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.

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

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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

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

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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

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

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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

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...

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

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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.

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

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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.

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

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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.

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

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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

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

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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.

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

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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

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

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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.

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...

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

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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.

[Individual, community, regulatory, and systemic approaches to tobacco control interventions].

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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

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

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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

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

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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.

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...

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

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…

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.

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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

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

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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

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.

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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

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...

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

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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.

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

Comprehensive self-control training benefits depressed college students: A six-month randomized controlled intervention trial.

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Yang, Xueling; Zhao, Jiubo; Chen, Yu; Zu, Simeng; Zhao, Jingbo

2018-01-15

Depressive disorder was associated with dysfunctional self-regulation. The current study attempted to design and test a comprehensive self-control training (CSCT) program with an overall emphasis on behaviral activation in depressed Chinese college students. Participants included 74 students who had diagnosed with major depression, they were randomly assigned to one of the two groups: intervention group (n=37), and control group (n=37). The intervention participants received an eight-week CSCT and four-month follow-up consolidation program, as compared to the control group who received only pre-post-and-follow-up measurements. All participants measured Beck Depression Inventory (BDI-Ⅱ) and Self-control Scale (SCS) at three time points: baseline, post-training, and four-month follow-up. The dropout rates were 6 (8.1%) in the intervention group and 3 (4.1%) in the control group at the end of six-month intervention. The general linear model repeated measures analysis of variance revealed that comparing with the control group, the intervention group participants had more increase in their trait self-control score, at the meantime, their depressive symptoms had significantly improved. Univariate and logistic regression analyses revealed that participants with milder baseline depressive symptoms were more likely to benefit from CSCT interventions; depression improvement was also associated with the number of sessions attended. The main limitation was related to the small sample size which consisted of college students who were relatively young and well educated. The current study demonstrates that CSCT program could temporarily enhance self-control capacity as well as improve depressive symptoms; participants who are mildly to moderately depressed, and who could adhere to the training protocol are more likely to benefit from the intervention. Copyright © 2017 Elsevier B.V. All rights reserved.

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

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

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

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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.

Humans, 'things' and space: costing hospital infection control interventions.

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Page, K; Graves, N; Halton, K; Barnett, A G

2013-07-01

Previous attempts at costing infection control programmes have tended to focus on accounting costs rather than economic costs. For studies using economic costs, estimates tend to be quite crude and probably underestimate the true cost. One of the largest costs of any intervention is staff time, but this cost is difficult to quantify and has been largely ignored in previous attempts. To design and evaluate the costs of hospital-based infection control interventions or programmes. This article also discusses several issues to consider when costing interventions, and suggests strategies for overcoming these issues. Previous literature and techniques in both health economics and psychology are reviewed and synthesized. This article provides a set of generic, transferable costing guidelines. Key principles such as definition of study scope and focus on large costs, as well as pitfalls (e.g. overconfidence and uncertainty), are discussed. These new guidelines can be used by hospital staff and other researchers to cost their infection control programmes and interventions more accurately. Copyright © 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

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

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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.

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

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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

A multistage controlled intervention to increase stair climbing at work: effectiveness and process evaluation.

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Bellicha, Alice; Kieusseian, Aurélie; Fontvieille, Anne-Marie; Tataranni, Antonio; Copin, Nane; Charreire, Hélène; Oppert, Jean-Michel

2016-04-11

Stair climbing helps to accumulate short bouts of physical activity throughout the day as a strategy for attaining recommended physical activity levels. There exists a need for effective long-term stair-climbing interventions that can be transferred to various worksite settings. The aims of this study were: 1) to evaluate short- and long-term effectiveness of a worksite stair-climbing intervention using an objective measurement of stair climbing and a controlled design; and 2) to perform a process evaluation of the intervention. We performed a controlled before-and-after study. The study was conducted in two corporate buildings of the same company located in Paris (France), between September, 2013 and September, 2014. The status of either "intervention site" or "control site" was assigned by the investigators. Participants were on-site employees (intervention site: n = 783; control site: n = 545 at baseline). Two one-month intervention phases using signs (intervention phase 1) and enhancement of stairwell aesthetics (intervention phase 2) were performed. The main outcome was the change in stair climbing, measured with automatic counters and expressed in absolute counts/day/100 employees and percent change compared to baseline. Qualitative outcomes were used to describe the intervention process. Stair climbing significantly increased at the intervention site (+18.7%) but decreased at the control site (-13.3%) during the second intervention phase (difference between sites: +4.6 counts/day/100 employees, p levels at the intervention site, but a significant difference between sites was found (intervention site vs. control site: +2.9 counts/day/100 employees, p level after the end of the study. This study shows a successful stair-climbing intervention at the worksite. The main barriers to adoption and implementation were related to location and visibility of posters. Process evaluation was useful in identifying these barriers throughout the study, and in

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

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

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

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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.

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

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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

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

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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.

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

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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

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.

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

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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

Testing a workplace physical activity intervention: a cluster randomized controlled trial.

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McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M

2011-04-11

Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.

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

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

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

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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.

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

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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.

Cognitive Rehabilitation in Alzheimer's Disease: A Controlled Intervention Trial.

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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.

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

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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

Baduanjin Mind-Body Intervention Improves the Executive Control Function.

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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.

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

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Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

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

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

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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.

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

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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

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.

Schizophrenia and weight management: a systematic review of interventions to control weight.

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Faulkner, G; Soundy, A A; Lloyd, K

2003-11-01

Weight gain is a frequent side effect of antipsychotic medication which has serious implications for a patient's health and well being. This study systematically reviews the literature on the effectiveness of interventions designed to control weight gain in schizophrenia. A systematic search strategy was conducted of major databases in addition to citation searches. Study quality was rated. Sixteen studies met the inclusion criteria. Five of eight pharmacological intervention studies reported small reductions in weight (weight). All behavioural (including diet and/or exercise) interventions reported small reductions in, or maintenance of, weight. Weight loss may be difficult but it is not impossible. Given the inconsistent results, the widespread use of pharmacological interventions cannot be recommended. Both dietary and exercise counselling set within a behavioural modification programme is necessary for sustained weight control.

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...

Glycemic control in the infectious diseases ward; role of clinical pharmacist interventions.

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Farsaei, Shadi; Karimzadeh, Iman; Elyasi, Sepideh; Hatamkhani, Shima; Khalili, Hossein

2014-04-15

Hyperglycemia is one of the most frequent metabolic complications in hospitalized patients. Increased risk of infection following hyperglycemia has been reported in hospitalized patients and infections may also cause insulin resistance which complicates the control of blood glucose level. In this study the impact of the clinical pharmacist interventions on the glycemic control in patients admitted to infectious diseases ward has been evaluated. We conducted a prospective, pre-post interventional study among patients with hyperglycemia. The clinical pharmacist-led multidisciplinary team managed the glycemic profile of patients according to an established insulin protocol commonly used in internal wards. Clinical pharmacists reviewed patients' medical charts for proper insulin administration, evaluated nurses' technique for insulin injection and blood glucose measurement, and educated patients about symptoms of hypoglycemia and the importance of adherence to different aspects of their glycemic management. The percentage of controlled random blood sugar increased from 13.8% in the pre-intervention to 22.3% in the post-intervention group (p value percentage of controlled fasting blood sugars in the post-intervention group was non-significantly higher than in the pre-intervention group. Pharmacists and additional health care providers from other departments such as nursing and dietary departments need to be devoted to glycemic control service. Collaborative practice agreement between physicians is necessary to promote this service and help to increase the use of such services in different settings for diabetes control.

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....

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...

Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials.

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Matteson, Michelle L; Russell, Cynthia

2010-10-01

Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

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

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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

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

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

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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.

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

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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

Intervention for children with word-finding difficulties: a parallel group randomised control trial.

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Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

2017-07-31

The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

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

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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…

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

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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.

Intervention for hazardous alcohol use and high level of stress in university freshmen: a comparison between an intervention and a control university.

Science.gov (United States)

Andersson, Claes; Johnsson, Kent O; Berglund, Mats; Ojehagen, Agneta

2009-12-11

The first year of university studies is associated with increased levels of alcohol drinking and stress. This study examines the one-year outcome of both primary and secondary interventions of one alcohol programme and one stress intervention programme at an intervention university in comparison with a control university. At the intervention university all freshmen were offered a primary prevention programme for hazardous alcohol use and stress management and, in addition, those who had high ratings for stress and/or hazardous alcohol use were offered a secondary intervention programme for alcohol consumption and/or stress management. Freshmen still attending the two universities one year later responded to follow-up questionnaires. The primary alcohol and stress interventions were associated with lower alcohol expectancies and mental symptoms, but no differences in AUDIT scores (-0.2, CI 95% -0.5 to 0.1), estimated blood alcohol concentrations or stress in comparison to freshmen at the control university. The secondary alcohol interventions were associated with decreased AUDIT (-1.1, CI 95% -2.0 to -0.2) as well as alcohol expectancies, blood alcohol concentrations, stress and mental symptoms in comparison to high-risk freshmen at the control university. The secondary stress interventions were associated with decreased mental symptoms and alcohol expectancies, but not stress, AUDIT scores (-0.6, CI 95% -1.4 to 0.2) and blood alcohol concentrations in comparison to high-risk freshmen at the control university. This study suggests that both primary and secondary alcohol and stress interventions have 1-year effects in university freshmen and could be implemented in university settings.

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

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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.

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...

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

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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

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

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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.

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,

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,

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...

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...

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

Problem Solving Interventions for Diabetes Self-management and Control: A Systematic Review of the Literature

Science.gov (United States)

Fitzpatrick, Stephanie L.; Schumann, Kristina P.; Hill-Briggs, Felicia

2013-01-01

Aims Problem solving is deemed a core skill for patient diabetes self-management education. The purpose of this systematic review is to examine the published literature on the effect of problem-solving interventions on diabetes self-management and disease control. Data Sources We searched PubMed and PsychINFO electronic databases for English language articles published between November 2006 and September 2012. Reference lists from included studies were reviewed to capture additional studies. Study Selection Studies reporting problem-solving intervention or problem solving as an intervention component for diabetes self-management training and disease control were included. Twenty-four studies met inclusion criteria. Data Extraction Study design, sample characteristics, measures, and results were reviewed. Data Synthesis Sixteen intervention studies (11 adult, 5 children/adolescents) were randomized controlled trials, and 8 intervention studies (6 adult, 2 children/adolescents) were quasi-experimental designs. Conclusions Studies varied greatly in their approaches to problem-solving use in patient education. To date, 36% of adult problem-solving interventions and 42% of children/adolescent problem-solving interventions have demonstrated significant improvement in HbA1c, while psychosocial outcomes have been more promising. The next phase of problem-solving intervention research should employ intervention characteristics found to have sufficient potency and intensity to reach therapeutic levels needed to demonstrate change. PMID:23312614

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

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

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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

Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

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van Balkom Anton

2008-11-01

Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

Motivational interviewing in a Web-based physical activity intervention with an avatar: randomized controlled trial.

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Friederichs, Stijn; Bolman, Catherine; Oenema, Anke; Guyaux, Janneke; Lechner, Lilian

2014-02-13

Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based. The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based. A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention. Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta(AVATARvsCONTROL)=.39, P=.011; beta(TEXTvsCONTROL)=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone. The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user's state and input. Dutch Trial

An intervention for noise control of blast furnace in steel industry.

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Golmohammadi, Rostam; Giahi, Omid; Aliabadi, Mohsen; Darvishi, Ebrahim

2014-01-01

Noise pollution is currently a major health risk factor for workers in industries. The aim of this study was to investigate noise pollution and implement a control intervention plan for blast furnace in a steel industry. The measurement of sound pressure level (SPL) along with frequency analysis was done with the sound-level-meter Cell-450. Personal noise exposure was performed using dosimeter TES-1345 calibrated with CEL-282. Before planning noise controls, acoustic insulation properties of the furnace control unit and workers' rest room were assessed. Control room and workers' rest room were redesigned in order to improve acoustical condition. The SPL before intervention around the Blast Furnace was 90.3 dB (L) and its dominant frequency was 4000 Hz. Besides, noise transmission loss of the control and rest rooms were 10.3 dB and 4.2 dB, respectively. After intervention, noise reduction rates in the control and rest rooms were 27.4 dB and 27.7 dB, respectively. The workers' noise dose before and after the intervention was 240% and less than 100%, respectively. Improvement the workroom acoustic conditions through noise insulation can be considered effective method for preventing workers exposure to harmful noise.

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

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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

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

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Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

2015-11-01

To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

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

Early rigorous control interventions can largely reduce dengue outbreak magnitude: experience from Chaozhou, China.

Science.gov (United States)

Liu, Tao; Zhu, Guanghu; He, Jianfeng; Song, Tie; Zhang, Meng; Lin, Hualiang; Xiao, Jianpeng; Zeng, Weilin; Li, Xing; Li, Zhihao; Xie, Runsheng; Zhong, Haojie; Wu, Xiaocheng; Hu, Wenbiao; Zhang, Yonghui; Ma, Wenjun

2017-08-02

Dengue fever is a severe public heath challenge in south China. A dengue outbreak was reported in Chaozhou city, China in 2015. Intensified interventions were implemented by the government to control the epidemic. However, it is still unknown the degree to which intensified control measures reduced the size of the epidemics, and when should such measures be initiated to reduce the risk of large dengue outbreaks developing? We selected Xiangqiao district as study setting because the majority of the indigenous cases (90.6%) in Chaozhou city were from this district. The numbers of daily indigenous dengue cases in 2015 were collected through the national infectious diseases and vectors surveillance system, and daily Breteau Index (BI) data were reported by local public health department. We used a compartmental dynamic SEIR (Susceptible, Exposed, Infected and Removed) model to assess the effectiveness of control interventions, and evaluate the control effect of intervention timing on dengue epidemic. A total of 1250 indigenous dengue cases was reported from Xiangqiao district. The results of SEIR modeling using BI as an indicator of actual control interventions showed a total of 1255 dengue cases, which is close to the reported number (n = 1250). The size and duration of the outbreak were highly sensitive to the intensity and timing of interventions. The more rigorous and earlier the control interventions implemented, the more effective it yielded. Even if the interventions were initiated several weeks after the onset of the dengue outbreak, the interventions were shown to greatly impact the prevalence and duration of dengue outbreak. This study suggests that early implementation of rigorous dengue interventions can effectively reduce the epidemic size and shorten the epidemic duration.

“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

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

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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.

Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease.

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Anderegg, Maxwell D; Gums, Tyler H; Uribe, Liz; MacLaughlin, Eric J; Hoehns, James; Bazaldua, Oralia V; Ives, Timothy J; Hahn, David L; Coffey, Christopher S; Carter, Barry L

2018-03-01

The objectives of this study were to determine if hypertensive patients with comorbid diabetes mellitus (DM) and/or chronic kidney disease (CKD) receiving a pharmacist intervention had a greater reduction in mean blood pressure (BP) and improved BP control at 9 months compared with those receiving usual care; and compare Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline and 2014 guideline (JNC 8) BP control rates in patients with DM and/or CKD. This cluster randomized trial included 32 medical offices in 15 states. Clinical pharmacists made treatment recommendations to physicians at intervention sites. This post hoc analysis evaluated mean BP and BP control rates in the intervention and control groups. The study included 335 patients (227 intervention, 108 control) when mean BP and control rates were evaluated by JNC 7 inclusion and control criteria. When JNC 8 inclusion and control criteria were applied, 241 patients (165 intervention, 76 control) remained and were included in the analysis. The pharmacist-intervention group had significantly greater mean systolic blood pressure reduction compared with usual care at 9 months (8.64 mm Hg; 95% confidence interval [CI] -12.8 to -4.49, pcontrol at 9 months than usual care by either the JNC 7 or JNC 8 inclusion and control groups (adjusted odds ratio [OR] 1.97, 95% CI 1.01-3.86, p=0.0470 and OR 2.16, 95% CI 1.21-3.85, p=0.0102, respectively). This study demonstrated that a physician-pharmacist collaborative intervention was effective in reducing mean systolic BP and improving BP control in patients with uncontrolled hypertension with DM and/or CKD, regardless of which BP guidelines were used. © 2018 Pharmacotherapy Publications, Inc.

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

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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

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

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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

Effectiveness of a multi-level asthma intervention in increasing controller medication use: a randomized control trial.

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Canino, Glorisa; Shrout, Patrick E; Vila, Doryliz; Ramírez, Rafael; Rand, Cynthia

2016-01-01

Poor self-management by families is an important factor in explaining high rates of asthma morbidity in Puerto Rico, and for this reason we previously tested a family intervention called CALMA that was found effective in improving most asthma outcomes, but not effective in increasing the use of controller medications. CALMA-plus was developed to address this issue by adding to CALMA, components of provider training and screening for asthma in clinics. Study participants were selected from claims Medicaid data in San Juan, Puerto Rico. After screening, 404 children in eight clinics were selected after forming pairs of clinics and randomizing the clinics) to CALMA-only or CALMA-plus. For all three primary outcomes at 12 months, the mean differences between treatment arms were small but in the predicted direction. However, after adjusting for clinic variation, the study failed to demonstrate that the CALMA-plus intervention was more efficacious than the CALMA-only intervention for increasing controller medication use, or decreasing asthma symptoms. Both groups had lower rates of asthma symptoms and service utilization, consistent with previous results of the CALMA-only intervention. Compliance of providers with the intervention and training, small number of clinics available and the multiple barriers experienced by providers for medicating may have been related to the lack of difference observed between the groups. Future interventions should respond to the limitations of the present study design and provide more resources to providers that will increase provider participation in training and implementation of the intervention.

Communication interventions to improve adherence to infection control precautions: a randomised crossover trial.

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Ong, Mei-Sing; Magrabi, Farah; Post, Jeffrey; Morris, Sarah; Westbrook, Johanna; Wobcke, Wayne; Calcroft, Ross; Coiera, Enrico

2013-02-06

Ineffective communication of infection control requirements during transitions of care is a potential cause of non-compliance with infection control precautions by healthcare personnel. In this study, interventions to enhance communication during inpatient transfers between wards and radiology were implemented, in the attempt to improve adherence to precautions during transfers. Two interventions were implemented, comprising (i) a pre-transfer checklist used by radiology porters to confirm a patient's infectious status; (ii) a coloured cue to highlight written infectious status information in the transfer form. The effectiveness of the interventions in promoting adherence to standard precautions by radiology porters when transporting infectious patients was evaluated using a randomised crossover trial at a teaching hospital in Australia. 300 transfers were observed over a period of 4 months. Compliance with infection control precautions in the intervention groups was significantly improved relative to the control group (p group was 38%. Applying the coloured cue resulted in a compliance rate of 73%. The pre-transfer checklist intervention achieved a comparable compliance rate of 71%. When both interventions were applied, a compliance rate of 74% was attained. Acceptability of the coloured cue was high, but adherence to the checklist was low (40%). Simple measures to enhance communication through the provision of a checklist and the use a coloured cue brought about significant improvement in compliance with infection control precautions by transport personnel during inpatient transfers. The study underscores the importance of effective communication in ensuring compliance with infection control precautions during transitions of care.

Physical Activity, Exercise, And Nutrition Interventions For Weight Control In African American Women

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Matthew Asare

2010-01-01

Full Text Available The purpose of this paper was to review the physical activity, exercise, and nutritionrelated weight control interventions done with African American women that were publishedbetween 2006 and 2010 and suggest ways of enhancing these interventions. A total of 13 studiesmet the inclusion criteria. The review found significant results with regard to impact ofintervention. Twelve of those studies revealed significant increase in physical activity and weightreduction behavior. In terms of use of theory in designing the interventions only five interventionsused a theory. In three of those cases social cognitive theory was used. Appropriate sample sizewas found to be the major strength of most of the interventions. Six interventions usedrandomized controlled design. Recommendations for enhancing the effectiveness of physicalactivity interventions in African American women are presented.

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

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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

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

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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.

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

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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

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

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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.

Innovative dengue vector control interventions in Latin America: what do they cost?

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Basso, César; Beltrán-Ayala, Efraín; Mitchell-Foster, Kendra; Cortés, Sebastián; Manrique-Saide, Pablo; Guillermo-May, Guillermo; Carvalho de Lima, Edilmar

2016-01-01

Background Five studies were conducted in Fortaleza (Brazil), Girardot (Colombia), Machala (Ecuador), Acapulco (Mexico), and Salto (Uruguay) to assess dengue vector control interventions tailored to the context. The studies involved the community explicitly in the implementation, and focused on the most productive breeding places for Aedes aegypti. This article reports the cost analysis of these interventions. Methods We conducted the costing from the perspective of the vector control program. We collected data on quantities and unit costs of the resources used to deliver the interventions. Comparable information was requested for the routine activities. Cost items were classified, analyzed descriptively, and aggregated to calculate total costs, costs per house reached, and incremental costs. Results Cost per house of the interventions were $18.89 (Fortaleza), $21.86 (Girardot), $30.61 (Machala), $39.47 (Acapulco), and $6.98 (Salto). Intervention components that focused mainly on changes to the established vector control programs seem affordable; cost savings were identified in Salto (−21%) and the clean patio component in Machala (−12%). An incremental cost of 10% was estimated in Fortaleza. On the other hand, there were also completely new components that would require sizeable financial efforts (installing insecticide-treated nets in Girardot and Acapulco costs $16.97 and $24.96 per house, respectively). Conclusions The interventions are promising, seem affordable and may improve the cost profile of the established vector control programs. The costs of the new components could be considerable, and should be assessed in relation to the benefits in reduced dengue burden. PMID:26924235

Early rigorous control interventions can largely reduce dengue outbreak magnitude: experience from Chaozhou, China

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Tao Liu

2017-08-01

Full Text Available Abstract Background Dengue fever is a severe public heath challenge in south China. A dengue outbreak was reported in Chaozhou city, China in 2015. Intensified interventions were implemented by the government to control the epidemic. However, it is still unknown the degree to which intensified control measures reduced the size of the epidemics, and when should such measures be initiated to reduce the risk of large dengue outbreaks developing? Methods We selected Xiangqiao district as study setting because the majority of the indigenous cases (90.6% in Chaozhou city were from this district. The numbers of daily indigenous dengue cases in 2015 were collected through the national infectious diseases and vectors surveillance system, and daily Breteau Index (BI data were reported by local public health department. We used a compartmental dynamic SEIR (Susceptible, Exposed, Infected and Removed model to assess the effectiveness of control interventions, and evaluate the control effect of intervention timing on dengue epidemic. Results A total of 1250 indigenous dengue cases was reported from Xiangqiao district. The results of SEIR modeling using BI as an indicator of actual control interventions showed a total of 1255 dengue cases, which is close to the reported number (n = 1250. The size and duration of the outbreak were highly sensitive to the intensity and timing of interventions. The more rigorous and earlier the control interventions implemented, the more effective it yielded. Even if the interventions were initiated several weeks after the onset of the dengue outbreak, the interventions were shown to greatly impact the prevalence and duration of dengue outbreak. Conclusions This study suggests that early implementation of rigorous dengue interventions can effectively reduce the epidemic size and shorten the epidemic duration.

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...

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

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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.

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

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

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

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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

A control systems engineering approach for adaptive behavioral interventions: illustration with a fibromyalgia intervention.

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Deshpande, Sunil; Rivera, Daniel E; Younger, Jarred W; Nandola, Naresh N

2014-09-01

The term adaptive intervention has been used in behavioral medicine to describe operationalized and individually tailored strategies for prevention and treatment of chronic, relapsing disorders. Control systems engineering offers an attractive means for designing and implementing adaptive behavioral interventions that feature intensive measurement and frequent decision-making over time. This is illustrated in this paper for the case of a low-dose naltrexone treatment intervention for fibromyalgia. System identification methods from engineering are used to estimate dynamical models from daily diary reports completed by participants. These dynamical models then form part of a model predictive control algorithm which systematically decides on treatment dosages based on measurements obtained under real-life conditions involving noise, disturbances, and uncertainty. The effectiveness and implications of this approach for behavioral interventions (in general) and pain treatment (in particular) are demonstrated using informative simulations.

Differential effects of two virtual reality interventions: distraction versus pain control.

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Loreto-Quijada, Desirée; Gutiérrez-Maldonado, José; Nieto, Rubén; Gutiérrez-Martínez, Olga; Ferrer-García, Marta; Saldaña, Carmina; Fusté-Escolano, Adela; Liutsko, Liudmila

2014-06-01

There is evidence that virtual reality (VR) pain distraction is effective at improving pain-related outcomes. However, more research is needed to investigate VR environments with other pain-related goals. The main aim of this study was to compare the differential effects of two VR environments on a set of pain-related and cognitive variables during a cold pressor experiment. One of these environments aimed to distract attention away from pain (VRD), whereas the other was designed to enhance pain control (VRC). Participants were 77 psychology students, who were randomly assigned to one of the following three conditions during the cold pressor experiment: (a) VRD, (b) VRC, or (c) Non-VR (control condition). Data were collected regarding both pain-related variables (intensity, tolerance, threshold, time perception, and pain sensitivity range) and cognitive variables (self-efficacy and catastrophizing). Results showed that in comparison with the control condition, the VRC intervention significantly increased pain tolerance, the pain sensitivity range, and the degree of time underestimation. It also increased self-efficacy in tolerating pain and led to a reduction in reported helplessness. The VRD intervention significantly increased the pain threshold and pain tolerance in comparison with the control condition, but it did not affect any of the cognitive variables. Overall, the intervention designed to enhance control seems to have a greater effect on the cognitive variables assessed. Although these results need to be replicated in further studies, the findings suggest that the VRC intervention has considerable potential in terms of increasing self-efficacy and modifying the negative thoughts that commonly accompany pain problems.

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

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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�

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

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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.

Intervention studies to foster resilience - A systematic review and proposal for a resilience framework in future intervention studies.

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Chmitorz, A; Kunzler, A; Helmreich, I; Tüscher, O; Kalisch, R; Kubiak, T; Wessa, M; Lieb, K

2018-02-01

Psychological resilience refers to the phenomenon that many people are able to adapt to the challenges of life and maintain mental health despite exposure to adversity. This has stimulated research on training programs to foster psychological resilience. We evaluated concepts, methods and designs of 43 randomized controlled trials published between 1979 and 2014 which assessed the efficacy of such training programs and propose standards for future intervention research based on recent developments in the field. We found that concepts, methods and designs in current resilience intervention studies are of limited use to properly assess efficacy of interventions to foster resilience. Major problems are the use of definitions of resilience as trait or a composite of resilience factors, the use of unsuited assessment instruments, and inappropriate study designs. To overcome these challenges, we propose 1) an outcome-oriented definition of resilience, 2) an outcome-oriented assessment of resilience as change in mental health in relation to stressor load, and 3) methodological standards for suitable study designs of future intervention studies. Our proposals may contribute to an improved quality of resilience intervention studies and may stimulate further progress in this growing research field. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

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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.

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

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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.

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

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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.

Choosing a control intervention for a randomised clinical trial

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Djulbegovic Benjamin

2003-04-01

Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

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

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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.

Skin cancer interventions across the cancer control continuum: Review of technology, environment, and theory.

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Taber, Jennifer M; Dickerman, Barbra A; Okhovat, Jean-Phillip; Geller, Alan C; Dwyer, Laura A; Hartman, Anne M; Perna, Frank M

2018-06-01

The National Cancer Institute's Skin Cancer Intervention across the Cancer Control Continuum model was developed to summarize research and identify gaps concerning skin cancer interventions. We conducted a mapping review to characterize whether behavioral interventions addressing skin cancer prevention and control from 2000 to 2015 included (1) technology, (2) environmental manipulations (policy and/or built environment), and (3) a theoretical basis. We included 86 studies with a randomized controlled or quasi-experimental design that targeted behavioral intervention in skin cancer for children and/or adults; seven of these were dissemination or implementation studies. Of the interventions described in the remaining 79 articles, 57 promoted only prevention behaviors (e.g., ultraviolet radiation protection), five promoted only detection (e.g., skin examinations), 10 promoted both prevention and detection, and seven focused on survivorship. Of the 79 non-dissemination studies, two-thirds used some type of technology (n=52; 65.8%). Technology specific to skin cancer was infrequently used: UVR photography was used in 15.2% of studies (n=12), reflectance spectroscopy was used in 12.7% (n=10), and dermatoscopes (n=1) and dosimeters (n=2) were each used in less than 3%. Ten studies (12.7%) targeted the built environment. Fifty-two (65.8%) of the studies included theory-based interventions. The most common theories were Social Cognitive Theory (n=20; 25.3%), Health Belief Model (n=17; 21.5%), and the Theory of Planned Behavior/Reasoned Action (n=12; 15.2%). Results suggest that skin cancer specific technology and environmental manipulations are underutilized in skin cancer behavioral interventions. We discuss implications of these results for researchers developing skin cancer behavioral interventions. Copyright © 2017. Published by Elsevier Inc.

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

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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

A videotaped intervention to enhance child control and reduce anxiety of the pain of dental injections.

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Weinstein, P; Raadal, M; Naidu, S; Yoshida, T; Kvale, G; Milgrom, P

2003-12-01

While the psychological literature shows that perceptions of uncontrollability contribute to anxiety and other pathologies, interventions that enhance perceived control have been shown to reduce anxiety. This study attempted to assess a brief videotape to enhance child perceived control in a dental setting. 101 children aged 7-9 years completed warm-up procedures and viewed either: a) the experimental intervention, a 2 minutes video of a dentist explaining what an injection will feel like and proposing hand raising as a signal mechanism; or b) the control condition, a 2 minutes video of Disneyland. Fear of dental injections was assessed on a 10 cm visual analogue scale before and after the intervention. In the experimental group there was a significant fear reduction from pre- to post-intervention, while this was not the case in the control group. Children with higher pre-existing levels of fear benefited more from the intervention than children with lower levels of fear. The results of this pilot study suggest that intervention packages that impact child control have promise in lowering anxiety.

A healthcare utilization cost comparison between employees receiving a worksite mindfulness or a diet/exercise lifestyle intervention to matched controls 5 years post intervention.

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Klatt, Maryanna D; Sieck, Cynthia; Gascon, Gregg; Malarkey, William; Huerta, Timothy

2016-08-01

To compare healthcare costs and utilization among participants in a study of two active lifestyle interventions implemented in the workplace and designed to foster awareness of and attention to health with a propensity score matched control group. We retrospectively compared changes in healthcare (HC) utilization among participants in the mindfulness intervention (n=84) and the diet/exercise intervention (n=86) to a retrospectively matched control group (n=258) drawn for this study. The control group was matched from the non-participant population on age, gender, relative risk score, and HC expenditures in the 9 month preceding the study. Measures included number of primary care visits, number and cost of pharmacy prescriptions, number of hospital admissions, and overall healthcare costs tracked for 5 years after the intervention. Significantly fewer primary care visits (porganization health cost savings that such programs can generate. Copyright © 2016 Elsevier Ltd. All rights reserved.

Social marketing-based communications to integrate and support the HEALTHY study intervention

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The HEALTHY study was a randomized, controlled, multicenter, middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth gr...

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)

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

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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�

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

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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

Specialty substance use disorder services following brief alcohol intervention: a meta-analysis of randomized controlled trials.

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Glass, Joseph E; Hamilton, Ashley M; Powell, Byron J; Perron, Brian E; Brown, Randall T; Ilgen, Mark A

2015-09-01

Brief alcohol interventions in medical settings are efficacious in improving self-reported alcohol consumption among those with low-severity alcohol problems. Screening, Brief Intervention and Referral to Treatment initiatives presume that brief interventions are efficacious in linking patients to higher levels of care, but pertinent evidence has not been evaluated. We estimated main and subgroup effects of brief alcohol interventions, regardless of their inclusion of a referral-specific component, in increasing the utilization of alcohol-related care. A systematic review of English language papers published in electronic databases to 2013. We included randomized controlled trials (RCTs) of brief alcohol interventions in general health-care settings with adult and adolescent samples. We excluded studies that lacked alcohol services utilization data. Extractions of study characteristics and outcomes were standardized and conducted independently. The primary outcome was post-treatment alcohol services utilization assessed by self-report or administrative data, which we compared across intervention and control groups. Thirteen RCTs met inclusion criteria and nine were meta-analyzed (n = 993 and n = 937 intervention and control group participants, respectively). In our main analyses the pooled risk ratio (RR) was = 1.08, 95% confidence interval (CI) = 0.92-1.28. Five studies compared referral-specific interventions with a control condition without such interventions (pooled RR = 1.08, 95% CI = 0.81-1.43). Other subgroup analyses of studies with common characteristics (e.g. age, setting, severity, risk of bias) yielded non-statistically significant results. There is a lack of evidence that brief alcohol interventions have any efficacy for increasing the receipt of alcohol-related services. © 2015 Society for the Study of Addiction.

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

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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

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

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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

Malnutrition in hip fracture patients: an intervention study.

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Olofsson, Birgitta; Stenvall, Michael; Lundström, Maria; Svensson, Olle; Gustafson, Yngve

2007-11-01

To investigate whether a nutritional intervention in older women and men with femoral neck fracture had an effect on postoperative complications during hospitalization and on nutritional status at a four-month follow-up. The design was a randomized controlled trial. The present study sample consisted of 157 patients aged 70 years and above with femoral neck fracture. The nutritional intervention included, among other things, a nutritional journal to detect nutrition deficiencies and protein-enriched meals for at least four days postoperatively. Further, at least two nutritional and protein drinks were served each day during the whole hospitalization and other factors that would influence the patient's nutrition were also considered and dealt with. Postoperative complications were registered and patients were assessed using the Mini Nutritional Assessment (MNA) scale, including body mass index (BMI), on admission and at a four-month follow-up. Malnutrition was common and low MNA scores were associated with postoperative complications such as delirium and decubitus ulcers. There were significantly fewer days of delirium in the intervention group, seven patients in the intervention group developed decubitus ulcers vs. 14 patients in the control group and the total length of hospitalization was shorter. There were no detectable significant improvements regarding nutritional parameters between the intervention and the control group at the four-month follow-up but men improved their mean BMI, body weight and MNA scores in both the intervention and the control groups while women deteriorated in both groups. Malnutrition was common among older people with hip fractures admitted to hospital. The nutritional intervention might have contributed to the patients suffering fewer days with delirium, fewer decubitus ulcers and shorter hospitalization but did not improve the long-term nutritional status, at least not in women. This nutritional intervention, which was included in a

The effects of the Odense Overweight Intervention Study

DEFF Research Database (Denmark)

Larsen, Kristian Traberg; Huang, Tao; Ried-Larsen, Mathias

of the DCIA in BMI z-score, clustered risk z-score, systolic blood pressure, abdominal fat-%, waist circumference, cardiorespiratory fitness, and total cholesterol/HDL ratio. In body fat-%, waist circumference and triglycerides, there is only a significant group difference at 6 weeks and not at 52 weeks......Aim: The primary aim of the study is to evaluate the effect of the Odense Overweight Intervention Study on BMI development. Methods: The OOIS is a semi-blinded randomized controlled trial with three measurement occasions. Participants were allocated into two intervention arms; a day camp...... intervention arm (DCIA) and a standard intervention arm (SIA). For the DCIA the camp lasted for six weeks and consisted of fun-based physical activities, healthy eating, and health classes. The following 10 months a family based intervention was accomplished. The SIA was offered a weekly activity session...

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

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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.

Control of Aedes aegypti Breeding: A Novel Intervention for Prevention and Control of Dengue in an Endemic Zone of Delhi, India.

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B N Nagpal

Full Text Available The study is based on hypothesis that whether continuous entomological surveillance of Ae. aegypti and simultaneous appropriate interventions in key containers during non-transmission (December-May months would have any impact on breeding of Aedes and dengue cases during the following transmission months (June-November. The impact of the surveillance and intervention measures undertaken during non-transmission months were assessed by entomological indicators namely container index (CI, house index (HI, pupal index (PI and breteau index (BI.A total of 28 localities of West Zone of Delhi with persistent dengue endemicity were selected for the study. Out of these localities, 20 were included in study group while other 8 localities were in control group. IEC and various Aedes breeding control activities were carried out in study group in both non-transmission and transmission season whereas control group did not have any such interventions during non-transmission months as per guidelines of MCD. These activities were undertaken by a team of investigators from NIMR and SDMC, Delhi. In control group, investigators from NIMR carried out surveillance activity to monitor the breeding of Aedes mosquito in localities.Comparison of baseline data revealed that all indices in control and study group of localities were comparable and statistically non-significant (p>0.05. In both study and control groups, indices were calculated after pooling data on seasonal basis, i.e., transmission and non-transmission months for both years. The test of significance conducted on all the four indices, i.e., HI, PI, CI, and BI, revealed a significant difference (p<0.05 between the study group and control group during transmission and non-transmission months except in HI. Due to consistent intervention measures undertaken in non-transmission months in study group, reduction in CI, HI, BI and PI was observed 63%, 62%, 64% and 99% respectively during transmission months as

Childhood obesity prevention interventions in childcare settings: systematic review of randomized and nonrandomized controlled trials.

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Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C

2014-01-01

Childcare settings are an opportune location for early intervention programs seeking to prevent childhood obesity. This article reports on a systematic review of controlled trials of obesity prevention interventions in childcare settings. The review was limited to English language articles published in PubMed, Web of Science, and Education Resources Information Center (ERIC) between January 2000 and April 2012. childhood obesity prevention interventions in childcare settings using controlled designs that reported adiposity and behavior outcomes. no interventions, non-childcare settings, clinical weight loss programs, non-English publications. Publications were identified by key word search. Two authors reviewed eligible studies to extract study information and study results. Qualitative synthesis was conducted, including tabulation of information and a narrative summary. Fifteen studies met the eligibility criteria. Seven studies reported improvements in adiposity. Six of the 13 interventions with dietary components reported improved intake or eating behaviors. Eight of the 12 interventions with physical activity components reported improved activity levels or physical fitness. Evidence was mixed for all outcomes. Results should be interpreted cautiously given the high variability in study designs and interventions. Further research needs long-term follow-up, multistrategy interventions that include changes in the nutrition and physical activity environment, reporting of cost data, and consideration of sustainability.

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

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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).

Costs and cost-effectiveness of malaria control interventions - a systematic review

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White Michael T

2011-11-01

Full Text Available Abstract Background The control and elimination of malaria requires expanded coverage of and access to effective malaria control interventions such as insecticide-treated nets (ITNs, indoor residual spraying (IRS, intermittent preventive treatment (IPT, diagnostic testing and appropriate treatment. Decisions on how to scale up the coverage of these interventions need to be based on evidence of programme effectiveness, equity and cost-effectiveness. Methods A systematic review of the published literature on the costs and cost-effectiveness of malaria interventions was undertaken. All costs and cost-effectiveness ratios were inflated to 2009 USD to allow comparison of the costs and benefits of several different interventions through various delivery channels, across different geographical regions and from varying costing perspectives. Results Fifty-five studies of the costs and forty three studies of the cost-effectiveness of malaria interventions were identified, 78% of which were undertaken in sub-Saharan Africa, 18% in Asia and 4% in South America. The median financial cost of protecting one person for one year was $2.20 (range $0.88-$9.54 for ITNs, $6.70 (range $2.22-$12.85 for IRS, $0.60 (range $0.48-$1.08 for IPT in infants, $4.03 (range $1.25-$11.80 for IPT in children, and $2.06 (range $0.47-$3.36 for IPT in pregnant women. The median financial cost of diagnosing a case of malaria was $4.32 (range $0.34-$9.34. The median financial cost of treating an episode of uncomplicated malaria was $5.84 (range $2.36-$23.65 and the median financial cost of treating an episode of severe malaria was $30.26 (range $15.64-$137.87. Economies of scale were observed in the implementation of ITNs, IRS and IPT, with lower unit costs reported in studies with larger numbers of beneficiaries. From a provider perspective, the median incremental cost effectiveness ratio per disability adjusted life year averted was $27 (range $8.15-$110 for ITNs, $143 (range $135

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

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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

Effectiveness of malaria control interventions in Madagascar: a nationwide case-control survey.

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Kesteman, Thomas; Randrianarivelojosia, Milijaona; Raharimanga, Vaomalala; Randrianasolo, Laurence; Piola, Patrice; Rogier, Christophe

2016-02-11

Madagascar, as other malaria endemic countries, depends mainly on international funding for the implementation of malaria control interventions (MCI). As these funds no longer increase, policy makers need to know whether these MCI actually provide the expected protection. This study aimed at measuring the effectiveness of MCI deployed in all transmission patterns of Madagascar in 2012-2013 against the occurrence of clinical malaria cases. From September 2012 to August 2013, patients consulting for non-complicated malaria in 31 sentinel health centres (SHC) were asked to answer a short questionnaire about long-lasting insecticidal nets (LLIN) use, indoor residual spraying (IRS) in the household and intermittent preventive treatment of pregnant women (IPTp) intake. Controls were healthy all-ages individuals sampled from a concurrent cross-sectional survey conducted in areas surrounding the SHC. Cases and controls were retained in the database if they were resident of the same communes. The association between Plasmodium infection and exposure to MCI was calculated by multivariate multilevel models, and the protective effectiveness (PE) of an intervention was defined as 1 minus the odds ratio of this association. Data about 841 cases (out of 6760 cases observed in SHC) and 8284 controls was collected. The regular use of LLIN provided a significant 51 % PE (95 % CI [16-71]) in multivariate analysis, excluding in one transmission pattern where PE was -11 % (95 % CI [-251 to 65]) in univariate analysis. The PE of IRS was 51 % (95 % CI [31-65]), and the PE of exposure to both regular use of LLIN and IRS was 72 % (95 % CI [28-89]) in multivariate analyses. Vector control interventions avoided yearly over 100,000 clinical cases of malaria in Madagascar. The maternal PE of IPTp was 73 %. In Madagascar, LLIN and IRS had good PE against clinical malaria. These results may apply to other countries with similar transmission profiles, but such case-control surveys could be

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

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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.

Impact of lifestyle intervention on dry eye disease in office workers: a randomized controlled trial.

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Kawashima, Motoko; Sano, Kokoro; Takechi, Sayuri; Tsubota, Kazuo

2018-04-04

To evaluate the effects of a 2-month lifestyle intervention for dry eye disease in office workers. Prospective interventional study (randomized controlled study). Forty-one middle-aged Japanese office workers (men, 22; women, 19; 39.2 ± 8.0 years) with definite and probable dry eye disease were enrolled and randomized to an intervention group (n = 22) and a control group (n = 19). The intervention aimed at modifying diet, increasing physical activity, and encouraging positive thinking. The primary outcome was change in dry eye disease diagnoses. Secondary outcome was change in disease parameters, including dry eye symptoms, as assessed using the Dry Eye-Related Quality of Life Score, corneal and conjunctival staining scores, tear break-up time, and Schirmer test results. A total of 36 participants (intervention group, 17; control group, 19) completed the study. The number of definite dry eye disease diagnoses decreased from four to none (p =.05), and the dry eye symptom score showed a significant decrease in the intervention group (p =.03). In contrast, the corneal and conjunctival staining scores, tear break-up time, and Schirmer test results did not differ significantly between groups. The 2-month lifestyle intervention employed in this study improved dry eye disease status among office workers, with a considerable decrease in subjective symptoms. Lifestyle intervention may be a promising management option for dry eye disease, although further investigation of long-term effects are required.

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

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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

School-Based Obesity Prevention Intervention in Chilean Children: Effective in Controlling, but not Reducing Obesity

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Juliana Kain

2014-01-01

Full Text Available Objective. To evaluate the effectiveness of a 12-month multicomponent obesity prevention intervention. Setting. 9 elementary schools in Santiago, Chile. Subjects. 6–8 y old low-income children (N=1474. Design. Randomized controlled study; 5 intervention/4 control schools. We trained teachers to deliver nutrition contents and improve the quality of PE classes. We determined % healthy snacks brought from home, children’s nutrition knowledge, nutritional status, duration of PE classes, and % time in moderate/vigorous activity (MVA. Effectiveness was determined by comparing Δ BMI Z between intervention and control children using PROCMIXED. Results. % obesity increased in boys from both types of schools and in girls from control schools, while decreasing in girls from intervention schools (all nonsignificant. % class time in MVA declined (24.5–16.2 while remaining unchanged (24.8–23.7% in classes conducted by untrained and trained teachers, respectively. In boys, BMI Z declined (1.33–1.24 and increased (1.22–1.35 in intervention and control schools, respectively. In girls, BMI Z remained unchanged in intervention schools, while increasing significantly in control schools (0.91–1.06, P=0.024. Interaction group * time was significant for boys (P<0.0001 and girls (P=0.004. Conclusions. This intervention was effective in controlling obesity, but not preventing it. Even though impact was small, results showed that when no intervention is implemented, obesity increases.

Cost-Effectiveness Analysis of Breast Cancer Control Interventions in Peru

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Zelle, Sten G.; Vidaurre, Tatiana; Abugattas, Julio E.; Manrique, Javier E.; Sarria, Gustavo; Jeronimo, José; Seinfeld, Janice N.; Lauer, Jeremy A.; Sepulveda, Cecilia R.; Venegas, Diego; Baltussen, Rob

2013-01-01

Objectives In Peru, a country with constrained health resources, breast cancer control is characterized by late stage treatment and poor survival. To support breast cancer control in Peru, this study aims to determine the cost-effectiveness of different breast cancer control interventions relevant for the Peruvian context. Methods We performed a cost-effectiveness analysis (CEA) according to WHO-CHOICE guidelines, from a healthcare perspective. Different screening, early detection, palliative, and treatment interventions were evaluated using mathematical modeling. Effectiveness estimates were based on observational studies, modeling, and on information from Instituto Nacional de Enfermedades Neoplásicas (INEN). Resource utilizations and unit costs were based on estimates from INEN and observational studies. Cost-effectiveness estimates are in 2012 United States dollars (US$) per disability adjusted life year (DALY) averted. Results The current breast cancer program in Peru ($8,426 per DALY averted) could be improved through implementing triennial or biennial screening strategies. These strategies seem the most cost-effective in Peru, particularly when mobile mammography is applied (from $4,125 per DALY averted), or when both CBE screening and mammography screening are combined (from $4,239 per DALY averted). Triennially, these interventions costs between $63 million and $72 million per year. Late stage treatment, trastuzumab therapy and annual screening strategies are the least cost-effective. Conclusions Our analysis suggests that breast cancer control in Peru should be oriented towards early detection through combining fixed and mobile mammography screening (age 45-69) triennially. However, a phased introduction of triennial CBE screening (age 40-69) with upfront FNA in non-urban settings, and both CBE (age 40-49) and fixed mammography screening (age 50-69) in urban settings, seems a more feasible option and is also cost-effective. The implementation of this

Evaluating health effects of transport interventions methodologic case study.

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Ogilvie, David; Mitchell, Richard; Mutrie, Nanette; Petticrew, Mark; Platt, Stephen

2006-08-01

There is little evidence about the effects of environmental interventions on population levels of physical activity. Major transport projects may promote or discourage physical activity in the form of walking and cycling, but researching the health effects of such "natural experiments" in transport policy or infrastructure is challenging. Case study of attempts in 2004-2005 to evaluate the effects of two major transport projects in Scotland: an urban congestion charging scheme in Edinburgh, and a new urban motorway (freeway) in Glasgow. These interventions are typical of many major transport projects. They are unique to their context. They cannot easily be separated from the other components of the wider policies within which they occur. When, where, and how they are implemented are political decisions over which researchers have no control. Baseline data collection required for longitudinal studies may need to be planned before the intervention is certain to take place. There is no simple way of defining a population or area exposed to the intervention or of defining control groups. Changes in quantitative measures of health-related behavior may be difficult to detect. Major transport projects have clear potential to influence population health, but it is difficult to define the interventions, categorize exposure, or measure outcomes in ways that are likely to be seen as credible in the field of public health intervention research. A final study design is proposed in which multiple methods and spatial levels of analysis are combined in a longitudinal quasi-experimental study.

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

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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.

The Impact of Water, Sanitation and Hygiene Interventions to Control Cholera: A Systematic Review.

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Dawn L Taylor

Full Text Available Cholera remains a significant threat to global public health with an estimated 100,000 deaths per year. Water, sanitation and hygiene (WASH interventions are frequently employed to control outbreaks though evidence regarding their effectiveness is often missing. This paper presents a systematic literature review investigating the function, use and impact of WASH interventions implemented to control cholera.The review yielded eighteen studies and of the five studies reporting on health impact, four reported outcomes associated with water treatment at the point of use, and one with the provision of improved water and sanitation infrastructure. Furthermore, whilst the reporting of function and use of interventions has become more common in recent publications, the quality of studies remains low. The majority of papers (>60% described water quality interventions, with those at the water source focussing on ineffective chlorination of wells, and the remaining being applied at the point of use. Interventions such as filtration, solar disinfection and distribution of chlorine products were implemented but their limitations regarding the need for adherence and correct use were not fully considered. Hand washing and hygiene interventions address several transmission routes but only 22% of the studies attempted to evaluate them and mainly focussed on improving knowledge and uptake of messages but not necessarily translating this into safer practices. The use and maintenance of safe water storage containers was only evaluated once, under-estimating the considerable potential for contamination between collection and use. This problem was confirmed in another study evaluating methods of container disinfection. One study investigated uptake of household disinfection kits which were accepted by the target population. A single study in an endemic setting compared a combination of interventions to improve water and sanitation infrastructure, and the resulting

The Impact of Water, Sanitation and Hygiene Interventions to Control Cholera: A Systematic Review.

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Taylor, Dawn L; Kahawita, Tanya M; Cairncross, Sandy; Ensink, Jeroen H J

2015-01-01

Cholera remains a significant threat to global public health with an estimated 100,000 deaths per year. Water, sanitation and hygiene (WASH) interventions are frequently employed to control outbreaks though evidence regarding their effectiveness is often missing. This paper presents a systematic literature review investigating the function, use and impact of WASH interventions implemented to control cholera. The review yielded eighteen studies and of the five studies reporting on health impact, four reported outcomes associated with water treatment at the point of use, and one with the provision of improved water and sanitation infrastructure. Furthermore, whilst the reporting of function and use of interventions has become more common in recent publications, the quality of studies remains low. The majority of papers (>60%) described water quality interventions, with those at the water source focussing on ineffective chlorination of wells, and the remaining being applied at the point of use. Interventions such as filtration, solar disinfection and distribution of chlorine products were implemented but their limitations regarding the need for adherence and correct use were not fully considered. Hand washing and hygiene interventions address several transmission routes but only 22% of the studies attempted to evaluate them and mainly focussed on improving knowledge and uptake of messages but not necessarily translating this into safer practices. The use and maintenance of safe water storage containers was only evaluated once, under-estimating the considerable potential for contamination between collection and use. This problem was confirmed in another study evaluating methods of container disinfection. One study investigated uptake of household disinfection kits which were accepted by the target population. A single study in an endemic setting compared a combination of interventions to improve water and sanitation infrastructure, and the resulting reductions in

The Impact of Water, Sanitation and Hygiene Interventions to Control Cholera: A Systematic Review

Science.gov (United States)

Taylor, Dawn L.; Kahawita, Tanya M.; Cairncross, Sandy; Ensink, Jeroen H. J.

2015-01-01

Background and Methods Cholera remains a significant threat to global public health with an estimated 100,000 deaths per year. Water, sanitation and hygiene (WASH) interventions are frequently employed to control outbreaks though evidence regarding their effectiveness is often missing. This paper presents a systematic literature review investigating the function, use and impact of WASH interventions implemented to control cholera. Results The review yielded eighteen studies and of the five studies reporting on health impact, four reported outcomes associated with water treatment at the point of use, and one with the provision of improved water and sanitation infrastructure. Furthermore, whilst the reporting of function and use of interventions has become more common in recent publications, the quality of studies remains low. The majority of papers (>60%) described water quality interventions, with those at the water source focussing on ineffective chlorination of wells, and the remaining being applied at the point of use. Interventions such as filtration, solar disinfection and distribution of chlorine products were implemented but their limitations regarding the need for adherence and correct use were not fully considered. Hand washing and hygiene interventions address several transmission routes but only 22% of the studies attempted to evaluate them and mainly focussed on improving knowledge and uptake of messages but not necessarily translating this into safer practices. The use and maintenance of safe water storage containers was only evaluated once, under-estimating the considerable potential for contamination between collection and use. This problem was confirmed in another study evaluating methods of container disinfection. One study investigated uptake of household disinfection kits which were accepted by the target population. A single study in an endemic setting compared a combination of interventions to improve water and sanitation infrastructure, and

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

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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

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

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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

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

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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.

Multifaceted shared care intervention for late life depression in residential care: randomised controlled trial.

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Llewellyn-Jones, R H; Baikie, K A; Smithers, H; Cohen, J; Snowdon, J; Tennant, C C

1999-09-11

To evaluate the effectiveness of a population based, multifaceted shared care intervention for late life depression in residential care. Randomised controlled trial, with control and intervention groups studied one after the other and blind follow up after 9.5 months. Population of residential facility in Sydney living in self care units and hostels. 220 depressed residents aged >/=65 without severe cognitive impairment. The shared care intervention included: (a) multidisciplinary consultation and collaboration, (b) training of general practitioners and carers in detection and management of depression, and (c) depression related health education and activity programmes for residents. The control group received routine care. Geriatric depression scale. Intention to treat analysis was used. There was significantly more movement to "less depressed" levels of depression at follow up in the intervention than control group (Mantel-Haenszel stratification test, P=0.0125). Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders, with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group (95% confidence interval 0.76 to 2.97, P=0.0011). The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration, by enhancing the clinical skills of general practitioners and care staff, and by providing depression related health education and activity programmes for residents.

Effectiveness of a web-based intervention for injured claimants: a randomized controlled trial.

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Elbers, Nieke A; Akkermans, Arno J; Cuijpers, Pim; Bruinvels, David J

2013-07-20

There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process. One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the claimant. The aim of this study was to empower injured claimants in order to facilitate recovery. Participants were recruited by three Dutch claims settlement offices. The participants had all been injured in a traffic crash and were involved in a compensation process. The study design was a randomized controlled trial. An intervention website was developed with (1) information about the compensation process, and (2) an evidence-based, therapist-assisted problem-solving course. The control website contained a few links to already existing websites. Outcome measures were empowerment, self-efficacy, health status (including depression, anxiety, and somatic symptoms), perceived fairness, ability to work, claims knowledge and extent of burden. The outcomes were self-reported through online questionnaires and were measured four times: at baseline, and at 3, 6, and 12 months. In total, 176 participants completed the baseline questionnaire after which they were randomized into either the intervention group (n=88) or the control group (n=88). During the study, 35 participants (20%) dropped out. The intervention website was used by 55 participants (63%). The health outcomes of the intervention group were no different to those of the control group. However, the intervention group considered the received compensation to be fairer (Pwebsite was evaluated positively. Although the web-based intervention was not used enough to improve the health of injured claimants in compensation processes, it increased the perceived fairness of the compensation amount. Netherlands Trial Register NTR2360.

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

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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

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

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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

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.

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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

Controlled trial of pharmacist intervention in general practice: the effect on prescribing costs.

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Rodgers, S; Avery, A J; Meechan, D; Briant, S; Geraghty, M; Doran, K; Whynes, D K

1999-09-01

It has been suggested that the employment of pharmacists in general practice might moderate the growth in prescribing costs. However, empirical evidence for this proposition has been lacking. We report the results of a controlled trial of pharmacist intervention in United Kingdom general practice. To determine whether intervention practices made savings relative to controls. An evaluation of an initiative set up by Doncaster Health Authority. Eight practices agreed to take part and received intensive input from five pharmacists for one year (September 1996 to August 1997) at a cost of 163,000 Pounds. Changes in prescribing patterns were investigated by comparing these practices with eight individually matched controls for both the year of the intervention and the previous year. Prescribing data (PACTLINE) were used to assess these changes. The measures used to take account of differences in the populations of the practices included the ASTRO-PU for overall prescribing and the STAR-PU for prescribing in specific therapeutic areas. Differences between intervention and control practices were subjected to Wilcoxon matched-pairs, signed-ranks tests. The median (minimum to maximum) rise in prescribing costs per ASTRO-PU was 0.85 Pound (-1.95 Pounds to 2.05 Pounds) in the intervention practices compared with 2.55 Pounds (1.74 Pounds to 4.65 Pounds) in controls (P = 0.025). Had the cost growth of the intervention group been as high as that of the controls, their total prescribing expenditure would have been around 347,000 Pounds higher. This study suggests that the use of pharmacists did control prescribing expenditure sufficiently to offset their employment costs.

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

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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

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

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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

Effectiveness of Internet-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Meta-Analysis of Randomized Controlled Trials

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Shen, Ying; Wang, Fengbin; Zhang, Xing; Zhu, Xiaorou; Sun, Qiudan; Fisher, Edwin

2018-01-01

Background The popularity of internet as an area of research has grown manifold over the years. Given its rapid development and increasing coverage worldwide, internet-based interventions seem to offer a promising option to ameliorate huge burdens brought by type 2 diabetes mellitus. However, studies conducted by different researchers have provided contradictory results on the effect of internet-based interventions in glycemic control. Objective This meta-analysis aims to summarize currently available evidence and evaluate the overall impact of internet-based interventions on glycemic management of type 2 diabetic patients. Methods A systematic literature search was performed in PubMed, ScienceDirect, and Web of Science. Randomized controlled trials that used glycosylated hemoglobin values as the outcome measure of glycemic control were considered. Risk of bias and publication bias were evaluated. Results Of the 492 studies, 35 were included in meta-analysis, and results indicated that the weighted mean difference (WMD) between usual care and internet-based interventions at endpoint was –0.426% (95% CI –0.540 to –0.312; P<.001). Subgroup analyses revealed that intervention duration ≤3 months yielded optimal performance (WMD –0.51%; 95% CI –0.71 to –0.31; P<.001). Combined mobile and website interventions were substantially superior to solely Web-based and mobile-based interventions in glycemic control (combined WMD –0.77%, 95% CI –1.07 to –0.47; P<.001; Web only: WMD –0.48%; 95% CI –0.71 to –0.24, P<.001; mobile only WMD –0.31%, 95% CI –0.49 to –0.14; P<.001). Furthermore, the effect of interventions with automated feedbacks was similar to those with manual feedbacks, and studies with internet-based educational contents were more effective in glycemic control. The assessment revealed a low risk of bias. Conclusions In conclusion, utilization of internet-based intervention is beneficial for patients with type 2 diabetes mellitus, and

Effectiveness of Internet-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Meta-Analysis of Randomized Controlled Trials.

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Shen, Ying; Wang, Fengbin; Zhang, Xing; Zhu, Xiaorou; Sun, Qiudan; Fisher, Edwin; Sun, Xinying

2018-05-07

The popularity of internet as an area of research has grown manifold over the years. Given its rapid development and increasing coverage worldwide, internet-based interventions seem to offer a promising option to ameliorate huge burdens brought by type 2 diabetes mellitus. However, studies conducted by different researchers have provided contradictory results on the effect of internet-based interventions in glycemic control. This meta-analysis aims to summarize currently available evidence and evaluate the overall impact of internet-based interventions on glycemic management of type 2 diabetic patients. A systematic literature search was performed in PubMed, ScienceDirect, and Web of Science. Randomized controlled trials that used glycosylated hemoglobin values as the outcome measure of glycemic control were considered. Risk of bias and publication bias were evaluated. Of the 492 studies, 35 were included in meta-analysis, and results indicated that the weighted mean difference (WMD) between usual care and internet-based interventions at endpoint was -0.426% (95% CI -0.540 to -0.312; P<.001). Subgroup analyses revealed that intervention duration ≤3 months yielded optimal performance (WMD -0.51%; 95% CI -0.71 to -0.31; P<.001). Combined mobile and website interventions were substantially superior to solely Web-based and mobile-based interventions in glycemic control (combined WMD -0.77%, 95% CI -1.07 to -0.47; P<.001; Web only: WMD -0.48%; 95% CI -0.71 to -0.24, P<.001; mobile only WMD -0.31%, 95% CI -0.49 to -0.14; P<.001). Furthermore, the effect of interventions with automated feedbacks was similar to those with manual feedbacks, and studies with internet-based educational contents were more effective in glycemic control. The assessment revealed a low risk of bias. In conclusion, utilization of internet-based intervention is beneficial for patients with type 2 diabetes mellitus, and taking full advantage of this type of intervention may substantially reduce the

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

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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

Control of Aedes aegypti Breeding: A Novel Intervention for Prevention and Control of Dengue in an Endemic Zone of Delhi, India.

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Nagpal, B N; Gupta, Sanjeev Kumar; Shamim, Arshad; Vikram, Kumar; Srivastava, Aruna; Tuli, N R; Saxena, Rekha; Singh, Himmat; Singh, V P; Bhagat, V N; Yadav, N K; Valecha, Neena

2016-01-01

The study is based on hypothesis that whether continuous entomological surveillance of Ae. aegypti and simultaneous appropriate interventions in key containers during non-transmission (December-May) months would have any impact on breeding of Aedes and dengue cases during the following transmission months (June-November). The impact of the surveillance and intervention measures undertaken during non-transmission months were assessed by entomological indicators namely container index (CI), house index (HI), pupal index (PI) and breteau index (BI). A total of 28 localities of West Zone of Delhi with persistent dengue endemicity were selected for the study. Out of these localities, 20 were included in study group while other 8 localities were in control group. IEC and various Aedes breeding control activities were carried out in study group in both non-transmission and transmission season whereas control group did not have any such interventions during non-transmission months as per guidelines of MCD. These activities were undertaken by a team of investigators from NIMR and SDMC, Delhi. In control group, investigators from NIMR carried out surveillance activity to monitor the breeding of Aedes mosquito in localities. Comparison of baseline data revealed that all indices in control and study group of localities were comparable and statistically non-significant (p>0.05). In both study and control groups, indices were calculated after pooling data on seasonal basis, i.e., transmission and non-transmission months for both years. The test of significance conducted on all the four indices, i.e., HI, PI, CI, and BI, revealed a significant difference (pcontrol group during transmission and non-transmission months except in HI. Due to consistent intervention measures undertaken in non-transmission months in study group, reduction in CI, HI, BI and PI was observed 63%, 62%, 64% and 99% respectively during transmission months as compared to control group where increase of 59

A randomized controlled trial of a personalized feedback intervention for problem gamblers.

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John A Cunningham

Full Text Available Personalized feedback is a promising self-help for problem gamblers. Such interventions have shown consistently positive results with other addictive behaviours, and our own pilot test of personalized normative feedback materials for gamblers yielded positive findings. The current randomized controlled trial evaluated the effectiveness, and the sustained efficacy, of the personalized feedback intervention materials for problem gamblers.Respondents recruited by a general population telephone screener of Ontario adults included gamblers with moderate and severe gambling problems. Those who agreed to participate were randomly assigned to receive: 1 the full personalized normative feedback intervention; 2 a partial feedback that contained all the feedback information provided to those in condition 1 but without the normative feedback content (i.e., no comparisons provided to general population gambling norms; or 3 a waiting list control condition. The primary hypothesis was that problem gamblers who received the personalized normative feedback intervention would reduce their gambling more than problem gamblers who did not receive any intervention (waiting list control condition by the six-month follow-up.The study found no evidence for the impact of normative personalized feedback. However, participants who received, the partial feedback (without norms reduced the number of days they gambled compared to participants who did not receive the intervention. We concluded that personalized feedback interventions were well received and the materials may be helpful at reducing gambling. Realistically, it can be expected that the personalized feedback intervention may have a limited, short term impact on the severity of participants' problem gambling because the intervention is just a brief screener. An Internet-based version of the personalized feedback intervention tool, however, may offer an easy to access and non-threatening portal that can be used to

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.

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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.

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

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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.

Population-based biomedical sexually transmitted infection control interventions for reducing HIV infection.

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Ng, Brian E; Butler, Lisa M; Horvath, Tara; Rutherford, George W

2011-03-16

The transmission of sexually transmitted infections (STIs) is closely related to the sexual transmission of human immunodeficiency virus (HIV). Similar risk behaviours, such as frequent unprotected intercourse with different partners, place people at high risk of HIV and STIs, and there is clear evidence that many STIs increase the likelihood of HIV transmission. STI control, especially at the population or community level, may have the potential to contribute substantially to HIV prevention.This is an update of an existing Cochrane review. The review's search methods were updated and its inclusion and exclusion criteria modified so that the focus would be on one well-defined outcome. This review now focuses explicitly on population-based biomedical interventions for STI control, with change in HIV incidence being an outcome necessary for a study's inclusion. To determine the impact of population-based biomedical STI interventions on the incidence of HIV infection. We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science/Social Science, PsycINFO, and Literatura Latino Americana e do Caribe em Ciências da Saúde (LILACS), for the period of 1 January1980 - 16 August 2010. We initially identified 6003 articles and abstracts. After removing 776 duplicates, one author (TH) removed an additional 3268 citations that were clearly irrelevant. Rigorously applying the inclusion criteria, three authors then independently screened the remaining 1959 citations and abstracts. Forty-six articles were chosen for full-text scrutiny by two authors. Ultimately, four studies were included in the review.We also searched the Aegis database of conference abstracts, which includes the Conference on Retroviruses and Opportunistic Infections (CROI), the International AIDS Conference (IAC), and International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS) meetings from their inception dates (1993, 1985 and

Clinical Impact Research - how to choose experimental or observational intervention study?

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Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

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

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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

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

Children of mentally ill parents—a pilot study of a group intervention program

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Christiansen, Hanna; Anding, Jana; Schrott, Bastian; Röhrle, Bernd

2015-01-01

Objective: The transgenerational transmission of mental disorders is one of the most prominent risk factors for the development of psychological disorders. Children of mentally ill parents are a vulnerable high risk group with overall impaired development and high rates of psychological disorders. To date there are only a few evidence based intervention programs for this group overall and hardly any in Germany. We translated the evidence based Family Talk Intervention by Beardslee (2009) and adapted it for groups. First results of this pilot study are presented. Method: This investigation evaluates a preventive group intervention for children of mentally ill parents. In a quasi-experimental design three groups are compared: an intervention group (Family Talk Intervention group: n = 28), a Wait Control group (n = 9), and a control group of healthy children (n = 40). Mean age of children was 10.41 years and parental disorders were mostly depressive/affective disorders (n = 30), but a small number also presented with Attention-Deficit/Hyperactivity Disorder (n = 7). Results: Children of mentally ill parents showed higher rates of internalizing/externalizing disorders before and after the intervention compared to children of parents with no disorders. Post intervention children's knowledge on mental disorders was significantly enhanced in the Family Talk Intervention group compared to the Wait Control group and the healthy control group. Parental ratings of externalizing symptoms in the children were reduced to normal levels after the intervention in the Family Talk Intervention group, but not in the Wait Control group. Discussion: This pilot study of a group intervention for children of mentally ill parents highlights the importance of psycho-education on parental mental disorders for children. Long-term effects of children's enhanced knowledge about parental psychopathology need to be explored in future studies. PMID:26539129

Children of mentally ill parents-a pilot study of a group intervention program.

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Christiansen, Hanna; Anding, Jana; Schrott, Bastian; Röhrle, Bernd

2015-01-01

The transgenerational transmission of mental disorders is one of the most prominent risk factors for the development of psychological disorders. Children of mentally ill parents are a vulnerable high risk group with overall impaired development and high rates of psychological disorders. To date there are only a few evidence based intervention programs for this group overall and hardly any in Germany. We translated the evidence based Family Talk Intervention by Beardslee (2009) and adapted it for groups. First results of this pilot study are presented. This investigation evaluates a preventive group intervention for children of mentally ill parents. In a quasi-experimental design three groups are compared: an intervention group (Family Talk Intervention group: n = 28), a Wait Control group (n = 9), and a control group of healthy children (n = 40). Mean age of children was 10.41 years and parental disorders were mostly depressive/affective disorders (n = 30), but a small number also presented with Attention-Deficit/Hyperactivity Disorder (n = 7). Children of mentally ill parents showed higher rates of internalizing/externalizing disorders before and after the intervention compared to children of parents with no disorders. Post intervention children's knowledge on mental disorders was significantly enhanced in the Family Talk Intervention group compared to the Wait Control group and the healthy control group. Parental ratings of externalizing symptoms in the children were reduced to normal levels after the intervention in the Family Talk Intervention group, but not in the Wait Control group. This pilot study of a group intervention for children of mentally ill parents highlights the importance of psycho-education on parental mental disorders for children. Long-term effects of children's enhanced knowledge about parental psychopathology need to be explored in future studies.

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

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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.

Effect of dietary intervention on serum lignan levels in pregnant women - a controlled trial

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Mäkelä Sari

2010-10-01

Full Text Available Abstract Background Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women. Methods A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline and 36-37 (end of intervention. The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method. Results The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml (p = 0.018, 95% CI 1.1-2.3 and 1.4 ng/mg (p = 0.08, 95% CI 1.0-1.9 higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations. Conclusion The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women. Trial registration ISRCTN21512277, http://www.isrctn.org

A randomized controlled trial testing a social network intervention to promote physical activity among adolescents.

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van Woudenberg, Thabo J; Bevelander, Kirsten E; Burk, William J; Smit, Crystal R; Buijs, Laura; Buijzen, Moniek

2018-04-23

The current study examined the effectiveness of a social network intervention to promote physical activity among adolescents. Social network interventions utilize peer influence to change behavior by identifying the most influential individuals within social networks (i.e., influence agents), and training them to promote the target behavior. A total of 190 adolescents (46.32% boys; M age = 12.17, age range: 11-14 years) were randomly allocated to either the intervention or control condition. In the intervention condition, the most influential adolescents (based on peer nominations of classmates) in each classroom were trained to promote physical activity among their classmates. Participants received a research smartphone to complete questionnaires and an accelerometer to measure physical activity (steps per day) at baseline, and during the intervention one month later. A multilevel model tested the effectiveness of the intervention, controlling for clustering of data within participants and days. No intervention effect was observed, b = .04, SE = .10, p = .66. This was one of the first studies to test whether physical activity in adolescents could be promoted via influence agents, and the first social network intervention to use smartphones to do so. Important lessons and implications are discussed concerning the selection criterion of the influence agents, the use of smartphones in social network intervention, and the rigorous analyses used to control for confounding factors. Dutch Trial Registry (NTR): NTR6173 . Registered 5 October 2016 Study procedures were approved by the Ethics Committee of the Radboud University (ECSW2014-100614-222).

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

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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.

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

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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.

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

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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

Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

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Arija Victoria; Martín Núria; Canela Teresa; Anguera Carme; Castelao Ana I; García-Barco Montserrat; García-Campo Antoni; González-Bravo Ana I; Lucena Carme; Martínez Teresa; Fernández-Barrés Silvia; Pedret Roser; Badia Waleska; Basora Josep

2012-01-01

Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of t...

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

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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

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

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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

An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

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Jeffries, Sherryl A.; Robinson, John W.; Craighead, Peter S.; Keats, Melanie R.

2006-01-01

Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

Interventions for improving modifiable risk factor control in the secondary prevention of stroke.

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Lager, Kate E; Mistri, Amit K; Khunti, Kamlesh; Haunton, Victoria J; Sett, Aung K; Wilson, Andrew D

2014-05-02

People with stroke or transient ischaemic attack (TIA) are at increased risk of future stroke and other cardiovascular events. Evidence-based strategies for secondary stroke prevention have been established. However, the implementation of prevention strategies could be improved. To assess the effects of stroke service interventions for implementing secondary stroke prevention strategies on modifiable risk factor control, including patient adherence to prescribed medications, and the occurrence of secondary cardiovascular events. We searched the Cochrane Stroke Group Trials Register (April 2013), the Cochrane Effective Practice and Organisation of Care Group Trials Register (April 2013), CENTRAL (The Cochrane Library 2013, issue 3), MEDLINE (1950 to April 2013), EMBASE (1981 to April 2013) and 10 additional databases. We located further studies by searching reference lists of articles and contacting authors of included studies. We included randomised controlled trials (RCTs) that evaluated the effects of organisational or educational and behavioural interventions (compared with usual care) on modifiable risk factor control for secondary stroke prevention. Two review authors selected studies for inclusion and independently extracted data. One review author assessed the risk of bias for the included studies. We sought missing data from trialists. This review included 26 studies involving 8021 participants. Overall the studies were of reasonable quality, but one study was considered at high risk of bias. Fifteen studies evaluated predominantly organisational interventions and 11 studies evaluated educational and behavioural interventions for patients. Results were pooled where appropriate, although some clinical and methodological heterogeneity was present. The estimated effects of organisational interventions were compatible with improvements and no differences in the modifiable risk factors mean systolic blood pressure (mean difference (MD) -2.57 mmHg; 95% confidence

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

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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

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

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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.

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

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

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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

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

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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

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.

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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.

Social media-delivered sexual health intervention: a cluster randomized controlled trial.

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Bull, Sheana S; Levine, Deborah K; Black, Sandra R; Schmiege, Sarah J; Santelli, John

2012-11-01

Youth are using social media regularly and represent a group facing substantial risk for sexually transmitted infection (STI). Although there is evidence that the Internet can be used effectively in supporting healthy sexual behavior, this has not yet extended to social networking sites. To determine whether STI prevention messages delivered via Facebook are efficacious in preventing increases in sexual risk behavior at 2 and 6 months. Cluster RCT, October 2010-May 2011. Individuals (seeds) recruited in multiple settings (online, via newspaper ads and face-to-face) were asked to recruit three friends, who in turn recruited additional friends, extending three waves from the seed. Seeds and waves of friends were considered networks and exposed to either the intervention or control condition. Exposure to Just/Us, a Facebook page developed with youth input, or to control content on 18-24 News, a Facebook page with current events for 2 months. Condom use at last sex and proportion of sex acts protected by condoms. Repeated measures of nested data were used to model main effects of exposure to Just/Us and time by treatment interaction. A total of 1578 participants enrolled, with 14% Latino and 35% African-American; 75% of participants completed at least one study follow-up. Time by treatment effects were observed at 2 months for condom use (intervention 68% vs control 56%, p=0.04) and proportion of sex acts protected by condoms (intervention 63% vs control 57%, p=0.03) where intervention participation reduced the tendency for condom use to decrease over time. No effects were seen at 6 months. Social networking sites may be venues for efficacious health education interventions. More work is needed to understand what elements of social media are compelling, how network membership influences effects, and whether linking social media to clinical and social services can be beneficial. This study is registered at www.clinicaltrials.govNCT00725959. Copyright © 2012 American

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.

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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

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

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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.

Facilitating sunscreen use in women by a theory-based online intervention: a randomized controlled trial.

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Craciun, Catrinel; Schüz, Natalie; Lippke, Sonia; Schwarzer, Ralf

2012-03-01

This study compares a motivational skin cancer prevention approach with a volitional planning and self-efficacy intervention to enhance regular sunscreen use. A randomized controlled trial (RCT) was conducted with 205 women (mean age 25 years) in three groups: motivational; volitional; and control. Sunscreen use, action planning, coping planning and coping self-efficacy were assessed at three points in time. The volitional intervention improved sunscreen use. Coping planning emerged as the only mediator between the intervention and sunscreen use at Time 3. Findings point to the role played by coping planning as an ingredient of sun protection interventions.

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults.

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Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. THE AIMS OF THIS SYSTEMATIC REVIEW ARE: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed.

A randomized controlled trial of stage-matched intervention for smoking cessation in cardiac out-patients.

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Chan, Sophia S C; Leung, Doris Y P; Wong, David C N; Lau, Chu-Pak; Wong, Vivian T; Lam, Tai-Hing

2012-04-01

To examine the effectiveness of a stage-matched smoking cessation counselling intervention for smokers who had cardiac diseases. A total of 1860 Chinese cardiac patients who smoked at least one cigarette in the past 7 days and aged 18 years or above recruited from cardiac out-patient clinics in Hong Kong hospitals were allocated randomly to an intervention group or control group. The intervention group (n = 938) received counselling matched with their stage of readiness to quit by trained counsellors at baseline, 1 week and 1 month. The control group (n = 922) received brief counselling on healthy diet at baseline. The primary outcomes were self-reported 7-day and 30-day point prevalence (PP) of tobacco abstinence at 12 months after baseline. The secondary outcome measures included biochemically validated abstinence at 12-month follow-up, self-reported 7-day and 30-day PP abstinence and reduction of cigarette consumption by 50% at 3 and 6 months. By intention-to-treat analysis, the intervention and control groups showed no significant difference in self-reported 7-day PP abstinence (intervention: 26.5% versus control: 25.5%; P = 0.60) and 30-day PP (intervention: 25.4% versus control: 24.2%; P = 0.55), biochemically validated abstinence (intervention: 6.6% versus control: 4.9%; P = 0.14) and overall quit attempts of least 24 hours (intervention: 40.3% versus control: 34.3%; P = 0.007) at the 12-month follow-up, adjusted for the baseline stage of readiness to quit smoking. An intervention, based on the Stages of Change model, to promote smoking cessation in cardiac patients in China failed to find any long-term benefit. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

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

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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

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

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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

Perceptions about interventions to control schistosomiasis among the Lake Victoria island communities of Koome, Uganda.

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Richard E Sanya

2017-10-01

Full Text Available Praziquantel-based mass treatment is the main approach to controlling schistosomiasis mansoni in endemic areas. Interventions such as provision and use of safe water, minimising contact with infested water, disposal of stool in latrines and snail control provide key avenues to break the transmission cycle and can sustain the benefits of mass treatment in the long term. Efforts are also being made to develop a schistosomiasis vaccine which, if effective, might reduce the incidence of re-infection after treatment. However, any interventions deployed need to be acceptable to, and sustainable by, the target communities.In this qualitative study, we investigated the perceptions of six Lake Victoria island communities of Koome, Uganda, about interventions to control Schistosoma mansoni infection and their willingness to participate in Schistosoma vaccine trials. Thirty-two in-depth interviews, 12 key informant interviews and 10 focus group discussions were conducted. Data were analysed using a thematic content approach.Intestinal schistosomiasis was not regarded as a serious health problem because a mass treatment programme is in place. However, the communities lack safe water sources and latrines. Mass treatment with praziquantel, safe water supplies and use of toilets were deemed the most acceptable interventions by the participants. The communities are willing to participate in Schistosoma vaccine trials.Knowledge of a community's perception about interventions to control schistosomiasis can be valuable to policy makers and programme implementers intending to set up interventions co-managed by the community members. In this study, the views of the Lake Victoria island communities of Koome are presented. This study also provides data to guide further work on alternative interventions such as Schistosoma vaccine trials in these communities.

Perceptions about interventions to control schistosomiasis among the Lake Victoria island communities of Koome, Uganda.

Science.gov (United States)

Sanya, Richard E; Tumwesige, Edward; Elliott, Alison M; Seeley, Janet

2017-10-01

Praziquantel-based mass treatment is the main approach to controlling schistosomiasis mansoni in endemic areas. Interventions such as provision and use of safe water, minimising contact with infested water, disposal of stool in latrines and snail control provide key avenues to break the transmission cycle and can sustain the benefits of mass treatment in the long term. Efforts are also being made to develop a schistosomiasis vaccine which, if effective, might reduce the incidence of re-infection after treatment. However, any interventions deployed need to be acceptable to, and sustainable by, the target communities. In this qualitative study, we investigated the perceptions of six Lake Victoria island communities of Koome, Uganda, about interventions to control Schistosoma mansoni infection and their willingness to participate in Schistosoma vaccine trials. Thirty-two in-depth interviews, 12 key informant interviews and 10 focus group discussions were conducted. Data were analysed using a thematic content approach. Intestinal schistosomiasis was not regarded as a serious health problem because a mass treatment programme is in place. However, the communities lack safe water sources and latrines. Mass treatment with praziquantel, safe water supplies and use of toilets were deemed the most acceptable interventions by the participants. The communities are willing to participate in Schistosoma vaccine trials. Knowledge of a community's perception about interventions to control schistosomiasis can be valuable to policy makers and programme implementers intending to set up interventions co-managed by the community members. In this study, the views of the Lake Victoria island communities of Koome are presented. This study also provides data to guide further work on alternative interventions such as Schistosoma vaccine trials in these communities.

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

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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.

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

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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.

The Impact of Water, Sanitation and Hygiene Interventions to Control Cholera: A Systematic Review.

OpenAIRE

Taylor, DL; Kahawita, TM; Cairncross, S; Ensink, JH

2015-01-01

Background and Methods Cholera remains a significant threat to global public health with an estimated 100,000 deaths per year. Water, sanitation and hygiene (WASH) interventions are frequently employed to control outbreaks though evidence regarding their effectiveness is often missing. This paper presents a systematic literature review investigating the function, use and impact of WASH interventions implemented to control cholera. Results The review yielded eighteen studies and of the five st...

Intervention strategies for control of foodborne pathogens

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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

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

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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.

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

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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.

Randomized controlled trial of computerized alcohol intervention for college students: role of class level.

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Strohman, Ashleigh Sweet; Braje, Sopagna Eap; Alhassoon, Omar M; Shuttleworth, Sylvie; Van Slyke, Jenna; Gandy, Sharareh

2016-01-01

Because of their ability to reach a much wider audience than face-to-face counseling or psychoeducation, computer-delivered interventions for risky or potentially problematic use have been increasing on college campuses. However, there are very few studies that examine who benefits most from such interventions. The purpose of this study was to determine if participation in Alcohol-Wise, a computerized intervention, is associated with changes in alcohol drinking behavior and its consequences, perceptions of college drinking norms, and expectancies. It was hypothesized that class level (i.e. freshman/sophomore versus junior/senior) would moderate the effectiveness of Alcohol-Wise. College students (n = 58) were randomly assigned to one of two conditions: (i) the computer-delivered intervention or (ii) wait-list control. Measures were completed at baseline and approximately 30-days later. At follow-up, freshman and sophomore students in the intervention group showed significant reduction in peak number of standard drinks and blood alcohol concentration, but the effect was not observed for juniors and seniors. The intervention group reported more accurate estimates of drinking norms at follow-up relative to controls. There were no significant changes over time in alcohol expectancies in either group. This study provides support for the potential usefulness of Alcohol-Wise intervention at reducing short-term drinking among underclassmen but not upperclassmen in a 4-year college setting. These findings suggest that computerized interventions may be more effective when provided early, but not later, in a student's college career.

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.

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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

Positive psychology interventions in people aged 50-79 years: long-term effects of placebo-controlled online interventions on well-being and depression.

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Proyer, René T; Gander, Fabian; Wellenzohn, Sara; Ruch, Willibald

2014-01-01

Various positive psychology interventions have been experimentally tested, but only few studies addressed the effects of such activities in participants aged 50 and above. We tested the impact of four self-administered positive psychology interventions in an online setting (i.e., gratitude visit, three good things, three funny things, and using signature strengths in a new way) on happiness and depressive symptoms in comparison with a placebo control exercise (i.e., early memories). A total of 163 females aged 50-79 tried the assigned interventions or the placebo control exercise for one week and completed measures on happiness and depressive symptoms at five times (pre- and post-test, 1, 3, and 6 months). Three out of the four interventions (i.e., gratitude visit, three good things, and using signature strengths in a new way) increased happiness, whereas two interventions (three funny things and using signature strengths in a new way) led to a reduction of depressive symptoms on at one post-measure. Positive psychology interventions yield similar results for people aged 50 and above as for younger people. The dissemination of such interventions via the Internet offers a valuable opportunity for older age groups as well.

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

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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

Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial.

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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

A Randomized Controlled Trial of an Appearance-focused Intervention to Prevent Skin Cancer

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Hillhouse, Joel; Turrisi, Rob; Stapleton, Jerod; Robinson, June

2014-01-01

BACKGROUND Skin cancer represents a significant health threat with over 1.3 million diagnoses, 8000 melanoma deaths, and more than $1 billion spent annually for skin cancer healthcare in the US. Despite findings from laboratory, case-control, and prospective studies that indicate a link between youthful indoor tanning (IT) and skin cancer, IT is increasing among US youth. Appearance-focused interventions represent a promising method to counteract these trends. METHODS A total of 430 female indoor tanners were randomized into intervention or no intervention control conditions. Intervention participants received an appearance-focused booklet based on decision-theoretical models of health behavior. Outcome variables included self-reports of IT behavior and intentions, as well as measures of cognitive mediating variables. RESULTS Normative increases in springtime IT rates were significantly lower (ie, over 35%) at 6-month follow-up in intervention versus control participants with similar reductions in future intentions. Mediation analyses revealed 6 cognitive variables (IT attitudes, fashion attitudes, perceived susceptibility to skin cancer and skin damage, subjective norms, and image norms) that significantly mediated change in IT behavior. CONCLUSIONS The appearance-focused intervention demonstrated strong effects on IT behavior and intentions in young indoor tanners. Appearance-focused approaches to skin cancer prevention need to present alternative behaviors as well as alter IT attitudes. Mediational results provide guides for strengthening future appearance-focused interventions directed at behaviors that increase risk of skin cancer. PMID:18937268

A randomized controlled trial of an appearance-focused intervention to prevent skin cancer.

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Hillhouse, Joel; Turrisi, Rob; Stapleton, Jerod; Robinson, June

2008-12-01

Skin cancer represents a significant health threat with over 1.3 million diagnoses, 8000 melanoma deaths, and more than $1 billion spent annually for skin cancer healthcare in the US. Despite findings from laboratory, case-control, and prospective studies that indicate a link between youthful indoor tanning (IT) and skin cancer, IT is increasing among US youth. Appearance-focused interventions represent a promising method to counteract these trends. A total of 430 female indoor tanners were randomized into intervention or no intervention control conditions. Intervention participants received an appearance-focused booklet based on decision-theoretical models of health behavior. Outcome variables included self-reports of IT behavior and intentions, as well as measures of cognitive mediating variables. Normative increases in springtime IT rates were significantly lower (ie, over 35%) at 6-month follow-up in intervention versus control participants with similar reductions in future intentions. Mediation analyses revealed 6 cognitive variables (IT attitudes, fashion attitudes, perceived susceptibility to skin cancer and skin damage, subjective norms, and image norms) that significantly mediated change in IT behavior. The appearance-focused intervention demonstrated strong effects on IT behavior and intentions in young indoor tanners. Appearance-focused approaches to skin cancer prevention need to present alternative behaviors as well as alter IT attitudes. Mediational results provide guides for strengthening future appearance-focused interventions directed at behaviors that increase risk of skin cancer. (c) 2008 American Cancer Society

Effect of a social intervention of choice vs. control on depressive symptoms, melancholy, feeling of loneliness, and perceived togetherness in older Finnish people: a randomized controlled trial.

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Pynnönen, Katja; Törmäkangas, Timo; Rantanen, Taina; Tiikkainen, Pirjo; Kallinen, Mauri

2018-01-01

This study examined effects of a social intervention on depressive symptoms, melancholy, loneliness, and perceived togetherness in community-dwelling Finnish older people. Promotion of mental well-being in older people (GoodMood; ISRCTN78426775) was a single-blinded randomized control trial lasting 1.5 years. Two hundred and twenty-three persons aged 75-79 years reporting symptoms of loneliness or melancholy were randomized into intervention and control groups. The intervention group was allowed to choose among supervised exercise, social activity, or personal counseling. Follow-up measurements were conducted at the end of 6-month intervention, and at 3, 6, and 12 months post intervention. Number of depressive symptoms remained unchanged, while loneliness and melancholy decreased in both the intervention and control groups during the study (p Social integration increased in the intervention group but not in controls (p = 0.041). Attachment and guidance increased in both groups (p intervention did not alleviate depressed mood. Positive changes over time were observed in loneliness, feelings of melancholy, attachment, and guidance but these occurred independently of the intervention. Our secondary analysis suggests that the intervention increased perceived social integration. In sum, the effects of the intervention were moderate only and did not expedite further overcoming depressive mood or loneliness.

Impact of tobacco control interventions on socioeconomic inequalities in smoking: review of the evidence.

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Hill, Sarah; Amos, Amanda; Clifford, David; Platt, Stephen

2014-11-01

We updated and expanded a previous systematic literature review examining the impact of tobacco control interventions on socioeconomic inequalities in smoking. We searched the academic literature for reviews and primary research articles published between January 2006 and November 2010 that examined the socioeconomic impact of six tobacco control interventions in adults: that is, price increases, smoke-free policies, advertising bans, mass media campaigns, warning labels, smoking cessation support and community-based programmes combining several interventions. We included English-language articles from countries at an advanced stage of the tobacco epidemic that examined the differential impact of tobacco control interventions by socioeconomic status or the effectiveness of interventions among disadvantaged socioeconomic groups. All articles were appraised by two authors and details recorded using a standardised approach. Data from 77 primary studies and seven reviews were synthesised via narrative review. We found strong evidence that increases in tobacco price have a pro-equity effect on socioeconomic disparities in smoking. Evidence on the equity impact of other interventions is inconclusive, with the exception of non-targeted smoking cessation programmes which have a negative equity impact due to higher quit rates among more advantaged smokers. Increased tobacco price via tax is the intervention with the greatest potential to reduce socioeconomic inequalities in smoking. Other measures studied appear unlikely to reduce inequalities in smoking without specific efforts to reach disadvantaged smokers. There is a need for more research evaluating the equity impact of tobacco control measures, and development of more effective approaches for reducing tobacco use in disadvantaged groups and communities. 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.

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

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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.

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

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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…

A brief intervention to improve exercising in patients with schizophrenia: a controlled pilot study with mental contrasting and implementation intentions (MCII).

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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

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

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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

Intervention for the control of Soil -transmitted helminthiasis in the community

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Albonico, Marco; Montresor, Antonio; Crompton, DWT; Savioli, Lorenzo

2017-01-01

The global strategy for the control of soil-transmitted helminthiasis, based on regular anthelminthic treatment, health education, and improved sanitation standards, is reviewed. The reasons for the development of a control strategy based on population intervention rather than on individual treatment are explained. The evidence and experience from control programmes that created the basis for i) the definition of the intervention package, ii) the identification of the groups at risk, iii) the standardization of the community diagnosis, and iv) the selection of the appropriate intervention for each category in the community are discussed. How to best deliver the appropriate intervention, the impact of the control measures on morbidity and on indicators such as school attendance, cognitive development and productivity are presented. The factors influencing the cost-benefits of helminth control are also considered. The recent progress on the control of soil-transmitted helminth infections is illustrated. Research needs are analysed in relation to the most recent perceptions from private-public partnerships involved in helminth control. The way forward for the control of soil-transmitted helminth infections is described as a multi-disease approach that goes beyond deworming and fosters a pro-poor strategy that supports the aims of the Millennium Development Goals. PMID:16735168

Control of trachoma in Australia: a model based evaluation of current interventions.

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Andrew J Shattock

2015-04-01

Full Text Available Australia is the only high-income country in which endemic trachoma persists. In response, the Australian Government has recently invested heavily towards the nationwide control of the disease.A novel simulation model was developed to reflect the trachoma epidemic in Australian Aboriginal communities. The model, which incorporates demographic, migration, mixing, and biological heterogeneities, was used to evaluate recent intervention measures against counterfactual past scenarios, and also to assess the potential impact of a series of hypothesized future intervention measures relative to the current national strategy and intensity. The model simulations indicate that, under the current intervention strategy and intensity, the likelihood of controlling trachoma to less than 5% prevalence among 5-9 year-old children in hyperendemic communities by 2020 is 31% (19%-43%. By shifting intervention priorities such that large increases in the facial cleanliness of children are observed, this likelihood of controlling trachoma in hyperendemic communities is increased to 64% (53%-76%. The most effective intervention strategy incorporated large-scale antibiotic distribution programs whilst attaining ambitious yet feasible screening, treatment, facial cleanliness and housing construction targets. Accordingly, the estimated likelihood of controlling trachoma in these communities is increased to 86% (76%-95%.Maintaining the current intervention strategy and intensity is unlikely to be sufficient to control trachoma across Australia by 2020. However, by shifting the intervention strategy and increasing intensity, the likelihood of controlling trachoma nationwide can be significantly increased.

Control of trachoma in Australia: a model based evaluation of current interventions.

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Shattock, Andrew J; Gambhir, Manoj; Taylor, Hugh R; Cowling, Carleigh S; Kaldor, John M; Wilson, David P

2015-04-01

Australia is the only high-income country in which endemic trachoma persists. In response, the Australian Government has recently invested heavily towards the nationwide control of the disease. A novel simulation model was developed to reflect the trachoma epidemic in Australian Aboriginal communities. The model, which incorporates demographic, migration, mixing, and biological heterogeneities, was used to evaluate recent intervention measures against counterfactual past scenarios, and also to assess the potential impact of a series of hypothesized future intervention measures relative to the current national strategy and intensity. The model simulations indicate that, under the current intervention strategy and intensity, the likelihood of controlling trachoma to less than 5% prevalence among 5-9 year-old children in hyperendemic communities by 2020 is 31% (19%-43%). By shifting intervention priorities such that large increases in the facial cleanliness of children are observed, this likelihood of controlling trachoma in hyperendemic communities is increased to 64% (53%-76%). The most effective intervention strategy incorporated large-scale antibiotic distribution programs whilst attaining ambitious yet feasible screening, treatment, facial cleanliness and housing construction targets. Accordingly, the estimated likelihood of controlling trachoma in these communities is increased to 86% (76%-95%). Maintaining the current intervention strategy and intensity is unlikely to be sufficient to control trachoma across Australia by 2020. However, by shifting the intervention strategy and increasing intensity, the likelihood of controlling trachoma nationwide can be significantly increased.

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

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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

Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

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Kwok T

2013-09-01

Full Text Available Timothy Kwok,1,2 Bel Wong,2 Isaac Ip,2 Kenny Chui,2 Daniel Young,2 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region; 2Jockey Club Centre for Positive Ageing, Hong Kong, Special Administrative Region Purpose: Many family caregivers of persons with dementia (PWD are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods: In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results: The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion: A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. Keywords: telephone intervention, psychoeducation, dementia caregivers

Clinical Impact Research – how to choose experimental or observational intervention study?

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Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

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.

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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

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 randomised controlled study

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Elisabeth Catharina Van Straaten

2016-10-01

Full Text Available 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 (MMSE. Peak frequencies of MEG were compared to 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

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

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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

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

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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.

"Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial.

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Björklund, Katja; Liski, Antti; Samposalo, Hanna; Lindblom, Jallu; Hella, Juho; Huhtinen, Heini; Ojala, Tiina; Alasuvanto, Paula; Koskinen, Hanna-Leena; Kiviruusu, Olli; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Solantaus, Tytti; Santalahti, Päivi

2014-10-07

Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods. The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants. This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a

Cost-benefit of infection control interventions targeting methicillin-resistant Staphylococcus aureus in hospitals: systematic review.

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Farbman, L; Avni, T; Rubinovitch, B; Leibovici, L; Paul, M

2013-12-01

Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) incur significant costs. We aimed to examine the cost and cost-benefit of infection control interventions against MRSA and to examine factors affecting economic estimates. We performed a systematic review of studies assessing infection control interventions aimed at preventing spread of MRSA in hospitals and reporting intervention costs, savings, cost-benefit or cost-effectiveness. We searched PubMed and references of included studies with no language restrictions up to January 2012. We used the Quality of Health Economic Studies tool to assess study quality. We report cost and savings per month in 2011 US$. We calculated the median save/cost ratio and the save-cost difference with interquartile range (IQR) range. We examined the effects of MRSA endemicity, intervention duration and hospital size on results. Thirty-six studies published between 1987 and 2011 fulfilled inclusion criteria. Fifteen of the 18 studies reporting both costs and savings reported a save/cost ratio >1. The median save/cost ratio across all 18 studies was 7.16 (IQR 1.37-16). The median cost across all studies reporting intervention costs (n = 31) was 8648 (IQR 2025-19 170) US$ per month; median savings were 38 751 (IQR 14 206-75 842) US$ per month (23 studies). Higher save/cost ratios were observed in the intermediate to high endemicity setting compared with the low endemicity setting, in hospitals with 6 months. Infection control intervention to reduce spread of MRSA in acute-care hospitals showed a favourable cost/benefit ratio. This was true also for high MRSA endemicity settings. Unresolved economic issues include rapid screening using molecular techniques and universal versus targeted screening. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

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

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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

Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

Directory of Open Access Journals (Sweden)

Gustafsson Lars

2008-03-01

Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria

The effects of the HEALTHY study intervention on middle school student dietary intakes

Directory of Open Access Journals (Sweden)

Volpe Stella L

2011-02-01

Full Text Available Abstract Background The HEALTHY study was designed to respond to the alarming trends in increasing rates of overweight, obesity, and type 2 diabetes mellitus in youth. The objective of this analysis was to examine the effects of the HEALTHY study on student self-reported dietary intakes (energy, macronutrients and grams consumed of selected food groups. Methods HEALTHY was a cluster-randomized study in 42 public middle schools. Students, n = 3908, self-reported dietary intake using the Block Kids Questionnaire. General linear mixed models were used to analyze differences in dietary intake at the end of the study between intervention and control schools. Results The reported average daily fruit consumption was 10% higher at the end of the study in the intervention schools than in the control schools (138 g or approximately 2 servings versus 122 g, respectively, p = 0.0016. The reported water intake was approximately 2 fluid ounces higher in the intervention schools than in the control (483 g versus 429 g respectively; p = 0.008. There were no significant differences between intervention and control for mean intakes of energy, macronutrients, fiber, grains, vegetables, legumes, sweets, sweetened beverages, and higher- or lower-fat milk consumption. Conclusion The HEALTHY study, a five-semester middle school-based intervention program that integrated multiple components in nutrition, physical education, behavior change, and social marketing-based communications, resulted in significant changes to student's reported fruit and water intake. Subsequent interventions need to go beyond the school environment to change diet behaviors that may affect weight status of children. Clinical Trials Registration NCT00458029

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.

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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

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

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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

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

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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.

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

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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.

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

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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

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

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

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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

Screening and brief intervention targeting risky drinkers in Danish general practice - a pragmatic controlled trial

DEFF Research Database (Denmark)

Beich, A.; Gannik, D.; Saelan, H.

2007-01-01

AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening......-14 months. Outcome measures focused on patients' acceptance of screening and intervention and their self-reported alcohol consumption. RESULTS: Patient acceptance of screening and intervention -10.3% (N = 794) of the target population (N = 7, 691) explicitly refused screening. All intervention group...

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

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Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

Science.gov (United States)

Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

2014-01-01

Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

An intervention to preschool children for reducing screen time: a randomized controlled trial.

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Yilmaz, G; Demirli Caylan, N; Karacan, C D

2015-05-01

Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.

Cost effectiveness of tobacco control policies in Vietnam: the case of population-level interventions.

Science.gov (United States)

Higashi, Hideki; Truong, Khoa D; Barendregt, Jan J; Nguyen, Phuong K; Vuong, Mai L; Nguyen, Thuy T; Hoang, Phuong T; Wallace, Angela L; Tran, Tien V; Le, Cuong Q; Doran, Christopher M

2011-05-01

Tobacco smoking is one of the leading public health problems in the world. It is also possible to prevent and/or reduce the harm from tobacco use through the use of cost-effective tobacco control measures. However, most of this evidence comes from developed countries and little research has been conducted on this issue in developing countries. The objective of this study was to analyse the cost effectiveness of four population-level tobacco control interventions in Vietnam. Four tobacco control interventions were evaluated: excise tax increase; graphic warning labels on cigarette packs; mass media campaigns; and smoking bans (in public or in work places). A multi-state life table model was constructed in Microsoft® Excel to examine the cost effectiveness of the tobacco control intervention options. A government perspective was adopted, with costing conducted using a bottom-up approach. Health improvement was considered in terms of disability-adjusted life-years (DALYs) averted. All assumptions were subject to sensitivity and uncertainty analysis. All the interventions fell within the definition of being very cost effective according to the threshold level suggested by the WHO (i.e. place smoking bans. If the cost offset was included in the analysis, all interventions would provide cost savings to the government health sector. All four interventions to reduce the harm from tobacco use appear to be highly cost effective and should be considered as priorities in the context of Vietnam. The government may initially consider graphic warning labels and tax increase, followed by other interventions.

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

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

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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.

A quality improvement plan for hypertension control: the INCOTECA Project (INterventions for COntrol of hyperTEnsion in CAtalonia

Directory of Open Access Journals (Sweden)

Vallès-Fernandez Roser

2009-03-01

Full Text Available Abstract Background Different studies have shown insufficient blood pressure (BP control in hypertensive patients. Multiple factors influence hypertension management, and the quality of primary care is one of them. We decided therefore to evaluate the effectiveness of a quality improvement plan directed at professionals of Primary Health Care Teams (PHCT with the aim to achieve a better control of hypertension. The hypothesis of the study is that the implementation of a quality improvement plan will improve the control of hypertension. The primary aim of this study will be to evaluate the effectiveness of this plan. Methods and design Design: multicentric study quasi-experimental before – after with control group. The non-randomised allocation of the intervention will be done at PHCT level. Setting: 18 PHCT in the Barcelona province (Spain. Sample: all patients with a diagnosis of hypertension (population based study. Exclusion criteria: patients with a diagnosis of hypertension made later than 01/01/2006 and patients younger than 18 years. Intervention: a quality improvement plan, which targets primary health care professionals and includes educational sessions, feedback to health professionals, audit and implementation of recommended clinical practice guidelines for the management of hypertensive patients. Measurements: age, sex, associated co-morbidity (diabetes mellitus type I and II, heart failure and renal failure. The following variables will be recorded: BP measurement, cardiovascular risk and antihypertensive drugs used. Results will be measured before the start of the intervention and twelve months after the start of the study. Dependent variable: prevalence of hypertensive patients with poor BP control. Analysis: Chi-square test and Student's t-test will be used to measure the association between independent qualitative and quantitative variables, respectively. Non-parametric tests will be used for the analysis of non

A repeated short educational intervention improves asthma control and quality of life.

Science.gov (United States)

Plaza, Vicente; Peiró, Meritxell; Torrejón, Montserrat; Fletcher, Monica; López-Viña, Antolín; Ignacio, José María; Quintano, José Antonio; Bardagí, Santiago; Gich, Ignasi

2015-11-01

We assessed the effectiveness of an asthma educational programme based on a repeated short intervention (AEP-RSI) to improve asthma control (symptom control and future risk) and quality of life. A total of 230 adults with mild-to-moderate persistent uncontrolled asthma participated in a 1-year cluster randomised controlled multicentre study. The AEP-RSI was given in four face-to-face sessions at 3-month intervals, and included administration of a written personalised action plan and training on inhaler technique. Centres were randomised to the AEP-RSI (intervention) group or usual clinical practice group. Specialised centres using a standard educational programme were the gold standard group. A significant improvement in the Asthma Control Test score was observed in all three groups (pQuality of Life Questionnaire scores (0.95±1.04 and 0.89±0.84 versus 0.52±0.97, respectively). The AEP-RSI was effective in improving asthma symptom control, future risk and quality of life. Copyright ©ERS 2015.

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.

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

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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.

Using engineering control principles to inform the design of adaptive interventions: a conceptual introduction.

Science.gov (United States)

Rivera, Daniel E; Pew, Michael D; Collins, Linda M

2007-05-01

The goal of this paper is to describe the role that control engineering principles can play in developing and improving the efficacy of adaptive, time-varying interventions. It is demonstrated that adaptive interventions constitute a form of feedback control system in the context of behavioral health. Consequently, drawing from ideas in control engineering has the potential to significantly inform the analysis, design, and implementation of adaptive interventions, leading to improved adherence, better management of limited resources, a reduction of negative effects, and overall more effective interventions. This article illustrates how to express an adaptive intervention in control engineering terms, and how to use this framework in a computer simulation to investigate the anticipated impact of intervention design choices on efficacy. The potential benefits of operationalizing decision rules based on control engineering principles are particularly significant for adaptive interventions that involve multiple components or address co-morbidities, situations that pose significant challenges to conventional clinical practice.

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...

Intervention study on school meal habits in Norwegian 10-12-year-old children.

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IlløKken, Kristine E; Bere, Elling; Øverby, Nina C; Høiland, Renate; Petersson, Kirsten O; Vik, Frøydis N

2017-07-01

The aim of this study was to investigate whether a free school meal every day was associated with children's intake of healthy food during school. A non-randomized study design with an intervention and a control group was used to measure change in children's meal habits at lunchtime. In total, 164 children participated; 55 in the intervention group and 109 in the control group. Children in the intervention group were served a free, healthy school meal every school day. Participating children completed a questionnaire at baseline and at 6 months' follow up. Possible associations were evaluated with a healthy food score, which was calculated based on a food frequency questionnaire on lunch habits at school. Chi-square and Independent Samples t-test were used to analyse the data. At baseline, there was no significant difference in the healthy food score between the intervention and the control group ( p = 0.08). Children in the intervention group increased their healthy food score significantly compared with children in the control group after 6 months ( p ⩽ 0.01). Change in the healthy food score was mainly due to an increase in the intake of fruit ( p ⩽ 0.01), vegetables ( p ⩽ 0.01) and fish spread ( p = 0.02); all in favour of the intervention group. A serving of a free school meal every day for 6 months increased children's intake of healthy food at lunchtime compared with the control group. Further studies are needed to establish possible long-term effects.

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

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

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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

An experimental test of control theory-based interventions for physical activity.

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Prestwich, Andrew; Conner, Mark; Hurling, Robert; Ayres, Karen; Morris, Ben

2016-11-01

To provide an experimental test of control theory to promote physical activity. Parallel groups, simple randomized design with an equal chance of allocation to any group. Participants not meeting recommended levels of physical activity but physically safe to do so (N = 124) were recruited on a UK university campus and randomized to goal-setting + self-monitoring + feedback (GS + SM + F, n = 40), goal-setting + self-monitoring (GS + SM, n = 40), or goal-setting only (GS, n = 44) conditions that differentially tapped the key features of control theory. Accelerometers assessed physical activity (primary outcome) as well as self-report over a 7-day period directly before/after the start of the intervention. The participants in the GS + SM + F condition significantly outperformed those in the GS condition, d = 0.62, 95% CI d = 0.15-1.08, and marginally outperformed those in the GS + SM condition in terms of total physical activity at follow-up on the accelerometer measure, d = 0.33, 95% CI d = -0.13 to 0.78. The feedback manipulation (GS + SM + F vs. GS + SM and GS) was most effective when baseline intentions were weak. These patterns did not emerge on the self-report measure but, on the basis of this measure, the feedback manipulation increased the risk that participants coasted in relation to their goal in the first few days of the intervention period. Using behaviour change techniques consistent with control theory can lead to significant short-term improvements on objectively assessed physical activity. Further research is needed to examine the underlying theoretical principles of the model. Statement of contribution What is already known on this subject? Interventions incorporating more techniques that are consistent with control theory are associated with larger positive changes in health behaviours and related outcomes (see reviews by Dombrowski et al., ; Michie et al., ). However, none of the studies included in these

Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial.

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Berrouiguet, Sofian; Larsen, Mark Erik; Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe

2018-01-10

Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. This text message-based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing

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

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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

Rationale, design and methods of the HEALTHY study nutrition intervention component.

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Gillis, B; Mobley, C; Stadler, D D; Hartstein, J; Virus, A; Volpe, S L; El ghormli, L; Staten, M A; Bridgman, J; McCormick, S

2009-08-01

The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakfast, lunch, after school snack and supper programs; a la carte venues, including snack bars and school stores; vending machines; fundraisers; and classroom parties and celebrations. Study staff implemented the intervention using core and toolbox strategies to achieve and maintain the following five intervention goals: (1) lower the average fat content of foods, (2) increase the availability and variety of fruits and vegetables, (3) limit the portion sizes and energy content of dessert and snack foods, (4) eliminate whole and 2% milk and all added sugar beverages, with the exception of low fat or nonfat flavored milk, and limit 100% fruit juice to breakfast in small portions and (5) increase the availability of higher fiber grain-based foods and legumes. Other nutrition intervention component elements were taste tests, cafeteria enhancements, cafeteria line messages and other messages about healthy eating, cafeteria learning laboratory (CLL) activities, twice-yearly training of food service staff, weekly meetings with food service managers, incentives for food service departments, and twice yearly local meetings and three national summits with district food service directors. Strengths of the intervention design were the integration of nutrition with the other HEALTHY intervention components (physical education, behavior change and communications), and the collaboration and rapport between the nutrition intervention study staff members and food service personnel at both school

A 3-Year Workplace-Based Intervention Program to Control Noncommunicable Disease Risk Factors in Sousse, Tunisia.

Science.gov (United States)

Bhiri, Sana; Maatoug, Jihene; Zammit, Nawel; Msakni, Zineb; Harrabi, Imed; Amimi, Souad; Mrizek, Nejib; Ghannem, Hassen

2015-07-01

To assess the effectiveness of a 3-year workplace-based intervention program on the control of the main noncommunicable disease risk factors (poor nutrition, physical inactivity, and tobacco use) among the employees of Sousse, Tunisia. We conducted a quasi-experimental study (pre- and postassessments with intervention and control groups) in six companies of the governorate of Sousse in Tunisia.The intervention program consisted of health education programs (eg, workshops, films and open sensitization days). We also scheduled free physical activity sessions and free smoking cessation consultations. Our intervention program showed meaningful improvement among the employees toward dietary and physical activity behaviors but not for tobacco use. Workplace is a crucial setting for health promotion, and future programs should consider a multisectoral approach to control the main noncommunicable disease risk factors.

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

Interventions to reduce postpartum stress in first-time mothers: a randomized-controlled trial.

Science.gov (United States)

Osman, Hibah; Saliba, Matilda; Chaaya, Monique; Naasan, Georges

2014-10-15

The postpartum period can be a challenging time particularly for first-time mothers. This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers. Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut, Lebanon after delivery. The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline. Participants were randomized to one of four study arms to receive either the postpartum support film, the hotline service, both interventions, or a music CD (control). Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale (PSS-10). Of the 632 eligible women, 552 (88%) agreed to participate in the study. Of those, 452 (82%) completed the study. Mean PSS-10 scores of mothers who received the film alone (15.76) or the film with the hotline service (15.86) were significantly lower than that of the control group (18.93) (p-value film and the 24-hour telephone hotline service reduced stress in the postpartum period in first-time mothers. These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers. The trial was registered with clinicaltrials.gov (identifier # NCT00857051) on March 5, 2009.

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

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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

A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

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Ong Ken K

2010-03-01

Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

Controlling Campylobacter in the chicken meat chain; Estimation of intervention costs

NARCIS (Netherlands)

Mangen, M.J.J.; Havelaar, A.H.; Poppe, K.J.

2005-01-01

Campylobacter infections are a serious public health problem in the Netherlands. As a part of the CARMA project, this study focus on the estimation of the potential direct costs related to the implementation of various intervention measures to control campylobacters in the chicken meat chain. Costs

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

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.

Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials.

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de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Millán-Calenti, José C

2015-12-02

Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for randomized, controlled trials published during the period of 2003-2015, which enrolled frail older adults in an exercise intervention program. Studies where frailty had been defined were included in the review. A narrative synthesis approach was performed to examine the results. The Physiotherapy Evidence Database (PEDro scale) was used to assess the methodological quality of the selected studies. Of 507 articles, nine papers met the inclusion criteria. Of these, six included multi-component exercise interventions (aerobic and resistance training not coexisting in the intervention), one included physical comprehensive training, and two included exercises based on strength training. All nine of these trials included a control group receiving no treatment, maintaining their habitual lifestyle or using a home-based low level exercise program. Five investigated the effects of exercise on falls, and among them, three found a positive impact of exercise interventions on this parameter. Six trials reported the effects of exercise training on several aspects of mobility, and among them, four showed enhancements in several measurements of this outcome. Three trials focused on the effects of exercise intervention on balance performance, and one demonstrated enhanced balance. Four trials investigated functional ability, and two showed positive results after the intervention. Seven trials investigated the effects of exercise intervention on muscle strength, and five of them reported increases; three trials

Prevention of Insulin Resistance by Dietary Intervention among Pregnant Mothers: A Randomized Controlled Trial.

Science.gov (United States)

Goodarzi-Khoigani, Masoomeh; Mazloomy Mahmoodabad, Seyed Saeed; Baghiani Moghadam, Mohammad Hossein; Nadjarzadeh, Azadeh; Mardanian, Farahnaz; Fallahzadeh, Hossein; Dadkhah-Tirani, Azam

2017-01-01

Chronic insulin resistance (IR) is a basic part of the pathophysiology of gestational diabetes mellitus. Nutrition significantly impacts IR and weight loss reduces insulin levels, whereas weight gain increases the concentrations. Therefore, we surveyed the effect of nutrition intervention on IR in pregnant women and whether this effect is irrespective of weight gaining in accordance with Institute of Medicine limits. This prospective, randomized clinical trial was carried out among 150 primiparous pregnant mothers in fifteen health centers, five hospitals, and 15 private obstetrical offices in Isfahan. The nutrition intervention included education of healthy diet with emphasize on 50%-55% of total energy intake from carbohydrate (especially complex carbohydrates), 25%-30% from fat (to increase mono unsaturated fatty acids and decrease saturated and trans-fatty acids), and 15%-20% from protein during pregnancy for experimental group. The controls received the usual prenatal care by their health-care providers. This trial decreased pregnancy-induced insulin increases ( P = 0.01) and IR marginally ( P = 0.05). ANCOVA demonstrated that control of gestational weight gaining was more effective to decrease IR ( P = 0.02) while insulin values decreased by nutrition intervention and irrespective of weight control ( P = 0.06). Fasting plasma glucose (FPG) concentrations did not decrease by intervention ( P = 0.56) or weight management ( P = 0.15). The current intervention was effective to decrease pregnancy-induced insulin increases and IR. Considering study results on FPG levels and incidence of GDM, we suggest repeat of study design in a larger sample.

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

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

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Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

2014-12-01

To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

Modeling malaria control intervention effect in KwaZulu-Natal, South Africa using intervention time series analysis.

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Ebhuoma, Osadolor; Gebreslasie, Michael; Magubane, Lethumusa

The change of the malaria control intervention policy in South Africa (SA), re-introduction of dichlorodiphenyltrichloroethane (DDT), may be responsible for the low and sustained malaria transmission in KwaZulu-Natal (KZN). We evaluated the effect of the re-introduction of DDT on malaria in KZN and suggested practical ways the province can strengthen her already existing malaria control and elimination efforts, to achieve zero malaria transmission. We obtained confirmed monthly malaria cases in KZN from the malaria control program of KZN from 1998 to 2014. The seasonal autoregressive integrated moving average (SARIMA) intervention time series analysis (ITSA) was employed to model the effect of the re-introduction of DDT on confirmed monthly malaria cases. The result is an abrupt and permanent decline of monthly malaria cases (w 0 =-1174.781, p-value=0.003) following the implementation of the intervention policy. The sustained low malaria cases observed over a long period suggests that the continued usage of DDT did not result in insecticide resistance as earlier anticipated. It may be due to exophagic malaria vectors, which renders the indoor residual spraying not totally effective. Therefore, the feasibility of reducing malaria transmission to zero in KZN requires other reliable and complementary intervention resources to optimize the existing ones. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Web-based physical activity interventions: a systematic review and meta-analysis of randomized controlled trials.

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Jahangiry, Leila; Farhangi, Mahdieh Abbasalizad; Shab-Bidar, Sakineh; Rezaei, Fatemeh; Pashaei, T

2017-11-01

It was estimated that approximately 60% of the world's population is classified as inactive or insufficiently active. This meta-analysis investigated the effect of web-based interventions on different types of physical activity (PA) measurements in general population and potential moderating variables. PubMed, CINAHL, EBSCOhost, PsycINFO, Scopus, Ovid, and ScienceDirect literature searches were conducted to identify studies investigating the effect of web-based interventions on PA. Randomized controlled trials on PA changes reported in moderate to vigorous intensity, walking, and step count in the intervention group in comparison with the control group were pooled with a fixed-effects model separately. A total of 22 studies comprising 16,476 and 14,475 subjects in intervention and control groups respectively were included. Web-based interventions had positive and significant effect on increasing PA. Of 14 trials reporting moderate to vigorous physical activity (MVPA), five showed a significant increase in the MVPA level after the intervention. There was significant heterogeneity between studies (P < 0.001 and I 2  = 67.8%). Of six trials that reported the number of steps by using the pedometer, three showed a significant increase for the step counts in intervention groups (P < 0.001 and I 2  = 93.3%), of 14 trials assessed PA level by reporting walking minutes per week, four studies showed a significant increase in walking minutes. There was significant heterogeneity between studies (P < 0.001, I 2  = 68.1%). Overall, the effect of web-based interventions seemed to be influenced by the characteristics of mean age of participants, trial duration, and study quality (P < 0.05). The web-based PA interventions had a positive significant effect on increasing all the three types of PA among the general population. However, the effects appear to depend on the design of the study, age, and duration of studies. Copyright © 2017 The Royal Society for Public

Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials

OpenAIRE

Ewald, H.; Kirby, J.; Rees, K.; Robertson, W.

2017-01-01

Background An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. Methods A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. Inclusion criteria: randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child,...

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.

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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

Effects of lifestyle intervention and meal replacement on glycaemic and body-weight control in Chinese subjects with impaired glucose regulation: a 1-year randomised controlled trial.

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Xu, Dan-Feng; Sun, Jian-Qin; Chen, Min; Chen, Yan-Qiu; Xie, Hua; Sun, Wei-Jia; Lin, Yi-Fan; Jiang, Jing-Jing; Sun, Wei; Chen, Ai-Fang; Tang, Qian-Ru

2013-02-14

The purpose of the present study was to evaluate the impact of a lifestyle intervention programme, combined with a daily low-glycaemic index meal replacement, on body-weight and glycaemic control in subjects with impaired glucose regulation (IGR). Subjects with IGR were randomly assigned to an intervention group (n 46) and a control group (n 42). Both groups received health counselling at baseline. The intervention group also received a daily meal replacement and intensive lifestyle intervention to promote healthy eating habits during the first 3 months of the study, and follow-up visits performed monthly until the end of the 1-year study. Outcome measurements included changes in plasma glucose, glycated Hb (HbA1c), plasma lipids, body weight, blood pressure and body composition (such as body fat mass and visceral fat area). The results showed that body-weight loss after 1 year was significant in the intervention group compared with the control group (-1·8 (SEM 0·35) v. -0·6 (SEM 0·40) 2·5 kg, Pmeal replacement is beneficial in promoting IGR to NGR.

Can relaxation interventions reduce anxiety in patients receiving radiotherapy? outcomes and study validity

International Nuclear Information System (INIS)

Elith, C.A.; Perkins, B.A.; Johnson, L.S.; Skelly, M.H.; Dempsey, S.

2001-01-01

This study piloted the use of three relaxation interventions in an attempt to reduce levels of anxiety in patients who are immobilised for radiotherapy treatment of head and neck cancers, as well as trying to validate the study methodology. In addition to receiving normal radiation therapy treatment, 14 patients were assigned to either a control group not receiving the relaxation intervention or one of three validated relaxation intervention techniques; music therapy, aromatherapy or guided imagery. Patients in the intervention groups underwent the relaxation technique daily for the first seven days of treatment. On days 1, 3, 5 and 7 of treatment patients were required to complete the State Anxiety Inventory survey. While caution should be taken in accepting the results due to the small numbers of patients involved in the study and the non-randomised assignment of patients within the study, the results of the study demonstrate a clinically significant reduction in anxiety levels in each of the three relaxation interventions compared to the control group. The study demonstrated good study validity due to the ease of implementation, the unambiguous results generated, and the use of already validated anxiety intersections and measurement tools. Copyright (2001) Australian Institute of Radiography

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

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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

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...

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.

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Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

2012-06-29

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! an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. 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. This is one of few cluster randomised trials globally to assess

Home Environmental Interventions for the Prevention or Control of Allergic and Respiratory Diseases: What Really Works.

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Le Cann, Pierre; Paulus, Hélène; Glorennec, Philippe; Le Bot, Barbara; Frain, Sophie; Gangneux, Jean Pierre

Home health care workers interventions have been implemented in western countries to improve health status of patients with respiratory diseases especially asthma and allergic illnesses. Twenty-six controlled studies dealing with prevention and control of these diseases through home environmental interventions were reviewed. After a comprehensive description of the characteristics of these studies, the effectiveness of each intervention was then evaluated in terms of participants' compliance with the intervention program, improvement of quality of the indoor environment, and finally improvement of health outcomes, in detailed tables. Limitations and biases of the studies are also discussed. Overall, this review aims at giving a toolbox for home health care workers to target the most appropriate measures to improve health status of the patient depending on his and/or her environment and disease. Only a case-by-case approach with achievable measures will warrant the efficacy of home interventions. This review will also provide to the research community a tool to better identify targets to focus in future evaluation studies of home health care workers action. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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

Effect of a participatory ergonomics intervention on psychosocial factors at work in a randomised controlled trial.

Science.gov (United States)

Haukka, Eija; Pehkonen, Irmeli; Leino-Arjas, Päivi; Viikari-Juntura, Eira; Takala, Esa-Pekka; Malmivaara, Antti; Hopsu, Leila; Mutanen, Pertti; Ketola, Ritva; Virtanen, Tuija; Holtari-Leino, Merja; Nykänen, Jaana; Stenholm, Sari; Ojajärvi, Anneli; Riihimäki, Hilkka

2010-03-01

To study the effect of a participatory ergonomics intervention on psychosocial factors among kitchen workers. A cluster randomised controlled trial. Four cities in Finland, 2002-2005. 504 workers in 119 municipal kitchens. Kitchens were randomised to intervention (n=59) and control (n=60) groups. The intervention lasted 11-14 months and was based on the workers' active participation in work analysis, planning and implementing the ergonomic changes aimed at decreasing the physical and mental workload. Mental stress, mental strenuousness of work, hurry, job satisfaction, job control, skill discretion, co-worker relationships and supervisor support. Data were collected by questionnaire at baseline, at the end of the intervention, and at a 12-month follow-up (PI(12)). At the end of the intervention, the OR of job dissatisfaction for the intervention group as compared with the control group was 3.0 (95% CI 1.1 to 8.5), of mental stress 2.3 (1.2 to 4.7) and of poor co-worker relationships 2.3 (1.0 to 5.2). At the PI(12), the OR of job dissatisfaction was 3.0 (1.2 to 7.8). Analysis of the independent and joint effects of the intervention and unconnected organisational reforms showed that adverse changes were accentuated among those with exposure to both. No favourable effects on psychosocial factors at work were found. The adverse changes were due to a joint effect of the intervention and the unconnected organisational reforms. The findings do not support the usefulness of this kind of intervention in changing unsatisfactory psychosocial working conditions.

A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

Directory of Open Access Journals (Sweden)

Randall A. Kramer

2014-05-01

Full Text Available The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1 a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2 vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding. The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

A randomized longitudinal factorial design to assess malaria vector control and disease management interventions in rural Tanzania.

Science.gov (United States)

Kramer, Randall A; Mboera, Leonard E G; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H; Paul, Christopher J; Miranda, Marie Lynn

2014-05-16

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

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

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.

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.

Exercise-training intervention studies in competitive swimming.

Science.gov (United States)

Aspenes, Stian Thoresen; Karlsen, Trine

2012-06-01

Competitive swimming has a long history and is currently one of the largest Olympic sports, with 16 pool events. Several aspects separate swimming from most other sports such as (i) the prone position; (ii) simultaneous use of arms and legs for propulsion; (iii) water immersion (i.e. hydrostatic pressure on thorax and controlled respiration); (iv) propulsive forces that are applied against a fluctuant element; and (v) minimal influence of equipment on performance. Competitive swimmers are suggested to have specific anthropometrical features compared with other athletes, but are nevertheless dependent on physiological adaptations to enhance their performance. Swimmers thus engage in large volumes of training in the pool and on dry land. Strength training of various forms is widely used, and the energetic systems are addressed by aerobic and anaerobic swimming training. The aim of the current review was to report results from controlled exercise training trials within competitive swimming. From a structured literature search we found 17 controlled intervention studies that covered strength or resistance training, assisted sprint swimming, arms-only training, leg-kick training, respiratory muscle training, training the energy delivery systems and combined interventions across the aforementioned categories. Nine of the included studies were randomized controlled trials. Among the included studies we found indications that heavy strength training on dry land (one to five repetitions maximum with pull-downs for three sets with maximal effort in the concentric phase) or sprint swimming with resistance towards propulsion (maximal pushing with the arms against fixed points or pulling a perforated bowl) may be efficient for enhanced performance, and may also possibly have positive effects on stroke mechanics. The largest effect size (ES) on swimming performance was found in 50 m freestyle after a dry-land strength training regimen of maximum six repetitions across three

Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial.

Science.gov (United States)

McCall, Hugh Cameron; Richardson, Chris G; Helgadottir, Fjola Dogg; Chen, Frances S

2018-03-21

Treatment rates for social anxiety, a prevalent and potentially debilitating condition, remain among the lowest of all major mental disorders today. Although computer-delivered interventions are well poised to surmount key barriers to the treatment of social anxiety, most are only marginally effective when delivered as stand-alone treatments. A new, Web-based cognitive behavioral therapy (CBT) intervention called Overcome Social Anxiety was recently created to address the limitations of prior computer-delivered interventions. Users of Overcome Social Anxiety are self-directed through various CBT modules incorporating cognitive restructuring and behavioral experiments. The intervention is personalized to each user's symptoms, and automatic email reminders and time limits are used to encourage adherence. The purpose of this study was to conduct a randomized controlled trial to investigate the effectiveness of Overcome Social Anxiety in reducing social anxiety symptoms in a nonclinical sample of university students. As a secondary aim, we also investigated whether Overcome Social Anxiety would increase life satisfaction in this sample. Following eligibility screening, participants were randomly assigned to a treatment condition or a wait-list control condition. Only those assigned to the treatment condition were given access to Overcome Social Anxiety; they were asked to complete the program within 4 months. The social interaction anxiety scale (SIAS), the fear of negative evaluation scale (FNE), and the quality of life enjoyment and satisfaction questionnaire-short form (Q-LES-Q-SF) were administered to participants from both conditions during baseline and 4-month follow-up lab visits. Over the course of the study, participants assigned to the treatment condition experienced a significant reduction in social anxiety (SIAS: Psocial anxiety in the 2 conditions over the course of the study showed that those assigned to the treatment condition experienced significantly

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults

Directory of Open Access Journals (Sweden)

Agmon M

2014-03-01

Full Text Available Maayan Agmon,1 Basia Belza,2 Huong Q Nguyen,2,3 Rebecca G Logsdon,2 Valerie E Kelly41The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Studies, University of Haifa, Israel; 2School of Nursing, University of Washington, Seattle, WA, USA; 3Department of Research and Evaluation, Kaiser Permanente, CA, USA; 4School of Medicine, University of Washington, Seattle, WA, USABackground: Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk.Purpose: The aims of this systematic review are: 1 to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2 to identify the key elements of those interventions.Data sources: Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science.Study selection: Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected.Data extraction: All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted.Data synthesis: Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions.Limitations: The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome

Social marketing-based communications to integrate and support the HEALTHY study intervention

Science.gov (United States)

DeBar, LL; Schneider, M; Ford, EG; Hernandez, AE; Showell, B; Drews, KL; Moe, EL; Gillis, B; Jessup, AN; Stadler, DD; White, M

2009-01-01

The HEALTHY study was a randomized, controlled, multicenter, middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Participants were a racially, ethnically and geographically diverse cohort from across the United States. Here, we describe the conceptual underpinnings and design of the social marketing-based communications component of the HEALTHY study intervention that combined changes in the school nutrition and physical education (PE) environment with behavior change initiatives. The communications intervention component coordinated multiple elements to deliver campaigns that served to integrate and support all aspects of the HEALTHY intervention. The campaigns unfolded across five semesters of middle school, each targeting a specific theme related to the HEALTHY objectives. Communications campaigns comprised (1) core elements such as branding, posters, banners and visual and verbal messaging, (2) student events supporting the nutrition, PE and behavior intervention components through the application of social marketing and communications strategies, including the incorporation of student-generated media and (3) distribution of premiums and theme enhancers to extend the visibility of the study beyond the intervention environment. Formative research conducted with students, parents and school administrators was used to refine the communications strategy. Student peer communicators selected from the student body were involved to influence the normative student environment. Marketing and creative design experts developed a brand, logo, activities and materials. In the latter half of the study, student-generated messages and media were used to reflect local interests and culture and enhance peer influence. The HEALTHY intervention delivery and impact were strengthened by the

Social marketing-based communications to integrate and support the HEALTHY study intervention.

Science.gov (United States)

DeBar, L L; Schneider, M; Ford, E G; Hernandez, A E; Showell, B; Drews, K L; Moe, E L; Gillis, B; Jessup, A N; Stadler, D D; White, M

2009-08-01

The HEALTHY study was a randomized, controlled, multicenter, middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Participants were a racially, ethnically and geographically diverse cohort from across the United States. Here, we describe the conceptual underpinnings and design of the social marketing-based communications component of the HEALTHY study intervention that combined changes in the school nutrition and physical education (PE) environment with behavior change initiatives. The communications intervention component coordinated multiple elements to deliver campaigns that served to integrate and support all aspects of the HEALTHY intervention. The campaigns unfolded across five semesters of middle school, each targeting a specific theme related to the HEALTHY objectives. Communications campaigns comprised (1) core elements such as branding, posters, banners and visual and verbal messaging, (2) student events supporting the nutrition, PE and behavior intervention components through the application of social marketing and communications strategies, including the incorporation of student-generated media and (3) distribution of premiums and theme enhancers to extend the visibility of the study beyond the intervention environment. Formative research conducted with students, parents and school administrators was used to refine the communications strategy. Student peer communicators selected from the student body were involved to influence the normative student environment. Marketing and creative design experts developed a brand, logo, activities and materials. In the latter half of the study, student-generated messages and media were used to reflect local interests and culture and enhance peer influence. The HEALTHY intervention delivery and impact were strengthened by the

Effects of early support intervention on workplace ergonomics--a two-year followup study.

Science.gov (United States)

Turja, Johanna; Kaleva, Simo; Kivistö, Marketta; Seitsamo, Jorma

2012-01-01

The purpose of the controlled longitudinal study was to determine the effect of a tailored early support intervention method on workers' workplace ergonomics. The main areas of the early support intervention were training, guidance and support for supervisors in finding weak signals of impaired ergonomics. Supervisors were also trained to bring up these weak signals in discussion with employees and to make necessary changes at the workplace. The data consisted of 301 intervention subjects and 235 control subjects working in the field of commerce. The questionnaires were carried out in 2008 and in 2010, and the response rates among both groups were 45%. We used multivariate repeated measures analysis of variance (MANOVA) to test the difference in the groups at two points of time. The main result was that in the areas of work environment, the interaction between group and time was statistically significant (p=0.0004). The work environment improved in the intervention group, but deteriorated in the control. Working methods improved due to the interventions, but physical load factors increased over time in both groups. According to the study, tailored early support intervention has a generally beneficial impact on workers' workplace ergonomics in the areas of work methods, work environment and accident factors.

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

Testing the Efficacy of a Tier 2 Mathematics Intervention: A Conceptual Replication Study

Science.gov (United States)

Doabler, Christian T.; Clarke, Ben; Kosty, Derek B.; Kurtz-Nelson, Evangeline; Fien, Hank; Smolkowski, Keith; Baker, Scott K.

2016-01-01

The purpose of this closely aligned conceptual replication study was to investigate the efficacy of a Tier 2 kindergarten mathematics intervention. The replication study differed from the initial randomized controlled trial on three important elements: geographical region, timing of the intervention, and instructional context of the…