P < 0.01) in the postassessment compared with their preassessment scores. Overall psychological intervention is effective to reduce anxiety scores and its related variables.

  10. Can timely vector control interventions triggered by atypical environmental conditions prevent malaria epidemics? A case-study from Wajir County, Kenya.

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    Peter Maes

    Full Text Available Atypical environmental conditions with drought followed by heavy rainfall and flooding in arid areas in sub-Saharan Africa can lead to explosive epidemics of malaria, which might be prevented through timely vector-control interventions.Wajir County in Northeast Kenya is classified as having seasonal malaria transmission. The aim of this study was to describe in Wajir town the environmental conditions, the scope and timing of vector-control interventions and the associated resulting burden of malaria at two time periods (1996-1998 and 2005-2007.This is a cross-sectional descriptive and ecological study using data collected for routine program monitoring and evaluation.In both time periods, there were atypical environmental conditions with drought and malnutrition followed by massive monthly rainfall resulting in flooding and animal/human Rift Valley Fever. In 1998, this was associated with a large and explosive malaria epidemic (weekly incidence rates peaking at 54/1,000 population/week with vector-control interventions starting over six months after the massive rainfall and when the malaria epidemic was abating. In 2007, vector-control interventions started sooner within about three months after the massive rainfall and no malaria epidemic was recorded with weekly malaria incidence rates never exceeding 0.5 per 1,000 population per week.Did timely vector-control interventions in Wajir town prevent a malaria epidemic? In 2007, the neighboring county of Garissa experienced similar climatic events as Wajir, but vector-control interventions started six months after the heavy un-seasonal rainfall and large scale flooding resulted in a malaria epidemic with monthly incidence rates peaking at 40/1,000 population. In conclusion, this study suggests that atypical environmental conditions can herald a malaria outbreak in certain settings. In turn, this should alert responsible stakeholders about the need to act rapidly and preemptively with appropriate

  11. Testing a videogame intervention to recalibrate physician heuristics in trauma triage: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mohan, Deepika; Rosengart, Matthew R; Fischhoff, Baruch; Angus, Derek C; Farris, Coreen; Yealy, Donald M; Wallace, David J; Barnato, Amber E

    2016-11-11

    Between 30 and 40 % of patients with severe injuries receive treatment at non-trauma centers (under-triage), largely because of physician decision making. Existing interventions to improve triage by physicians ignore the role that intuition (heuristics) plays in these decisions. One such heuristic is to form an initial impression based on representativeness (how typical does a patient appear of one with severe injuries). We created a video game (Night Shift) to recalibrate physician's representativeness heuristic in trauma triage. We developed Night Shift in collaboration with emergency medicine physicians, trauma surgeons, behavioral scientists, and game designers. Players take on the persona of Andy Jordan, an emergency medicine physician, who accepts a new job in a small town. Through a series of cases that go awry, they gain experience with the contextual cues that distinguish patients with minor and severe injuries (based on the theory of analogical encoding) and receive emotionally-laden feedback on their performance (based on the theory of narrative engagement). The planned study will compare the effect of Night Shift with that of an educational program on physician triage decisions and on physician heuristics. Psychological theory predicts that cognitive load increases reliance on heuristics, thereby increasing the under-triage rate when heuristics are poorly calibrated. We will randomize physicians (n = 366) either to play the game or to review an educational program, and will assess performance using a validated virtual simulation. The validated simulation includes both control and cognitive load conditions. We will compare rates of under-triage after exposure to the two interventions (primary outcome) and will compare the effect of cognitive load on physicians' under-triage rates (secondary outcome). We hypothesize that: a) physicians exposed to Night Shift will have lower rates of under-triage compared to those exposed to the educational program

  12. Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Huntink, Elke; Heijmans, Naomi; Wensing, Michel; van Lieshout, Jan

    2013-12-17

    Cardiovascular disease (CVD) is an important worldwide cause of mortality. In The Netherlands, CVD is the leading cause of death for women and the second cause of death for men. Recommendations for diagnosis and treatment of CVD are not well implemented in primary care. In this study, we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with (high risk for) CVD. A two-arm cluster randomized trial is planned. We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values, risk profiling and lifestyle advice. Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management (CVRM). They are also advised to screen for the presence and severity of depressive symptoms in patients. We also advise practice nurses to use selected E-health options (selected websites and Twitter-consult) in patients without symptoms of depression. Patients with mild depressive symptoms are referred to a physical exercise group. We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM. Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practices in several geographical areas in The Netherlands. The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients. Patients' health-related lifestyles (physical exercise, diet and smoking status) will be measured with validated questionnaires and medical record audit will be performed to document estimated CVD risk. Additionally, we will survey and interview participating healthcare professionals for exploration of processes of change. The control

  13. Smoking cessation at the workplace. Results of a randomised controlled intervention study. Worksite physicians from the AIREL group.

    Science.gov (United States)

    Lang, T; Nicaud, V; Slama, K; Hirsch, A; Imbernon, E; Goldberg, M; Calvel, L; Desobry, P; Favre-Trosson, J P; Lhopital, C; Mathevon, P; Miara, D; Miliani, A; Panthier, F; Pons, G; Roitg, C; Thoores, M

    2000-05-01

    To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a "quit date" and extra support. Employees of an electrical and gas company seen at the annual visit by their occupational physicians. CRITERIA END POINTS: Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year. Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups. Randomised controlled trial. The unit of randomisation was the work site physician and a random sample of the employees of whom he or she was in charge. The length of the follow up was one year. Each of 30 work site physicians included in the study 100 to 150 employees. Among 504 subjects classified as smokers at baseline receiving simple advice (group A) and 591 the more active programme (group B), 68 (13.5%) in group A and 109 (18. 4%) were non-smokers one year later (p=0.03; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test). Twenty three subjects (4.6%) in group A and 36 (6.1%) in group B (p=0.26) declared abstinence of six months or more. Among non-smokers at baseline, 3.4% in both groups were smokers after one year follow up. The prevalence of smokers did not differ significantly at baseline (32.9% and 32.4%, p=0.75). After the intervention the prevalence of smoking was 30.8% in group A and 28. 7% in group B (p=0.19). An increase of the mean symptoms score for depression in those who quit was observed during this period. A simple cessation intervention strategy during a mandatory annual examination, targeting a population of smokers independently of their motivation to stop smoking or their health status, showed a 36% relative increase of the proportion of smokers who quit smoking as compared with what can be achieved through simple advice.

  14. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

    2016-06-24

    Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample

  15. The Danish Alzheimer intervention study

    DEFF Research Database (Denmark)

    Waldemar, G; Waldorff, F B; Buss, D V

    2011-01-01

    Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteri......Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline...

  16. Preventing and controlling foodborne disease in commercial and institutional food service settings: a systematic review of published intervention studies.

    Science.gov (United States)

    Viator, Catherine; Blitstein, Jonathan; Brophy, Jenna E; Fraser, Angela

    2015-02-01

    This study reviews the current literature on behavioral and environmental food safety interventions conducted in commercial and institutional food service settings. A systematic search of the published literature yielded 268 candidate articles, from which a set of 23 articles reporting intervention outcomes was retained for evaluation. A categorization of measured outcomes is reported; studies addressed multiple outcomes ranging from knowledge, attitudes, and behavior of personal hygiene and food safety to management practices and disease rates and outbreaks. This study also investigates the quality of reported research methods used to evaluate the effectiveness of the interventions, using a nine-point quality index adapted by the authors. The observed scores suggest that there are opportunities to improve the design and reporting of research in the field of foodborne disease prevention as it applies to food safety interventions that target the food service industry. The aim is to aid researchers in this area to design higher quality studies and to produce clearer and more useful reports of their research. In turn, this can help to create a more complete evidence base that can be used to continually improve interventions in this domain.

  17. A randomized controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol.

    Science.gov (United States)

    Lim, Siew Hoon; Chan, Sally Wai-Chi; Lai, Jiunn Herng; He, Hong-Gu

    2015-06-01

    To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. A randomized controlled trial is planned. Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4 weeks after discharge (postintervention 1) and at 4 months after discharge (postintervention 2). This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life. © 2014 John Wiley & Sons Ltd.

  18. The effect of a cognitive-motor intervention on voluntary step execution under single and dual task conditions in older adults: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Pichierri G

    2012-07-01

    Full Text Available Giuseppe Pichierri,1 Amos Coppe,1 Silvio Lorenzetti,2 Kurt Murer,1 Eling D de Bruin11Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Switzerland; 2Institute for Biomechanics, Department of Health Sciences and Technology, ETH Zurich, SwitzerlandBackground: This randomized controlled pilot study aimed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention demanding dual task conditions.Methods: Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks (intervention group. The control group received no specific intervention. Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention (Week 12.Results: After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions (U = 9, P = 0.034, r = 0.55 and backward steps under dual task conditions (U = 10, P = 0.045, r = 0.52 in favor of the intervention group, showing altered stepping levels in the intervention group compared to the control group.Conclusion: A cognitive-motor intervention based on strength and balance exercises with additional dance video gaming is able to improve voluntary step execution under both single and dual task conditions in older adults.Keywords: fall prevention, exercise, dance, video game

  19. Effects of a psychosocial intervention on survival among patients with stage I breast and prostate cancer: a matched case-control study.

    Science.gov (United States)

    Shrock, D; Palmer, R F; Taylor, B

    1999-05-01

    Psychosocial factors have been linked to the development and progression of cancer and shown to be relevant in cancer care. However, the evidence that psychosocial interventions affect cancer survival is less conclusive. Few methodologically sound studies have addressed this issue. To investigate the effects of a 6-week psychosocial intervention on survival among patients with stage I breast and prostate cancer. Matched case-control. 3 rural hospitals or cancer centers in central Pennsylvania. 21 breast and 29 prostate stage I cancer patients (treatment group) matched with 74 breast and 65 prostate stage I cancer patients from the same hospitals who did not receive the intervention (control group). Six 2-hour health psychology classes conducted by a licensed staff psychologist. Survival time was compared between the 2 groups and with national norms. The intervention group lived significantly longer than did matched controls. At 4- to 7-year follow-up (median = 4.2 years), none of the breast cancer patients in the intervention group died, whereas 12% of those in the control group died. Twice as many matched-control prostate cancer patients died compared with those in the intervention group (28% vs 14%). Control group survival was similar to national norms. These results are consistent with prior clinical trials and suggest that short-term psychosocial interventions that encourage the expression of emotions, provide social support, and teach coping skills can influence survival among cancer patients. However, self-selection bias cannot be ruled out as an alternative explanation for the results. These interventions merit further consideration and research.

  20. Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Grünzig, Sasha-Denise; Baumeister, Harald; Bengel, Jürgen; Ebert, David; Krämer, Lena

    2018-05-22

    Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration

  1. An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

    2013-05-29

    Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.

  2. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  3. Effectiveness of time-related interventions in children with ADHD aged 9-15 years: a randomized controlled study.

    Science.gov (United States)

    Wennberg, Birgitta; Janeslätt, Gunnel; Kjellberg, Anette; Gustafsson, Per A

    2018-03-01

    Specific problems with time and timing that affect daily routines, homework, school work, and social relations have been recognized in children with ADHD. The primary treatments for children with ADHD do not specifically focus on time-related difficulties. The aim of this randomized controlled study (RCT) was to investigate how multimodal interventions, consisting of training in time-processing ability (TPA) and compensation with time-assistive devices (TAD), affect TPA and daily time management (DTM) in children with ADHD and time difficulties, compared with only educational intervention. Thirty-eight children on stable medication for ADHD in the 9-15-year age range were randomly allocated to an intervention or a control group. The children's TPA was measured with a structured assessment (KaTid), and the children's DTM was rated by a parent questionnaire (Time-Parent scale) and by children's self-reporting (Time-Self-rating). The intervention consisted of time-skill training and compensation with TAD. Data were analysed for differences in TPA and in DTM between the control and intervention groups in the 24-week follow-up. Children in the intervention group increased their TPA significantly (p = 0.019) more compared to the control group. The largest increase was in orientation to time. In addition, the parents in the intervention group rated their children's DTM as significantly (p = 0.01) improved compared with the parents in the control group. According to the children, their DTM was not significantly changed. In conclusion, a multimodal intervention consisting of time-skill training and TAD improved TPA and DTM in children with ADHD aged 9-15 years.

  4. A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA): study protocol.

    Science.gov (United States)

    Papamiltiadous, Elena S; Roberts, Stuart K; Nicoll, Amanda J; Ryan, Marno C; Itsiopoulos, Catherine; Salim, Agus; Tierney, Audrey C

    2016-02-02

    Non-alcoholic fatty liver disease, the most prevalent liver disease in developed countries, remains difficult to manage with no proven safe and effective pharmacotherapy available. While weight reduction is the most commonly practiced treatment strategy, this is difficult to both achieve and/or maintain in the majority. Furthermore evidence-based dietary recommendations to guide the nutritional management of these patients are lacking. Using a randomised controlled trial design, this study compares the effectiveness of the Mediterranean diet to a standard low fat diet in terms of differences in insulin sensitivity, hepatic steatosis and metabolic outcomes in participants with non-alcoholic fatty liver disease. Ninety four eligible patients who have non-alcoholic fatty liver disease and who are insulin resistant, will be randomised into either a Mediterranean or low fat diet group for a 3 month intervention period. Insulin sensitivity will be measured on peripheral blood using Homeostatic Model Assessment and liver fat content quantified using Magnetic Resonance Spectroscopy. Both arms will consist of three face to face and three telephone call follow up consultations delivered by an Accredited Practicing Dietitian. The intervention arm focuses on recommendations from the traditional Mediterranean diet which have been tailored for use in the Australian population The standard arm uses the Australian Guide to Healthy Eating and the Australian National Heart Foundation dietary guidelines. Study recruitment will take place at four major metropolitan hospitals in Melbourne, Australia. Data collection will occur at all face to face reviews including baseline, 6, and 12 weeks. A follow up assessment to measure sustainability will take place at 6 and 12 months. The primary end point is improved insulin sensitivity scores at the 12 week time point. This trial aims to demonstrate in a large cohort of participants with NALFD that a Mediterranean diet independent of weight

  5. Lifestyle intervention using Internet of Things (IoT) for the elderly: A study protocol for a randomized control trial (the BEST-LIFE study).

    Science.gov (United States)

    Kato, Sawako; Ando, Masahiko; Kondo, Takaaki; Yoshida, Yasuko; Honda, Hiroyuki; Maruyama, Shoichi

    2018-05-01

    Modification of lifestyle habits, including diet and physical activity, is essential for the prevention and control of type 2 diabetes mellitus (T2DM) in elderly patients. However, individualized treatment is more critical for the elderly than for general patients. This study aimed to determine lifestyle interventions that resulted in lowering hemoglobin A 1c (HbA 1c ) in Japanese pre- and early diabetic elderly subjects. The BEST-LIFE trial is an ongoing, open-label, 6-month, randomized (1:1) parallel group trial. Subjects with HbA 1c of ≥5.6%-randomly assigned to the intervention or control group -use wearable monitoring devices loaded with Internet of things (IoT) systems that aids them with self-management and obtaining monthly remote health guidance from a public health nurse. The primary outcome is changes in HbA 1c after a 6-month intervention relative to the baseline values. The secondary outcome is the change of behavior modification stages. The background, rationale, and study design of this trial are also presented. One hundred forty-five subjects have already been enrolled in this lifestyle intervention program, which will end in 2019. The BEST-LIFE trial will provide new evidence regarding the effectiveness and safety of our program on lowering HbA 1c in elderly subjects with T2DM. It will also investigate whether information communication technology tools and monitoring devices loaded with IoT can support health care in elderly subjects. The trial registration number is UMIN-CTR: UMIN 000023356.

  6. Combining a leadership course and multi-source feedback has no effect on leadership skills of leaders in postgraduate medical education. An intervention study with a control group

    DEFF Research Database (Denmark)

    Malling, Bente; Mortensen, Lene; Bonderup, Thomas

    2009-01-01

    regarding development of leadership skills over time. METHODS: Study participants were consultants responsible for postgraduate medical education at clinical departments. STUDY DESIGN: pre-post measures with an intervention and control group. The intervention was participation in a seven-day leadership...... of variances. RESULTS: There were no differences in multi-source feedback scores at one year follow up compared to baseline measurements, either in the intervention or in the control group (p = 0.149). CONCLUSION: The study indicates that a leadership course following a MSF procedure compared to MSF alone does...... not improve leadership skills of consultants responsible for education in clinical departments. Developing leadership skills takes time and the time frame of one year might have been too short to show improvement in leadership skills of consultants responsible for education. Further studies are needed...

  7. Cost-Effectiveness of a Community Pharmacist Intervention in Patients with Depression: A Randomized Controlled Trial (PRODEFAR Study)

    NARCIS (Netherlands)

    Rubio-Valera, M.; Bosmans, J.E.; Fernandez, A.; Penarrubia-Maria, M.; March, M.; Trave, P.; Bellon, J.A.; Serrano-Blanco, A.

    2013-01-01

    Background:Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist

  8. Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders

    Directory of Open Access Journals (Sweden)

    Castle David

    2011-01-01

    Full Text Available Abstract Background The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD. The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders. Methods/Design 250 smokers with a severe mental disorder will be recruited. After completion of a baseline assessment and an initial face-to-face intervention session, participants will be randomly assigned to either a multi-component intervention for smoking cessation and CVD risk reduction or a telephone-based minimal intervention focusing on smoking cessation. Randomisation will be stratified by site (Newcastle, Sydney, Melbourne, Australia, Body Mass Index (BMI category (normal, overweight, obese and type of antipsychotic medication (typical, atypical. Participants will receive 8 weekly, 3 fortnightly and 6 monthly sessions delivered face to face (typically 1 hour or by telephone (typically 10 minutes. Assessments will be conducted by research staff blind to treatment allocation at baseline, 15 weeks, and 12-, 18-, 24-, 30- and 36-months. Discussion This study will provide comprehensive data on the effect of a healthy lifestyle intervention on smoking and CVD risk among people with severe mental disorders. If shown to be effective, this intervention can be disseminated to treating clinicians using the treatment manuals. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR identifier: ACTRN12609001039279

  9. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

    2017-11-14

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

  10. Comparing three forms of early intervention for youth with borderline personality disorder (the MOBY study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Chanen, Andrew; Jackson, Henry; Cotton, Sue M; Gleeson, John; Davey, Christopher G; Betts, Jennifer; Reid, Sophie; Thompson, Katherine; McCutcheon, Louise

    2015-10-21

    Borderline personality disorder is a severe mental disorder that usually has its onset in youth, but its diagnosis and treatment are often delayed. Psychosocial 'early intervention' is effective in improving symptoms and behaviours, but no trial has studied adaptive functioning as a primary outcome, even though this remains the major persistent impairment in this patient group. Also, the degree of complexity of treatment and requirements for implementation in mainstream health services are unclear. The primary aim of this trial is to evaluate the effectiveness of three forms of early intervention for borderline personality disorder in terms of adaptive functioning. Each treatment is defined by combining either a specialised or a general service delivery model with either an individual psychotherapy or a control psychotherapy condition. The study is a parallel-group, single-blind, randomised controlled trial, which has randomised permuted blocking, stratified by depression score, sex and age. The treatments are: (1) the specialised Helping Young People Early service model plus up to 16 sessions of individual cognitive analytic therapy; (2) the Helping Young People Early service plus up to 16 sessions of a control psychotherapy condition known as 'befriending'; (3) a general youth mental health care model plus up to 16 sessions of befriending. Participants will comprise 135 help-seeking youth aged 15-25 years with borderline personality disorder. After baseline assessment, staff blind to the study design and treatment group allocation will conduct assessments at 3, 6, 12 and 18 months. At the 12-month primary endpoint, the primary outcome is adaptive functioning (measures of social adjustment and interpersonal problems); secondary outcomes include measures of client satisfaction, borderline personality disorder features, depression and substance use. The results of this trial will help to clarify the comparative effectiveness of a specialised early intervention

  11. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy

    Directory of Open Access Journals (Sweden)

    Ulberg Randi

    2012-09-01

    Full Text Available Abstract Background Depression in adolescents seems to be a growing problem that causes mental suffering and prevents young people from joining the workforce. There is also a high risk of relapse during adult life. There is emerging evidence for the effect of psychodynamic psychotherapy in adolescents. In-session relational intervention (that is, transference intervention is a key component of psychodynamic psychotherapy. However, whether depressed adolescents profit most from psychodynamic psychotherapy with or without transference interventions has not been stated. Object The effect of transference interventions in depressed adolescents and the moderator moderating effect of quality of object relations, personality disorder and gender will be explored. Methods and study design The First Experimental Study of Transference Work–In Teenagers (FEST–IT will be a randomized clinical trial with a dismantling design. The study is aimed to explore the effects of transference work in psychodynamic psychotherapy for adolescents with depression. One hundred patients ages 16 to 18 years old will be randomized to one of two treatment groups, in both of which general psychodynamic techniques will be used. The patients will be treated over 28 weeks with either a moderate level of transference intervention or no transference intervention. Follow-up will be at 1 year after treatment termination. The outcome measures will be the Psychodynamic Functioning Scales (PFS, Inventory of Interpersonal Problems–Circumplex Version (IIP-C, Global Assessment of Functioning (GAF, and the total mean score of Symptom Checklist–90 (Global Severity Index; GSI, Beck Depression Inventory (BDI, and Montgomery Åsberg Rating Scale (MADRS. The quality of adolescents’ relationships will be a central focus of the study, and the Adolescent Relationship Scales (ARS and Differentiation–Relatedness Scale (DRS will also be used. Change will be assessed using linear-mixed models

  12. A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India.

    Science.gov (United States)

    Kapoor, Neha; Naufahu, Jane; Tewfik, Sundus; Bhatnagar, Sushma; Garg, Rakesh; Tewfik, Ihab

    2017-03-01

    Advanced cancer patients with disease progression develop cachexia. Nevertheless, cancer patients at nutritional risk have shown improved body weight and quality of life with oral nutritional supplements. This was a randomized controlled trial in adult female cancer patients (n = 63) attending palliative clinics, with symptoms of cachexia. Eligible patients were randomly distributed into control (n = 33) and intervention (n = 30) groups. Both groups were provided with nutritional and physical activity counseling, but the intervention group received an additional 100 g of Improved Atta (IAtta) for 6 months daily consumption. This study was designed to assess the efficacy of IAtta (with counseling) in enhancing the health status of cachexic patients. Anthropometric measurements, dietary intake, physical activity level and quality of life parameters were assessed at baseline, after 3 months, and at the end of 6 months. Patients in the control group (n = 15) had significantly decreased body weight ( P = .003), mid-upper-arm circumference ( P = .002), and body fat ( P = .002) by the end of intervention. A trend of body weight gain in the intervention group (n = 17; P = .08) and significant increase of body fat ( P = .002) was observed; moreover, patients reported a significant improvement in fatigue ( P = .002) and appetite scores ( P = .006) under quality-of-life domains at the end of intervention. Embedding a nutrition-sensitive intervention ( IAtta ) within Indian palliative care therapy may improve quality of life and stabilize body weight in cancer cachexia patients.

  13. Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol

    Directory of Open Access Journals (Sweden)

    Jin Yan

    2017-04-01

    Full Text Available Abstract Background Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM. Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. Methods This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs, personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers’ development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject’s participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis

  14. Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol.

    Science.gov (United States)

    Yan, Jin; Zhang, Aidi; Zhou, Liang; Huang, Zhulin; Zhang, Pan; Yang, Guoli

    2017-04-24

    Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM). Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app) aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs), personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers' development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject's participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis. This will be the first study of its kind in China to

  15. Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

    Science.gov (United States)

    Klein, Jan Philipp; Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

    2017-07-13

    This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. The study takes place in five diagnostic centres in Germany. A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. ClinicalTrials.gov NCT01636752. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  16. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy.

    Science.gov (United States)

    Ulberg, Randi; Hersoug, Anne Grete; Høglend, Per

    2012-09-06

    Depression in adolescents seems to be a growing problem that causes mental suffering and prevents young people from joining the workforce. There is also a high risk of relapse during adult life. There is emerging evidence for the effect of psychodynamic psychotherapy in adolescents. In-session relational intervention (that is, transference intervention) is a key component of psychodynamic psychotherapy. However, whether depressed adolescents profit most from psychodynamic psychotherapy with or without transference interventions has not been stated. The effect of transference interventions in depressed adolescents and the moderator moderating effect of quality of object relations, personality disorder and gender will be explored. The First Experimental Study of Transference Work-In Teenagers (FEST-IT) will be a randomized clinical trial with a dismantling design. The study is aimed to explore the effects of transference work in psychodynamic psychotherapy for adolescents with depression. One hundred patients ages 16 to 18 years old will be randomized to one of two treatment groups, in both of which general psychodynamic techniques will be used. The patients will be treated over 28 weeks with either a moderate level of transference intervention or no transference intervention. Follow-up will be at 1 year after treatment termination. The outcome measures will be the Psychodynamic Functioning Scales (PFS), Inventory of Interpersonal Problems-Circumplex Version (IIP-C), Global Assessment of Functioning (GAF), and the total mean score of Symptom Checklist-90 (Global Severity Index; GSI), Beck Depression Inventory (BDI), and Montgomery Åsberg Rating Scale (MADRS). The quality of adolescents' relationships will be a central focus of the study, and the Adolescent Relationship Scales (ARS) and Differentiation-Relatedness Scale (DRS) will also be used. Change will be assessed using linear-mixed models. Gender personality disorder (PD) and quality of object relations (QOR

  17. A group-based counselling intervention for depression comorbid with HIV/AIDS using a task shifting approach in South Africa: a randomized controlled pilot study.

    Science.gov (United States)

    Petersen, I; Hanass Hancock, J; Bhana, A; Govender, K

    2014-04-01

    Co-morbid depression in HIV-positive patients on anti-retroviral (ART) treatment poses a public health threat. It compromises treatment adherence and accelerates disease progression. This study aimed to assess the feasibility of a group-based counselling intervention for depressed HIV-positive patients in primary health care (PHC) in South Africa using a task shifting approach. Using a randomized control design, 76 HIV-positive patients with co-morbid depression were initially recruited. This reduced to 34 in the final cohort. Participants were assessed using the Patient Health Questionnaire (PHQ9), Hopkins Symptom Checklist (HSCL-25) and Multidimensional Scale of Perceived Social Support (MSPSS) at baseline and 3-month follow-up. The intervention was adapted from a local group-based Interpersonal Therapy (IPT) intervention. Process evaluation interviews were held with the HIV counsellors who delivered the intervention and a sub-sample of participants. Repeated measures ANOVA analysis showed significantly greater improvement on depression scores on the PHQ9 in the intervention group compared to the control group. A significant decline in the mean scores on the HSCL-25 was found for both groups although this was more pronounced for the intervention group. There was no significant improvement in the MSPSS scores. The small sample size of the final cohort affected the power of the study to detect significant differences between the intervention and control groups on the MSPSS. Longer term impact of the intervention is unknown. These preliminary findings suggest that group-based counselling for depression in HIV-positive patients can potentially be effectively delivered by appropriately trained and supported lay HIV counsellors. The need for a larger trial is indicated. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol.

    Science.gov (United States)

    Williams, Amanda; Wiggers, John; O'Brien, Kate M; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Robson, Emma; McAuley, James; Haskins, Robin; Kamper, Steven J; Williams, Christopher M

    2016-02-11

    Low back pain is a highly prevalent condition with a significant global burden. Management of lifestyle factors such as overweight and obesity may improve low back pain patient outcomes. Currently there are no randomised controlled trials that have been conducted to assess the effectiveness of lifestyle behavioural interventions in managing low back pain. The aim of this trial is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care. A randomised controlled trial will be conducted with patients waiting for an outpatient consultation with an orthopaedic surgeon at a public tertiary referral hospital within New South Wales, Australia for chronic low back pain. Patients will be randomly allocated in a 1:1 ratio to receive a lifestyle behavioural intervention (intervention group) or continue with usual care (control group). After baseline data collection, patients in the intervention group will receive a clinical consultation followed by a 6-month telephone-based lifestyle behavioural intervention (10 individually tailored sessions over a 6-month period) and patients in the control group will continue with usual care. Participants will be followed for 26 weeks and asked to undertake three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 post randomisation to collect primary and secondary outcome data. The study requires a sample of 80 participants per group to detect a 1.5 point difference in pain intensity (primary outcome) 26 weeks post randomisation. The primary outcome, pain intensity, will be measured using a 0-10 numerical rating scale. The study will provide robust evidence regarding the effectiveness of a lifestyle behavioural intervention in reducing pain intensity in overweight or obese patients with low back pain and inform management of these patients. Australian New Zealand Clinical Trials Registry

  19. A randomised controlled trial of a theory-based intervention to improve sun protective behaviour in adolescents ('you can still be HOT in the shade': study protocol

    Directory of Open Access Journals (Sweden)

    Hawkes Anna L

    2012-01-01

    Full Text Available Abstract Background Most skin cancers are preventable by encouraging consistent use of sun protective behaviour. In Australia, adolescents have high levels of knowledge and awareness of the risks of skin cancer but exhibit significantly lower sun protection behaviours than adults. There is limited research aimed at understanding why people do or do not engage in sun protective behaviour, and an associated absence of theory-based interventions to improve sun safe behaviour. This paper presents the study protocol for a school-based intervention which aims to improve the sun safe behaviour of adolescents. Methods/design Approximately 400 adolescents (aged 12-17 years will be recruited through Queensland, Australia public and private schools and randomized to the intervention (n = 200 or 'wait-list' control group (n = 200. The intervention focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour, and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during three × one hour sessions over a three week period from a trained facilitator during class time. Data will be collected one week pre-intervention (Time 1, and at one week (Time 2 and four weeks (Time 3 post-intervention. Primary outcomes are intentions to sun protect and sun protection behaviour. Secondary outcomes include attitudes toward performing sun protective behaviours (i.e., attitudes, perceptions of normative support to sun protect (i.e., subjective norms, group norms, and image norms, and perceived control over performing sun protective behaviours (i.e., perceived behavioural control. Discussion The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of adolescents.

  20. Rapid reduction of malaria following introduction of vector control interventions in Tororo District, Uganda: a descriptive study.

    Science.gov (United States)

    Oguttu, David W; Matovu, Joseph K B; Okumu, David C; Ario, Alex R; Okullo, Allen E; Opigo, Jimmy; Nankabirwa, Victoria

    2017-05-30

    In 2012, Tororo District had the highest malaria burden in Uganda with community Plasmodium prevalence of 48%. To control malaria in the district, the Ministry of Health introduced universal distribution of long lasting insecticide-treated nets (LLINs) in 2013 and added indoor residual spraying (IRS) in 2014. This study assessed malaria incidence, test positivity rates and outpatient (OPD) attendance due to malaria before and after vector control interventions. This study was based on analysis of Health Management Information System (HMIS) secondary malaria surveillance data of 2,727,850 patient records in OPD registers of 61 health facilities from 2012 to 2015. The analysis estimated monthly malaria incidence for the entire population and also separately for malaria cases in OPD. Chi square for trends was used to analyse annual change in malaria incidence and logistic regression for monthly reduction. Following universal LLINs coverage, the annual mean monthly malaria incidence fell from 95 cases in 2013 to 76 cases per 1000 in 2014 with no significant monthly reduction (OR = 0.99, 95% CI 0.96-1.01, P = 0.37). Among children malaria incidence reduced from 130 to 100 cases per 1000 (OR = 0.98, 95% CI 0.97-1.00, P = 0.08) when LLINs were used alone in 2014, but declined to 45 per 1000 in 2015 when IRS was combined with LLINs (OR = 0.94, 95% CI 0.91-0.996, P malaria incidence reduced from 59 to 52 cases per 1000 (OR = 0.99, 95% CI 0.97-1.02, P = 0.8) when LLINs were used alone in 2014, but reduced significantly to 25 per 1000 in 2015 (OR = 0.91, 95% CI 0.88-0.94, P Malaria test positivity rate reduced from 57% in 2013 to 30% (Chi = 15, P malaria incidence was observed in Tororo District following the introduction of IRS in addition to LLINs. There was no significant reduction in malaria incidence following universal distribution of LLINs to communities before introduction of IRS.

  1. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

    2018-04-15

    To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

  2. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol.

    Science.gov (United States)

    Tan, Ai May; Lamontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-04-29

    Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis

  3. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  4. Effectiveness of a minimal intervention for stress-related mental disorders with sick leave (MISS): study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641

    NARCIS (Netherlands)

    Bakker, I.M.; Terluin, B.; van Marwijk, H.W.J.; Cundy, C.M.; Smit, J.H.; van Mechelen, W.; Stalman, W.A.B.

    2006-01-01

    Background: The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS), as well as to ascertain the study complies with the requirements for a cluster randomised controlled

  5. The UPBEAT Nurse-Delivered Personalized Care Intervention for People with Coronary Heart Disease Who Report Current Chest Pain and Depression: A Randomised Controlled Pilot Study

    NARCIS (Netherlands)

    Barley, E.A.; Walters, P.; Haddad, M.; Phillips, R.; Achilla, E.; McCrone, P.; van Marwijk, H.W.J.; Mann, A.; Tylee, A.

    2014-01-01

    Background: Depression is common in people with coronary heart disease (CHD) and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial

  6. A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

    Science.gov (United States)

    Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

    2012-01-01

    Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according

  7. Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy

    International Nuclear Information System (INIS)

    Gollhofer, Sandra M; Wiskemann, Joachim; Schmidt, Martina E; Klassen, Oliver; Ulrich, Cornelia M; Oelmann, Jan; Hof, Holger; Potthoff, Karin; Steindorf, Karen

    2015-01-01

    Over the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials. However, it has been argued that results may be biased by selective participation. Therefore, we investigated factors influencing participation in a randomized exercise intervention trial for breast cancer patients. Non-metastatic breast cancer patients were systematically screened for a randomized exercise intervention trial on cancer-related fatigue. Participants and nonparticipants were compared concerning sociodemographic characteristics (age, marital status, living status, travel time to the training facility), clinical data (body-mass-index, tumor stage, tumor size and lymph node status, comorbidities, chemotherapy), fatigue, and physical activity. Reasons for participation or declination were recorded. 117 patients (52 participants, 65 nonparticipants) were evaluable for analysis. Multiple regression analyses revealed significantly higher odds to decline participation among patients with longer travel time (p = 0.0012), living alone (p = 0.039), with more comorbidities (0.031), previous chemotherapy (p = 0.0066), of age ≥ 70 years (p = 0.025), or being free of fatigue (p = 0.0007). No associations were found with BMI or physical activity. By far the most frequently reported reason for declination of participation was too long commuting time to the training facility. Willingness of breast cancer patients to participate in a randomized exercise intervention study differed by sociodemographic factors and health status. Neither current physical activity level nor BMI appeared to be selective for participation. Reduction of personal inconveniences and time effort, e.g. by decentralized training facilities or flexible training schedules, seem most promising for enhancing participation in exercise intervention trials. Registered at ClinicalTrials.gov: NCT01468766 (October 2011)

  8. PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    de Jonge Peter

    2011-06-01

    Full Text Available Abstract Background There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease. The main objective of this study is to assess the effects of cognitive behavioural therapy in pregnant women with symptoms of anxiety or depression on the child's development as well as behavioural and emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of cognitive behavioural therapy relative to usual care. Methods/design We will include 300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women we will be able to demonstrate effect sizes of 0.35 or over on the total problems scale of the child behavioural checklist 1.5-5 with alpha 5% and power (1-beta 80%. Women in the intervention arm are offered 10-14 individual cognitive behavioural therapy sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week. Women in the control group receive care as usual. Primary outcome is behavioural/emotional problems at 1.5 years of age as assessed by the total problems scale of the child behaviour checklist 1.5 - 5 years. Secondary outcomes will be mental, psychomotor and behavioural development of the child at age 18 months according to the Bayley scales, maternal anxiety and depression during pregnancy and postpartum, and neonatal outcomes such as birth weight, gestational age and Apgar score, health care consumption and general health status

  9. A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

    Science.gov (United States)

    Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

    2016-06-01

    To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

  10. Cluster randomised controlled trial of a consumer behaviour intervention to improve healthy food purchases from online canteens: study protocol

    OpenAIRE

    Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris; Wolfenden, Luke

    2017-01-01

    Introduction School canteens represent an opportune setting in which to deliver public health nutrition strategies given their wide reach, and frequent use by children. Online school canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer behaviour strategies that impact on purchasing decisions. The aim of this study is to assess the efficacy of a consumer behaviour intervention i...

  11. A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students

    OpenAIRE

    Coumaravelou Saravanan; Rajiah Kingston

    2014-01-01

    Background: Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Materials and Methods: Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress a...

  12. Protocol for a randomized controlled dismantling study of a brief telephonic psychological intervention applied to non-professional caregivers with symptoms of depression.

    Science.gov (United States)

    Vázquez, Fernando L; Torres, Ángela; Díaz, Olga; Otero, Patricia; Blanco, Vanessa; Hermida, Elisabet

    2015-11-23

    Although depression is a common problem in caregivers and there are effective cognitive-behavioral interventions for its prevention, the ability of caregivers to attend these treatments is often limited by logistics. Furthermore, the efficacy of the components of these interventions is unknown. The objectives of this study are to (a) evaluate the efficacy of a telephone-administered cognitive-behavioral intervention to prevent depression with all its components (cognitive and behavioral) and only with behavioral activation, and to (b) analyze the mediators of the change in depressive symptoms. A randomized controlled clinical trial was designed to dismantle the components of a cognitive-behavioral intervention. Caregivers with elevated depressive symptoms will be randomly assigned to a cognitive-behavioral intervention, an intervention with only the behavioral activation component, or a usual care control group. Each condition will consist of approximately 60 participants. The two interventions will consist of five sessions lasting 90 min each, applied to groups of about 5 participants at a time via conference call. Trained interviewers, blind to the experimental conditions, will conduct the assessments at the pre-treatment, post-treatment and 1-, 3-, 6- and 12-month follow-ups. This study will provide evidence of the efficacy of a cognitive-behavioral intervention to prevent depression in caregivers with elevated depressive symptoms administered via conference call, and on the impact of the behavioral activation component on the overall efficacy of the program. If we find favorable results, it would mean that we have developed a program of prevention of depression of higher clinical utility and efficacy than those currently available, which would make it possible for a large number of caregivers to have access to such resources. ClinicalTrials.gov: NCT02292394. Registered 6 November 2014.

  13. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  14. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia

    NARCIS (Netherlands)

    Peters, R.M.H.; Zweekhorst, M.B.M.; Bunders-Aelen, J.G.F.; van Brakel, W.H.

    2015-01-01

    Background: Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’. Methods/Principal Findings: This cluster-randomized controlled

  15. Efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline in Twin Families (VIPP-Twins): Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Euser, Saskia; Bakermans-Kranenburg, Marian J; van den Bulk, Bianca G; Linting, Mariëlle; Damsteegt, Rani C; Vrijhof, Claudia I; van Wijk, Ilse C; Crone, Eveline A; van IJzendoorn, Marinus H

    2016-06-06

    Intervention programs with the aim of enhancing parenting quality have been found to be differentially effective in decreasing negative child outcomes such as externalizing behavioral problems, resulting in modest overall effect sizes. Here we present the protocol for a randomized controlled trial to examine the efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline for Twin Families (VIPP-Twins) on parenting quality and children's behavioral control and social competence. In addition, we aim to test the differential susceptibility theory; we examine differential efficacy of the intervention based on genetic make-up or temperament for both parents and children. Lastly, we explore neurobiological mechanisms underlying intervention effects on children's developmental outcomes. The original VIPP-SD was adapted for use in families with twins. The VIPP-Twins consists of five biweekly sessions in which the families are visited at home, parent-child interactions are videotaped and parents receive positive feedback on selected video fragments. Families (N = 225) with a same sex twin (mean age = 3.6 years) were recruited to participate in the study. The study consists of four assessments. After two baseline assessments in year 1 and year 2, a random 40 % of the sample will receive the VIPP-Twins program. The first post-test assessment will be carried out one month after the intervention and there will be a long term follow-up assessment two years after the intervention. Measures include observational assessments of parenting and children's social competence and behavioral control, and neurobiological assessments (i.e., hormonal functioning and neural (re-)activity). Results of the study will provide insights in the efficacy of the VIPP-Twins and reveal moderators and mediators of program efficacy. Overall the randomized controlled trial is an experimental test of the differential susceptibility theory. Dutch Trial

  16. The role of a personalized dietary intervention in managing gestational weight gain: a prospective, controlled study in a low-risk antenatal population.

    Science.gov (United States)

    Di Carlo, Costantino; Iannotti, Giuseppina; Sparice, Stefania; Chiacchio, Maria Pia; Greco, Elena; Tommaselli, Giovanni Antonio; Nappi, Carmine

    2014-04-01

    To compare the efficacy of a personal dietary intervention on gestational weight gain control with a general intervention promoting healthy eating. Prospective, controlled study including 154 low-risk pregnant women randomly allocated to two groups: 77 receiving a personalized diet plan and a close follow-up by a dietician (intervention group), 77 receiving standard dietary care by means of a brochure on healthy eating during pregnancy (control group). Pre-pregnancy weight, gestational age, height, weight and BMI at baseline, weight at term, gestational age at delivery and newborn weight were recorded for all participants. The primary end-point was the difference in body weight between baseline and term. Secondary end-points were the difference in body weight between pre-pregnancy and term and in newborn weights. Maternal weight gain at term was significantly lower both as compared to pre-pregnancy weight (8.2 ± 4.0 vs. 13.4 ± 4.2 kg; p weight at baseline (7.7 ± 3.8 vs. 13.7 ± 4.3 kg; p weight between baseline and term and newborn weight was observed in both groups, but stronger in patients from the intervention group (intervention group R = 0.76, p weight gain in pregnant women.

  17. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial.

    Science.gov (United States)

    Koivusalo, Saila B; Rönö, Kristiina; Klemetti, Miira M; Roine, Risto P; Lindström, Jaana; Erkkola, Maijaliisa; Kaaja, Risto J; Pöyhönen-Alho, Maritta; Tiitinen, Aila; Huvinen, Emilia; Andersson, Sture; Laivuori, Hannele; Valkama, Anita; Meinilä, Jelena; Kautiainen, Hannu; Eriksson, Johan G; Stach-Lempinen, Beata

    2016-01-01

    To assess whether gestational diabetes mellitus (GDM) can be prevented by a moderate lifestyle intervention in pregnant women who are at high risk for the disease. Two hundred ninety-three women with a history of GDM and/or a prepregnancy BMI of ≥30 kg/m(2) were enrolled in the study at lifestyle intervention reduced the incidence of GDM by 39% in high-risk pregnant women. These findings may have major health consequences for both the mother and the child. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  18. Nutrition and Culinary in the Kitchen Program: a randomized controlled intervention to promote cooking skills and healthy eating in university students - study protocol.

    Science.gov (United States)

    Bernardo, Greyce Luci; Jomori, Manuela Mika; Fernandes, Ana Carolina; Colussi, Claudia Flemming; Condrasky, Margaret D; Proença, Rossana Pacheco da Costa

    2017-12-20

    Community-based intervention studies that aim at developing cooking skills have increased in the scientific literature and are related to healthier food practices. However, methodological limitations are observed and only a few studies have university students as the target. The university entrance period has been related to negative changes in eating habits among young people and it represents an important period for developing interventions for health promotion. This study describes the study protocol and the evaluation framework for the Nutrition and Culinary in the Kitchen program. This program aims to develop cooking skills in university students, and is based on the Cooking with a Chef program in the United States. This ongoing, randomized controlled intervention was designed with a six month follow-up study. The intervention consisted of three-hour weekly classes during a six week period with printed materials provided. Five of the classes were hands-on cooking and one was a tour to a popular food market. There were eight primary outcome measures: changes in relation to i) accessibility and availability of fruits and vegetables; ii) cooking attitudes; iii) cooking behaviors at home; iv) cooking behaviors away from home; v) produce consumption self-efficacy; vi) self-efficacy for using basic cooking techniques; vii) self-efficacy for using fruits, vegetables, and seasonings (while cooking); and viii) knowledge of cooking terms and techniques. Secondary outcomes included changes in body mass index and in personal characteristics related to cooking. Repeated measures were collected through the application of an online self-completed survey, at baseline, after intervention and six months after intervention. A sample of 80 university students (40: intervention group; 40: control group) was estimated to detect a mean change of 1.5 points in cooking knowledge, with study power of 80%, and 95% level of confidence, plus 20% for random losses and 10% for confounding

  19. A randomised control crossover trial of a theory based intervention to improve sun-safe and healthy behaviours in construction workers: study protocol.

    Science.gov (United States)

    Nioi, Amanda; Wendelboe-Nelson, Charlotte; Cowan, Sue; Cowie, Hilary; Rashid, Shahzad; Ritchie, Peter; Cherrie, Mark; Lansdown, Terry C; Cherrie, John W

    2018-02-15

    Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels. Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and

  20. Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rachel Chambers

    2016-04-01

    Full Text Available Abstract Background American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States. Methods/Design The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18–49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex. Discussion This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other

  1. Magnetoencephalography for the Detection of Intervention Effects of a Specific Nutrient Combination in Patients with Mild Alzheimer's Disease: Results from an Exploratory Double-Blind, Randomized, Controlled Study.

    Science.gov (United States)

    van Straaten, Elisabeth C W; de Waal, Hanneke; Lansbergen, Marieke M; Scheltens, Philip; Maestu, Fernando; Nowak, Rafal; Hillebrand, Arjan; Stam, Cornelis J

    2016-01-01

    Synaptic loss is an early pathological finding in Alzheimer's disease (AD) and correlates with memory impairment. Changes in macroscopic brain activity measured with electro- and magnetoencephalography (EEG and MEG) in AD indicate synaptic changes and may therefore serve as markers of intervention effects in clinical trials. EEG peak frequency and functional networks have shown, in addition to improved memory performance, to be sensitive to detect an intervention effect in mild AD patients of the medical food Souvenaid containing the specific nutrient combination Fortasyn ® Connect, which is designed to enhance synapse formation and function. Here, we explore the value of MEG, with higher spatial resolution than EEG, in identifying intervention effects of the nutrient combination by comparing MEG spectral measures, functional connectivity, and networks between an intervention and a control group. Quantitative markers describing spectral properties, functional connectivity, and graph theoretical aspects of MEG from the exploratory 24-week, double-blind, randomized, controlled Souvenir II MEG sub-study (NTR1975, http://www.trialregister.nl) in drug naïve patients with mild AD were compared between a test group ( n  = 27), receiving Souvenaid, and a control group ( n  = 28), receiving an isocaloric control product. The groups were unbalanced at screening with respect to Mini-Mental State Examination. Peak frequencies of MEG were compared with EEG peak frequencies, recorded in the same patients at similar time points, were compared with respect to sensitivity to intervention effects. No consistent statistically significant intervention effects were detected. In addition, we found no difference in sensitivity between MEG and EEG peak frequency. This exploratory study could not unequivocally establish the value of MEG in detecting interventional effects on brain activity, possibly due to small sample size and unbalanced study groups. We found no indication that

  2. Multistrategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services: a study protocol for a randomised controlled trial

    Science.gov (United States)

    Seward, Kirsty; Finch, Meghan; Wiggers, John; Wyse, Rebecca; Jones, Jannah; Gillham, Karen; Yoong, Sze Lin

    2016-01-01

    Introduction Interventions to improve child diet are recommended as dietary patterns developed in childhood track into adulthood and influence the risk of chronic disease. For child health, childcare services are required to provide foods to children consistent with nutrition guidelines. Research suggests that foods and beverages provided by services to children are often inconsistent with nutrition guidelines. The primary aim of this study is to assess, relative to a usual care control group, the effectiveness of a multistrategy childcare-based intervention in improving compliance with nutrition guidelines in long day care services. Methods and analysis The study will employ a parallel group randomised controlled trial design. A sample of 58 long day care services that provide all meals (typically includes 1 main and 2 mid-meals) to children while they are in care, in the Hunter New England region of New South Wales, Australia, will be randomly allocated to a 6-month intervention to support implementation of nutrition guidelines or a usual care control group in a 1:1 ratio. The intervention was designed to overcome barriers to the implementation of nutrition guidelines assessed using the theoretical domains framework. Intervention strategies will include the provision of staff training and resources, audit and feedback, ongoing support and securing executive support. The primary outcome of the trial will be the change in the proportion of long day care services that have a 2-week menu compliant with childcare nutrition guidelines, measured by comprehensive menu assessments. As a secondary outcome, child dietary intake while in care will also be assessed. To assess the effectiveness of the intervention, the measures will be undertaken at baseline and ∼6 months postbaseline. Ethics and dissemination The study was approved by the Hunter New England Human Research Ethics Committee. Study findings will be disseminated widely through peer-reviewed publications. PMID

  3. Systematic review of control groups in nutrition education intervention research.

    Science.gov (United States)

    Byrd-Bredbenner, Carol; Wu, FanFan; Spaccarotella, Kim; Quick, Virginia; Martin-Biggers, Jennifer; Zhang, Yingting

    2017-07-11

    Well-designed research trials are critical for determining the efficacy and effectiveness of nutrition education interventions. To determine whether behavioral and/or cognition changes can be attributed to an intervention, the experimental design must include a control or comparison condition against which outcomes from the experimental group can be compared. Despite the impact different types of control groups can have on study outcomes, the treatment provided to participants in the control condition has received limited attention in the literature. A systematic review of control groups in nutrition education interventions was conducted to better understand how control conditions are described in peer-reviewed journal articles compared with experimental conditions. To be included in the systematic review, articles had to be indexed in CINAHL, PubMed, PsycINFO, WoS, and/or ERIC and report primary research findings of controlled nutrition education intervention trials conducted in the United States with free-living consumer populations and published in English between January 2005 and December 2015. Key elements extracted during data collection included treatment provided to the experimental and control groups (e.g., overall intervention content, tailoring methods, delivery mode, format, duration, setting, and session descriptions, and procedures for standardizing, fidelity of implementation, and blinding); rationale for control group type selected; sample size and attrition; and theoretical foundation. The search yielded 43 publications; about one-third of these had an inactive control condition, which is considered a weak study design. Nearly two-thirds of reviewed studies had an active control condition considered a stronger research design; however, many failed to report one or more key elements of the intervention, especially for the control condition. None of the experimental and control group treatments were sufficiently detailed to permit replication of the

  4. Efficacy of a family intervention program for prevention of hospitalization in patients with schizophrenia. A naturalistic multicenter controlled and randomized study in Spain.

    Science.gov (United States)

    Mayoral, Fermín; Berrozpe, Adela; de la Higuera, Jesús; Martinez-Jambrina, Juan José; de Dios Luna, Juan; Torres-Gonzalez, Francisco

    2015-01-01

    According to most relevant guidelines, family psycho-educational interventions are considered to be one the most effective psychosocial treatments for people with schizophrenia. The main outcome measure in controlled and randomized studies has been prevention of relapses and admissions, and encouragement of compliance, although some questions remain about its applicability and results in clinical practice. The aim of study was to evaluate the efficacy and implementation of a single family psychoeducational intervention in 'real' conditions for people diagnosed with schizophrenia. A total of 88 families were randomized in two groups. The family intervention group received a 12 months psychoeducational treatment, and the other group followed normal standard treatment. Assessments were made at baseline, at 12 and at 18 months. The main outcome measure was hospitalization, and secondary outcome measures were clinical condition (BPRS-E) and social disability (DAS-II). A total of 71 patients finished the study (34 family intervention group and 37 control group). Patients who received family intervention reduced the risk of hospitalization by 40% (P = .4018; 95%CI: 0.1833-0.6204). Symptomatology improved significantly at 12 months (P = .4018; 95%CI: 0.1833-0.6204), but not at 18 months (P = .4018; 95%CI: 0.1833-0.6204). Social disability was significantly reduced in the family intervention group at 12 months and 18 months. Family psychoeducational intervention reduces hospitalization risk and improves clinical condition and social functioning of people with schizophrenia. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

  5. The Classroom Communication Resource (CCR) intervention to change peer's attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Mallick, Rizwana; Kathard, Harsha; Thabane, Lehana; Pillay, Mershen

    2018-01-17

    Children who stutter (CWS) are at a high-risk of being teased and bullied in primary school because of negative peer attitudes and perceptions towards stuttering. There is little evidence to determine if classroom-based interventions are effective in changing peer attitudes towards stuttering. The primary objective is to determine the effect of the Classroom Communication Resource (CCR) intervention versus usual practice, measured using the Stuttering Resource Outcomes Measure (SROM) 6-months post-intervention among grade 7 students. The secondary objective is to investigate attitude changes towards stuttering among grade participants on the SROM subscales. A cluster randomised controlled trial (RCT) will be conducted with schools as the unit of randomization. Schools will be stratified into quintile groups, and then randomized to receive the CCR intervention or usual practice. Quintile stratification will be conducted in accordance to the Western Cape Department of Education classification of schools according to geographical location, fee per school and allocation of resources and funding. Participants will include primary schools in the lower (second and third) and higher (fourth and fifth) quintiles and children aged 11 years or older in grade 7 will be included. The study will consist of the CCR intervention program or usual practice as a no-CCR control. The CCR is a classroom-based, teacher led intervention tool including a story, role-play and discussion. The grade 7 teachers allocated to the CCR intervention, will be trained and will administer the intervention. The analysis will follow intention-to-treat (ITT) principle and generalized estimating equations (GEE) to compare groups on the global SROM and its subscales to account for possible clustering within schools. The subgroup hypothesis will be tested by adding an interaction term of quintile group x intervention. This study is designed to assess whether the CCR intervention versus usual practice in

  6. Effects of sodium and potassium supplementation on blood pressure and arterial stiffness: a fully controlled dietary intervention study

    NARCIS (Netherlands)

    Gijsbers, L.; Dower, J.I.; Mensink, M.R.; Siebelink, A.E.; Bakker, S.J.L.; Geleijnse, J.M.

    2015-01-01

    We performed a randomised, placebo-controlled, crossover study to examine the effects of sodium and potassium supplementation on blood pressure (BP) and arterial stiffness in untreated (pre)hypertensive individuals. During the study, subjects were on a fully controlled diet that was relatively low

  7. Effects of a brief mindfulness-based intervention program for stress management among medical students: the Mindful-Gym randomized controlled study.

    Science.gov (United States)

    Phang, Cheng Kar; Mukhtar, Firdaus; Ibrahim, Normala; Keng, Shian-Ling; Mohd Sidik, Sherina

    2015-12-01

    Pursuing undergraduate medical training can be very stressful and academically challenging experience. A 5-week mindfulness-based stress management (MBSM/Mindful-Gym) program was developed to help medical students cope with stress. The aim of this study was to evaluate the effectiveness of the intervention in reducing stress among students in a medical school in Malaysia. Seventy-five medical students participated in the program. They were stratified according to years of studies and randomly allocated to intervention (N = 37) and control groups (N = 38). The following outcome variables were measured at pre- and post-intervention: mindfulness (with Mindful Awareness Attention Scale); perceived stress (with Perceived Stress Scale); mental distress (with General Health Questionnaire), and self-efficacy (with General Self-efficacy Scale). Hierarchical multiple regressions were used to analyse the effect of group (intervention vs. control) on changes in the outcome variables. There were significant improvements at one week post-intervention in all outcome variables: mindfulness (β = 0.19, ΔR2 = 0.04, p = .040, f (2) = 0.05), perceived stress (β = -0.26, ΔR2 = 0.07, p = .009, f (2) = 0.10); mental distress (β = -0.28, ΔR2 = 0.10, p = .003, f (2) = 0.15); and self-efficacy (β = 0.30, ΔR2 = 0.09, p students in Malaysia.

  8. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

    Science.gov (United States)

    Wright, Julie A; Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

    2014-11-10

    Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405

  9. Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial.

    Science.gov (United States)

    Schag, Kathrin; Leehr, Elisabeth J; Martus, Peter; Bethge, Wolfgang; Becker, Sandra; Zipfel, Stephan; Giel, Katrin E

    2015-12-18

    The core symptom of binge eating disorder (BED) is recurrent binge eating that is accompanied by a sense of loss of control. BED is frequently associated with obesity, one of the main public health challenges today. Experimental studies deliver evidence that general trait impulsivity and disorder-specific food-related impulsivity constitute risk factors for BED. Cognitive-behavioural treatment (CBT) is deemed to be the most effective intervention concerning BED. We developed a group intervention based on CBT and especially focusing on impulsivity. We hypothesise that such an impulsivity-focused group intervention is able to increase control over impulsive eating behaviour, that is, reduce binge eating episodes, further eating pathology and impulsivity. Body weight might also be influenced in the long term. The present randomised controlled trial investigates the feasibility, acceptance and efficacy of this impulsivity-focused group intervention in patients with BED. We compare 39 patients with BED in the experimental group to 39 patients with BED in the control group at three appointments: before and after the group intervention and in a 3-month follow-up. Patients with BED in the experimental group receive 8 weekly sessions of the impulsivity-focused group intervention with 5-6 patients per group. Patients with BED in the control group receive no group intervention. The primary outcome is the binge eating frequency over the past 4 weeks. Secondary outcomes comprise further eating pathology, general impulsivity and food-related impulsivity assessed by eye tracking methodology, and body weight. Additionally, we assess binge eating and other impulsive behaviour weekly in process analyses during the time period of the group intervention. This study has been approved by the ethics committee of the medical faculty of Eberhard Karls University Tübingen and the University Hospital Tübingen. Data are monitored by the Centre of Clinical Studies, University Hospital T

  10. Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

    Directory of Open Access Journals (Sweden)

    Victoria Jane Palmer

    2016-10-01

    Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

  11. Study sponsorship and the nutrition research agenda: analysis of randomized controlled trials included in systematic reviews of nutrition interventions to address obesity.

    Science.gov (United States)

    Fabbri, Alice; Chartres, Nicholas; Scrinis, Gyorgy; Bero, Lisa A

    2017-05-01

    To categorize the research topics covered by a sample of randomized controlled trials (RCT) included in systematic reviews of nutrition interventions to address obesity; to describe their funding sources; and to explore the association between funding sources and nutrition research topics. Cross-sectional study. RCT included in Cochrane Reviews of nutrition interventions to address obesity and/or overweight. Two hundred and thirteen RCT from seventeen Cochrane Reviews were included. Funding source and authors' conflicts of interest were disclosed in 82·6 and 29·6 % of the studies, respectively. RCT were more likely to test an intervention to manipulate nutrients in the context of reduced energy intake (44·2 % of studies) than food-level (11·3 %) and dietary pattern-level (0·9 %) interventions. Most of the food industry-sponsored studies focused on interventions involving manipulations of specific nutrients (66·7 %). Only 33·1 % of the industry-funded studies addressed dietary behaviours compared with 66·9 % of the non-industry-funded ones (P=0·002). The level of food processing was poorly considered across all funding sources. The predominance of RCT examining nutrient-specific questions could limit the public health relevance of rigorous evidence available for systematic reviews and dietary guidelines.

  12. Interventional studies in nuclear medicine

    International Nuclear Information System (INIS)

    Saha, G.B.; Swanson, D.P.; Hladik, W.B. III

    1987-01-01

    Pharmacological interventions in nuclear medicine studies have been in practice for a long time. The triiodothyronine (T/sub 3/) suppression, Thyroid-stimulating hormone (TSH) stimulation, and perchlorate discharge tests are common examples of well-established diagnostic interventional studies. In recent years, pharmacologic and physiologic interventions in other nuclear medicine procedures have drawn considerable attention. The primary purpose of these interventions is to augment, complement or, more often, differentiate the information obtained from conventional nuclear medicine diagnostic studies. Pharmacologic interventions involve the administration of a specific drug before, during, or after the administration of radiopharmaceutical for a given study. The change in information due to intervention of the drug offers clues to differentiating various disease conditions. These changes can be brought about by physiologic interventions also, e.g., exercise in radionuclide ventriculography. In the latter interventions, the physiologic function of an organ is enhanced or decreased by physical maneuvers, and the changes observed can be used to differentiate various disease conditions

  13. Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

    2013-08-19

    Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

  14. Combining a leadership course and multi-source feedback has no effect on leadership skills of leaders in postgraduate medical education. An intervention study with a control group

    Directory of Open Access Journals (Sweden)

    Scherpbier Albert

    2009-12-01

    Full Text Available Abstract Background Leadership courses and multi-source feedback are widely used developmental tools for leaders in health care. On this background we aimed to study the additional effect of a leadership course following a multi-source feedback procedure compared to multi-source feedback alone especially regarding development of leadership skills over time. Methods Study participants were consultants responsible for postgraduate medical education at clinical departments. Study design: pre-post measures with an intervention and control group. The intervention was participation in a seven-day leadership course. Scores of multi-source feedback from the consultants responsible for education and respondents (heads of department, consultants and doctors in specialist training were collected before and one year after the intervention and analysed using Mann-Whitney's U-test and Multivariate analysis of variances. Results There were no differences in multi-source feedback scores at one year follow up compared to baseline measurements, either in the intervention or in the control group (p = 0.149. Conclusion The study indicates that a leadership course following a MSF procedure compared to MSF alone does not improve leadership skills of consultants responsible for education in clinical departments. Developing leadership skills takes time and the time frame of one year might have been too short to show improvement in leadership skills of consultants responsible for education. Further studies are needed to investigate if other combination of initiatives to develop leadership might have more impact in the clinical setting.

  15. Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Becker, Jan; Beutel, Manfred E; Gerzymisch, Katharina; Schulz, Dirk; Siepmann, Martin; Knickenberg, Rudolf J; Schmädeke, Stefan; Ferdinand, Peter; Zwerenz, Rüdiger

    2016-06-13

    Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation. All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform. We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation. ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

  16. A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial.

    Science.gov (United States)

    Crombie, Iain K; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Petrie, Dennis; Evans, Josie Mm; Emslie, Carol; Jones, Claire; Ricketts, Ian W; Humphris, Gerry; Norrie, John; Rice, Peter; Slane, Peter W

    2014-12-19

    Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems. The frequency of heavy drinking in a single session is high among disadvantaged men. Brief alcohol interventions were developed for, and are usually delivered in, healthcare settings. The group who binge drink most frequently, young to middle-aged disadvantaged men, have less contact with health services and there is a need for an alternative method of intervention delivery. Text messaging has been used successfully to modify other adverse health behaviours. This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men. Disadvantaged men aged 25 to 44 years who drank >8 units of alcohol at least twice in the preceding month will be recruited from the community. Two recruitment strategies will be used: contacting men listed in primary care registers, and a community outreach method (time-space sampling). The intended sample of 798 men will be randomised to intervention or control, stratifying by recruitment method. The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans. The control group will receive behaviourally neutral text messages intended to promote retention in the study. The primary outcome measure is the proportion of men consuming >8 units on at least three occasions in the previous 30 days. Secondary outcomes include total alcohol consumption and the frequency of consuming more than 16 units of alcohol in one session in the previous month. Process measures, developed during a previous feasibility study, will monitor engagement with the key behaviour change components of the intervention. The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm. This study will assess the effectiveness of a brief

  17. Baduanjin Mind-Body Intervention Improves the Executive Control Function

    OpenAIRE

    Chen, Tingting; Yue, Guang H.; Tian, Yingxue; Jiang, Changhao

    2017-01-01

    This study aims at comparing the effects of the Baduanjin mind-body (BMB) intervention with a conventional relaxation training program on enhancing the executive function. The study also attempts to explore the neural substrates underlying the cognitive effect of BMB intervention using near-infrared spectroscopy (NIRS) technique. Forty-two healthy college students were randomly allocated into either the Baduanjin intervention group or relaxation training (control) group. Training lasted for 8...

  18. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

    Directory of Open Access Journals (Sweden)

    Carrasquillo O

    2014-02-01

    Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added

  19. Improving discharge care: the potential of a new organisational intervention to improve discharge after hospitalisation for acute stroke, a controlled before–after pilot study

    OpenAIRE

    Cadilhac, Dominique A; Andrew, Nadine E; Stroil Salama, Enna; Hill, Kelvin; Middleton, Sandy; Horton, Eleanor; Meade, Ian; Kuhle, Sarah; Nelson, Mark R; Grimley, Rohan

    2017-01-01

    Objective Provision of a discharge care plan and prevention therapies is often suboptimal. Our objective was to design and pilot test an interdisciplinary, organisational intervention to improve discharge care using stroke as the case study using a mixed-methods, controlled before–after observational study design. Setting Acute care public hospitals in Queensland, Australia (n=15). The 15 hospitals were ranked against a benchmark based on a composite outcome of three discharge care processes....

  20. Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Harrington Kathleen F

    2012-08-01

    Full Text Available Abstract Background E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit. Design A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Methods A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality

  1. An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Brodbeck, Jeannette; Berger, Thomas; Znoj, Hans Joerg

    2017-01-13

    Marital bereavement and separation or divorce are among the most stressful critical life events in later life. These events require a dissolution of social and emotional ties, adjustments in daily routine and changes in identity and perspectives for the future. After a normative grief or distress reaction, most individuals cope well with the loss. However, some develop a prolonged grief reaction. Internet-based self-help interventions have proved beneficial for a broad range of disorders, including complicated grief. Based on the task model and the dual-process model of coping with bereavement, we developed a guided internet-based self-help intervention for individuals who experienced marital bereavement, separation or divorce at least 6 months prior to enrolment. The intervention consists of 10 text-based self-help sessions and one supportive email a week. The primary purpose of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting control group. The secondary purpose is to compare the effects in bereaved and separated participants. Furthermore, we aim to analyze other predictors, moderators and mediators of the outcome, such as age, psychological distress and intensity of use of the intervention. The design is a randomized controlled trial with a waiting control condition of 12 weeks and a 24-weeks follow-up. At least 72 widowed or separated participants will be recruited via our study website and internet forums. Primary outcomes are reductions in grief symptoms, depression and psychological distress. Secondary outcome measures are related to loneliness, satisfaction with life, embitterment and the sessions. The trial will provide insights into the acceptance and efficacy of internet-based interventions among adults experiencing grief symptoms, psychological distress and adaptation problems in daily life after spousal bereavement, separation or divorce. Findings will add to existing knowledge by (1) evaluating

  2. Combining a leadership course and multi-source feedback has no effect on leadership skills of leaders in postgraduate medical education. An intervention study with a control group.

    Science.gov (United States)

    Malling, Bente; Mortensen, Lene; Bonderup, Thomas; Scherpbier, Albert; Ringsted, Charlotte

    2009-12-10

    Leadership courses and multi-source feedback are widely used developmental tools for leaders in health care. On this background we aimed to study the additional effect of a leadership course following a multi-source feedback procedure compared to multi-source feedback alone especially regarding development of leadership skills over time. Study participants were consultants responsible for postgraduate medical education at clinical departments. pre-post measures with an intervention and control group. The intervention was participation in a seven-day leadership course. Scores of multi-source feedback from the consultants responsible for education and respondents (heads of department, consultants and doctors in specialist training) were collected before and one year after the intervention and analysed using Mann-Whitney's U-test and Multivariate analysis of variances. There were no differences in multi-source feedback scores at one year follow up compared to baseline measurements, either in the intervention or in the control group (p = 0.149). The study indicates that a leadership course following a MSF procedure compared to MSF alone does not improve leadership skills of consultants responsible for education in clinical departments. Developing leadership skills takes time and the time frame of one year might have been too short to show improvement in leadership skills of consultants responsible for education. Further studies are needed to investigate if other combination of initiatives to develop leadership might have more impact in the clinical setting.

  3. E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Antypas, Konstantinos; Wangberg, Silje C

    2012-07-09

    Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open

  4. E-Rehabilitation – an Internet and mobile phone based tailored intervention to enhance self-management of Cardiovascular Disease: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Antypas Konstantinos

    2012-07-01

    Full Text Available Abstract Background Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. Methods/Design A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. Discussion The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively

  5. The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression.

    Science.gov (United States)

    Lloyd-Evans, Brynmor; Bone, Jessica K; Pinfold, Vanessa; Lewis, Glyn; Billings, Jo; Frerichs, Johanna; Fullarton, Kate; Jones, Rebecca; Johnson, Sonia

    2017-10-23

    Loneliness is associated with poor health outcomes at all ages, including shorter life expectancy and greater risk of developing depression. People with mental health problems are particularly vulnerable to loneliness and, for those with anxiety or depression, loneliness is associated with poorer outcomes. Interventions which support people to utilise existing networks and access new social contact are advocated in policy but there is little evidence regarding their effectiveness. People with mental health problems have potential to benefit from interventions to reduce loneliness, but evidence is needed regarding their feasibility, acceptability and outcomes. An intervention to reduce loneliness for people with anxiety or depression treated in secondary mental health services was developed for this study, which will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial. In this feasibility trial, 40 participants with anxiety or depression will be recruited through two secondary mental health services in London and randomised to an intervention (n = 30) or control group (n = 10). The control group will receive standard care and written information about local community resources. The coproduced intervention, developed in this study, includes up to ten sessions with a 'Community Navigator' over a 6-month period. Community Navigators will work with people individually to increase involvement in social activities, with the aim of reducing feelings of loneliness. Data will be collected at baseline and at 6-month follow-up - the end of the intervention period. The acceptability of the intervention and feasibility of participant recruitment and retention will be assessed. Potential primary and secondary outcomes for a future definitive trial will be completed to assess response and completeness, including measures of loneliness, depression and anxiety. Qualitative interviews with participants, staff and other

  6. How does a lifestyle intervention during pregnancy influence perceived barriers to leisure-time physical activity? The Norwegian fit for delivery study, a randomized controlled trial.

    Science.gov (United States)

    Haakstad, Lene A H; Vistad, Ingvild; Sagedal, Linda Reme; Lohne-Seiler, Hilde; Torstveit, Monica K

    2018-05-03

    To develop effective health promotional and preventive prenatal programs, it is important to understand perceived barriers to leisure-time physical activity during pregnancy, including exercise and sport participation. The aims of the present study was 1) to assess the effect of prenatal lifestyle intervention on the perceived barrier to leisure-time physical activity during pregnancy and the first year after delivery and 2) identify the most important perceived barriers to leisure-time physical activity at multiple time points during and after pregnancy. This secondary analysis was part of the Norwegian Fit for Delivery study, a combined lifestyle intervention evaluated in a blinded, randomized controlled trial. Healthy, nulliparous women with singleton pregnancy of ≤20 gestational weeks, age ≥ 18 years and body mass index ≥19 kg/m 2 were recruited via healthcare clinics in southern Norway, including urban and rural settings. Participants were randomized to either twice-weekly supervised exercise sessions and nutritional counselling (n = 303) or standard prenatal care (n = 303). The principal analysis was based on the participants who completed the standardized questionnaire assessing their perceived barriers to leisure-time physical activity at inclusion (gestational week 16, n = 589) and following intervention (gestational week 36, n = 509), as well as six months (n = 470) and 12 months (n = 424) postpartum. Following intervention (gestation week 35.4 ± 1.0), a significant between-group difference in perceived barriers to leisure-time physical activity was found with respect to time constraints: "... I do not have the time" (intervention: 22 vs. control: 38, p = 0.030), mother-child safety concerns: "... afraid to harm the baby" (intervention: 8 vs. control: 25, p = 0.002) and self-efficacy: "... I do not believe/think that I can do it" (intervention: 3 vs. control: 10, p = 0.050). No positive effect was seen

  7. Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sagedal Linda Reme

    2013-02-01

    Full Text Available Abstract Background The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, complications of pregnancy and delivery, and maternal weight retention up to 12 months postpartum. Methods/design Fit for Delivery is a randomized controlled trial that will include 600 women expecting their first child. To be eligible, women must be 18 years of age or older, of less than 20 weeks gestational age, with a singleton pregnancy, and have a Body Mass Index (BMI ≥ 19 kg/m2. The women will be randomly allocated to either an intervention group or a control group. The control group will receive standard prenatal care. The intervention group will, in addition, receive nutritional counseling by phone, access to twice-weekly exercise sessions, and information on healthy eating and physical activity provided in pamphlets, evening meetings and an interactive website. Both groups will be monitored by weighing (including bioimpedance measurements of percent body fat, blood tests, self-report questionnaires and hospital record review. Discussion Weight gained in pregnancy affects the health of both the mother and her unborn child, and simple models for efficient intervention are in high demand. The Fit for Delivery intervention provides concrete advice on limiting energy intake and practical training in increasing physical activity. This lifestyle intervention

  8. Exercise as an Intervention to Reduce Study-Related Fatigue among University Students: A Two-Arm Parallel Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Juriena D de Vries

    Full Text Available Many university students experience high levels of study-related fatigue. This high prevalence, and the negative impact of fatigue on health and academic performance, call for prevention and reduction of these symptoms. The primary aim of the current study was to investigate to what extent an exercise intervention is effective in reducing three indicators of study-related fatigue (emotional exhaustion, overall fatigue, and need for recovery. Effects of exercise on secondary outcomes (sleep quality, self-efficacy, physical fitness, and cognitive functioning were also investigated.Participants were students with high levels of study-related fatigue, currently not exercising or receiving other psychological or pharmacological treatments, and with no medical cause of fatigue. They were randomly assigned to either a six-week exercise intervention (low-intensity running three times a week, n = 49 or wait list (no intervention, n = 48. All participants were measured before the intervention (T0, and immediately after the intervention (T1. Exercisers were also investigated 4 weeks (T2 and 12 weeks (T3 after the intervention.Participants in the exercise condition showed a larger decrease in two of the three indicators of study-related fatigue (i.e., overall fatigue and need for recovery as compared to controls. Additionally, sleep quality and some indicators of cognitive functioning improved more among exercisers than among controls. No effects were found for self-efficacy, and physical fitness. The initial effects of the exercise intervention lasted at follow-up (T2 and T3. At 12-week follow up (T3, 80% of participants in the exercise condition still engaged in regular exercise, and further enhancements were seen for emotional exhaustion, overall fatigue, and sleep quality.These results underline the value of low-intensity exercise for university students with high levels of study-related fatigue. The follow-up effects that were found in this study imply

  9. Evaluation of ergonomic and education interventions to reduce occupational sitting in office-based university workers: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Radas, Antonia; Mackey, Martin; Leaver, Andrew; Bouvier, Anna-Louise; Chau, Josephine Y; Shirley, Debra; Bauman, Adrian

    2013-10-12

    Prolonged sitting is a specific occupational hazard in office workers. There is growing evidence that prolonged sitting is detrimental to metabolic health. The aim of this study is to determine whether providing office workers with education along with adjustable sit-stand workstations leads to reduction in sitting behavior. A randomized control trial (RCT) with three groups (one control group and two intervention groups) will be conducted in an office workplace setting. The education intervention group will receive an education package that encourages reduction in sitting behaviors. The sit-stand desk intervention group will receive the same education package along with an adjustable sit-stand desk. Participants will be included in the study if they are currently employed in a full-time academic or administrative role that involves greater than 15 hours per week or greater than 4 hours per day computer-based work. Baseline data will include participant's age, gender, weight, height, smoking habit, employment position, level of education, and baseline self-reported leisure time physical activity. The primary outcome is the average daily sedentary time during work hours, measured by an accelerometer. Participant recruitment commenced in March 2013 and will be completed by December 2013. This study will determine whether providing office workers with an adjustable sit-stand desk and individually targeted education, or education alone, is more effective in decreasing sitting behaviors than no intervention. Australian New Zealand Clinical Trials Registry: ACTRN12613000366752.

  10. The effect of an expressive writing intervention (EWI) on stress in infertile couples undergoing assisted reproductive technlogy (ART) treatment: A randomized controlled pilot study

    DEFF Research Database (Denmark)

    Matthiesen, Signe Maria Schneevoigt; Klonoff-Cohen, Hillary; Zachariae, Robert

    2012-01-01

    Objectives. Infertile couples undergoing fertility treatments may experience stress and could benefit from psychological intervention. Expressive Writing Intervention (EWI) has shown promising results on various psychological outcomes, yet only one study has applied the method to infertility......-related stress. Our aim was to assess feasibility and effectiveness of EWI for patients in treatment with Assisted Reproductive Technology (ART). Design and participants. Patients enrolling in their first ART treatment at the fertility clinic, Aarhus University Hospital, Denmark were offered to participate....... A total of 82 participants (45 women, 37 men), mean age: 33.17, were randomized to home-based EWI or neutral writing control group and completed an infertility-related stress questionnaire at treatment enrollment, 3 weeks later (at the time of down regulation), and 6 weeks after the intervention...

  11. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence. Cognitive models have contributed significantly to the understanding of unipolar depression and its psychological treatment. However, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence. Our research group has been working on the notion of cognitive conflict viewed as personal dilemmas according to personal construct theory. We use a novel method for identifying those conflicts using the repertory grid technique (RGT). Preliminary results with depressive patients show that about 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused on the resolution of these internal conflicts. This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will enhance the efficacy of cognitive behavioral therapy (CBT) for depression. Design A therapy manual for a dilemma-focused intervention will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: combined group CBT (eight, 2-hour weekly sessions) plus individual dilemma-focused therapy (eight, 1-hour weekly sessions) and CBT alone (eight, 2-hour group weekly sessions plus eight, 1-hour individual weekly sessions). Method Participants are

  12. Psychophysiological effects of a web-based stress management system: a prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861].

    Science.gov (United States)

    Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

    2005-07-25

    The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor alpha (TNFalpha) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

  13. Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861

    Directory of Open Access Journals (Sweden)

    Theorell Töres

    2005-07-01

    Full Text Available Abstract Background The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. Methods A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23–64 from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. Results After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor α (TNFα decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference remained a significant factor in five out of nine predictive models. Conclusion The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

  14. Alcohol-related brief intervention in patients treated for opiate or cocaine dependence: a randomized controlled study

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    Khan Riaz

    2011-08-01

    Full Text Available Abstract Background Despite the importance of heavy drinking and alcohol dependence among patients with opiate and cocaine dependence, few studies have evaluated specific interventions within this group. The aim of the present study was to evaluate the impact of screening with the Alcohol Use Disorders Identification Test (AUDIT and of brief intervention (BI on alcohol use in a sample of patients treated for opioid or cocaine dependence in a specialized outpatient clinic. Methods Adult outpatients treated for opioid or cocaine dependence in Switzerland were screened for excessive alcohol drinking and dependence with the AUDIT. Patients with AUDIT scores that indicated excessive drinking or dependence were randomized into two groups--treatment as usual or treatment as usual together with BI--and assessed at 3 months and 9 months. Results Findings revealed a high rate (44% of problematic alcohol use (excessive drinking and dependence among patients with opiate and cocaine dependence. The number of drinks per week decreased significantly between T0 (inclusion and T3 (month 3. A decrease in average AUDIT scores was observed between T0 and T3 and between T0 and T9 (month 9. No statistically significant difference between treatment groups was observed. Conclusions In a substance abuse specialized setting, screening for alcohol use with the AUDIT, followed by feedback on the score, and use of alcohol BI are both possibly useful strategies to induce changes in problematic alcohol use. Definitive conclusions cannot, however, be drawn from the study because of limitations such as lack of a naturalistic group. An important result of the study is the excellent internal consistency of AUDIT in a population treated for opiate or cocaine dependence.

  15. The efficacy of a brief intervention to reduce alcohol misuse in patients with HIV in South Africa: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Huis in ’t Veld Diana

    2012-10-01

    Full Text Available Abstract Background Alcohol abuse comes with risks for increased morbidity and mortality among patients with HIV. This study aims to determine the prevalence of alcohol use and other risk factors in a sample of primary care patients with HIV in South Africa and to assess a brief intervention to reduce the use of alcohol in this group. Methods/Design A single-blinded randomized controlled trial is designed to determine the efficacy of a brief intervention to reduce hazardous alcohol use in patients with HIV. The study will be carried out on out-patients with HIV in two primary healthcare HIV clinics near Pretoria, South Africa. Alcohol use will be assessed with the Alcohol Use Disorder Identification Test questionnaire. Other data that will be collected relate to health-related quality of life, depression, sexual behavior, internalized AIDS stigma, HIV-related information and adherence to antiretroviral therapy (self-reported 7-day recall of missed doses, Visual Analog Scale and pill count. The intervention consists of a brief counseling session to reduce alcohol risk; the control group receives a health education leaflet. Discussion The findings will be important in the public health setting. If the intervention proves to be efficient, it could potentially be incorporated into the HIV care policy of the Ministry of Health. Trial registration Pan African Clinical trial Registry: PACTR201202000355384

  16. Intervention strategies for control of foodborne pathogens

    Science.gov (United States)

    Juneja, Vijay K.

    2004-03-01

    The increasing numbers of illnesses associated with foodborne pathogens such as Listeria monocytogenes and Escherichia coli O157:H7, has renewed concerns about food safety because of consumer preferences for minimally processed foods that offer convenience in availability and preparation. Accordingly, the need for better control of foodborne pathogens has been paramount in recent years. Mechanical removal of microorganisms from food can be accomplished by centrifugation, filtration, trimming and washing. Cleaning and sanitation strategies can be used for minimizing the access of microorganisms in foods from various sources. Other strategies for control of foodborne pathogens include established physical microbiocidal treatments such as ionizing radiation and heating. Research has continued to demonstrate that food irradiation is a suitable process to control and possibly eliminate foodborne pathogens, for example Listeria monocytogenes and Escherichia coli O157:H7, from a number of raw and cooked meat and poultry products. Heat treatment is the most common method in use today for the inactivation of microorganisms. Microorganisms can also be destroyed by nonthermal treatments, such as application of high hydrostatic pressure, pulsed electric fields, oscillating magnetic fields or a combination of physical processes such as heat-irradiation, or heat-high hydrostatic pressure, etc. Each of the non-thermal technologies has specific applications in terms of the types of food that can be processed. Both conventional and newly developed physical treatments can be used in combination for controlling foodborne pathogens and enhancing the safety and shelf life of foods. Recent research has focused on combining traditional preservation factors with emerging intervention technologies. However, many key issues still need to be addressed for combination preservation factors or technologies to be useful in the food industry to meet public demands for foods with enhanced safety

  17. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Murphy, Jill; Goldsmith, Charles H; Jones, Wayne; Oanh, Pham Thi; Nguyen, Vu Cong

    2017-05-05

    Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces. The MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization's Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat. This study has the potential to add to the knowledge base about

  18. Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial

    OpenAIRE

    Schag, Kathrin; Leehr, Elisabeth J; Martus, Peter; Bethge, Wolfgang; Becker, Sandra; Zipfel, Stephan; Giel, Katrin E

    2015-01-01

    Introduction The core symptom of binge eating disorder (BED) is recurrent binge eating that is accompanied by a sense of loss of control. BED is frequently associated with obesity, one of the main public health challenges today. Experimental studies deliver evidence that general trait impulsivity and disorder-specific food-related impulsivity constitute risk factors for BED. Cognitive-behavioural treatment (CBT) is deemed to be the most effective intervention concerning BED. We developed a gr...

  19. Moderate alcohol consumption reduces plasma C-reactive protein and fibrinogen levels : a randomized, diet-controlled intervention study

    NARCIS (Netherlands)

    Sierksma, A.; Gaag, M.S. van der; Kluft, C.; Hendriks, H.F.J.

    2002-01-01

    Objective: To evaluate the effect of moderate alcohol consumption on the acute phase proteins C-reactive protein and fibrinogen. Design: Randomized, diet-controlled, cross-over study. Setting: The study was performed at TNO Nutrition and Food Research, Zeist, The Netherlands. Subjects: Ten

  20. The Treatment of cardiovascular Risk in Primary care using Electronic Decision supOrt (TORPEDO) study-intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare.

    Science.gov (United States)

    Peiris, David; Usherwood, Tim; Panaretto, Katie; Harris, Mark; Hunt, Jenny; Patel, Bindu; Zwar, Nicholas; Redfern, Julie; Macmahon, Stephen; Colagiuri, Stephen; Hayman, Noel; Patel, Anushka

    2012-01-01

    Large gaps exist in the implementation of guideline recommendations for cardiovascular disease (CVD) risk management. Electronic decision support (EDS) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia. We have developed HealthTracker, a multifaceted EDS and quality improvement intervention to improve the management of CVD risk. It is hypothesised that the use of HealthTracker over a 12-month period will result in: (1) an increased proportion of patients receiving guideline-indicated measurements of CVD risk factors and (2) an increased proportion of patients at high risk will receive guideline-indicated prescriptions for lowering their CVD risk. Sixty health services (40 general practices and 20 Aboriginal Community Controlled Health Services (ACCHSs) will be randomised in a 1:1 allocation to receive either the intervention package or continue with usual care, stratified by service type, size and participation in existing quality improvement initiatives. The intervention consists of point-of-care decision support; a risk communication interface; a clinical audit tool to assess performance on CVD-related indicators; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance. The control arm will continue with usual care without access to these intervention components. Quantitative data will be derived from cross-sectional samples at baseline and end of study via automated data extraction. Detailed process and economic evaluations will also be conducted. The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee (HREC) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC. Formal agreements with each of the participating sites have been signed. In addition to the usual scientific forums, results will be disseminated via newsletters

  1. Understanding perceived availability and importance of tobacco control interventions to inform European adoption of a UK economic model: a cross-sectional study.

    Science.gov (United States)

    Kulchaitanaroaj, Puttarin; Kaló, Zoltán; West, Robert; Cheung, Kei Long; Evers, Silvia; Vokó, Zoltán; Hiligsmann, Mickael; de Vries, Hein; Owen, Lesley; Trapero-Bertran, Marta; Leidl, Reiner; Pokhrel, Subhash

    2018-02-14

    The evidence on the extent to which stakeholders in different European countries agree with availability and importance of tobacco-control interventions is limited. This study assessed and compared stakeholders' views from five European countries and compared the perceived ranking of interventions with evidence-based ranking using cost-effectiveness data. An interview survey (face-to-face, by phone or Skype) was conducted between April and July 2014 with five categories of stakeholders - decision makers, service purchasers, service providers, evidence generators and health promotion advocates - from Germany, Hungary, the Netherlands, Spain, and the United Kingdom. A list of potential stakeholders drawn from the research team's contacts and snowballing served as the sampling frame. An email invitation was sent to all stakeholders in this list and recruitment was based on positive replies. Respondents were asked to rate availability and importance of 30 tobacco control interventions. Kappa coefficients assessed agreement of stakeholders' views. A mean importance score for each intervention was used to rank the interventions. This ranking was compared with the ranking based on cost-effectiveness data from a published review. Ninety-three stakeholders (55.7% response rate) completed the survey: 18.3% were from Germany, 17.2% from Hungary, 30.1% from the Netherlands, 19.4% from Spain, and 15.1% from the UK. Of those, 31.2% were decision makers, 26.9% evidence generators, 19.4% service providers, 15.1% health-promotion advocates, and 7.5% purchasers of services/pharmaceutical products. Smoking restrictions in public areas were rated as the most important intervention (mean score = 1.89). The agreement on availability of interventions between the stakeholders was very low (kappa = 0.098; 95% CI = [0.085, 0.111] but the agreement on the importance of the interventions was fair (kappa = 0.239; 95% CI = [0.208, 0.253]). A correlation was found between

  2. Study protocol: the development of a randomised controlled trial testing a postcard intervention designed to reduce suicide risk among young help-seekers

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    McGorry Patrick

    2009-09-01

    Full Text Available Abstract Background Suicidal behaviour and deliberate self harm are common among adolescents. Limited evidence exists regarding interventions that can reduce risk; however research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from services can reduce risk. The aim of the study is to test a postcard intervention among people aged 15-24 who presented to mental health services but are not accepted, yet are at risk of suicide. Methods/design The study is a 3-year randomised controlled trial conducted at Orygen Youth Health Research Centre in Melbourne Australia. Participants are young help-seekers aged 15-24 who are at risk of suicide. Participants will be recruited over a 12 month period. The intervention comprises a regular postcard to be sent monthly for 12 months. The postcard enquires after their well being and includes information regarding individual sources of help and evidence-based self help strategies. Participants are assessed at baseline, 12 and 18 months. Discussion This paper describes the development of a study which aims to reduce suicide risk in a sample of young help-seekers. If effective, this intervention could have significant clinical and research implications for a population who can be hard to treat and difficult to research. Trial Registration The study was registered with the Australian Clinical Trials Registry; number: ACTRN012606000274572.

  3. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Crétel-Durand, Elodie; Nouguerède, Emilie; Le Caer, Hervé; Rousseau, Frédérique; Retornaz, Frédérique; Guillem, Olivier; Couderc, Anne-Laure; Greillier, Laurent; Norguet, Emmanuelle; Cécile, Maud; Boulahssass, Rabia; Le Caer, Francoise; Tournier, Sandrine; Butaud, Chantal; Guillet, Pierre; Nahon, Sophie; Poudens, Laure; Kirscher, Sylvie; Loubière, Sandrine; Diaz, Nadine; Dhorne, Jean; Auquier, Pascal; Baumstarck, Karine

    2017-04-12

    Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy. This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected). The randomized

  4. Changing Efficacy of Wet Cupping Therapy in Migraine with Lunar Phase: A Self-Controlled Interventional Study

    OpenAIRE

    Benli, Ali Ramazan; Sunay, Didem

    2017-01-01

    Background The aim of this study was to evaluate the effect of blood-letting with wet cupping therapy (WCT) in migraine treatment and to determine whether there was any difference according to the phase of the moon when the treatment was applied. Material/Methods This self-controlled study was conducted in Karabuk between 2014 and 2016. Patients who were diagnosed with migraine were enrolled in the study. Migraine disability assessment questionnaire (MIDAS), demographic characteristics, migra...

  5. Improving discharge care: the potential of a new organisational intervention to improve discharge after hospitalisation for acute stroke, a controlled before-after pilot study.

    Science.gov (United States)

    Cadilhac, Dominique A; Andrew, Nadine E; Stroil Salama, Enna; Hill, Kelvin; Middleton, Sandy; Horton, Eleanor; Meade, Ian; Kuhle, Sarah; Nelson, Mark R; Grimley, Rohan

    2017-08-04

    Provision of a discharge care plan and prevention therapies is often suboptimal. Our objective was to design and pilot test an interdisciplinary, organisational intervention to improve discharge care using stroke as the case study using a mixed-methods, controlled before-after observational study design. Acute care public hospitals in Queensland, Australia (n=15). The 15 hospitals were ranked against a benchmark based on a composite outcome of three discharge care processes. Clinicians from a 'top-ranked' hospital participated in a focus group to elicit their success factors. Two pilot hospitals then participated in the organisational intervention that was designed with experts and consumers. Hospital clinicians involved in discharge care for stroke and patients admitted with acute stroke or transient ischaemic attack. A four-stage, multifaceted organisational intervention that included data reviews, education and facilitated action planning. Three discharge processes collected in Queensland hospitals within the Australian Stroke Clinical Registry were used to select study hospitals: (1) discharge care plan; (2) antihypertensive medication prescription and (3) antiplatelet medication prescription (ischaemic events only). Primary measure: composite outcome. Secondary measures: individual adherence changes for each discharge process; sensitivity analyses. The performance outcomes were compared 3 months before the intervention (preintervention), 3 months postintervention and at 12 months (sustainability). Data from 1289 episodes of care from the two pilot hospitals were analysed. Improvements from preintervention adherence were: antiplatelet therapy (88%vs96%, p=0.02); antihypertensive prescription (61%vs79%, porganisational intervention. The intervention warrants further application and trialling on a larger scale. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is

  6. Sustained effects of a psychoeducational group intervention following bariatric surgery: follow-up of the randomized controlled BaSE study.

    Science.gov (United States)

    Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Schellberg, Dieter; Müller-Stich, Beat Peter; Königsrainer, Alfred; Weiner, Rudolf; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

    2017-09-01

    Evidence regarding the efficacy of psychosocial interventions after bariatric surgery is rare and shows conflicting results. The Bariatric Surgery and Education (BaSE) study aimed to assess the efficacy of a psychoeducational group intervention in patients after bariatric surgery. The BaSE study was a randomized, controlled, multicenter clinical trial involving 117 patients who underwent bariatric surgery. Patients received either conventional postsurgical visits or, in addition, a 1-year psychoeducational group program. The present study evaluated the sustained effects of the intervention program. Mean follow-up duration was 37.9 months (standard deviation [SD] 8.2 months) after surgery. Outcome measures were as follows: body mass index (BMI), weight loss, self-efficacy, depression severity, and health-related quality of life (HRQOL). Groups were compared using an intention-to-treat approach with a mixed model for repeated measurements. A total of 74 patients (63.2%) completed the follow-up (T5) assessment. Mean weight loss for all patients was 43 kg (SD 15.5 kg) at T5 (mean BMI 35.1 kg/m 2 ). Mean excess weight loss was 60.4%. The effects of the surgery during the first postsurgical year were reflected, on average, by both decreasing weight and psychosocial burden. At the T5 time point, patients had slowly started to regain weight and to deteriorate regarding psychosocial aspects. However, at T5, patients who had participated in the intervention program (n = 39) showed significantly lower depression severity scores (p = .03) and significantly higher self-efficacy (p = .03) compared to the control group (n = 35). The 2 groups did not differ regarding weight loss and quality of life. Psychoeducational intervention shows sustained effects on both depression severity scores and self-efficacy. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  7. Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

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    Kristoffersen Espen

    2012-08-01

    Full Text Available Abstract Background Chronic headache (headache ≥ 15 days/month for at least 3 months affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH can be identified by using the Severity of Dependence Scale (SDS. A “brief intervention” scheme (BI has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication

  8. Protocol for SAMS (Support and Advice for Medication Study: A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

    Directory of Open Access Journals (Sweden)

    Sutton Stephen

    2008-04-01

    Full Text Available Abstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation

  9. Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial.

    Science.gov (United States)

    Dam, Alieske E H; de Vugt, Marjolein E; van Boxtel, Martin P J; Verhey, Frans R J

    2017-08-29

    Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics. A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T 0 ) and at 8-week (T 1 ), 16-week (T 2 ) and 42-week follow up (T 3 ). The 16-week follow-up assessment (T 2 ) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention. Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care. Dutch trial register, NTR6131 . Registered on 20 October 2016.

  10. Moderate alcohol consumption and changes in postprandial lipoproteins of premenopausal and postmenopausal women : a diet-controlled, randomized intervention study

    NARCIS (Netherlands)

    Gaag, van der M.S.; Sierksma, A.; Schaafsma, G.; Bakker, M.; Hendriks, J.F.J.

    2000-01-01

    Moderate alcohol consumption is associated with a reduced risk of coronary heart disease. Earlier studies in men have shown that moderate alcohol consumption affects lipoprotein metabolism and hemostasis. In this diet-controlled, randomized, crossover trial, we investigated the effect on lipoprotein

  11. Learning Historical Thinking with Oral History Interviews: A Cluster Randomized Controlled Intervention Study of Oral History Interviews in History Lessons

    Science.gov (United States)

    Bertram, Christiane; Wagner, Wolfgang; Trautwein, Ulrich

    2017-01-01

    The present study examined the effectiveness of the oral history approach with respect to students' historical competence. A total of 35 ninth-grade classes (N = 900) in Germany were randomly assigned to one of four conditions--live, video, text, or a (nontreated) control group--in a pretest, posttest, and follow-up design. Comparing the three…

  12. INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial.

    Science.gov (United States)

    Bogaerts, Annick; Ameye, Lieveke; Bijlholt, Margriet; Amuli, Kelly; Heynickx, Dorine; Devlieger, Roland

    2017-05-26

    Excessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy. INTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum. At week 6 postpartum, participants are randomised into the intervention or control arm of the study. The intervention focuses on weight, diet, physical activity and mental well-being, and comprises face-to-face coaching, in which behavioural change techniques are central, and use of a mobile application, which is Bluetooth-connected to a weighing scale and activity tracker. The intervention is rolled out postpartum (4 coaching sessions between week 6 and month 6) and in a new pregnancy (3 coaching sessions, one in each trimester of pregnancy); the mobile app is used throughout the two intervention phases. Data collection includes data from the medical record of the participants (pregnancy outcomes and medical history), anthropometric data (height, weight, waist- and hip circumferences, skinfold thickness and body composition by bio-electrical impedance analysis), data from the mobile app (physical activity and weight; intervention group only) and questionnaires (socio-demographics, breastfeeding, food intake, physical activity, lifestyle, psychosocial factors and process evaluation). Medical record data are collected at inclusion and at delivery of the subsequent pregnancy. All other data are collected at week 6 and month 6 postpartum and every subsequent 6 months until a new pregnancy, and in every trimester in the new pregnancy. Primary outcome is the composite endpoint score of pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, and large

  13. A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics

    Directory of Open Access Journals (Sweden)

    Jade A Pham

    2013-06-01

    Full Text Available Purpose: To evaluate whether medication counseling with emphasis on auxiliary labels improves recall of auxiliary label information and adherence to medication schedules. Methods: A prospective, randomized study of an educational intervention in community pharmacies near Baltimore, Maryland. Fifty literate, English-speaking adults receiving one of the 18 commonly dispensed antibiotics were randomized to receive a counseling session or no counseling. Five to seven days after medication pickup, a structured phone interview was conducted to capture data on recall of auxiliary labels and adherence. Results: A total of 39 subjects completed the phone interview (78%. The rate of correct recall was high: 77% correct recall for all three labels. Among those with incorrect recall, 7 out of 9 subjects received no counseling (p = 0.11. The auxiliary labels incorrectly recalled were all related to dietary restrictions. Conclusion: The findings from this study suggest that medication counseling emphasizing auxiliary label information may lead to improved recall and adherence to antibiotics. Additional studies are required to confirm the preliminary findings and determine whether they correspond to improved adherence. Information most commonly misunderstood were related to dietary restrictions. Additional research focusing on counseling related to dietary restrictions is recommended.

  14. Effect of lead pollution control on environmental and childhood blood lead level in Nantong, China: an interventional study.

    Science.gov (United States)

    Chen, Kai; Huang, Lei; Yan, Beizhan; Li, Hongbo; Sun, Hong; Bi, Jun

    2014-11-04

    Children's blood lead levels and prevalence of lead poisoning in China are significantly higher than in developed countries, though a substantial decrease has been observed. Since 2011, strict lead control policies in lead-related industries have been implemented in China, but the success of these policies is unknown. In this study, we collected environmental samples, questionnaire data, and blood samples from 106 children from 1 to 14 years old, before and after implementation of lead-usage control policy in wire rope factories by local government in Zhuhang, Nantong in 2012. Results showed that, one year after the lead control, lead concentrations sharply decreased in both environmental and biological samples with a decrease of 0.43 μg/m3 (-84.3%) in ambient air samples, 0.22 mg/kg (-36.1%) in vegetable samples, 441.1 mg/kg (-43.7%) in dust samples, and 6.24 μg/dL (-51.5%) in childhood blood lead levels (BLL). This study demonstrates the success of lead control policies in promoting the prevention and control of childhood lead poisoning in Nantong, China.

  15. Building better bones in childhood: a randomized controlled study to test the efficacy of a dietary intervention program to increase calcium intake.

    Science.gov (United States)

    Weber, D R; Stark, L J; Ittenbach, R F; Stallings, V A; Zemel, B S

    2017-06-01

    Many children do not consume the recommended daily allowance of calcium. Inadequate calcium intake in childhood may limit bone accrual. The objective of this study was to determine if a behavioral modification and nutritional education (BM-NE) intervention improved dietary calcium intake and bone accrual in children. 139 (86 female) healthy children, 7-10 years of age, were enrolled in this randomized controlled trial conducted over 36 months. Participants randomized to the BM-NE intervention attended five sessions over a 6-week period designed to increase calcium intake to 1500 mg/day. Participants randomized to the usual care (UC) group received a single nutritional counseling session. The Calcium Counts Food Frequency Questionnaire was used to assess calcium intake; dual energy X-ray absorptiometry was used to assess areal bone mineral density (aBMD) and bone mineral content (BMC). Longitudinal mixed effects models were used to assess for an effect of the intervention on calcium intake, BMC and aBMD. BM-NE participants had greater increases in calcium intake that persisted for 12 months following the intervention compared with UC. The intervention had no effect on BMC or aBMD accrual. Secondary analyses found a negative association between calcium intake and adiposity such that greater calcium intake was associated with lesser gains in body mass index and fat mass index. A family-centered BM-NE intervention program in healthy children was successful in increasing calcium intake for up to 12 months but had no effect on bone accrual. A beneficial relationship between calcium intake and adiposity was observed and warrants future study.

  16. Indications for use of thoracic, abdominal, pelvic, and vascular damage control interventions in trauma patients: A content analysis and expert appropriateness rating study.

    Science.gov (United States)

    Roberts, Derek J; Bobrovitz, Niklas; Zygun, David A; Ball, Chad G; Kirkpatrick, Andrew W; Faris, Peter D; Parry, Neil; Nicol, Andrew J; Navsaria, Pradeep H; Moore, Ernest E; Leppäniemi, Ari K; Inaba, Kenji; Fabian, Timothy C; D'Amours, Scott; Brohi, Karim; Stelfox, Henry T

    2015-10-01

    The use of abbreviated or damage control (DC) interventions may improve outcomes in severely injured patients when appropriately indicated. We sought to determine which indications for DC interventions have been most commonly reported in the peer-reviewed literature to date and evaluate the opinions of experts regarding the appropriateness (expected benefit-to-harm ratio) of the reported indications for use in practice. Two investigators used an abbreviated grounded theory method to synthesize indications for 16 different DC interventions reported in peer-reviewed articles between 1983 and 2014 into a reduced number of named, content-characteristic codes representing unique indications. For each indication code, an international panel of trauma surgery experts (n = 9) then rated the appropriateness of conducting the DC intervention of interest in an adult civilian trauma patient. The 424 indications identified in the literature were synthesized into 101 unique indications. The panel assessed 12 (70.6%) of the coded indications for the 7 different thoracic, 47 (78.3%) for the 7 different abdominal/pelvic, and 18 (75.0%) for the 2 different vascular interventions to be appropriate for use in practice. These included indications for rapid lung-sparing surgery (pneumonorrhaphy, pulmonary tractotomy, and pulmonary wedge resection) (n = 1); pulmonary tractotomy (n = 3); rapid, simultaneously stapled pneumonectomy (n = 1); therapeutic mediastinal and/or pleural space packing (n = 4); temporary thoracic closure (n = 3); therapeutic perihepatic packing (n = 28); staged pancreaticoduodenectomy (n = 2); temporary abdominal closure (n = 12); extraperitoneal pelvic packing (n = 5); balloon catheter tamponade (n = 6); and temporary intravascular shunting (n = 11). This study identified a list of candidate appropriate indications for use of 12 different DC interventions that were suggested by authors of peer-reviewed articles and assessed by a panel of independent experts to be

  17. Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study.

    Science.gov (United States)

    Trivedi, Madhukar H; Greer, Tracy L; Rethorst, Chad D; Carmody, Thomas; Grannemann, Bruce D; Walker, Robrina; Warden, Diane; Shores-Wilson, Kathy; Stoutenberg, Mark; Oden, Neal; Silverstein, Meredith; Hodgkins, Candace; Love, Lee; Seamans, Cindy; Stotts, Angela; Causey, Trey; Szucs-Reed, Regina P; Rinaldi, Paul; Myrick, Hugh; Straus, Michele; Liu, David; Lindblad, Robert; Church, Timothy; Blair, Steven N; Nunes, Edward V

    To evaluate exercise as a treatment for stimulant use disorders. The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data. Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2). The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose. ClinicalTrials.gov identifier: NCT01141608. © Copyright 2017 Physicians Postgraduate Press, Inc.

  18. An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial.

    Science.gov (United States)

    van Luenen, Sanne; Kraaij, Vivian; Spinhoven, Philip; Garnefski, Nadia

    2016-03-31

    Many people living with HIV suffer from depressive symptoms. In a previous pilot study, self-help cognitive behavioral therapy (in booklet format) was found to be effective in treating depressive symptoms in people with HIV. We developed an online self-help program in Dutch and English (based on the booklet) for people with HIV and depressive symptoms. Besides the main question regarding the effectiveness of the program aimed at lowering depressive symptoms, sub-questions will focus on the moderators of treatment success (for which patients is the program especially beneficial?) and the mechanisms of change underlying the treatment outcome (which mediators affect the outcome of treatment?). In this paper, the protocol of the study will be described. The effectiveness of the program will be investigated by comparing the intervention group with a waiting list-control group in a randomized controlled design, by including a pretest and three post-tests. The self-help program contains four main components: activation, relaxation, changing maladaptive cognitions, and goal attainment. Participants with mild to moderate depressive symptoms will work on the program for 6 to 10 weeks, during which a coach will provide motivational support by telephone once a week. Participants in the control condition will receive weekly minimal support from a coach for 8 weeks, and after the second post-test, they can gain access to the self-help program. Depressive symptoms and possible mediators (e.g., activation, cognitive coping, self-efficacy, and goal adjustment) will be assessed by self-report three times during the intervention/waiting period and at the pretest and first post-test. The proposed study aims to evaluate the effectiveness of an online self-help intervention for people with HIV and depressive symptoms. If the intervention is shown to be effective, the program will be implemented. Consequently, many patients with HIV could be reached, and their psychological care may be

  19. Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Bennett, Sophie; Heyman, Isobel; Coughtrey, Anna; Simmonds, Jess; Varadkar, Sophia; Stephenson, Terence; DeJong, Margaret; Shafran, Roz

    2016-11-04

    Rates of mental health disorders are significantly greater in children with physical illnesses than in physically well children. Children with neurological conditions, such as epilepsy, are known to have particularly high rates of mental health disorders. Despite this, mental health problems in children with neurological conditions have remained under-recognised and under-treated in clinical settings. Evidence-based guided self-help interventions are efficacious in reducing symptoms of mental health disorders in children, but their efficacy in reducing symptoms of common mental health disorders in children with neurological conditions has not been investigated. We aim to pilot a guided self-help intervention for the treatment of mental health disorders in children with neurological conditions. A pilot randomised controlled trial with 18 patients with neurological conditions and mental health disorders will be conducted. Participants attending specialist neurology clinics at a National UK Children's Hospital will be randomised to receive guided self-help for common mental health disorders or to a 12-week waiting list control. Participants in the treatment group will receive 10 sessions of guided self-help delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 12 weeks. The primary outcome measure is reduction in symptoms of mental health disorders. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than anxiety, depression or disruptive behaviour (e.g. psychosis, eating disorder, obsessive-compulsive disorder) or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Camden and Islington NHS Research Ethics Committee, registration number 14.LO.1353. Results will be disseminated to patients, the wider public, clinicians and

  20. Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

    Science.gov (United States)

    Matthews, Lynsay; Pugmire, Juliana; Moore, Laurence; Kelson, Mark; McConnachie, Alex; McIntosh, Emma; Morgan-Trimmer, Sarah; Murphy, Simon; Hughes, Kathryn; Coulman, Elinor; Utkina-Macaskill, Olga; Simpson, Sharon Anne

    2017-10-25

    HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI) > 30 kg/m 2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual

  1. The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Schakel, L.; Veldhuijzen, D.S.; Middendorp, H. van; Prins, C.; Joosten, S.A.; Ottenhoff, T.H.; Visser, L.G.; Evers, A.W.M.

    2017-01-01

    BACKGROUND: Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising

  2. Impact of a school-based intervention on nutritional education and physical activity in primary public schools in Chile (KIND programme study protocol: cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Nelly Bustos

    2016-12-01

    Full Text Available Abstract Background Chile has suffered a fast increase in childhood obesity in the last 10 years. As a result, several school programmes have been implemented, however the effectiveness of these needs to be evaluated to identify and prioritize strategies to curve this trend. Methods Cluster randomized controlled trial. Twelve primary public schools chosen at random over three regions of the country will take part in this study. The sample size consisted of a total of 1,655 children. For each region one school will be selected for each of the three nutritional intervention modes and one school will be selected as the control group. The intervention modes consist of the following: Healthy Kiosk and nutritional education (KSEAN; Optimized physical activity (AFSO; Healthy Kiosk and nutritional education (KSEAN + optimized physical activity (AFSO; Control group. The effectiveness of each intervention will be evaluated by determining the nutritional condition of each child by measuring percentage of body fat, BMI and the z-score of the BMI. This study will also identify the eating behaviours, nutritional knowledge and fitness of each child, along with the effective time of moderate activity during physical education classes. Discussion A protocol to evaluate the effectiveness of a school based intervention to control and/or reduce the rates of childhood obesity for children between 6 and 10 years of age was developed. The protocol was developed in line with the Declaration of Helsinski, the Nüremberg Code and the University of Chile Guidelines for ethical committees, and was approved by the INTA, Universidad de Chile ethical committee on Wednesday 12 March 2014. There is consensus among researchers and health and education personnel that schools are a favourable environment for actions to prevent and/or control childhood obesity. However a lack of evidence on the effectiveness of interventions to date has led some to question the wisdom of

  3. Impact of a school-based intervention on nutritional education and physical activity in primary public schools in Chile (KIND) programme study protocol: cluster randomised controlled trial.

    Science.gov (United States)

    Bustos, Nelly; Olivares, Sonia; Leyton, Bárbara; Cano, Marcelo; Albala, Cecilia

    2016-12-03

    Chile has suffered a fast increase in childhood obesity in the last 10 years. As a result, several school programmes have been implemented, however the effectiveness of these needs to be evaluated to identify and prioritize strategies to curve this trend. Cluster randomized controlled trial. Twelve primary public schools chosen at random over three regions of the country will take part in this study. The sample size consisted of a total of 1,655 children. For each region one school will be selected for each of the three nutritional intervention modes and one school will be selected as the control group. The intervention modes consist of the following: Healthy Kiosk and nutritional education (KSEAN); Optimized physical activity (AFSO); Healthy Kiosk and nutritional education (KSEAN) + optimized physical activity (AFSO); Control group. The effectiveness of each intervention will be evaluated by determining the nutritional condition of each child by measuring percentage of body fat, BMI and the z-score of the BMI. This study will also identify the eating behaviours, nutritional knowledge and fitness of each child, along with the effective time of moderate activity during physical education classes. A protocol to evaluate the effectiveness of a school based intervention to control and/or reduce the rates of childhood obesity for children between 6 and 10 years of age was developed. The protocol was developed in line with the Declaration of Helsinski, the Nüremberg Code and the University of Chile Guidelines for ethical committees, and was approved by the INTA, Universidad de Chile ethical committee on Wednesday 12 March 2014. There is consensus among researchers and health and education personnel that schools are a favourable environment for actions to prevent and/or control childhood obesity. However a lack of evidence on the effectiveness of interventions to date has led some to question the wisdom of allocating resources to programmes. This is the first study

  4. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy

    OpenAIRE

    Ulberg, Randi; Hersoug, Anne Grete; H?glend, Per

    2012-01-01

    Background Depression in adolescents seems to be a growing problem that causes mental suffering and prevents young people from joining the workforce. There is also a high risk of relapse during adult life. There is emerging evidence for the effect of psychodynamic psychotherapy in adolescents. In-session relational intervention (that is, transference intervention) is a key component of psychodynamic psychotherapy. However, whether depressed adolescents profit most from psyc...

  5. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale

    Science.gov (United States)

    Arnold, Benjamin F; Null, Clair; Luby, Stephen P; Unicomb, Leanne; Stewart, Christine P; Dewey, Kathryn G; Ahmed, Tahmeed; Ashraf, Sania; Christensen, Garret; Clasen, Thomas; Dentz, Holly N; Fernald, Lia C H; Haque, Rashidul; Hubbard, Alan E; Kariger, Patricia; Leontsini, Elli; Lin, Audrie; Njenga, Sammy M; Pickering, Amy J; Ram, Pavani K; Tofail, Fahmida; Winch, Peter J; Colford, John M

    2013-01-01

    Introduction Enteric infections are common during the first years of life in low-income countries and contribute to growth faltering with long-term impairment of health and development. Water quality, sanitation, handwashing and nutritional interventions can independently reduce enteric infections and growth faltering. There is little evidence that directly compares the effects of these individual and combined interventions on diarrhoea and growth when delivered to infants and young children. The objective of the WASH Benefits study is to help fill this knowledge gap. Methods and analysis WASH Benefits includes two cluster-randomised trials to assess improvements in water quality, sanitation, handwashing and child nutrition—alone and in combination—to rural households with pregnant women in Kenya and Bangladesh. Geographically matched clusters (groups of household compounds in Bangladesh and villages in Kenya) will be randomised to one of six intervention arms or control. Intervention arms include water quality, sanitation, handwashing, nutrition, combined water+sanitation+handwashing (WSH) and WSH+nutrition. The studies will enrol newborn children (N=5760 in Bangladesh and N=8000 in Kenya) and measure outcomes at 12 and 24 months after intervention delivery. Primary outcomes include child length-for-age Z-scores and caregiver-reported diarrhoea. Secondary outcomes include stunting prevalence, markers of environmental enteropathy and child development scores (verbal, motor and personal/social). We will estimate unadjusted and adjusted intention-to-treat effects using semiparametric estimators and permutation tests. Ethics and dissemination Study protocols have been reviewed and approved by human subjects review boards at the University of California, Berkeley, Stanford University, the International Centre for Diarrheal Disease Research, Bangladesh, the Kenya Medical Research Institute, and Innovations for Poverty Action. Independent data safety monitoring

  6. Nutrient intake and dietary changes during a 2-year multi-domain lifestyle intervention among older adults: secondary analysis of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) randomised controlled trial.

    Science.gov (United States)

    Lehtisalo, Jenni; Ngandu, Tiia; Valve, Päivi; Antikainen, Riitta; Laatikainen, Tiina; Strandberg, Timo; Soininen, Hilkka; Tuomilehto, Jaakko; Kivipelto, Miia; Lindström, Jaana

    2017-08-01

    Advancing age increases the risk for diseases and health concerns like cognitive decline, constituting a major public health challenge. Lifestyle, especially healthy diet, affects many risk factors related to chronic diseases, and thus lifestyle interventions among older adults may be beneficial in promoting successful ageing. We completed a randomised 2-year multi-domain lifestyle intervention trial aiming at prevention of cognitive decline among 631 participants in the intervention and 629 in the control group, aged 60-77 years at baseline. Dietary counselling was one of the intervention domains together with strength exercise, cognitive training and management of CVD risk factors. The aim of this paper was to describe success of the intervention - that is, how an intervention based on national dietary recommendations affected dietary habits as a part of multi-intervention. Composite dietary intervention adherence score comprising nine distinct goals (range 0-9 points from none to achieving all goals) was 5·0 at baseline, and increased in the intervention group after the 1st (Pchange compared with the control group was significant at both years (P<0·001 and P=0·018). Intake of several vitamins and minerals decreased in the control group but remained unchanged or increased in the intervention group during the 2 years. Well-targeted dietary counselling may prevent age-related decline in diet quality and help in preventing cognitive decline.

  7. A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Downing, Katherine L; Salmon, Jo; Hinkley, Trina; Hnatiuk, Jill A; Hesketh, Kylie D

    2017-03-03

    Sedentary behaviour (e.g. television viewing, sitting time) tracks over time and is associated with adverse health and developmental outcomes across the lifespan. Young children (5 years or younger) spend up to 12 h/day sedentary, of which around 2 h is spent in screen time (e.g. watching television). Interventions to reduce sedentary behaviour in early childhood report mixed results and many have limited potential for scalability. Mobile phones offer a wide-reaching, low-cost avenue for the delivery of health behaviour programmes to parents but their potential to reduce young children's sedentary behaviour has not been widely tested. This study aims to test the feasibility and efficacy of a parent-focused, predominantly mobile telephone-delivered intervention to support parents to minimise the amount of time their child spends using screens and in overall sitting time. Mini Movers is a pilot randomised controlled trial recruiting 100 parents and children. Inclusion criteria include having a child aged between 2 and 4 years, being able to speak, read and write English, and smartphone ownership. Participants will be randomised to the intervention or a wait-list control group at a 1:1 ratio. Intervention group parents will receive printed materials including a content booklet and goal-checking magnet and will participate in a one-on-one discussion with the interventionist to plan two goals to reduce their child's sedentary behaviour. Subsequently, the intervention will be delivered over 6 weeks via personalised and interactive text messages promoting positive health behaviours (strategies for decreasing screen time and overall sitting time), goal setting and self-monitoring. Outcomes to be assessed include intervention feasibility and children's screen time and objectively-assessed sitting time. Few studies have used mobile phone technology to deliver health behaviour programmes to parents of young children. Findings will inform the development of larger

  8. Effectiveness of Cognitive-Functional (Cog-Fun) occupational therapy intervention for young children with attention deficit hyperactivity disorder: a controlled study.

    Science.gov (United States)

    Maeir, Adina; Fisher, Orit; Bar-Ilan, Ruthie Traub; Boas, Naomi; Berger, Itai; Landau, Yael E

    2014-01-01

    The purpose of this study was to examine the effectiveness of the Cognitive-Functional (Cog-Fun) intervention for young children with attention deficit hyperactivity disorder (ADHD). Nineteen children ages 5-7 yr diagnosed with ADHD were allocated to treatment and wait-list control groups. After the 12-wk intervention, the control group was crossed over to treatment. Follow-up was conducted 3 mo after treatment. Outcome measures included the Behavior Rating Inventory of Executive Function and the Canadian Occupational Performance Measure. Before crossover, significant differences were found between groups in change scores on the outcome measures. After crossover, no significant differences were found in treatment effects, and significant moderate to large treatment effects were found for both COPM and BRIEF scores. Treatment gains were maintained at follow-up. The study supports the effectiveness of the Cog-Fun intervention in improving occupational performance and executive functions in daily life for young children with ADHD. Copyright © 2014 by the American Occupational Therapy Association, Inc.

  9. Implementing an early childhood school-based mental health promotion intervention in low-resource Ugandan schools: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Huang, Keng-Yen; Nakigudde, Janet; Calzada, Esther; Boivin, Michael J; Ogedegbe, Gbenga; Brotman, Laurie Miller

    2014-12-01

    Children in Sub-Saharan Africa (SSA) are burdened by significant unmet mental health needs, but this region has limited access to mental health workers and resources to address these needs. Despite the successes of numerous school-based interventions for promoting child mental health, most evidence-based interventions are not available in SSA. This study will investigate the transportability of an evidence-based program from a developed country (United States) to a SSA country (Uganda). The approach includes task-shifting to early childhood teachers and consists of professional development (five days) to introduce strategies for effective behavior management and positive teacher-student interactions, and group-based consultation (14 sessions) to support adoption of effective practices and tailoring to meet the needs of individual students. The design of this study is guided by two implementation frameworks, the Consolidated Framework for Implementation Research and the Teacher Training Implementation Model, that consider multidimensional aspects of intervention fidelity and contextual predictors that may influence implementation and teacher outcomes. Using a cluster randomized design, 10 schools in Uganda will be randomized to either the intervention group (five schools) or the waitlist control group (five schools). A total of 80 to 100 early childhood teachers will be enrolled in the study. Teacher utilization of evidence-based strategies and practices will be assessed at baseline, immediate post-intervention (six months after baseline), and at seven months post-intervention (during a new academic year). Fidelity measures will be assessed throughout the program implementation period (during professional development and consultation sessions). Individual teacher and contextual factors will be assessed at baseline. Data will be collected from multiple sources. Linear mixed-effect modeling, adjusting for school nesting, will be applied to address study questions. The

  10. Transportability of an Evidence-Based Early Childhood Intervention in a Low-Income African Country: Results of a Cluster Randomized Controlled Study.

    Science.gov (United States)

    Huang, Keng-Yen; Nakigudde, Janet; Rhule, Dana; Gumikiriza-Onoria, Joy Louise; Abura, Gloria; Kolawole, Bukky; Ndyanabangi, Sheila; Kim, Sharon; Seidman, Edward; Ogedegbe, Gbenga; Brotman, Laurie Miller

    2017-11-01

    Children in Sub-Saharan Africa (SSA) are burdened by significant unmet mental health needs. Despite the successes of numerous school-based interventions for promoting child mental health, most evidence-based interventions (EBIs) are not available in SSA. This study investigated the implementation quality and effectiveness of one component of an EBI from a developed country (USA) in a SSA country (Uganda). The EBI component, Professional Development, was provided by trained Ugandan mental health professionals to Ugandan primary school teachers. It included large-group experiential training and small-group coaching to introduce and support a range of evidence-based practices (EBPs) to create nurturing and predictable classroom experiences. The study was guided by the Consolidated Framework for Implementation Research, the Teacher Training Implementation Model, and the RE-AIM evaluation framework. Effectiveness outcomes were studied using a cluster randomized design, in which 10 schools were randomized to intervention and wait-list control conditions. A total of 79 early childhood teachers participated. Teacher knowledge and the use of EBPs were assessed at baseline and immediately post-intervention (4-5 months later). A sample of 154 parents was randomly selected to report on child behavior at baseline and post-intervention. Linear mixed effect modeling was applied to examine effectiveness outcomes. Findings support the feasibility of training Ugandan mental health professionals to provide Professional Development for Ugandan teachers. Professional Development was delivered with high levels of fidelity and resulted in improved teacher EBP knowledge and the use of EBPs in the classroom, and child social competence.

  11. Transverse effects on the nasomaxillary complex one year after rapid maxillary expansion as the only intervention: A controlled study

    Directory of Open Access Journals (Sweden)

    Carolina da Luz Baratieri

    2014-10-01

    Full Text Available The aim of this study was to assess by means of cone-beam computed tomography (CBCT scans the transverse effects on the nasomaxillary complex in patients submitted to rapid maxillary expansion (RME using Haas expander in comparison to untreated individuals. This prospective controlled clinical study assessed 30 subjects (18 boys and 12 girls with mixed dentition and during pubertal growth. The treated group was submitted to RME with Haas expander, retention for six months and a six-month follow-up after removal. The control group matched the treated group in terms of age and sex distribution. CBCT scans were taken at treatment onset and one year after the expander was activated. Maxillary first molars (U6 width, right and left U6 angulation, maxillary alveolar width, maxillary basal width, palatal alveolar width, palatal base width, right and left alveolar angulation, palatal area, nasal base width, nasal cavity width and inferior nasal cavity area on the posterior, middle and anterior coronal slices were measured with Dolphin Imaging Software(r 11.5, except for the first two variables which were performed only on the posterior slice. All transverse dimensions increased significantly (P 0.05. Results suggest that increase of molar, maxillary, palatal and nasal transverse dimensions was stable in comparison to the control group one year after treatment with RME.

  12. The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial.

    Science.gov (United States)

    Geaney, Fiona; Scotto Di Marrazzo, Jessica; Kelly, Clare; Fitzgerald, Anthony P; Harrington, Janas M; Kirby, Ann; McKenzie, Ken; Greiner, Birgit; Perry, Ivan J

    2013-11-06

    Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council's framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic 'nudge' theoretical perspective. It will draw on a soft paternalistic "nudge" theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16

  13. The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial

    Science.gov (United States)

    2013-01-01

    Background Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. Methods/design A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council’s framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic “nudge” theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process

  14. The continuous reaction time test for minimal hepatic encephalopathy validated by a randomized controlled multi-modal intervention-A pilot study

    DEFF Research Database (Denmark)

    Lauridsen, M M; Mikkelsen, S; Svensson, T

    2017-01-01

    Background: Minimal hepatic encephalopathy (MHE) is clinically undetectable and the diagnosis requires psychometric tests. However, a lack of clarity exists as to whether the tests are in fact able to detect changes in cognition. Aim: To examine if the continuous reaction time test (CRT) can detect...... changes in cognition with anti-HE intervention in patients with cirrhosis and without clinically manifest hepatic encephalopathy (HE). Methods: Firstly, we conducted a reproducibility analysis and secondly measured change in CRT induced by anti-HE treatment in a randomized controlled pilot study: We...... stratified 44 patients with liver cirrhosis and without clinically manifest HE according to a normal (n = 22) or abnormal (n = 22) CRT. Each stratum was then block randomized to receive multimodal anti-HE intervention (lactulose+branched-chain amino acids+rifaximin) or triple placebos for 3 months...

  15. Basic life support training into cardiac rehabilitation programs: A chance to give back. A community intervention controlled manikin study.

    Science.gov (United States)

    González-Salvado, Violeta; Abelairas-Gómez, Cristian; Peña-Gil, Carlos; Neiro-Rey, Carmen; Barcala-Furelos, Roberto; González-Juanatey, José Ramón; Rodríguez-Núñez, Antonio

    2018-03-12

    Early basic life support is crucial to enhance survival from out-of-hospital cardiac arrest but rates remain low, especially in households. High-risk groups' training has been advocated, but the optimal method is unclear. The CArdiac REhabilitation and BAsic life Support (CAREBAS) project aims to compare the effectiveness of two basic life support educational strategies implemented in a cardiac rehabilitation program. A community intervention study including consecutive patients enrolled on an exercise-based cardiac rehabilitation program after acute coronary syndrome or revascularization was conducted. A standard basic life support training (G-Stan) and a novel approach integrating cardiopulmonary resuscitation hands-on rolling refreshers (G-CPR) were randomly assigned to each group and compared. Basic life support performance was assessed by means of simulation at baseline, following brief instruction and after the 2-month program. 114 participants were included and 108 completed the final evaluation (G-Stan:58, G-CPR:50). Basic life support performance was equally poor at baseline and significantly improved following a brief instruction. A better skill retention was found after the 2-month program in G-CPR, significantly superior for safety and sending for an automated external defibrillator. Confidence and self-perceived preparation were also significantly greater in G-CPR after the program. Integrating cardiopulmonary resuscitation hands-on rolling refreshers in the training of an exercise-based cardiac rehabilitation program is feasible and improves patients' skill retention and confidence to perform a basic life support sequence, compared to conventional training. Exporting this formula to other programs may result in increased numbers of trained citizens, enhanced social awareness and bystander resuscitation. Copyright © 2018 Elsevier B.V. All rights reserved.

  16. Contrast Media Use in Radiation Oncology: A Prospective, Controlled Educational Intervention Study with Retrospective Analysis of Patient Outcomes

    Science.gov (United States)

    Barker, Christopher A.; Mutter, Robert W.; Shapiro, Lauren Q.; Zhang, Zhigang; Wolden, Suzanne L.; Yahalom, Joachim

    2016-01-01

    Purpose Intravenous contrast media (ICM) administration is recommended as part of radiation therapy (RT) simulation in a variety of clinical scenarios, but can cause adverse events. We sought to assess radiation oncology resident knowledge about ICM, and to determine if an educational intervention (EI) could improve this level of knowledge. In conjunction, we retrospectively analyzed risk factors and adverse events related to ICM use before and after the EI to determine whether any improvements in patient outcomes could be realized. Methods Over 2 years, 21 residents in radiation oncology at Memorial Sloan-Kettering Cancer Center (MSKCC) participated in a pretest-EI-posttest study based on the ACR’s Manual on Contrast Media. Medical and RT records were reviewed, and ICM use, risk factors and adverse events were recorded. Results There was no significant difference in resident understanding of ICM use in residents of different years of training (p=0.85). Understanding of ICM use increased in residents that attended the EI (p<0.05), but this was not sustained 1 year after the EI (p=0.48). Of the 6852 RT simulations that were performed at MSKCC, 1350 (19.7%) involved ICM. Mild adverse events occurred in a few patients (<5%) simulated with ICM, but there was no difference in the number of risk factors or adverse events before and after the EI. Conclusions The EI effectively improved short-term understanding of ICM use. However, the effect was not sustained. The frequency of adverse events related to ICM use was small and not significantly impacted by the EI. PMID:21129689

  17. The impact of a minimal smoking cessation intervention for pregnant women and their partners on perinatal smoking behaviour in primary health care: A real-life controlled study

    Directory of Open Access Journals (Sweden)

    Jenssen Jon A

    2008-09-01

    Full Text Available Abstract Background There is a demand for strategies to promote smoking cessation in high-risk populations like smoking pregnant women and their partners. The objectives of this study were to investigate parental smoking behaviour during pregnancy after introduction of a prenatal, structured, multi-disciplinary smoking cessation programme in primary care, and to compare smoking behaviour among pregnant women in the city of Trondheim with Bergen and Norway. Methods Sequential birth cohorts were established to evaluate the intervention programme from September 2000 to December 2004 in primary care as a part of the Prevention of Allergy among Children in Trondheim study (PACT. The primary outcome variables were self reported smoking behaviour at inclusion and six weeks postnatal. Data from the Medical Birth Registry of Norway (MBR were used to describe smoking cessation during pregnancy in Trondheim, Bergen and Norway 1999–2004. Results Maternal smoking prevalence at inclusion during pregnancy were 5% (CI 95% 4–6 in the intervention cohort compared to 7% (CI 95% 6–9, p = 0.03, in the control cohort. Of the pre-pregnancy maternal smokers 25% (CI 95% 20–31 and 32% (CI 95% 26–38, p = 0.17, were still smoking at inclusion in the intervention and control cohorts, respectively. Six weeks postnatal 72% (CI 95% 59–83 and 68% (CI 95% 57–77, p = 0.34 of the maternal smokers at inclusion still smoked. No significant difference in paternal smoking between the cohorts was found after the intervention period. Data from the MBR showed a significantly higher proportion of women who stopped smoking during pregnancy in Trondheim than in Bergen in 2003 and 2004, p = 0.03 and Conclusion No impact on parental smoking behaviour between the cohorts was observed after the smoking intervention programme. Of the women who stopped smoking during pregnancy most of them stopped smoking before the intervention. However, we observed a significantly higher quitting

  18. Study protocol: the effectiveness and cost effectiveness of an employer-led intervention to increase walking during the daily commute: the Travel to Work randomised controlled trial.

    Science.gov (United States)

    Audrey, Suzanne; Cooper, Ashley R; Hollingworth, William; Metcalfe, Chris; Procter, Sunita; Davis, Adrian; Campbell, Rona; Gillison, Fiona; Rodgers, Sarah E

    2015-02-18

    Physical inactivity increases the risk of many chronic diseases including coronary heart disease, type 2 diabetes and some cancers. It is recommended that adults should undertake at least 150 minutes of moderate intensity physical activity throughout the week but many adults do not achieve this. An opportunity for working adults to accumulate the recommended activity levels is through the daily commute. Employees will be recruited from workplaces in south-west England and south Wales. In the intervention arm, workplace Walk-to-Work promoters will be recruited and trained. Participating employees will receive Walk-to-Work materials and support will be provided through four contacts from the promoters over 10 weeks. Workplaces in the control arm will continue with their usual practice. The intervention will be evaluated by a cluster randomized controlled trial including economic and process evaluations. The primary outcome is daily minutes of moderate to vigorous physical activity (MVPA). Secondary outcomes are: overall physical activity; sedentary time; modal shift away from private car use during the commute; and physical activity/MVPA during the commute. Accelerometers, GPS receivers and travel diaries will be used at baseline and one year follow-up. Questionnaires will be used at baseline, immediately post intervention, and one year follow-up. The process evaluation will examine the context, delivery and response to the intervention from the perspectives of employers, Walk-to-Work promoters and employees using questionnaires, descriptive statistics, fieldnotes and interviews. A cost-consequence study will include employer, employee and health service costs and outcomes. Time and consumables used in implementing the intervention will be measured. Journey time, household commuting costs and expenses will be recorded using travel diaries to estimate costs to employees. Presenteeism, absenteeism, employee wellbeing and health service use will be recorded. Compared

  19. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial.

    Science.gov (United States)

    Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane

    2012-09-26

    Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT) study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400) or an assessment only control group (N = 400) depending on their screening for risky substance use (using the CRAFFT). Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent-child relationship. The trial is expected to contribute to the growing literature on theory- and web-based brief interventions for adolescents. We will explore the potential of using web

  20. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arnaud Nicolas

    2012-09-01

    Full Text Available Abstract Background Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. Methods/design To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400 or an assessment only control group (N = 400 depending on their screening for risky substance use (using the CRAFFT. Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent–child relationship. Discussion The trial is expected to contribute to the growing literature on theory- and web-based brief interventions

  1. Effects of mouthwash interventions on xerostomia and unstimulated whole saliva flow rate among hemodialysis patients: A randomized controlled study.

    Science.gov (United States)

    Yu, I-Chen; Tsai, Yun-Fang; Fang, Ji-Tseng; Yeh, Mei-Ming; Fang, Jia-You; Liu, Chieh-Yu

    2016-11-01

    Dry mouth (xerostomia) is a common symptom in hemodialysis patients, which is associated with a reduced salivary flow. Xerostomia affects patients' oral health and quality of life. The aim of this study was to investigate using a mouthwash as a means to reduce xerostomia and improve saliva flow rates in hemodialysis patients. A randomized controlled trial. Three dialysis centers in Northern Taiwan served as the study sites. Patients were purposively sampled from three hemodialysis centers in Taiwan and randomly assigned to one of three groups: pure water mouthwash; n=41, licorice mouthwash; n=44, or no mouthwash (control); n=37. The Summated Xerostomia Inventory, and unstimulated whole salivary flow rate measured dry mouth and salivary flow, respectively. Data was collected at baseline, dialysis Day 5 and Day 10. One hundred twenty-two patients participated in this study. Baselines were adjusted for any imbalances in variables and generalized estimating equations analysed the data. Compared to control, a pure water mouthwash resulted in an increase in the unstimulated salivary flow rate of 25.85×10 -3 mL/min and 25.78×10 -3 mL/min (pXerostomia Inventory scores. The licorice mouthwash also significantly improved the unstimulated salivary flow rates to 114.92×10 -3 mL/min, and 131.61×10 -3 mL/min at Day 5 and Day 10, respectively (pXerostomia Inventory (pxerostomia. This suggests the use of a licorice mouthwash may effectively relieve feelings of dry mouth in hemodialysis patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. An organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bonevski, Billie; Guillaumier, Ashleigh; Shakeshaft, Anthony; Farrell, Michael; Tzelepis, Flora; Walsberger, Scott; D'Este, Catherine; Paul, Chris; Dunlop, Adrian; Searles, Andrew; Kelly, Peter; Fry, Rae; Stirling, Robert; Fowlie, Carrie; Skelton, Eliza

    2016-06-14

    The provision of smoking cessation support in Australian drug and alcohol treatment services is sub-optimal. This study examines the cost-effectiveness of an organisational change intervention to reduce smoking amongst clients attending drug and alcohol treatment services. A cluster-randomised controlled trial will be conducted with drug and alcohol treatment centres as the unit of randomisation. Biochemically verified (carbon monoxide by breath analysis) client 7-day-point prevalence of smoking cessation at 6 weeks will be the primary outcome measure. The study will be conducted in 33 drug and alcohol treatment services in four mainland states and territories of Australia: New South Wales, Australian Capital Territory, Queensland, and South Australia. Eligible services are those with ongoing client contact and that include pharmacotherapy services, withdrawal management services, residential rehabilitation, counselling services, and case management services. Eligible clients are those aged over 16 years who are attending their first of a number of expected visits, are self-reported current smokers, proficient in the English language, and do not have severe untreated mental illness as identified by the service staff. Control services will continue to provide usual care to the clients. Intervention group services will receive an organisational change intervention, including assistance in developing smoke-free policies, nomination of champions, staff training and educational client and service resources, and free nicotine replacement therapy in order to integrate smoking cessation support as part of usual client care. If effective, the organisational change intervention has clear potential for implementation as part of the standard care in drug and alcohol treatment centres. Australian and New Zealand Clinical Trials Registry, ACTRN12615000204549 . Registered on 3 March 2015.

  3. An interactive sports video game as an intervention for rehabilitation of community-living patients with schizophrenia: A controlled, single-blind, crossover study.

    Science.gov (United States)

    Shimizu, Nobuko; Umemura, Tomohiro; Matsunaga, Masahiro; Hirai, Takayoshi

    2017-01-01

    Hypofrontality is a state of decreased cerebral blood flow in the prefrontal cortex during executive function performance; it is commonly observed in patients with schizophrenia. Cognitive dysfunction, as well as the psychological symptoms of schizophrenia, influences the ability of patients to reintegrate into society. The current study investigated the effects of an interactive sports video game (IVG; Nintendo Wii™ Sports Resort) on frontal lobe function of patients with schizophrenia. A sample of eight patients (6 male and 2 female; mean age = 46.7 years, standard deviation (SD) = 13.7) engaged in an IVG every week for 3 months in a controlled, single-blind, crossover study. Before and after the intervention we examined frontal lobe blood-flow volume using functional near-infrared spectroscopy (fNIRS), and assessed functional changes using the Frontal Assessment Battery, Health-Related Quality of Life scale, and behaviorally-assessed physical function tests. fNIRS revealed that prefrontal activity during IVG performance significantly increased in the IVG period compared with the control period. Furthermore, significant correlations between cerebral blood flow changes in different channels were observed during IVG performance. In addition, we observed intervention-related improvement in health-related quality of life following IVG. IVG intervention was associated with increased prefrontal cortex activation and improved health-related quality of life performance in patients with schizophrenia. Patients with chronic schizophrenia are characterized by withdrawal and a lack of social responsiveness or interest in others. Interventions using IVG may provide a useful low-cost rehabilitation method for such patients, without the need for specialized equipment.

  4. An interactive sports video game as an intervention for rehabilitation of community-living patients with schizophrenia: A controlled, single-blind, crossover study.

    Directory of Open Access Journals (Sweden)

    Nobuko Shimizu

    Full Text Available Hypofrontality is a state of decreased cerebral blood flow in the prefrontal cortex during executive function performance; it is commonly observed in patients with schizophrenia. Cognitive dysfunction, as well as the psychological symptoms of schizophrenia, influences the ability of patients to reintegrate into society. The current study investigated the effects of an interactive sports video game (IVG; Nintendo Wii™ Sports Resort on frontal lobe function of patients with schizophrenia. A sample of eight patients (6 male and 2 female; mean age = 46.7 years, standard deviation (SD = 13.7 engaged in an IVG every week for 3 months in a controlled, single-blind, crossover study. Before and after the intervention we examined frontal lobe blood-flow volume using functional near-infrared spectroscopy (fNIRS, and assessed functional changes using the Frontal Assessment Battery, Health-Related Quality of Life scale, and behaviorally-assessed physical function tests. fNIRS revealed that prefrontal activity during IVG performance significantly increased in the IVG period compared with the control period. Furthermore, significant correlations between cerebral blood flow changes in different channels were observed during IVG performance. In addition, we observed intervention-related improvement in health-related quality of life following IVG. IVG intervention was associated with increased prefrontal cortex activation and improved health-related quality of life performance in patients with schizophrenia. Patients with chronic schizophrenia are characterized by withdrawal and a lack of social responsiveness or interest in others. Interventions using IVG may provide a useful low-cost rehabilitation method for such patients, without the need for specialized equipment.

  5. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

    Science.gov (United States)

    Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

    2017-01-01

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

  6. Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

    Science.gov (United States)

    Dowling, S.; Hubert, J.; White, S.; Hollins, S.

    2006-01-01

    Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

  7. A Controlled Health Promoting School Study in the Netherlands : Effects After 1 and 2 Years of Intervention

    NARCIS (Netherlands)

    Busch, Vincent; De Leeuw, Johannes Rob Josephus; Zuithoff, Nicolaas P A; Van Yperen, Tom Albert; Schrijvers, Augustinus Jacobus Petrus

    2015-01-01

    Purpose. Many unhealthy behavioral habits often originate in adolescence. In the literature, the school-based whole school approach is stated be the most promising way to promote healthy behavior. Herein, interventions are evidence based and integrated into the curriculum, while embedded in

  8. A brief intervention to improve exercising in patients with schizophrenia: a controlled pilot study with mental contrasting and implementation intentions (MCII).

    Science.gov (United States)

    Sailer, Pascal; Wieber, Frank; Pröpster, Karl; Stoewer, Steffen; Nischk, Daniel; Volk, Franz; Odenwald, Michael

    2015-09-03

    Regular exercise can have positive effects on both the physical and mental health of individuals with schizophrenia. However, deficits in cognition, perception, affect, and volition make it especially difficult for people with schizophrenia to plan and follow through with their exercising intentions, as indicated by poor attendance and high drop-out rates in prior studies. Mental Contrasting and Implementation Intentions (MCII) is a well-established strategy to support the enactment of intended actions. This pilot study tests whether MCII helps people with schizophrenia in highly structured or autonomy-focused clinical hospital settings to translate their exercising intentions into action. Thirty-six inpatients (eleven women) with a mean age of 30.89 years (SD = 11.41) diagnosed with schizophrenia spectrum disorders from specialized highly structured or autonomy-focused wards were randomly assigned to two intervention groups. In the equal contact goal intention control condition, patients read an informative text about physical activity; they then set and wrote down the goal to attend jogging sessions. In the MCII experimental condition, patients read the same informative text and then worked through the MCII strategy. We hypothesized that MCII would increase attendance and persistence relative to the control condition over the course of four weeks and this will be especially be the case when applied in an autonomy-focused setting compared to when applied in a highly structured setting. When applied in autonomy-focused settings, MCII increased attendance and persistence in jogging group sessions relative to the control condition. In the highly structured setting, no differences between conditions were found, most likely due to a ceiling effect. These results remained even when adjusting for group differences in the pre-intervention scores for the control variables depression (BDI), physical activity (IPAQ), weight (BMI), age, and education. Whereas commitment and

  9. A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Skau, Jutta K H; Nordin, Awatef Binti Amer; Cheah, Julius C H; Ali, Roslinah; Zainal, Ramli; Aris, Tahir; Ali, Zainudin Mohd; Matzen, Priya; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark A; Norris, Shane A

    2016-04-27

    Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14

  10. Effectiveness of two web-based cognitive bias modification interventions targeting approach and attentional bias in gambling problems: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Boffo, Marilisa; Willemen, Ronny; Pronk, Thomas; Wiers, Reinout W; Dom, Geert

    2017-10-03

    Disordered gamblers have phenotypical and pathological similarities to those with substance use disorders (SUD), including exaggerated automatic cognitive processing of motivationally salient gambling cues in the environment (i.e., attentional and approach bias). Cognitive bias modification (CBM) is a family of computerised interventions that have proved effective in successfully re-training these automatic cognitive biases in SUD. CBM interventions can, in principle, be administered online, thus showing potential of being a low-cost, low-threshold addition to conventional treatments. This paper presents the design of a pilot randomised controlled trial exploring the effectiveness of two web-based CBM interventions targeting attentional and approach bias towards gambling cues in a sample of Dutch and Belgian problematic and pathological gamblers. Participants (N = 182) are community-recruited adults experiencing gambling problems, who have gambled at least twice in the past 6 months and are motivated to change their gambling behaviour. After a baseline assessment session, participants are randomly assigned to one of four experimental conditions (attentional or approach bias training, or the placebo version of the two trainings) and complete six sessions of training. At baseline and before each training session, participants receive automated personalised feedback on their gambling motives and reasons to quit or reduce gambling. The post-intervention, 1-month, and 3-month follow-up assessments will examine changes in gambling behaviour, with frequency and expenditure as primary outcomes, and depressive symptoms and gambling-related attentional and approach biases as secondary outcomes. Secondary analyses will explore possible moderators (interference control capacity and trait impulsivity) and mediators (change in cognitive bias) of training effects on the primary outcomes. This study is the first to explore the effectiveness of an online CBM intervention for

  11. Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Hospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital. Methods/design We carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame. Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial. The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy. Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST. Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes. Discussion Our results will provide an overall response regarding

  12. A randomized-controlled trial focusing on socio-economic status for promoting vegetable intake among adults using a web-based nutrition intervention programme: study protocol

    Directory of Open Access Journals (Sweden)

    Saki Nakamura

    2017-01-01

    Full Text Available Abstract Background Web-based nutritional education programmes appear to be comparable to those delivered face-to-face. However, no existing web-based nutrition education or similar programme has yet been evaluated with consideration of socio-economic status. The objective of a nutritional education programme of promoting vegetable intake designed a randomized controlled trial (RCT is to evaluate the results of intervention and to determine how socio-economic status influences the programme effects. Methods/Design Participants will be randomly sampled individuals (aged 30–59 stratified according national population statistics for sex, age, and household income. Participants were consented to survey participation (n = 1500, and will be randomly divided into intervention and control groups. The intervention period is 5 weeks with one step of diet-related education per week. The main outcome of the programme is dietary behaviour as eating vegetable (350 g per day, five small bowl. To encourage behavioural changes, the programme contents are prepared using behavioural theories and techniques tailored to the assumed group stages of behavioural change. In the first step, we employ the health belief model to encourage a shift from the pre-contemplative to the contemplative phase; in the second and third steps, social cognitive theory is used to encourage transition to the preparatory phase; in the fourth step, social cognitive theory and strengthening social support are used to promote progression to the execution phase; finally, in the fifth step, strengthening social capital and social support are used to promote the shift to the maintenance phase. The baseline, post intervention and follow-up survey was assessed using a self-administered questionnaire. For process evaluation, we use five items relating to programme participation and satisfaction. A follow-up survey of participants will be carried out 3 months after intervention completion

  13. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    Science.gov (United States)

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (Pfruit intake significantly reduced genotoxicity in human faecal water relative to control (Pfruit may reduce colon cancer risk without inducing changes in the microbiota.

  14. Standards of resuscitation during inter-hospital transportation: the effects of structured team briefing or guideline review - a randomised, controlled simulation study of two micro-interventions.

    Science.gov (United States)

    Høyer, Christian B; Christensen, Erika F; Eika, Berit

    2011-03-03

    Junior physicians are sometimes sent in ambulances with critically ill patients who require urgent transfer to another hospital. Unfamiliar surroundings and personnel, time pressure, and lack of experience may imply a risk of insufficient treatment during transportation as this can cause the physician to loose the expected overview of the situation. While health care professionals are expected to follow complex algorithms when resuscitating, stress can compromise both solo-performance and teamwork. To examine whether inter-hospital resuscitation improved with a structured team briefing between physician and ambulance crew in preparation for transfer vs. review of resuscitation guidelines. The effect parameters were physician team leadership (requesting help, delegating tasks), time to resuscitation key elements (chest compressions, defibrillation, ventilations, medication, or a combination of these termed "the first meaningful action"), and hands-off ratio. 46 physicians graduated within 5 years. A simulation intervention study with a control group and two interventions (structured team briefing or review of guidelines). Scenario: Cardiac arrest during simulated inter-hospital transfer. Forty-six candidates participated: 16 (control), 13 (review), and 17 (team briefing). Reviewing guidelines delayed requesting help to 162 seconds, compared to 21 seconds in control and team briefing groups (p = 0.021). Help was not requested in 15% of cases; never requesting help was associated with an increased hands-off ratio, from 39% if the driver's assistance was requested to 54% if not (p delegating tasks and warrants the need for further studies focusing on how to avoid this cognitive impairment.

  15. Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol.

    Science.gov (United States)

    Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John; Wolfenden, Luke

    2018-01-23

    A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and presentations at conferences. ACTRN12617001044314; Pre

  16. Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol

    Science.gov (United States)

    Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John

    2018-01-01

    Introduction A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. Methods and analysis The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. Ethics and dissemination The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and

  17. The Melanoma care study: protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease.

    Science.gov (United States)

    Dieng, Mbathio; Kasparian, Nadine A; Morton, Rachael L; Mann, Graham J; Butow, Phyllis; Menzies, Scott; Costa, Daniel S J; Cust, Anne E

    2015-01-01

    Despite a good prognosis for most melanoma survivors, many experience substantial fear of new or recurrent melanoma, worry and anxiety about the future, and unmet healthcare needs. In this protocol, we outline the design and methods of the Melanoma Care Study for melanoma survivors at high risk of developing new primary disease. The objective of this study is to evaluate the efficacy and cost-effectiveness of a psycho-educational intervention for improving psychological and behavioural adjustment to melanoma risk. The study design is a two-arm randomised controlled trial comparing a psycho-educational intervention to usual care. The intervention is comprised of a newly-developed psycho-educational booklet and three telephone sessions delivered by a trained psychologist. A total of 154 melanoma survivors at high risk of developing new primary disease who are attending one of three melanoma high risk clinics in New South Wales, Australia, will be recruited. Participants will be assessed at baseline (6 weeks before their high risk clinic dermatological appointment), and then 4 weeks and 6 months after their appointment. If effectiveness of the intervention is demonstrated at 6 months, an additional assessment at 12 months is planned. The primary outcome is fear of new or recurrent melanoma, as assessed by the Fear of Cancer Recurrence Inventory (FCRI). Secondary outcomes include anxiety, depression, unmet supportive care needs, satisfaction with clinical care, knowledge, behavioural adjustment to melanoma risk, quality of life, and cost-effectiveness of the intervention from a health system perspective. Following the intention-to-treat principle, linear mixed models will be used to analyse the data to account for repeated measures. A process evaluation will also be carried out to inform and facilitate potential translation and implementation into clinical practice. This study will provide high quality evidence on the efficacy and cost-effectiveness of a psycho

  18. Applicable study of patient-controlled epidural analgesia in peri-interventional uterine arterial embolization for uterine myomata

    International Nuclear Information System (INIS)

    Wang Miao; She Shouzhang; Chen Chunlin; Xu Xuebing; Xie Xiaoqing

    2006-01-01

    Objective: To study the effectiveness and safety of epidural patient-controlled analgesia (PCEA) for post-operative pain relief and adverse reactions after uterine arterial embolization (UAE). Methods: 100 patients (ASA I-II grade) undergoing transcatheter UAE of uterine myomata were randomly divided into five groups. All patients except group V used PCEA; including group I ( n=20) for epidural infusion with 0.2% ropivacaine plus 0.004% morphine, group II (n=20) with epidural infusion of 0.2% ropivacaine and 0.004% morphine plus 0.005% droperidol, group III (n=20) with epidural infusion of 0.2% ropivacaine and 0.004% morphine plus 0.01% droperidol, group IV (n=20) of epidural infusion of 0.2% ropivacaine plus 0.01% morphine, group V (n=20) served as the control with either traditional oral drugs of micronized nimesulide, or intramuscular injection (plus analgesic of rotundin or pethidine hydrochloride), or both. Results The quality of pain relief in the group I, group II, group III and group IV was obviously superior to that of group V. The PCEA application group recovered faster than that of group V after the procedure (P<0.01). Conclusions: During or after UEA, PCEA could effectively relieve pain by providing less side effects, faster recovery and high safety to the patient. The best analgetic methods of PCEA are coincident with the use of 0.2% ropivacaine plus 0.01% morphine. (authors)

  19. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol

    OpenAIRE

    Tsai Midi; Jiang Yannan; Epstein Leonard; Foley Louise; Mhurchu Cliona; Maddison Ralph; Dewes Ofa; Heke Ihirangi

    2011-01-01

    Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family orie...

  20. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina: study design of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Niederer Iris

    2009-03-01

    Full Text Available Abstract Background Childhood obesity and physical inactivity are increasing dramatically worldwide. Children of low socioeconomic status and/or children of migrant background are especially at risk. In general, the overall effectiveness of school-based programs on health-related outcomes has been disappointing. A special gap exists for younger children and in high risk groups. Methods/Design This paper describes the rationale, design, curriculum, and evaluation of a multicenter preschool randomized intervention study conducted in areas with a high migrant population in two out of 26 Swiss cantons. Twenty preschool classes in the German (canton St. Gallen and another 20 in the French (canton Vaud part of Switzerland were separately selected and randomized to an intervention and a control arm by the use of opaque envelopes. The multidisciplinary lifestyle intervention aimed to increase physical activity and sleep duration, to reinforce healthy nutrition and eating behaviour, and to reduce media use. According to the ecological model, it included children, their parents and the teachers. The regular teachers performed the majority of the intervention and were supported by a local health promoter. The intervention included physical activity lessons, adaptation of the built infrastructure; promotion of regional extracurricular physical activity; playful lessons about nutrition, media use and sleep, funny homework cards and information materials for teachers and parents. It lasted one school year. Baseline and post-intervention evaluations were performed in both arms. Primary outcome measures included BMI and aerobic fitness (20 m shuttle run test. Secondary outcomes included total (skinfolds, bioelectrical impedance and central (waist circumference body fat, motor abilities (obstacle course, static and dynamic balance, physical activity and sleep duration (accelerometry and questionnaires, nutritional behaviour and food intake, media use, quality of

  1. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial.

    Science.gov (United States)

    Niederer, Iris; Kriemler, Susi; Zahner, Lukas; Bürgi, Flavia; Ebenegger, Vincent; Hartmann, Tim; Meyer, Ursina; Schindler, Christian; Nydegger, Andreas; Marques-Vidal, Pedro; Puder, Jardena J

    2009-03-31

    Childhood obesity and physical inactivity are increasing dramatically worldwide. Children of low socioeconomic status and/or children of migrant background are especially at risk. In general, the overall effectiveness of school-based programs on health-related outcomes has been disappointing. A special gap exists for younger children and in high risk groups. This paper describes the rationale, design, curriculum, and evaluation of a multicenter preschool randomized intervention study conducted in areas with a high migrant population in two out of 26 Swiss cantons. Twenty preschool classes in the German (canton St. Gallen) and another 20 in the French (canton Vaud) part of Switzerland were separately selected and randomized to an intervention and a control arm by the use of opaque envelopes. The multidisciplinary lifestyle intervention aimed to increase physical activity and sleep duration, to reinforce healthy nutrition and eating behaviour, and to reduce media use. According to the ecological model, it included children, their parents and the teachers. The regular teachers performed the majority of the intervention and were supported by a local health promoter. The intervention included physical activity lessons, adaptation of the built infrastructure; promotion of regional extracurricular physical activity; playful lessons about nutrition, media use and sleep, funny homework cards and information materials for teachers and parents. It lasted one school year. Baseline and post-intervention evaluations were performed in both arms. Primary outcome measures included BMI and aerobic fitness (20 m shuttle run test). Secondary outcomes included total (skinfolds, bioelectrical impedance) and central (waist circumference) body fat, motor abilities (obstacle course, static and dynamic balance), physical activity and sleep duration (accelerometry and questionnaires), nutritional behaviour and food intake, media use, quality of life and signs of hyperactivity (questionnaires

  2. Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial.

    Science.gov (United States)

    Bölenius, Karin; Lämås, Kristina; Sandman, Per-Olof; Edvardsson, David

    2017-02-16

    The literature indicates that current home care service are largely task oriented with limited focus on the involvement of the older people themselves, and studies show that lack of involvement might reduce older people's quality of life. Person-centred care has been shown to improve the satisfaction with care and quality of life in older people cared for in hospitals and nursing homes, with limited published evidence about the effects and meanings of person-centred interventions in home care services for older people. This study protocol outlines a study aiming to evaluate such effects and meanings of a person-centred and health-promoting intervention in home aged care services. The study will take the form of a non-randomised controlled trial with a before/after approach. It will include 270 older people >65 years receiving home care services, 270 relatives and 65 staff, as well as a matched control group of equal size. All participants will be recruited from a municipality in northern Sweden. The intervention is based on the theoretical concepts of person-centredness and health-promotion, and builds on the four pedagogical phases of: theory apprehension, experimental learning, operationalization, and clinical supervision. Outcome assessments will focus on: a) health and quality of life (primary outcomes), thriving and satisfaction with care for older people; b) caregiver strain, informal caregiving engagement and relatives' satisfaction with care: c) job satisfaction and stress of conscience among care staff (secondary outcomes). Evaluation will be conducted by means of self-reported questionnaires and qualitative research interviews. Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services, and the results can point the way to establishing a more person-centred and health-promoting model for home care services for older people. NCT02846246 .

  3. INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

    Science.gov (United States)

    Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

    2017-11-13

    Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger

  4. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

    2018-05-11

    Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of

  5. Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Brody, Carinne; Tuot, Sovannary; Chhoun, Pheak; Swendenman, Dallas; Kaplan, Kathryn C; Yi, Siyan

    2018-04-19

    In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia. A two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV). If the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them

  6. Using a technology-based intervention to promote weight loss in sedentary overweight or obese adults: a randomized controlled trial study design

    Directory of Open Access Journals (Sweden)

    Vaughn W Barry

    2011-02-01

    Full Text Available Vaughn W Barry1, Amanda C McClain1, Sara Shuger1, Xuemei Sui1, James W Hardin2, Gregory A Hand1, Sara Wilcox1, Steven N Blair1,21Department of Exercise Science; 2Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USAPurpose: The SenseWear™ Armband is an activity monitor developed to improve lifestyle self-monitoring. Currently, few studies assess electronic self-monitoring and weight loss with a lifestyle intervention program. To our knowledge, only one study has used the SenseWear Armband in combination with a lifestyle intervention to improve weight loss, and no studies have evaluated whether a self-monitoring intervention based solely on the armband can promote weight loss. Consequently, the aims of the study were to assess weight loss from electronic self-monitoring, to compare these values to the lifestyle intervention and standard care groups, and to compare weight loss with lifestyle intervention with and without the armband.Patients and methods: We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 years; BMI, 33.3 ± 5.2 kg/m2 to participate in the 9-month study. Participants were randomized into one of four weight loss groups: 1 the standard care group received a self-directed weight loss program, complete with an evidence-based weight loss manual (standard care, n = 50; 2 a 14-week group-based behavioral weight loss program followed by weekly, biweekly, and monthly telephone counseling calls (GWL, n = 49; 3 the use of the armband to help improve lifestyle self-monitoring (SWA alone, n = 49; or (4 the group-based behavioral weight loss program and follow-up telephone counseling calls plus the armband (GWL + SWA, n = 49. All participants received the evidence-based weight loss manual at baseline. All measures were performed at baseline and months 4 and 9. The primary outcomes were weight loss and waist circumference reduction.Results: This study is a well-designed randomized

  7. Moderate alcohol consumption and changes in postprandial lipoproteins of premenopausal and postmenopausal women: a diet-controlled, randomized intervention study.

    Science.gov (United States)

    van der Gaag, M S; Sierksma, A; Schaafsma, G; van Tol, A; Geelhoed-Mieras, T; Bakker, M; Hendriks, H F

    2000-01-01

    Moderate alcohol consumption is associated with a reduced risk of coronary heart disease. Earlier studies in men have shown that moderate alcohol consumption affects lipoprotein metabolism and hemostasis. In this diet-controlled, randomized, crossover trial, we investigated the effect on lipoprotein metabolism of moderate consumption of red wine or red grape juice with evening dinner for 3 weeks in premenopausal women using oral contraceptives and in postmenopausal women. After 3 weeks, blood samples were collected 1 hour before dinner up to 19 hours after starting dinner at 2-hour or 4-hour intervals. Plasma triglyceride concentrations and very low density lipoprotein (VLDL) triglyceride levels peaked 3 hours after dinner with wine in both premenopausal and postmenopausal women. After wine consumption, the overall high-density lipoprotein (HDL) cholesterol level was increased in postmenopausal women (mean increase 0.17 mmol/L, or 12%, p = 0.03), and the plasma low-density lipoprotein (LDL) cholesterol level was reduced in premenopausal women (mean reduction 0.35 mmol/L, or 12%, p = 0.01) as compared with grape juice consumption. The findings suggest that postprandial lipoprotein metabolism after moderate alcohol consumption differs between oral contraceptive-using premenopausal women and postmenopausal women. The response of postmenopausal women to alcohol resembled the response found in earlier studies in men.

  8. Effect of pharmacological interventions on the fronto-cingulo-parietal cognitive control network in psychiatric disorders: a transdiagnostic systematic review of fMRI studies

    Directory of Open Access Journals (Sweden)

    Therese eVan Amelsvoort

    2016-05-01

    Full Text Available Executive function deficits such as working memory, decision-making, and attention problems are a common feature of several psychiatric disorders for which no satisfactory treatment exists. Here, we transdiagnostically investigate the effects of pharmacological interventions (other than methylphenidate on the fronto-cingulo-parietal cognitive control network, in order to identify functional brain markers for future pro-cognitive pharmacological interventions. 29 manuscripts investigated the effect of pharmacological treatment on executive function-related brain correlates in psychotic disorders (n=11, depression (n=4, bipolar disorder (n=4, ADHD (n=4, OCD (n=2, smoking dependence (n=2, alcohol dependence (n=1 and pathological gambling (n=1. In terms of impact on the fronto-cingulo-parietal networks, the preliminary evidence for catechol-o-methyl-transferase inhibitors, nicotinic receptor agonists and atomoxetine suggested was relatively consistent, the data for atypical antipsychotics and anticonvulsants moderate, and interpretation of the data for antidepressants was hampered by the employed study designs. Increased activity in task-relevant areas and decreased activity in task-irrelevant areas were the most common transdiagnostic effects of pharmacological treatment. These markers showed good positive and moderate negative predictive value. It is concluded that fronto-cingulo-parietal activity changes can serve as a marker for future pro-cognitive interventions. Future recommendations include the use of randomized double-blind designs and selective cholinergic and glutamatergic compounds.

  9. Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol.

    Science.gov (United States)

    Ruffault, Alexis; Carette, Claire; Lurbe I Puerto, Kàtia; Juge, Nicolas; Beauchet, Alain; Benoliel, Jean-Jacques; Lacorte, Jean-Marc; Fournier, Jean F; Czernichow, Sébastien; Flahault, Cécile

    2016-07-01

    Mindfulness-based interventions for healthy behaviors such as exercise and dietary modifications have aroused growing interest. This study aims to test the effectiveness of a mindfulness-based intervention for the reduction of impulsive eating and the improvement of motivation to exercise among obese individuals. One-hundred and twenty obese outpatients, aged 18 to 65years, diagnosed with a binge eating disorder, will be randomly assigned to one of the three following groups: mindfulness practice, sham meditation, or treatment as usual control. The tested intervention consists of a 1-year computerized mindfulness-based program. Mindfulness sessions are audio recordings that the patients are asked to listen to, 10min every day. Self-reported questionnaires measuring impulsive eating, motivation to exercise, physical activity level, mood, and mindfulness skills are filled in at baseline, 1, 6, and 12months. Physical activity, calories consumption, and biomarkers are measured with more objective measurement tools at baseline, 6months and 12months. Mindfulness, as both a de-automation element and as a moderator of motivation to exercise, can lead to the reduction of impulsive eating and also to an increase in levels of physical activity. These effects could cause weight loss in obese patients suffering from binge eating disorder. clinicaltrials.gov: NCT02571387. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. A descriptive study of a manual therapy intervention within a randomised controlled trial for hamstring and lower limb injury prevention

    Directory of Open Access Journals (Sweden)

    Hoskins Wayne

    2010-08-01

    Full Text Available Abstract Background There is little literature describing the use of manual therapy performed on athletes. It was our purpose to document the usage of a sports chiropractic manual therapy intervention within a RCT by identifying the type, amount, frequency, location and reason for treatment provided. This information is useful for the uptake of the intervention into clinical settings and to allow clinicians to better understand a role that sports chiropractors offer. Methods All treatment rendered to 29 semi-elite Australian Rules footballers in the sports chiropractic intervention group of an 8 month RCT investigating hamstring and lower-limb injury prevention was recorded. Treatment was pragmatically and individually determined and could consist of high-velocity, low-amplitude (HVLA manipulation, mobilization and/or supporting soft tissue therapies. Descriptive statistics recorded the treatment rendered for symptomatic or asymptomatic benefit, delivered to joint or soft tissue structures and categorized into body regions. For the joint therapy, it was recorded whether treatment consisted of HVLA manipulation, HVLA manipulation and mobilization, or mobilization only. Breakdown of the HVLA technique was performed. Results A total of 487 treatments were provided (mean 16.8 consultations/player with 64% of treatment for asymptomatic benefit (73% joint therapies, 57% soft tissue therapies. Treatment was delivered to approximately 4 soft tissue and 4 joint regions each consultation. The most common asymptomatic regions treated with joint therapies were thoracic (22%, knee (20%, hip (19%, sacroiliac joint (13% and lumbar (11%. For soft tissue therapies it was gluteal (22%, hip flexor (14%, knee (12% and lumbar (11%. The most common symptomatic regions treated with joint therapies were lumbar (25%, thoracic (15% and hip (14%. For soft tissue therapies it was gluteal (22%, lumbar (15% and posterior thigh (8%. Of the joint therapy, 56% was HVLA

  11. Changing Efficacy of Wet Cupping Therapy in Migraine with Lunar Phase: A Self-Controlled Interventional Study.

    Science.gov (United States)

    Benli, Ali Ramazan; Sunay, Didem

    2017-12-29

    BACKGROUND The aim of this study was to evaluate the effect of blood-letting with wet cupping therapy (WCT) in migraine treatment and to determine whether there was any difference according to the phase of the moon when the treatment was applied. MATERIAL AND METHODS This self-controlled study was conducted in Karabuk between 2014 and 2016. Patients who were diagnosed with migraine were enrolled in the study. Migraine disability assessment questionnaire (MIDAS), demographic characteristics, migraine attack frequency and duration, and family history was used to assess the severity of headache. WCT was applied in 3 sessions and the questionnaire was administered before and 3 months after the final WCT session. Wilcoxon signed-rank test was used in pre-and posttreatment measurements, and the Chi-square test was used to check independence in two-way categorical tables. RESULTS A total of 85 patients were included. The reduction in MIDAS scores and number of migraine attacks was significantly greater in the WCT applications made in the first half of the month compared to those in the second half of the month. Although the reduction in visual analog scale (VAS) scores was greater in the second half of the month, it was also significant in the applications made in the first half of the month. CONCLUSIONS WCT was found to be an effective treatment of migraine. The effect on MIDAS, VAS, and the number of attacks was significantly better when the application was made in the second half of the month compared to those made in the first half.

  12. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior.

    Science.gov (United States)

    Rodrigues, Ana Maria; Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena

    2017-03-13

    The limited or uncertain access to adequate food in elderly people includes not only economic restrictions but also inability of food utilization due to functional or cognitive impairment, health problems, and illiteracy. The aim of this work is to present the protocol of the randomized controlled trial Saúde.Come Senior, an educational and motivational television (TV)-based intervention to promote healthy lifestyles and decrease food insecurity in elderly people. A randomized controlled study will be conducted in subjects aged 60 years and older with food insecurity, identified at 17 primary care centers in the Lisboa e Vale do Tejo health region in Lisbon, Portugal. The primary outcome will be the changes in participants' food insecurity score (evaluated by the Household Food Insecurity Scale) at 3 months. Change in other outcomes will be assessed (dietary habits, nutritional status, physical activity, health status, and clinical outcomes). Subjects will be followed over 6 months; the intervention will last 3 months. Data collection will be performed at 3 different time points (baseline, end of intervention at 3 months, and follow-up at 6 months). The intervention is based on an interactive TV app with an educational and motivational program specifically developed for the elderly that has weekly themes and includes daily content in video format: (1) nutrition and diet tips for healthy eating, (2) healthy, easy to cook and low-cost recipes, and (3) physical exercise programs. Furthermore, brief reminders on health behaviors will also be broadcasted through the TV app. The total duration of the study will be 6 months. The intervention is considered to be effective and meaningful if 50% of the individuals in the experimental group have a decrease of 1 point in the food insecurity score, all the remaining being unchanged. We expect to include and randomize 282 (141 experimental and 141 control) elderly with food insecurity. We will recruit a total of 1,128 subjects

  13. Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness.

    Science.gov (United States)

    Looijmans, Anne; Jörg, Frederike; Bruggeman, Richard; Schoevers, Robert; Corpeleijn, Eva

    2017-03-21

    The cardiometabolic health of persons with a severe mental illness (SMI) is alarming with obesity rates of 45-55% and diabetes type 2 rates of 10-15%. Unhealthy lifestyle behaviours play a large role in this. Despite the multidisciplinary guideline for SMI patients recommending to monitor and address patients' lifestyle, most mental health care professionals have limited lifestyle-related knowledge and skills, and (lifestyle) treatment protocols are lacking. Evidence-based practical lifestyle tools may support both patients and staff in improving patients' lifestyle. This paper describes the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial, to investigate whether a multidimensional lifestyle intervention using a web tool can be effective in improving cardiometabolic health in SMI patients. The LION study is a 12-month pragmatic single-blind multi-site cluster randomised controlled trial. 21 Flexible Assertive Community Treatment (ACT) teams and eight sheltered living teams of five mental health organizations in the Netherlands are invited to participate. Per team, nurses are trained in motivational interviewing and use of the multidimensional web tool, covering lifestyle behaviour awareness, lifestyle knowledge, motivation and goal setting. Nurses coach patients to change their lifestyle using the web tool, motivational interviewing and stages-of-change techniques during biweekly sessions in a) assessing current lifestyle behaviour using the traffic light method (healthy behaviours colour green, unhealthy behaviours colour red), b) creating a lifestyle plan with maximum three attainable lifestyle goals and c) discussing the lifestyle plan regularly. The study population is SMI patients and statistical inference is on patient level using multilevel analyses. Primary outcome is waist circumference and other cardiometabolic risk factors after six and twelve months intervention, which are measured as part of routine outcome

  14. Effects of Reducing Antimicrobial Use and Applying a Cleaning and Disinfection Program in Veal Calf Farming: Experiences from an Intervention Study to Control Livestock-Associated MRSA.

    Directory of Open Access Journals (Sweden)

    Alejandro Dorado-García

    Full Text Available With the ultimate aim of containing the emergence of resistant bacteria, a Dutch policy was set in place in 2010 promoting a reduction of antimicrobial use (AMU in food-producing animals. In this context, a study evaluated strategies to curb livestock-associated methicillin resistant Staphylococcus aureus (LA-MRSA. Fifty-one veal calf farms were assigned to one of 3 study arms: RAB farms reducing antimicrobials by protocol; RAB-CD farms reducing antimicrobials by protocol and applying a cleaning and disinfection program; and Control farms without interventions. MRSA carriage was tested in week 0 and week 12 of 2 consecutive production cycles in farmers, family members and veal calves. Interventions were validated and a cyclic rise in MRSA-prevalence in animals was shown with a more moderate increase in RAB farms. Prevalence in humans declined parallel over time in the study arms but RAB farms were at the lowest MRSA levels from the beginning of the study. In RAB-CD farms, human and animal prevalence did not differ from Control farms and MRSA air loads were significantly higher than in the other study arms. Mimicking the national trend, an overall AMU decrease (daily dosages per animal per cycle (DDDA/C was observed over 4 pre-study and the 2 study cycles; this trend did not have a significant effect on a set of evaluated farm technical parameters. AMU was positively associated with MRSA across study arms (ORs per 10 DDDA/C increase = 1.26 for both humans (p = 0.07 and animals (p = 0.12 in first cycle. These results suggest that AMU reduction might be a good strategy for curbing MRSA in veal calf farming, however the specific cleaning and disinfecting program in RAB-CD farms was not effective. The drop in MRSA prevalence in people during the study could be attributed to the observed long-term AMU decreasing trend.

  15. Effects of Reducing Antimicrobial Use and Applying a Cleaning and Disinfection Program in Veal Calf Farming: Experiences from an Intervention Study to Control Livestock-Associated MRSA.

    Science.gov (United States)

    Dorado-García, Alejandro; Graveland, Haitske; Bos, Marian E H; Verstappen, Koen M; Van Cleef, Brigitte A G L; Kluytmans, Jan A J W; Wagenaar, Jaap A; Heederik, Dick J J

    2015-01-01

    With the ultimate aim of containing the emergence of resistant bacteria, a Dutch policy was set in place in 2010 promoting a reduction of antimicrobial use (AMU) in food-producing animals. In this context, a study evaluated strategies to curb livestock-associated methicillin resistant Staphylococcus aureus (LA-MRSA). Fifty-one veal calf farms were assigned to one of 3 study arms: RAB farms reducing antimicrobials by protocol; RAB-CD farms reducing antimicrobials by protocol and applying a cleaning and disinfection program; and Control farms without interventions. MRSA carriage was tested in week 0 and week 12 of 2 consecutive production cycles in farmers, family members and veal calves. Interventions were validated and a cyclic rise in MRSA-prevalence in animals was shown with a more moderate increase in RAB farms. Prevalence in humans declined parallel over time in the study arms but RAB farms were at the lowest MRSA levels from the beginning of the study. In RAB-CD farms, human and animal prevalence did not differ from Control farms and MRSA air loads were significantly higher than in the other study arms. Mimicking the national trend, an overall AMU decrease (daily dosages per animal per cycle (DDDA/C)) was observed over 4 pre-study and the 2 study cycles; this trend did not have a significant effect on a set of evaluated farm technical parameters. AMU was positively associated with MRSA across study arms (ORs per 10 DDDA/C increase = 1.26 for both humans (p = 0.07) and animals (p = 0.12 in first cycle)). These results suggest that AMU reduction might be a good strategy for curbing MRSA in veal calf farming, however the specific cleaning and disinfecting program in RAB-CD farms was not effective. The drop in MRSA prevalence in people during the study could be attributed to the observed long-term AMU decreasing trend.

  16. Control of deaths from diarrheal disease in rural communities. I. Design of an intervention study and effects on child mortality.

    Science.gov (United States)

    Kielmann, A A; Mobarak, A B; Hammamy, M T; Gomaa, A I; Abou-el-Saad, S; Lotfi, R K; Mazen, I; Nagaty, A

    1985-12-01

    From May through October 1980, the "Strengthening Rural Health Delivery" project (SRHD) under the Rural Health Department of the Ministry of Health of Egypt had conducted an investigation into prevention of child mortality from diarrheal disease through testing various modules of Oral Rehydration Therapy delivery mechanisms. In a six-cell design counting a total of almost 29,000 children, ORT was provided both as hypotonic sucrose/salt solution prepared and administered by mothers and normotonic, balanced electrolyte solution in the hands of both mothers and health care providers and the effects on child mortality during the peak season of diarrheal incidence were measured. In addition, utilization and effects of ORT when made readily available through commercial channels was similarly examined. A cost-benefit analysis was performed on the cost of the services as well as on the outcome for each of five study cells using the sixth, the control, as reference. Results showed that early rehydration with a sucrose/salt solution in the hands of mothers, backed by balanced oral rehydration solution in the hands of health care providers proved the most cost-effective means of reducing diarrhea-specific mortality as well as being as safe as prepackaged commercial preparations.

  17. School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES

    Directory of Open Access Journals (Sweden)

    Stallard Paul

    2012-11-01

    Full Text Available Abstract Background Emotional problems such as anxiety and low mood in children are common, impair everyday functioning and increase the risk of severe mental health disorders in adulthood. Relatively few children with emotional health problems are identified and referred for treatment indicating the need to investigate preventive approaches. Methods/Design The study is designed to be a pragmatic cluster randomized controlled trial evaluating the effectiveness of an efficacious school-based cognitive behavior therapy (CBT prevention program (FRIENDS on symptoms of anxiety and low mood in children 9 to 10 years of age. The unit of allocation is schools which are assigned to one of three conditions: school-led FRIENDS, health-led FRIENDS or treatment as usual. Assessments will be undertaken at baseline, 6 months and 12 months. The primary outcome measure is change on the Revised Child Anxiety and Depression Scale. Secondary outcome measures assess changes in self-esteem, worries, bullying and life satisfaction. An economic evaluation will be undertaken. Discussion As of September 2011, 41 schools have been recruited and randomized. Final 12-month assessments are scheduled to be completed by May 2013. Trial Registration ISRCTN23563048

  18. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  19. Study protocol: a randomized controlled trial of a computer-based depression and substance abuse intervention for people attending residential substance abuse treatment

    Directory of Open Access Journals (Sweden)

    Kelly Peter J

    2012-02-01

    Full Text Available Abstract Background A large proportion of people attending residential alcohol and other substance abuse treatment have a co-occurring mental illness. Empirical evidence suggests that it is important to treat both the substance abuse problem and co-occurring mental illness concurrently and in an integrated fashion. However, the majority of residential alcohol and other substance abuse services do not address mental illness in a systematic way. It is likely that computer delivered interventions could improve the ability of substance abuse services to address co-occurring mental illness. This protocol describes a study in which we will assess the effectiveness of adding a computer delivered depression and substance abuse intervention for people who are attending residential alcohol and other substance abuse treatment. Methods/Design Participants will be recruited from residential rehabilitation programs operated by the Australian Salvation Army. All participants who satisfy the diagnostic criteria for an alcohol or other substance dependence disorder will be asked to participate in the study. After completion of a baseline assessment, participants will be randomly assigned to either a computer delivered substance abuse and depression intervention (treatment condition or to a computer-delivered typing tutorial (active control condition. All participants will continue to complete The Salvation Army residential program, a predominantly 12-step based treatment facility. Randomisation will be stratified by gender (Male, Female, length of time the participant has been in the program at the commencement of the study (4 weeks or less, 4 weeks or more, and use of anti-depressant medication (currently prescribed medication, not prescribed medication. Participants in both conditions will complete computer sessions twice per week, over a five-week period. Research staff blind to treatment allocation will complete the assessments at baseline, and then 3, 6, 9

  20. Implementation and impact of an audit and feedback antimicrobial stewardship intervention in the orthopaedics department of a tertiary-care hospital: a controlled interrupted time series study.

    Science.gov (United States)

    Tavares, Margarida; Carvalho, Ana Cláudia; Almeida, José Pedro; Andrade, Paulo; São-Simão, Ricardo; Soares, Pedro; Alves, Carlos; Pinto, Rui; Fontanet, Arnaud; Watier, Laurence

    2018-06-01

    A prospective audit and feedback antimicrobial stewardship intervention conducted in the Orthopaedics Department of a university hospital in Portugal was evaluated by comparing an interrupted time series in the intervention group with a non-intervention (control) group. Monthly antibiotic use (except cefazolin) was measured as the World Health Organization's Anatomical Therapeutic Chemical defined daily doses (ATC-DDD) from January 2012 to September 2016, excluding the 6-month phase of intervention implementation starting on 1 January 2015. Compared with the control group, the intervention group had a monthly decrease in the use of fluoroquinolones by 2.3 DDD/1000 patient-days [95% confidence interval (CI) -3.97 to -0.63]. An increase in the use of penicillins by 103.3 DDD/1000 patient-days (95% CI 47.42 to 159.10) was associated with intervention implementation, followed by a decrease during the intervention period (slope = -5.2, 95% CI -8.56 to -1.82). In the challenging scenario of treatment of osteoarticular and prosthetic joint infections, an audit and feedback intervention reduced antibiotic exposure and spectrum. Copyright © 2018 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

  1. Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

    Science.gov (United States)

    Ramallo-Fariña, Yolanda; García-Pérez, Lidia; Castilla-Rodríguez, Iván; Perestelo-Pérez, Lilisbeth; Wägner, Ana María; de Pablos-Velasco, Pedro; Domínguez, Armando Carrillo; Cortés, Mauro Boronat; Vallejo-Torres, Laura; Ramírez, Marcos Estupiñán; Martín, Pablo Pedrianes; García-Puente, Ignacio; Salinero-Fort, Miguel Ángel; Serrano-Aguilar, Pedro Guillermo

    2015-04-09

    Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands. The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used

  2. Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

    Directory of Open Access Journals (Sweden)

    Moskowitz JT

    2014-09-01

    currently few established interventions for people who are newly diagnosed with HIV. We present the design and methods for a randomized trial in which we test the efficacy of one such skills-based intervention that targets positive affect as a novel mechanism of change. The proposed research builds on observational findings of the important unique functions of positive affect. We aim to determine whether a five-session theory- and evidence-based intervention designed to teach skills for increasing the frequency and intensity of daily positive affect does so, and whether this intervention has beneficial effects on subsequent psychological well-being, health behaviors, and physical health up to 15 months after diagnosis with HIV. This is a randomized controlled trial in a sample of adults recruited within 12 weeks of testing positive for HIV. The control group is attention-matched, and follow up assessments will be conducted immediately post intervention (approximately 5 months post diagnosis and at 10 and 15 months post diagnosis. This study is an important next step in research concerning the adaptive functions of positive affect for people coping with HIV or other health-related life stress. Keywords: positive affect, HIV diagnosis, stress, coping, RCT, intervention, physical health

  3. Mindfulness Intervention for Stress Eating to Reduce Cortisol and Abdominal Fat among Overweight and Obese Women: An Exploratory Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Jennifer Daubenmier

    2011-01-01

    Full Text Available Psychological distress and elevated cortisol secretion promote abdominal fat, a feature of the Metabolic Syndrome. Effects of stress reduction interventions on abdominal fat are unknown. Forty-seven overweight/obese women (mean BMI =31.2 were randomly assigned to a 4-month intervention or waitlist group to explore effects of a mindfulness program for stress eating. We assessed mindfulness, psychological distress, eating behavior, weight, cortisol awakening response (CAR, and abdominal fat (by dual-energy X-ray absorptiometry pre- and posttreatment. Treatment participants improved in mindfulness, anxiety, and external-based eating compared to control participants. Groups did not differ on average CAR, weight, or abdominal fat over time. However, obese treatment participants showed significant reductions in CAR and maintained body weight, while obese control participants had stable CAR and gained weight. Improvements in mindfulness, chronic stress, and CAR were associated with reductions in abdominal fat. This proof of concept study suggests that mindfulness training shows promise for improving eating patterns and the CAR, which may reduce abdominal fat over time.

  4. Mindfulness Intervention for Stress Eating to Reduce Cortisol and Abdominal Fat among Overweight and Obese Women: An Exploratory Randomized Controlled Study.

    Science.gov (United States)

    Daubenmier, Jennifer; Kristeller, Jean; Hecht, Frederick M; Maninger, Nicole; Kuwata, Margaret; Jhaveri, Kinnari; Lustig, Robert H; Kemeny, Margaret; Karan, Lori; Epel, Elissa

    2011-01-01

    Psychological distress and elevated cortisol secretion promote abdominal fat, a feature of the Metabolic Syndrome. Effects of stress reduction interventions on abdominal fat are unknown. Forty-seven overweight/obese women (mean BMI = 31.2) were randomly assigned to a 4-month intervention or waitlist group to explore effects of a mindfulness program for stress eating. We assessed mindfulness, psychological distress, eating behavior, weight, cortisol awakening response (CAR), and abdominal fat (by dual-energy X-ray absorptiometry) pre- and posttreatment. Treatment participants improved in mindfulness, anxiety, and external-based eating compared to control participants. Groups did not differ on average CAR, weight, or abdominal fat over time. However, obese treatment participants showed significant reductions in CAR and maintained body weight, while obese control participants had stable CAR and gained weight. Improvements in mindfulness, chronic stress, and CAR were associated with reductions in abdominal fat. This proof of concept study suggests that mindfulness training shows promise for improving eating patterns and the CAR, which may reduce abdominal fat over time.

  5. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial

    Science.gov (United States)

    Macready, Anna L; Fallaize, Rosalind; Butler, Laurie T; Ellis, Judi A; Kuznesof, Sharron; Frewer, Lynn J; Celis-Morales, Carlos; Livingstone, Katherine M; Araújo-Soares, Vera; Fischer, Arnout RH; Stewart-Knox, Barbara J; Mathers, John C

    2018-01-01

    Background To determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation interventions undergo continuous development, and most are not adapted for Web-based delivery. The Food4Me study (N=1607) provided the opportunity to use existing frameworks to describe standardized Web-based techniques employed in a large-scale, internet-based intervention to change dietary behavior and physical activity. Objective The aims of this study were (1) to describe techniques embedded in the Food4Me study design and explain the selection rationale and (2) to demonstrate the use of behavior change technique taxonomies, develop standard operating procedures for training, and identify strengths and limitations of the Food4Me framework that will inform its use in future studies. Methods The 6-month randomized controlled trial took place simultaneously in seven European countries, with participants receiving one of four levels of personalized advice (generalized, intake-based, intake+phenotype–based, and intake+phenotype+gene–based). A three-phase approach was taken: (1) existing taxonomies were reviewed and techniques were identified a priori for possible inclusion in the Food4Me study, (2) a standard operating procedure was developed to maintain consistency in the use of methods and techniques across research centers, and (3) the Food4Me behavior change technique framework was reviewed and updated post intervention. An analysis of excluded techniques was also conducted. Results Of 46 techniques identified a priori as being applicable to Food4Me, 17 were embedded in the intervention design; 11 were from a dietary taxonomy, and 6 from a smoking cessation taxonomy. In addition, the four-category smoking cessation framework structure was adopted for clarity of

  6. Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Bucci, Sandra; Barrowclough, Christine; Ainsworth, John; Morris, Rohan; Berry, Katherine; Machin, Matthew; Emsley, Richard; Lewis, Shon; Edge, Dawn; Buchan, Iain; Haddock, Gillian

    2015-09-10

    Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to

  7. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods.

    Science.gov (United States)

    Gillison, Fiona; Standage, Martyn; Verplanken, Bas

    2014-03-04

    Physical inactivity and a poor diet predict lifestyle diseases such as diabetes, cardiovascular disease, and certain types of cancer. Marked declines in physical activity occur during late adolescence, coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours. The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning. As actively engaging young people in initiatives based on health messages is challenging, we also tested the efficacy of financial incentives in promoting initial engagement with the programme. A three-arm cluster-randomised design was used. Participants were school pupils from Year 11 and 13 (i.e., in their final year of study), aged 16-18 years. To reduce contamination effects, the unit of randomisation was school. Participants were randomly allocated to receive (i) a 12-week behavioural support intervention consisting of six appointments, (ii) a behavioural support intervention plus incentives (totalling £40), or (iii) an information-only control group. Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician. Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process. Consistent with self-determination theory, all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation. The primary outcome was objectively assessed physical activity (via GT1M accelerometers). Secondary outcome measures were diet, motivation and habit strength. Data were collected at baseline, post-intervention

  8. Study protocol of a parent-focused child feeding and dietary intake intervention: the feeding healthy food to kids randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duncanson Kerith

    2012-07-01

    Full Text Available Abstract Background Poor childhood nutrition is a more pervasive and insidious risk factor for lifestyle-related chronic disease than childhood obesity. Parents find it difficult to address the reported barriers to optimal child feeding, and to improve child dietary patterns. To impact at the population level, nutrition interventions need to be easy to disseminate, have a broad reach and appeal to parents while overcoming the barriers parents face when trying to improve child feeding behaviours. The Feeding Healthy Food to Kids (FHFK Randomised Control Trial (RCT examines the impact of providing low cost, self-directed nutrition and parenting resources to rural parents, on child dietary intake and parent–child feeding practices. Methods/Design Up to 150 parents of two-to-five year old children will be recruited in five rural Australian towns. Eligible, consenting parents will be randomly allocated to intervention or 12-month wait-list control groups. Intervention group parents will receive an interactive nutrition CD and parenting DVD, and be provided with instructions for optimal resource utilisation. Intervention and control group participants will also receive a generic nutrition and physical activity brochure and a physical activity resource to blind participants to group allocation. Primary outcome measures are dietary intake of vegetables (serves/day, fruit and energy dense nutrient poor foods (serves/day and %Energy. Secondary outcome measures are total energy (kCal, other food groups (serves/day and %Energy, key nutrients (mg/day, child feeding domains and parenting style domains. Analysis of dietary outcome measures, child feeding and parenting domains will be conducted on an intention-to-treat basis and compared at baseline, three and 12 months using the random effects model, using STATA software. Details of the methodological aspects of recruitment, inclusion criteria, randomisation and statistical analysis are described

  9. The talent study: a multicentre randomized controlled trial assessing the impact of a 'tailored lifestyle self-management intervention' (talent) on weight reduction.

    Science.gov (United States)

    Melchart, Dieter; Doerfler, Wolfgang; Eustachi, Axel; Wellenhofer-Li, Yanqing; Weidenhammer, Wolfgang

    2015-01-01

    Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a Body Mass Index of 28 to 35. The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons. The study is a multicentre randomized controlled trial with observation duration of 12 months. Eight study centres are involved to include a minimal sample size of 150 participants. Randomization ratio is 2:1. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A) intervention group: comprehensive lifestyle modification program (Individual Health Management IHM) with 3 months reduction phase plus 9 months maintaining phase, B) control group: written information with advice for healthy food habits (Usual care UC). Participants of the IHM group have access to a web-based health portal and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months four refresh trainings will be performed. There are 3 different diet strategies (fasting, two-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according to the German Nutrition Society (DGE). Examinations are conducted at baseline, after 3, 6, 9 and 12 months. They include body weight, waist circumference, blood pressure, laboratory findings and a bio-impedance analysis to measure body composition. Statistical analysis of the primary outcome 'change of body weight after 12 months' is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors 'group', 'baseline value' and 'study centre'. Secondary outcomes will be analyzed exploratively. The monitoring of the study will

  10. Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Fisker, Annette; Langberg, Henning; Petersen, Tom; Mortensen, Ole Steen

    2013-03-13

    Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient. A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT

  11. The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people.

    Science.gov (United States)

    Cockayne, Sarah; Adamson, Joy; Corbacho Martin, Belen; Fairhurst, Caroline; Hewitt, Catherine; Hicks, Kate; Hull, Robin; Keenan, Anne Maree; Lamb, Sarah E; Loughrey, Lorraine; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David

    2014-12-17

    Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. Current Controlled Trials ISRCTN68240461 assigned 01/07/2011. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  12. [Individual, community, regulatory, and systemic approaches to tobacco control interventions].

    Science.gov (United States)

    Gorini, Giuseppe

    2011-01-01

    During the 60s and the 70s strategies for decreasing initiation or quitting have been developed, in order to find those with high success rates. Unfortunately, interventions with an individual approach involved few smokers, so their impact in decreasing smoking prevalence was limited. The socio-ecological model offers a theoretical framework to community interventions for smoking cessation developed during the 80s, in which smoking was considered not only an individual, but also a social problem. In the 80s and the 90s smoking cessation community trials were developed, such as the Community Intervention Trial for Smoking Cessation (COMMIT). Afterwards, policy interventions (price policy; smoking bans in public places; advertising bans; bans of sales to minors) were developed, such as the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST). California has been the first State all over the world to develop a comprehensive Tobacco Control Program in 1988, becoming the place for an ever-conducted natural experiment. All policy interventions in tobacco control have been finally grouped together in the World Health Organization - Framework Convention on Tobacco Control (WHO-FCTC), the first Public Health Treaty. Study designs have changed, according to the individual, community, or regulatory approaches: the classical randomized controlled trials (RCTs), in which the sampling unit is the individual, have been carried out for the evaluation of smoking cessation treatments, whereas cluster RCTs, in which the sampling unit is the community, have been conducted for evaluating community interventions, such as COMMIT. Finally, quasi-experimental studies (before/after study; prospective cohorts, both with a control group), in which the observational unit is a State, have been used for evaluating tobacco control policies, such as ASSIST and the International Tobacco Control Policy Evaluation Project. Although the successes of the last 20 years, tobacco

  13. Prevention of Overweight in Infancy (POI.nz study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth

    Directory of Open Access Journals (Sweden)

    Taylor Barry J

    2011-12-01

    Full Text Available Abstract Background Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care. Methods/Design This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry, duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use. This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia. Discussion Infancy is likely to

  14. Fostering Social Cognition through an Imitation- and Synchronization-Based Dance/Movement Intervention in Adults with Autism Spectrum Disorder: A Controlled Proof-of-Concept Study.

    Science.gov (United States)

    Koehne, Svenja; Behrends, Andrea; Fairhurst, Merle T; Dziobek, Isabel

    2016-01-01

    Since social cognition is impaired in individuals with autism spectrum disorder (ASD), this study aimed at establishing the efficacy of a newly developed imitation- and synchronization-based dance/movement intervention (SI-DMI) in fostering emotion inference and empathic feelings (emotional reaction to feelings of others) in adults with high-functioning ASD. Fifty-five adults with ASD (IQ ≥85) who were blinded to the aim of the study were assigned to receive either 10 weeks of a dance/movement intervention focusing on interpersonal movement imitation and synchronization (SI-DMI, n = 27) or a control movement intervention (CMI, n = 24) focusing on individual motor coordination (2 participants from each group declined before baseline testing). The primary outcome measure was the objective Multifaceted Empathy Test targeting emotion inference and empathic feelings. Secondary outcomes were scores on the self-rated Interpersonal Reactivity Index. The well-established automatic imitation task and synchronization finger-tapping task were used to quantify effects on imitation and synchronization functions, complemented by the more naturalistic Assessment of Spontaneous Interaction in Movement. Intention-to-treat analyses revealed that from baseline to 3 months, patients treated with SI-DMI showed a significantly larger improvement in emotion inference (d = 0.58), but not empathic feelings, than those treated with CMI (d = -0.04). On the close generalization level, SI-DMI increased synchronization skills and imitation tendencies, as well as whole-body imitation/synchronization and movement reciprocity/dialogue, compared to CMI. SI-DMI can be successful in promoting emotion inference in adults with ASD and warrants further investigation. © 2015 S. Karger AG, Basel.

  15. Baduanjin Mind-Body Intervention Improves the Executive Control Function.

    Science.gov (United States)

    Chen, Tingting; Yue, Guang H; Tian, Yingxue; Jiang, Changhao

    2016-01-01

    This study aims at comparing the effects of the Baduanjin mind-body (BMB) intervention with a conventional relaxation training program on enhancing the executive function. The study also attempts to explore the neural substrates underlying the cognitive effect of BMB intervention using near-infrared spectroscopy (NIRS) technique. Forty-two healthy college students were randomly allocated into either the Baduanjin intervention group or relaxation training (control) group. Training lasted for 8 weeks (90 min/day, 5 days/week). Each participant was administered the shortened Profile of Mood States to evaluate their mood status and the flanker task to evaluate executive function before and after training. While performing the flanker task, the NIRS data were collected from each participant. After training, individuals who have participated in BMB exercise showed a significant reduction in depressive mood compared with the same measure before the intervention. However, participants in the control group showed no such reduction. The before vs. after measurement difference in the flanker task incongruent trails was significant only for the Baduanjin intervention group. Interestingly, an increase in oxygenated hemoglobin in the left prefrontal cortex was observed during the Incongruent Trails test only after the BMB exercise intervention. These findings implicate that Baduanjin is an effective and easy-to-administering mind-body exercise for improving executive function and perhaps brain self-regulation in a young and healthy population.

  16. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial

    NARCIS (Netherlands)

    Macready, Anna L.; Fallaize, Rosalind; Butler, Laurie T.; Ellis, Judi A.; Kuznesof, Sharron; Frewer, Lynn J.; Celis-Morales, Carlos; Livingstone, Katherine M.; Araújo-Soares, Vera; Fischer, Arnout R.H.; Stewart-Knox, Barbara J.; Mathers, John C.; Lovegrove, Julie A.

    2018-01-01

    Background: To determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation

  17. Efficacy of an exercise intervention for employees with work-related fatigue: Study protocol of a two-arm randomized controlled trial

    NARCIS (Netherlands)

    Vries, J.D. de; Hooff, M.L.M. van; Geurts, S.A.E.; Kompier, M.A.J.

    2015-01-01

    BACKGROUND: The aim of the current study is to evaluate the efficacy of an exercise intervention to reduce work-related fatigue. Exercise is a potentially effective intervention strategy to reduce work-related fatigue, since it may enhance employees' ability to cope with work stress and it helps to

  18. The effects of psychoeducational family intervention on coping strategies of relatives of patients with bipolar I disorder: results from a controlled, real-world, multicentric study

    Science.gov (United States)

    Sampogna, Gaia; Luciano, Mario; Vecchio, Valeria Del; Malangone, Claudio; De Rosa, Corrado; Giallonardo, Vincenzo; Borriello, Giuseppina; Pocai, Benedetta; Savorani, Micaela; Steardo, Luca; Lampis, Debora; Veltro, Franco; Bartoli, Francesco; Bardicchia, Francesco; Moroni, Anna Maria; Ciampini, Giusy; Orlandi, Emanuele; Ferrari, Silvia; Biondi, Silvia; Iapichino, Sonia; Pompili, Enrico; Piselli, Massimiliano; Tortorella, Alfonso; Carrà, Giuseppe; Fiorillo, Andrea

    2018-01-01

    Background Psychoeducational family intervention (PFI) has been proven to be effective in improving the levels of family burden and patients’ personal functioning in schizophrenia and bipolar disorders (BDs). Less is known about the impact of PFI on relatives’ coping strategies in BD. Methods A multicenter, controlled, outpatient trial funded by the Italian Ministry of Health and coordinated by the Department of Psychiatry of the University of Campania “Luigi Vanvitelli” has been conducted in patients with bipolar I disorder (BD-I) and their key relatives consecutively recruited in 11 randomly selected Italian community mental health centers. We aim to test the hypothesis that PFI improves problem-oriented coping strategies in relatives of BD-I patients compared to the Treatment As Usual (TAU) group. Results The final sample was constituted of 123 patients and 139 relatives. At baseline assessment (T0), the vast majority of relatives already adopted problem-oriented coping strategies more frequently than the emotion-focused ones. At the end of the intervention, relatives receiving PFI reported a higher endorsement of adaptive coping strategies, such as “maintenance of social interests” (odds ratio [OR]=0.309, CI=0.04–0.57; p=0.023), “positive communication with the patient” (OR=0.295, CI=0.13–0.46; p=0.001), and “searching for information” (OR=0.443, CI=0.12–0.76; p=0.007), compared to TAU relatives, after controlling for several confounders. As regards the emotion-focused coping strategies, relatives receiving the experimental intervention less frequently reported to adopt “resignation” (OR=−0.380, CI=−0.68 to −0.08; p=0.014) and “coercion” (OR=−0.268, CI=−0.46 to −0.08; p=0.006) strategies, compared to TAU relatives. Conclusion PFI is effective in improving the adaptive coping strategies of relatives of BD-I patients, but further studies are needed for evaluating the long-term benefits of this intervention. PMID

  19. Effects of a 3-year intervention: The Copenhagen School Child Intervention Study

    DEFF Research Database (Denmark)

    Bugge, Anna; El-Naaman, Bianca; Dencker, Magnus

    2012-01-01

    INTRODUCTION: This study assessed short and long term effects of a 3-year controlled school-based physical activity (PA) intervention on fatness, cardiorespiratory fitness (VO2peak) and cardiovascular disease (CVD) risk factors in children. METHODS: The study involved 18 schools (10 intervention...

  20. A randomised controlled intervention trial evaluating the efficacy of a Mediterranean dietary pattern on cognitive function and psychological wellbeing in healthy older adults: the MedLey study.

    Science.gov (United States)

    Knight, Alissa; Bryan, Janet; Wilson, Carlene; Hodgson, Jonathan; Murphy, Karen

    2015-04-28

    The incidence of age-related cognitive decline is rising considerably around the world. There is evidence from a number of recent cross-sectional and prospective studies indicating positive associations between the Mediterranean dietary pattern (MedDiet) and improved cognitive outcomes among the elderly including, reduced age-related cognitive decline and enhanced age-related cognitive performance. However, to date no study has validated these associations in healthy older adult populations (≥65 years and above) with randomised evidence. The main aim of the present study is to provide justified evidence regarding the efficacy of a MedDiet approach to safely reduce the onset of cognitive decline, and promote optimal cognitive performance among healthy older adults using rigorous, randomised intervention methodology. MedLey is a 6-month, randomised controlled 2-cohort parallel group intervention trial, with initial assessment at baseline and repeated every three months. A sample of 166 healthy Australian men and women aged 65 years and above, with normal cognitive function and proficient in English language were recruited from metropolitan Adelaide, South Australia for the study. Participants randomly allocated to the experimental group are required to maintain an intervention dietary pattern based from the traditional Cretan MedDiet (i.e. vegetables, fruits, olive oil, legumes, fish, whole grain cereals, nuts and seeds and low consumption of processed foods, dairy products, red meat and vegetable oils) for six months, while those participants allocated to the control group are asked to maintain their customary lifestyle and diet. The primary outcome of interest is the quantitative difference in age-related cognitive performance, as measured by latent variables (cognitive constructs) sensitive to normal ageing and diet (i.e. speed of processing, memory, attention, executive functions, visual spatial and visuomotor ability). Secondary outcomes include change in

  1. A School-Based, Peer-Led, Social Marketing Intervention To Engage Spanish Adolescents in a Healthy Lifestyle ("We Are Cool"-Som la Pera Study): A Parallel-Cluster Randomized Controlled Study.

    Science.gov (United States)

    Aceves-Martins, Magaly; Llauradó, Elisabet; Tarro, Lucia; Moriña, David; Papell-Garcia, Ignasi; Prades-Tena, Jordi; Kettner-Høeberg, Helle; Puiggròs, Francesc; Arola, Lluís; Davies, Amy; Giralt, Montse; Solà, Rosa

    2017-08-01

    Encouraging adolescents to adopt healthy lifestyles can be challenging. The aim of the "Som la Pera" study was to engage adolescents by applying new strategies to increase both their fruit and vegetable consumption and their physical activity (PA) while reducing their sedentary behavior. In disadvantaged neighborhoods of Reus (Spain), two high schools were randomly assigned to the intervention (n = 170 adolescents 13- to 16-year-olds) and two were assigned to the control group (n = 223 adolescents 13- to 16-year-olds). The intervention, which lasted 12 months and spanned 2 academic years (2013-2015), used social marketing (SM) to improve healthy choices. The peer-led strategy involved 5 adolescents who designed and implemented 10 activities as challenges for their 165 school-aged peers. The control group received no intervention. To assess self-reported lifestyles in both groups, the Health Behavior in School-Aged Children Survey was used at baseline and end of study. After 12 months, intervention adolescents showed an increase of 28.9% in ≥1 fruit/day (p < 0.01) and of 18.5% in ≥6 hours/week of PA (p < 0.01) compared with controls. Additionally, intervention group males had an increase of 28.8% in ≥1 vegetable/day (p < 0.01) and of 15.6% in ≤2 hours/day of sedentary activity (p = 0.01) compared with controls. A school-based, peer-led, SM intervention developed by adolescents attending high schools in low-income neighborhoods effectively improved the healthy choices of their school-aged peers, leading to increased fruit consumption and PA in adolescents of both genders. Furthermore, adolescent males were more sensitive to improvements in healthy choices, showing increased vegetable consumption and decreased sedentary behavior.

  2. Impact on quality of life of a nursing intervention programme for patients with chronic non-cancer pain: an open, randomized controlled parallel study protocol.

    Science.gov (United States)

    Morales-Fernandez, Angeles; Morales-Asencio, Jose Miguel; Canca-Sanchez, Jose Carlos; Moreno-Martin, Gabriel; Vergara-Romero, Manuel

    2016-05-01

    To determine the effect of a nurse-led intervention programme for patients with chronic non-cancer pain. Chronic non-cancer pain is a widespread health problem and one that is insufficiently controlled. Nurses can play a vital role in pain management, using best practices in the assessment and management of pain under a holistic approach where the patient plays a proactive role in addressing the disease process. Improving the quality of life, reducing disability, achieving acceptance of health status, coping and breaking the vicious circle of pain should be the prime objectives of our care management programme. Open randomized parallel controlled study. The experimental group will undertake one single initial session, followed by six group sessions led by nurses, aimed at empowering patients for the self-management of pain. Healthy behaviours will be encouraged, such as sleep and postural hygiene, promotion of physical activity and healthy eating. Educational interventions on self-esteem, pain-awareness, communication and relaxing techniques will be carried out. As primary end points, quality of life, perceived level of pain, anxiety and depression will be evaluated. Secondary end points will be coping and satisfaction. Follow-up will be performed at 12 and 24 weeks. The study was approved by the Ethics and Research Committee Costa del Sol. If significant effects were detected, impact on quality of life through a nurse-led programme would offer a complementary service to existing pain clinics for a group of patients with frequent unmet needs. © 2016 John Wiley & Sons Ltd.

  3. A theory-based implementation program for alcohol screening and brief intervention (ASBI) in general practices: Planned development and study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    Abidi, L; Oenema, A; Candel, M J J M; van de Mheen, D

    2016-11-01

    Previous studies have shown that alcohol screening and brief intervention (ASBI) in general practices can lead to significant reductions in alcohol consumption among patients, yet ASBI is rarely implemented into routine clinical practice. The aim of this paper is to describe the development and evaluation of an ASBI implementation program aimed at increasing ASBI delivery rates of general practitioners (GPs) and decreasing patients' alcohol consumption. This study protocol describes the step-wise development and evaluation of an ASBI implementation program. A four-step method is used to identify relevant determinants of change and intervention components based on the Behaviour Change Wheel and the Theoretical Domains Framework. The program will be evaluated in general practices in The Netherlands in a two-arm cluster randomised controlled trial which investigates the effect of the program on GPs' ASBI delivery behaviour as well as on patients' alcohol consumption. Effective theory- and practice-based strategies to implement ASBI in general practices are highly needed. Using a stepwise method we described the development of a program consisting of an e-learning module, a tailored feedback module and environmental support and materials. We hypothesize that this program will result in an increase of GPs' ASBI delivery behaviour. Secondly, we expect an overall decrease in percentage of patients with excessive or problematic alcohol use and a higher proportion of patients from GPs receiving the ASBI implementation program decreasing their alcohol consumption, compared to patients from GPs in the control group. NTR5539. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies

    NARCIS (Netherlands)

    Souverein, O.W.; Vries, J.H.M. de; Freese, R.; Watzl, B.; Bub, A.; Miller, E.R., III; Castenmiller, J.J.M.; Pasman, W.J.; Hof, K. van het; Chopra, M.; Karlsen, A.; Dragsted, L.O.; Winkels, R.; Itsiopoulos, C.; Brazionis, L.; O'Dea, K.; Loo-Bouwman, C.A. van; Naber, T.H.J.; Voet, H. van der; Boshuizen, H.C.

    2015-01-01

    Fruit and vegetable consumption produces changes in several biomarkers in blood. The present study aimed to examine the dose-response curve between fruit and vegetable consumption and carotenoid (α-carotene, β-carotene, β-cryptoxanthin, lycopene, lutein and zeaxanthin), folate and vitamin C

  5. Cognitive Rehabilitation in Alzheimer's Disease: A Controlled Intervention Trial.

    Science.gov (United States)

    Brueggen, Katharina; Kasper, Elisabeth; Ochmann, Sina; Pfaff, Henrike; Webel, Steffi; Schneider, Wolfgang; Teipel, Stefan

    2017-01-01

    Cognitive Rehabilitation for Alzheimer's disease (AD) is an integrative multimodal intervention. It aims to maintain autonomy and quality of life by enhancing the patients' abilities to compensate for decreased cognitive functioning. We evaluated the feasibility of a group-based Cognitive Rehabilitation approach in mild AD dementia and assessed its effect on activities of daily living (ADL). We included 16 patients with AD dementia in a controlled partial-randomized design. We adapted the manual-guided Cognitive Rehabilitation program (CORDIAL) to a group setting. Over the course of three months, one group received the Cognitive Rehabilitation intervention (n = 8), while the other group received a standardized Cognitive Training as an active control condition (n = 8). ADL-competence was measured as primary outcome. The secondary outcome parameters included cognitive abilities related to daily living, functional cognitive state, and non-cognitive domains, e.g., quality of life. For each scale, we assessed the interaction effect 'intervention by time', i.e., from pre-to post-intervention. We found no significant interaction effect of intervention by time on the primary outcome ADL-competence. The interaction effect was significant for quality of life (Cohen's d: -1.43), showing an increase in the intervention group compared with the control group. Our study demonstrates the feasibility of a group-based Cognitive Rehabilitation program for patients with mild AD dementia. The Cognitive Rehabilitation showed no significant effect on ADL, possibly reflecting a lack of transfer between the therapy setting and real life. However, the group setting enhanced communication skills and coping mechanisms. Effects on ADL may not have reached statistical significance due to a limited sample size. Furthermore, future studies might use an extended duration of the intervention and integrate caregivers to a greater extent to increase transfer to activities of daily living.

  6. Work environment and health determinants : Longitudinal, controlled intervention and cross-sectional studies in public-service broadcasting companies

    OpenAIRE

    Schell, Elisabet

    2008-01-01

    This thesis focuses on ongoing working life. The overall aim was to identify determinants for work health. Various occupational groups in two public service broadcasting companies in Sweden were included. Study persons: Participants were from all over the country (n=1961, participation rate 74%) divided in 11 occupational groups. Those on leave more than 6 months were excluded. Mean age was 48 yrs (21-67 yrs), 58% were males. Questionnaire and company register data were col...

  7. Gender norms and economic empowerment intervention to reduce intimate partner violence against women in rural Côte d'Ivoire: a randomized controlled pilot study.

    Science.gov (United States)

    Gupta, Jhumka; Falb, Kathryn L; Lehmann, Heidi; Kpebo, Denise; Xuan, Ziming; Hossain, Mazeda; Zimmerman, Cathy; Watts, Charlotte; Annan, Jeannie

    2013-11-01

    Gender-based violence against women, including intimate partner violence (IPV), is a pervasive health and human rights concern. However, relatively little intervention research has been conducted on how to reduce IPV in settings impacted by conflict. The current study reports on the evaluation of the incremental impact of adding "gender dialogue groups" to an economic empowerment group savings program on levels of IPV. This study took place in north and northwestern rural Côte d'Ivoire. Between 2010 and 2012, we conducted a two-armed, non-blinded randomized-controlled trial (RCT) comparing group savings only (control) to "gender dialogue groups" added to group savings (treatment). The gender dialogue group consisted of eight sessions that targeted women and their male partner. Eligible Ivorian women (18+ years, no prior experience with group savings) were invited to participate. 934 out of 981 (95.2%) partnered women completed baseline and endline data collection. The primary trial outcome measure was an overall measure of past-year physical and/or sexual IPV. Past year physical IPV, sexual IPV, and economic abuse were also separately assessed, as were attitudes towards justification of wife beating and a woman's ability to refuse sex with her husband. Intent to treat analyses revealed that compared to groups savings alone, the addition of gender dialogue groups resulted in a slightly lower odds of reporting past year physical and/or sexual IPV (OR: 0.92; 95% CI: 0.58, 1.47; not statistically significant). Reductions in reporting of physical IPV and sexual IPV were also observed (not statistically significant). Women in the treatment group were significantly less likely to report economic abuse than control group counterparts (OR = 0.39; 95% CI: 0.25, 0.60, p < .0001). Acceptance of wife beating was significantly reduced among the treatment group (β = -0.97; 95% CI: -1.67, -0.28, p = 0.006), while attitudes towards refusal of sex did not significantly change Per

  8. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France

    Directory of Open Access Journals (Sweden)

    Tubach Florence

    2012-08-01

    Full Text Available Abstract Background Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood. Method and design The objective of this multicentre randomized controlled parallel trial (PROBE methodology is to assess the impact in a multi-risk French urban sample of a home-visiting program targeting child mental health and its major determinants. This paper describes the protocol of this study. In the study, pregnant women were eligible if they were: living in the intervention area; able to speak French, less than 26 years old; having their first child; less than 27 weeks of amenorrhea; and if at least one of the following criteria were true: less than twelve years of education, intending to bring up their child without the presence of the child’s father, and 3 low income. Participants were randomized into either the intervention or the control group. All had access to usual care in mother-child centres and community mental health services free of charge in every neighbourhood. Psychologists conducted all home visits, which were planned on a weekly basis from the 7th month of pregnancy and progressively decreasing in frequency until the child’s second birthday. Principle outcome measures included child mental health at 24 months and two major mediating variables for infant mental health: postnatal maternal depression and the quality of the caring environment. A total of 440 families were recruited, of which a subsample of 120 families received specific attachment and caregiver behaviour assessment. Assessment was conducted by an independent assessment team during home visits and, for the attachment study, in a specifically created Attachment Assessment laboratory. Discussion The CAPEDP study is the first large-scale randomised, controlled infant mental health promotion programme to take place in France. A major specificity of the program was that all home visits were conducted by

  9. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France.

    Science.gov (United States)

    Tubach, Florence; Greacen, Tim; Saïas, Thomas; Dugravier, Romain; Guedeney, Nicole; Ravaud, Philippe; Tereno, Susana; Tremblay, Richard; Falissard, Bruno; Guedeney, Antoine

    2012-08-13

    Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood. The objective of this multicentre randomized controlled parallel trial (PROBE methodology) is to assess the impact in a multi-risk French urban sample of a home-visiting program targeting child mental health and its major determinants. This paper describes the protocol of this study. In the study, pregnant women were eligible if they were: living in the intervention area; able to speak French, less than 26 years old; having their first child; less than 27 weeks of amenorrhea; and if at least one of the following criteria were true: less than twelve years of education, intending to bring up their child without the presence of the child's father, and 3) low income. Participants were randomized into either the intervention or the control group. All had access to usual care in mother-child centres and community mental health services free of charge in every neighbourhood. Psychologists conducted all home visits, which were planned on a weekly basis from the 7th month of pregnancy and progressively decreasing in frequency until the child's second birthday. Principle outcome measures included child mental health at 24 months and two major mediating variables for infant mental health: postnatal maternal depression and the quality of the caring environment. A total of 440 families were recruited, of which a subsample of 120 families received specific attachment and caregiver behaviour assessment. Assessment was conducted by an independent assessment team during home visits and, for the attachment study, in a specifically created Attachment Assessment laboratory. The CAPEDP study is the first large-scale randomised, controlled infant mental health promotion programme to take place in France. A major specificity of the program was that all home visits were conducted by specifically trained, supervised psychologists rather than nurses

  10. Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Fandiño-Del-Rio, Magdalena; Goodman, Dina; Kephart, Josiah L; Miele, Catherine H; Williams, Kendra N; Moazzami, Mitra; Fung, Elizabeth C; Koehler, Kirsten; Davila-Roman, Victor G; Lee, Kathryn A; Nangia, Saachi; Harvey, Steven A; Steenland, Kyle; Gonzales, Gustavo F; Checkley, William

    2017-11-03

    Biomass fuel smoke is a leading risk factor for the burden of disease worldwide. International campaigns are promoting the widespread adoption of liquefied petroleum gas (LPG) in resource-limited settings. However, it is unclear if the introduction and use of LPG stoves, in settings where biomass fuels are used daily, reduces pollution concentration exposure, improves health outcomes, or how cultural and social barriers influence the exclusive adoption of LPG stoves. We will conduct a randomized controlled, field intervention trial of LPG stoves and fuel distribution in rural Puno, Peru, in which we will enroll 180 female participants aged 25-64 years and follow them for 2 years. After enrollment, we will collect information on sociodemographic characteristics, household characteristics, and cooking practices. During the first year of the study, LPG stoves and fuel tanks will be delivered to the homes of 90 intervention participants. During the second year, participants in the intervention arm will keep their LPG stoves, but the gas supply will stop. Control participants will receive LPG stoves and vouchers to obtain free fuel from distributors at the beginning of the second year, but gas will not be delivered. Starting at baseline, we will collect longitudinal measurements of respiratory symptoms, pulmonary function, blood pressure, endothelial function, carotid artery intima-media thickness, 24-h dietary recalls, exhaled carbon monoxide, quality-of-life indicators, and stove-use behaviors. Environmental exposure assessments will occur six times over the 2-year follow-up period, consisting of 48-h personal exposure and kitchen concentration measurements of fine particulate matter and carbon monoxide, and 48-h kitchen concentrations of nitrogen dioxide for a subset of 100 participants. Findings from this study will allow us to better understand behavioral patterns, environmental exposures, and cardiovascular and pulmonary outcomes resulting from the adoption of

  11. The UPBEAT nurse-delivered personalized care intervention for people with coronary heart disease who report current chest pain and depression: a randomised controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Elizabeth A Barley

    Full Text Available Depression is common in people with coronary heart disease (CHD and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial (RCT of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression.Multi-centre, outcome assessor-blinded, randomized parallel group study. CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care (PC or treatment as usual (TAU for 6 months and followed for 1 year. Primary outcome was acceptability and feasibility of procedures; secondary outcomes included mood, chest pain, functional status, well being and psychological process variables.1001 people from 17 General Practice CHD registers in South London consented to be contacted; out of 126 who were potentially eligible, 81 (35% female, mean age = 65 SD11 years were randomized. PC participants (n = 41 identified wide ranging problems to work on with nurse-case managers. Good acceptability and feasibility was indicated by low attrition (9%, high engagement and minimal nurse time used (mean/SD = 78/19 mins assessment, 125/91 mins telephone follow up. Both groups improved on all outcomes. The largest between group difference was in the proportion no longer reporting chest pain (PC 37% vs TAU 18%; mixed effects model OR 2.21 95% CI 0.69, 7.03. Some evidence was seen that self efficacy (mean scale increase of 2.5 vs 0.9 and illness perceptions (mean scale increase of 7.8 vs 2.5 had improved in PC vs TAU participants at 1 year. PC appeared to be more cost effective up to a QALY threshold of approximately £3,000.Trial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU.Controlled-Trials.com ISRCTN21615909.

  12. A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

    Directory of Open Access Journals (Sweden)

    Tourangeau Ann

    2008-12-01

    Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This

  13. Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Grossman Ellie

    2012-08-01

    Full Text Available Abstract Background Hospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders. Methods/design This randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis. Discussion This study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients. Trial registration Clinicaltrials.gov ID# NCT01363245

  14. A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage.

    Science.gov (United States)

    Bailey, Sarah; Bailey, Chris; Boivin, Jacky; Cheong, Ying; Reading, Isabel; Macklon, Nick

    2015-04-15

    Recurrent miscarriage (RM) is diagnosed when a woman has had three or more miscarriages. Increased levels of distress and anxiety are common during the waiting period of any subsequent pregnancies, posing a significant threat to psychological well-being. However, only limited support and therapy are available for these women, and many are left to cope alone. The Positive Reappraisal Coping Intervention (PRCI) is a novel self-administered supportive technique which has been shown to be effective in patients awaiting the outcome of in vitro fertilisation treatment. The primary objective of this study is to assess the feasibility and effectiveness of the PRCI in improving quality of life in the difficult waiting period which women with previous RM endure before an ongoing pregnancy can be confirmed. A randomised controlled trial (RCT) feasibility study will establish the viability of conducting a multicentre RCT to definitively test the effects of the PRCI on the psychological well-being of women who have experienced RM during the initial waiting period of a subsequent pregnancy. A second component consists of a qualitative process evaluation exploring the initial experience of pregnancy following repeated miscarriages. Participants (n=50) will be randomised into one of two groups. The PRCI intervention group will receive the PRCI card and weekly questionnaires to assess their psychological well-being during the waiting period of their new pregnancy. The non-intervention group will be asked to complete the same weekly questionnaires. The qualitative process analysis will employ semistructured interviews (n=20) to address relevant aspects of the study objectives. Ethics approval has been obtained from the National Research Ethics Service Committee South Central-Hampshire A. Participating centres have given National Health Service R&D approval. Study findings will be disseminated through peer reviewed journals, national and international conferences and lay user groups

  15. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  16. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  17. Estimation of on-farm interventions to control Campylobacter

    DEFF Research Database (Denmark)

    Sommer, Helle Mølgaard; Borck Høg, Birgitte; Rosenquist, Hanne

    2015-01-01

    Before making risk management decisions to control Campylobacter prevalence in broiler flocks, it is useful to identify effective interventions. A given risk factor may seem to have a large effect, but in practice interventions related to this risk factor may have only limited effect due...... to a relative small proportion of the farms that can actually be intervened for the given risk factors. We present a novel tool for risk assessors to obtain such estimates of the effect of interventions before it is implemented at the farms. A statistical method was developed in order to estimate the flock...... population. In the present study risk factor estimates from a European study was used and the reference population consisted of data from the risk factor study plus extra data from a large questionnaire survey to improve the representativeness of the reference population. The results showed that some...

  18. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Abramsky Tanya

    2012-06-01

    Full Text Available Abstract Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members; past year experience of physical intimate partner violence and sexual intimate partner violence (among females; community responses to women experiencing violence (among women reporting past year physical/sexual partner violence; and past year concurrency of sexual partners (among males. 1583 women and men (aged 18–49 years were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved

  19. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18–49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. Discussion This is one of few

  20. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Godfrey, Keith M; Cutfield, Wayne; Chan, Shiao-Yng; Baker, Philip N; Chong, Yap-Seng

    2017-03-20

    Improved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk. Maternal insulin resistance and glycaemia around conception and in early pregnancy may be key determinants of maternal physiology and placental function, affecting fetal nutrient supply and maternal-feto-placental communications throughout gestation, with implications for later postnatal health. This double-blind randomised controlled trial will recruit up to 1800 women, aged 18-38 years, who are planning a pregnancy in the United Kingdom (UK), Singapore and New Zealand, with a view to studying 600 pregnancies. The primary outcome is maternal glucose tolerance at 28 weeks' gestation following an oral glucose tolerance test. Secondary outcomes include metabolic, molecular and health-related outcomes in the mother and offspring, notably infant body composition. Participants will be randomly allocated to receive a twice-daily control nutritional drink, enriched with standard micronutrients, or a twice-daily intervention nutritional drink enriched with additional micronutrients, myo-inositol and probiotics, both demonstrated previously to assist in maintaining healthy glucose metabolism during pregnancy. Myo-inositol is a nutrient that enhances cellular glucose uptake. The additional micronutrients seek to address deficiencies of some B-group vitamins and vitamin D that are both common during pregnancy and that have been associated with maternal dysglycaemia, epigenetic changes and greater offspring adiposity. Women who conceive within a year of starting the nutritional drinks will be followed through pregnancy and studied with their infants at six time points during the first year of life. Blood, urine/stool, hair and cheek swabs will be collected from the mothers for genetic, epigenetic, hormone, nutrient and metabolite measurements, and assessments of the mother

  1. Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Dekker, Kim; Benjamins, Jeroen S; Van Straten, Annemieke; Hofman, Winni F; Van Someren, Eus J W

    2015-07-04

    DSM-V criteria for insomnia disorder are met by 6 to 10% of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses. The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following: 1. The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming; 2. Whether the effectiveness of internet-suppo