Komiya, Masami; Fujii, Gen; Takahashi, Mami; Iigo, Masaaki; Mutoh, Michihiro
There have been a number of candidates for chemopreventive agents from synthetic drugs and natural compounds suggested to prevent colorectal cancer. However, they have shown modest efficacy in humans. The reason for this could be partly explained by the use of inappropriate models in vitro and in vivo, and the limitation of chemoprevention trials. In Japan, there are no cancer chemopreventive medicines, and few cancer chemoprevention trials to date. In contrast, an increase in the prevalence of colorectal cancer in Japan has forced us to develop more efficient chemopreventive strategies. It is now a good time to review in detail the current status and future prospects for chemoprevention of colorectal cancer with respect to the future development of chemopreventive medicines, particularly using synthetic drugs and natural compounds in Asian populations. The role and mode of action of available synthetic drugs, mainly aspirin and metformin, are reviewed. In addition, the possible impact of natural compounds with anti-inflammatory/immunosuppressive properties, such as ω3 polyunsaturated fatty acid and lactoferrin, are also reviewed.
Bourdel-Marchasson, Isabelle; Rondeau, Virginie
The purpose of this study was to assess the effect of nutritional supplementation on dietary intake and on pressure ulcer development in critically ill older patients. The multi-center trial involved 19 wards stratified according to specialty and recruitment for critically ill older patients; 9 wards were randomly selected for nutritional intervention (nutritional intervention group), consisting of the daily distribution of two oral supplements, with each supplement containg 200 kcal, for 15 ...
Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.
Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…
Reilly, John J; Martin, Anne; Hughes, Adrienne R
To critique the evidence from recent and ongoing obesity prevention interventions in the first 1000 days in order to identify evidence gaps and weaknesses, and to make suggestions for more informative future intervention trials. Completed and ongoing intervention trials have had fairly modest effects, have been limited largely to high-income countries, and have used relatively short-term interventions and outcomes. Comparison of the evidence from completed prevention trials with the evidence from systematic reviews of behavioral risk factors shows that some life-course stages have been neglected (pre-conception and toddlerhood), and that interventions have neglected to target some important behavioral risk factors (maternal smoking during pregnancy, infant and child sleep). Finally, while obesity prevention interventions aim to modify body composition, few intervention trials have used body composition measures as outcomes, and this has limited their sensitivity to detect intervention effects. The new WHO Healthy Lifestyles Trajectory (HeLTI) initiative should address some of these weaknesses. Future early obesity prevention trials should be much more ambitious. They should, ideally: extend their interventions over the first 1000 days; have longer-term (childhood) outcomes, and improved outcome measures (body composition measures in addition to proxies for body composition such as the BMI for age); have greater emphasis on maternal smoking and child sleep; be global.
Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.
Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.
Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…
Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.
The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852
Pigeot, I; Baranowski, T; De Henauw, S
One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.
Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P
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.
van Reijen, Miriam; Vriend, Ingrid; van Mechelen, Willem; Finch, Caroline F; Verhagen, Evert A
Sport injury prevention studies vary in the way compliance with an intervention is defined, measured and adjusted for. The objective of this systematic review was to assess the extent to which sport injury prevention randomised controlled trials (RCTs) have defined, measured and adjusted results for compliance with an injury prevention intervention. An electronic search was performed in MEDLINE, PubMed, the Cochrane Center of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database) and SPORTDiscus. English RCTs, quasi-RCTs and cluster-RCTs were considered eligible. Trials that involved physically active individuals or examined the effects of an intervention aimed at the prevention of sport- or physical activity-related injuries were included. Of the total of 100 studies included, 71.6 % mentioned compliance or a related term, 68.8 % provided details on compliance measurement and 51.4 % provided compliance data. Only 19.3 % analysed the effect of compliance rates on study outcomes. While studies used heterogeneous methods, pooled effects could not be presented. Studies that account for compliance demonstrated that compliance significant affects study outcomes. The way compliance is dealt with in preventions studies is subject to a large degree of heterogeneity. Valid and reliable tools to measure and report compliance are needed and should be matched to a uniform definition of compliance.
Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C
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.
Martin, William Hal; Griest, Susan E; Sobel, Judith L; Howarth, Linda C
To evaluate the effectiveness of four NIHL prevention interventions at improving knowledge, attitudes, and intended behaviors regarding sound exposure and appropriate use of hearing protective strategies in children. A randomized trial of the four interventions with a non-intervention comparison group. Questionnaires were completed prior to, immediately after, and three months after each intervention. Interventions included: (1) A classroom presentation by older-peer educators, (2) A classroom presentation by health professionals, (3). Exploration of a museum exhibition, and (4). Exploration of an internet-based virtual museum. A comparison group received no intervention. Fifty-three fourth grade classrooms (1120 students) participated in the study. All interventions produced significant improvements but the number of improvements decreased over time. In terms of effectiveness, the classroom programs were more effective than the internet-based virtual exhibit, which was more effective than the visit to the museum exhibition. Self-reported exposures indicated that as many as 94.5% of participants were at risk for NIHL. Interpersonal, interactive educational interventions such as the classroom program are more effective and have longer impact than self-directed learning experiences for NIHL and tinnitus prevention, however each may have an important role in promoting hearing health in elementary school students.
Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda
Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients. Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented. The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (PInternet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high
Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas
Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted
Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine
PURPOSE: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS: A 1-yr randomized controlled intervention trial was done with three groups: specific...... resistance training (SRT, n = 180), all-round physical exercise (APE, n = 187), and reference intervention (REF, n = 182) with general health counseling. Physical tests were performed and questionnaires answered at pre-, mid-, and postintervention. The main outcome measures were compliance, changes......: Compliance was highest in SRT but generally decreased over time. SRT and APE caused increased shoulder elevation strength, were more effective than REF to decrease neck pain among those with symptoms at baseline, and prevent development of shoulder pain in those without symptoms at baseline....
Riley, Therese; Hawe, Penelope
Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions.
Background Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. Methods We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Results Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. Conclusions The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions. PMID:20003399
Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie
Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months
La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn
Background Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Objective Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Method Adolescents (N=14; 13–18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths’ clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Results Regarding feasibility, 86% of the adolescents completed the intervention (M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Conclusions Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed. PMID:27857509
La Greca, Annette M; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn
Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Adolescents (N=14; 13-18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths' clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Regarding feasibility, 86% of the adolescents completed the intervention ( M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed.
Williams, Andrew E; Vogt, Thomas M; Stevens, Victor J; Albright, Cheryl A; Nigg, Claudio R; Meenan, Richard T; Finucane, Melissa L
In this paper, we describe the aims, intervention, and design of the Work, Weight, and Wellness program, a group-randomized worksite obesity prevention and intervention trial being conducted at 31 hotels with 11,559 employees on the island of Oahu in Hawaii. We report baseline prevalence of overweight and obesity, and the distribution of BMI (kilograms per meter squared) across sex, race, and job categories. We also describe factors that have influenced intervention adoption and employee participation. The study's primary outcome is change in BMI among hotel employees over a 2-year intervention period. The intervention includes environmental and group components that target diet, physical activity, and weight management. Men, Pacific Islanders, and individuals employed in managerial or facility maintenance roles had higher prevalence of obesity and higher mean BMI than women and individuals from other races or in other occupational categories. These results may be helpful in guiding choices about the adoption or design of future worksite and community interventions addressing at-risk ethnically diverse populations and are especially relevant to the hotel industry and similar industries.
Guse, Clare E; Peterson, Donna J; Christiansen, Ann L; Mahoney, Jane; Laud, Purushottam; Layde, Peter M
We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007-2008) to follow-up (2010-2011). No significant difference was found between enhanced and standard support communities. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice.
Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.
Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja
Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. (c) 2015 APA, all rights reserved).
Lombard, Catherine B; Harrison, Cheryce L; Kozica, Samantha L; Zoungas, Sophia; Keating, Catherine; Teede, Helena J
To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies
Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.
Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19
Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups
Bruce, Julie; Ralhan, Shvaita; Sheridan, Ray; Westacott, Katharine; Withers, Emma; Finnegan, Susanne; Davison, John; Martin, Finbarr C; Lamb, Sarah E
This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and
Full Text Available Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.In the primary analysis were 484 (98.2% intervention and 507 (98.1% control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16. The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05 as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01. There was an increase (p = 0.02 in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY difference 0.0129, 95% CI -0.0050 to 0.0314 and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.There was a small reduction in falls. The intervention may be cost-effective.ISRCTN ISRCTN68240461.
Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David J
Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. There was a small reduction in falls. The intervention may be cost-effective. ISRCTN ISRCTN68240461.
Larimer, Mary E; Neighbors, Clayton; Lostutter, Ty W; Whiteside, Ursula; Cronce, Jessica M; Kaysen, Debra; Walker, Denise D
The purpose of the current study was to evaluate feasibility and efficacy of two promising approaches to indicated prevention of disordered gambling in a college population. Randomized clinical trial with assignment to a personalized feedback intervention (PFI), cognitive-behavioral intervention (CBI) or assessment-only control (AOC). PFI was delivered individually in a single session and included feedback regarding gambling behavior, norms, consequences and risk-reduction tips, delivered in a motivational interviewing style. CBI was delivered in small groups over four to six sessions and included functional analysis and brief cognitive correction, as well as identification of and alternatives for responding to gambling triggers. College campus. At-risk or probable pathological gamblers (n = 147; 65.3% male; group assignment: PFI, n = 52; CBI, n = 44; AOC, n = 51). Self-reported gambling quantity, frequency, consequences, psychopathology, normative perceptions and beliefs. Relative to control, results at 6-month follow-up indicated reductions in both interventions for gambling consequences (PFI d = 0.48; CBI d = 0.39) and DSM-IV criteria (PFI d = 0.60; CBI d = 0.48), reductions in frequency for PFI (d = 0.48). CBI was associated with reduced illusions of control, whereas PFI was associated with reduced perceptions of gambling frequency norms. Reductions in perceived gambling frequency norms mediated effects of PFI on gambling frequency. A single-session personalized feedback intervention and a multi-session cognitive-behavioral intervention may be helpful in reducing disordered gambling in US college students. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Hosek, Sybil G.; Green, Keith R.; Siberry, George; Lally, Michelle; Balthazar, Christopher; Serrano, Pedro A.; Kapogiannis, Bill
On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM. PMID:24223514
Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes
Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: email@example.com
Michele R. Sgambato
Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.
Sgambato, Michele R; Cunha, Diana B; Henriques, Viviana T; Estima, Camilla C P; Souza, Bárbara S N; Pereira, Rosangela A; Yokoo, Edna M; Paravidino, Vitor B; Sichieri, Rosely
The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls) in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.
Gorini, Giuseppe; Carreras, Giulia; Bosi, Sandra; Tamelli, Marco; Monti, Claudia; Storani, Simone; Martini, Andrea; Allara, Elias; Angelini, Paola; Faggiano, Fabrizio
We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme. We undertook a cluster randomized controlled trial of 989 students aged 14-15 years in 13 secondary schools located in Reggio Emilia, Italy. The intervention consisted of the "Smoking Prevention Tour" (SPT) out-of-school workshop, one in-depth lesson on one Smoking Prevention Tour topic, a life-skills peer-led intervention, and enforcement surveillance of school antismoking policy. Self-reported past 30-day smoking of ≥ 20 or 1-19 days of cigarette smoking (daily or frequent smoking, respectively) was recorded in 2 surveys administered immediately before and 18 months after the beginning of the programme. Analysis was by intention to treat. The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses. Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31% and 46% lower, respectively, for intervention students compared to control students. Taking into account non-smokers at baseline only, daily smoking at eighteen months follow-up was 59% lower in intervention students than in controls. Past 30-day smoking in school areas was 62% lower in intervention students compared to controls. The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas. Copyright © 2014 Elsevier Inc. All rights reserved.
Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui
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
Full Text Available Abstract Background Although most patients with low back pain (LBP recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. Methods/Design This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. Discussion This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. Trial registration ISRCTN 68205910
Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter
Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016
Full Text Available BackgroundChildhood obesity is a major clinical and economic health concern. Alongside the clinical understanding of obesity, there is a growing interest in designing and implementing interventions that are worth their money given the scarce resources in the health care sector. This study is one of the first efforts to provide evidence by assessing the effects and costs of a population-based primary prevention intervention targeting pre-school children attending child health centers in Sweden.MethodsThe economic evaluation is based on the PRIMROSE cluster-randomized controlled trial aiming to establish healthy eating and physical activity among pre-school children (9–48 months of age through motivational interviewing applied by trained nurses at child health centers. The cost-effectiveness is assessed over the trial period from a societal perspective. The primary outcome was BMI at age 4. Cost data was prospectively collected alongside the trial. Scenario analyses were carried out to identify uncertainty.ResultsThe estimated additional mean total costs of the PRIMROSE intervention were 342 Euro (95% CI: 334; 348 per child. During pre-school years direct costs mainly consist of training costs and costs for the additional time used by nurses to implement the intervention compared to usual care. Early indirect costs mainly consist of parents’ absence from work due to their participation in the intervention. The incremental cost-effectiveness ratio in the base case analysis was 3,109 Euro per 1 BMI unit prevented.ConclusionWe cannot provide evidence that the PRIMROSE intervention is cost-effective, given the uncertainty in the effect measure. Until further evidence is provided, we recommend resources to be spent elsewhere within the field of obesity prevention. Furthermore, to achieve valid and reliable cost-effectiveness results, the economic evaluation of obesity prevention programs in early childhood should incorporate the life time
Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk
Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.
Blanch, Carles; Fernández, Esteve; Martínez-Sánchez, Jose M; Ariza, Carles; López, María J; Moncada, Albert; Schiaffino, Anna; Rajmil, Luis; Saltó, Esteve; Pascual, José A; Nebot, Manel
To assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of schoolchildren (12-14 years old). This was a community trial with cluster randomization of schools to an intervention and comparison group (ClinicalTrials.Gov identifier NCT01881607). The intervention targeted schoolchildren in Terrassa (Catalonia, Spain). We assessed SHS exposure in different settings and tobacco consumption by means of a questionnaire before and one year after the intervention. We analyzed data from 1734 students with both baseline and follow-up data. The crude analysis showed that SHS exposure among students in the intervention group significantly decreased at school (-14.0%), at home (-19.9%), and on transportation (-21.8%). In the comparison group, SHS exposure significantly decreased only at home (-16.9%). After adjustment for potential confounders, the good accomplishment of the activities showed a possible trend towards a non-significant reduction in exposure at home, transportation, and leisure time. While this school-based multi-level intervention had no overall effect in SHS exposure, the improvement of the activities focused on preventing SHS would be needed in order to achieve a significant decrease in the proportion of children exposed to SHS. © 2013.
Aleksandra E. Zgierska
Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.
Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B.; van de Schoot, Rens; Goslings, J. Carel; Luitse, Jan S. K.; Bakker, Fred C.; Gersons, Berthold P. R.; Olff, Miranda
Background: Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. Objective: To determine
Mouthaan, J.; Sijbrandij, M.; de Vries, G.J.; Reitsma, J.B.; van de Schoot, R.; Goslings, J.C.; Luitse, J.S.K.; Bakker, F.C.; Gersons, B.P.R.; Olff, M.
Background: Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. Objective: To determine
Sheridan Stacey L
Full Text Available Abstract Background Efficacious strategies for the primary prevention of coronary heart disease (CHD are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice. Methods We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk and self-reported adherence between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved. Results We randomized 160 eligible patients (81 intervention; 79 control and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%, with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%, with a larger effect in a pre-specified subgroup of high risk patients. Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk. Clinical trials registration number ClinicalTrials
Hillhouse, Joel; Turrisi, Rob; Stapleton, Jerod; Robinson, June
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
Hillhouse, Joel; Turrisi, Rob; Stapleton, Jerod; Robinson, June
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
Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L
Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.
de Josselin de Jong, Sanne; Candel, Math; Segaar, Dewi; Cremers, Henricus-Paul; de Vries, Hein
Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease. This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents. The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial. We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years, as smoking uptake in that period is highest. The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants. A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition. Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up. Data on smoking initiation were collected from 897 students from these schools. To identify intervention effects, multilevel logistic regression analyses were conducted using multiple imputation. Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline (OR 0.25, 95% CI 0.05-1.21, P=.09). Additional analyses of the data for the 14-16 year age group showed a significant effect, with 11.5% (24/209) of the students in the control condition reporting initiation compared to 5.7% (10/176) in the experimental condition (OR 0.22, 95% CI 0.05-1.02, P=.05). No moderation effects were found regarding gender and educational level. The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months, in particular among the
Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul
Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord
Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul
Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we
Tobin, Karin; Kuramoto, Satoko J.; German, Danielle; Fields, Errol; Spikes, Pilgrim S.; Patterson, Jocelyn; Latkin, Carl
Unity in Diversity was a randomized controlled trial of a culturally tailored HIV prevention intervention for African American men who have sex with men. The intervention condition was six group-based sessions and one individual session. The control condition was a single-session HIV prevention review. Participants were aged 18 years or older,…
Schmidt, Maria Inês; Duncan, Bruce B; Castilhos, Cristina; Wendland, Eliana Márcia; Hallal, Pedro C; Schaan, Beatriz D'Agord; Drehmer, Michele; Costa E Forti, Adriana; Façanha, Cristina; Nunes, Maria Angélica
Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregnancy complicated by GDM in delaying or preventing the development of type 2 diabetes. Women aged 18 or older identified as having recent GDM are recruited and followed by telephone to assess eligibility for the trial. To be eligible, women must have used insulin during pregnancy or present intermediate hyperglycemia postpartum. Women are encouraged to enter the trial as early as 10 weeks, and are permitted to do so up to 2 years after a pregnancy with GDM. An estimated 740 women will be randomized to either conventional care or to coach-based interventions focused on breastfeeding, weight loss, healthy eating, and increased physical activity, and predominantly delivered by telephone. Women are followed annually to detect new onset diabetes, the primary outcome, and additional secondary outcomes which include reversion to normoglycemia, weight loss, physical activity and fitness, and insulin resistance. Though previous studies have demonstrated that type 2 diabetes can be delayed or prevented, no study has yet demonstrated the feasibility and effectiveness of similar interventions implemented in the postpartum period for women with recent GDM. If shown to be successful, this approach could become an important means of preventing diabetes in primary care settings. ClinicalTrials.gov Identifier: NCT02327286; Registered 23 December 2014.
Cebrià I Iranzo, Maria Dels Àngels; Tortosa-Chuliá, M Ángeles; Igual-Camacho, Celedonia; Sancho, Patricia; Galiana, Laura; Tomás, José Manuel
The institutionalized elderly with functional impairment show a greater decline in respiratory muscle (RM) function. The aims of the study are to evaluate outcomes and costs of RM training using Pranayama in institutionalized elderly people with functional impairment. A randomized controlled trial was conducted on institutionalized elderly people with walking limitation (n=54). The intervention consisted of 6 weeks of Pranayama RM training (5 times/week). The outcomes were measured at 4 time points, and were related to RM function: the maximum respiratory pressures and the maximum voluntary ventilation. Perceived satisfaction in the experimental group (EG) was assessed by means of an ad hoc questionnaire. Direct and indirect costs were estimated from the social perspective. The GE showed a significant improvement related with strength (maximum respiratory pressures) and endurance (maximum voluntary ventilation) of RM. Moreover, 92% of the EG reported a high satisfaction. The total social costs, direct and indirect, amounted to Euro 21,678. This evaluation reveals that RM function improvement is significant, that intervention is well tolerated and appreciated by patients, and the intervention costs are moderate. Copyright © 2013 SEGG. Published by Elsevier Espana. All rights reserved.
Morgan, Amy J; Rapee, Ronald M; Salim, Agus; Goharpey, Nahal; Tamir, Elli; McLellan, Lauren F; Bayer, Jordana K
The Cool Little Kids parenting group program is an effective intervention for preventing anxiety disorders in young children who are at risk because of inhibited temperament. The program has six group sessions delivered by trained psychologists to parents of 3- to 6-year-old children. An online adaptation (Cool Little Kids Online) has been developed to overcome barriers to its wide dissemination in the community. This study tested the efficacy of Cool Little Kids Online in a randomized controlled trial. A total of 433 parents of a child aged 3 to 6 years with an inhibited temperament were randomized to the online parenting program or to a 24-week waitlist. The online program has 8 interactive modules providing strategies that parents can implement with their child to manage their child's avoidant coping, reduce parental overprotection, and encourage child independence. Parents were provided telephone consultation support with a psychologist when requested. Parents completed self-report questionnaires at baseline and at 12 and 24 weeks after baseline. The intervention group showed significantly greater improvement over time in child anxiety symptoms compared to the control group (d = 0.38). The intervention group also showed greater reductions in anxiety life interference (ds = 0.33-0.35) and lower rates of anxiety disorders than the control group (40% versus 54%), but there were minimal effects on broader internalizing symptoms or overprotective parenting. Results provide empirical support for the efficacy of online delivery of the Cool Little Kids program. Online dissemination may improve access to an evidence-based prevention program for child anxiety disorders. Clinical trial registration information-Randomised Controlled Trial of Cool Little Kids Online: A Parenting Program to Prevent Anxiety Problems in Young Children; http://www.anzctr.org.au/; 12615000217505. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc
Full Text Available Background: Training programs and providing essential information such as preborn educational programs for women, unmarried girls are essential as the most important prevention methods for control and prevention of health outcomes and disability. The current study conducted to assess the training effectiveness of Prevention Disability Package in high school girls in a community trail.Materials and Methods: A community trial executed among 1,339 high school girls in Qom, Iran. Subjects were the students that training in 10th and 11th years of education. All of students in each class from all majors were included in the study. According to sampling framework, 55 classes selected randomly assigned to lecture (1264 girls [94.4%], 4 (3% girls to CD-based group and 35 (2.6% girls to control group. Data collection was conducted by a standard and valid questionnaire. Analysis of variance test was used to compare the mean of knowledge score among three groups. Analysis of covariance (ANCOVA used to control the confounding variables.Results: There were significant differences among three groups according to the total score of awareness of disability. Therefore, the mean score of in handicap, musculoskeletal diseases, pregnancy dimensions, and total knowledge about disability causes was higher than in lecture group than CD-based and control groups (P
Full Text Available Alcohol use is one of the leading modifiable morbidity and mortality risk factors among young adults.2 parallel-group randomized controlled trial with follow-up at 1 and 6 months.Internet based study in a general population sample of young men with low-risk drinking, recruited between June 2012 and February 2013. Intervention: Internet-based brief alcohol primary prevention intervention (IBI. The IBI aims at preventing an increase in alcohol use: it consists of normative feedback, feedback on consequences, calorific value alcohol, computed blood alcohol concentration, indication that the reported alcohol use is associated with no or limited risks for health. Intervention group participants received the IBI. Control group (CG participants completed only an assessment.Alcohol use (number of drinks per week, binge drinking prevalence. Analyses were conducted in 2014-2015.Of 4365 men invited to participate, 1633 did so; 896 reported low-risk drinking and were randomized (IBI: n = 451; CG: n = 445. At baseline, 1 and 6 months, the mean (SD number of drinks/week was 2.4(2.2, 2.3(2.6, 2.5(3.0 for IBI, and 2.4(2.3, 2.8(3.7, 2.7(3.9 for CG. Binge drinking, absent at baseline, was reported by 14.4% (IBI and 19.0% (CG at 1 month and by 13.3% (IBI and 13.0% (CG at 6 months. At 1 month, beneficial intervention effects were observed on the number of drinks/week (p = 0.05. No significant differences were observed at 6 months.We found protective short term effects of a primary prevention IBI.Controlled-Trials.com ISRCTN55991918.
Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial
Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
Richards-Belle, Alvin; Mouncey, Paul R; Wade, Dorothy; Brewin, Chris R; Emerson, Lydia M; Grieve, Richard; Harrison, David A; Harvey, Sheila; Howell, David; Mythen, Monty; Sadique, Zia; Smyth, Deborah; Weinman, John; Welch, John; Rowan, Kathryn M
Acute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial. This is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team. This protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals. ISRCTN53448131; Pre-results. © Article author(s) (or their employer(s) unless
Linde Jennifer A
Full Text Available Abstract Background U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Methods Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1 measured height and weight; 2 online surveys of individual dietary intake and physical activity behaviors; and 3 detailed worksite environment assessment. Results Mean participant age was 42.9 years (range 18-75, 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m2 (range 16.9-61.2 kg/m2. A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36. Conclusions Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. Trial Registration ClinicalTrials.gov: NCT00708461
Full Text Available Abstract Background Despite the growing emphasis on the inclusion of ethnic minority patients in research, there is little published on the recruitment of these populations especially to randomised, community based, lifestyle intervention trials in the UK. Methods We share our experience of recruitment to screening in the PODOSA (Prevention of Diabetes and Obesity in South Asians trial, which screened 1319 recruits (target 1800 for trial eligibility. A multi-pronged recruitment approach was used. Enrolment via the National Health Service included direct referrals from health care professionals and written invitations via general practices. Recruitment within the community was carried out by both the research team and through our partnerships with local South Asian groups and organisations. Participants were encouraged to refer friends and family throughout the recruitment period. Results Health care professionals referred only 55 potential participants. The response to written invitations via general practitioners was 5.2%, lower than reported in other general populations. Community orientated, personal approaches for recruitment were comparatively effective yielding 1728 referrals (82% to the screening stage. Conclusions The PODOSA experience shows that a community orientated, personal approach for recruiting South Asian ethnic minority populations can be successful in a trial setting. We recommend that consideration is given to cover recruitment costs associated with community engagement and other personalised approaches. Researchers should consider prioritising approaches that minimise interference with professionals' work and, particularly in the current economic climate, keep costs to a minimum. The lessons learned in PODOSA should contribute to future community based trials in South Asians. Trial Registration Current Controlled Trials ISRCTN25729565
Slater, Michael D; Edwards, Ruth W; Plested, Barbara A; Thurman, Pamela J; Kelly, Kathleen J; Comello, Maria Leonora G; Keefe, Thomas J
This study examines the role of key informant community readiness assessments in a randomized group trial testing the impact of a participatory community-media intervention (which was also complemented by in-school efforts). These assessments were used to help match communities in random assignment, as a source of formative data about the community, as the basis for a coalition-building workshop, and as an evaluation tool, with a follow-up set of surveys approximately 2 years after the baseline survey. Results of the nested, random effects analysis indicated that the intervention influenced community knowledge of efforts and (at marginally significant levels) improved prevention leadership quality and community climate supportive of prevention efforts. There was evidence that the professional affiliation of informants in some cases had an effect on their assessments, which could be controlled in the analysis. The authors conclude that key informant community readiness assessments can usefully serve to supplement aggregated measures of individual attitudes and behavior (reported elsewhere for this study) in evaluating community-based interventions.
Knowlden, Adam; Sharma, Manoj
The home and family environment is a highly influential psychosocial antecedent of pediatric obesity. Implementation of conventional family- and home-based childhood obesity interventions is challenging for parents, often requiring them to attend multiple educational sessions. Attrition rates for traditional interventions are frequently high due to competing demands for parents' time. Under such constraints, an Internet-based intervention has the potential to modify determinants of childhood obesity while making judicious use of parents' time. Theory-based interventions offer many advantages over atheoretical interventions, including reduced intervention dosage, increased likelihood of behavioral change, and efficient resource allocation. Social cognitive theory (SCT) is a robust theoretical framework for addressing childhood obesity. SCT is a behavior change model rooted in reciprocal determinism, a causal paradigm that states that human functioning is the product of a dynamic interplay of behavioral, personal, and environmental factors. To evaluate the efficacy of the Enabling Mothers to Prevent Childhood Obesity Through Web-Based Education and Reciprocal Determinism (EMPOWER) program, an Internet-based, theory-driven intervention for preventing childhood overweight and obesity. The project goal is supported by two specific aims: (1) modification of four obesogenic protective factors related to childhood obesity (minutes engaged in physical activity, servings of fruits and vegetables consumed, servings of sugar-sweetened and sugar-free beverages consumed, and minutes engaged in screen time), and (2) reification of five maternal-mediated constructs of SCT (environment, expectations, emotional coping, self-control, and self-efficacy). We will recruit mothers with children ages 4 to 6 years from childcare centers and randomly assign them to either the theory-based (experimental) or knowledge-based (control) arm of the trial. Data for the intervention will be
Full Text Available As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM. Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.A randomized controlled trial (RCT conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631. No participant incentives were provided.Follow-up was completed by 1,631 (53% of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told' with their last sexual partner (OR 1.32, 95% CI 1.01-1.74. Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91 and webpage condition (OR 0.43, 95% CI 0.25-0.72 significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67 and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96 at follow-up.Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.ClinicalTrials.gov NCT
Barker Ruth N
Full Text Available Abstract Background Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors. Methods and design Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition. Discussion This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if
Weigel, Angelika; Gumz, Antje; Uhlenbusch, Natalie; Wegscheider, Karl; Romer, Georg; Löwe, Bernd
There are a high number of adolescents who are at risk of developing an eating disorder. There is, therefore, a strong need to implement prevention programs aimed at reducing the incidence of eating disorders at this critical age. Among other factors, successful prevention programs have been shown to be interactive, carried out by professionals, focused on educational as well as psychosocial elements and have taken risk factors as well as resources into account. The objective of this study protocol is to present the design of a new prevention program for eating disorders in schools. The gender-adapted prevention program extends over six school hours. It contains interactive and educational elements about eating disorders and their treatment. Participants pass through different exercises and reflect on the influences of the media, self-esteem, body perception and individual resources. A cluster-randomized controlled trial is chosen to evaluate the program. Based on an estimated effect size of d = 0.3 a total of 1848 participants are enrolled in the study. Eating disorder risk, internalization of Western beauty ideals, body dissatisfaction, self-concept as well as anxiety and symptoms of depression are measured before and immediately after the intervention as well as at a six-month follow-up. In addition, the intervention group evaluates the different components of the program. The study intends to test the practicability and efficacy of an interactive, gender-adapted ED prevention program in schools. Moreover, it will provide valuable information about the occurrence of eating disorder risk factors in school-aged children. ISRCTN97989348; Registered 19 December 2012.
Karlijn J Joling
Full Text Available Family caregivers of dementia patients are at increased risk of developing depression or anxiety. A multi-component program designed to mobilize support of family networks demonstrated effectiveness in decreasing depressive symptoms in caregivers. However, the impact of an intervention consisting solely of family meetings on depression and anxiety has not yet been evaluated. This study examines the preventive effects of family meetings for primary caregivers of community-dwelling dementia patients.A randomized multicenter trial was conducted among 192 primary caregivers of community dwelling dementia patients. Caregivers did not meet the diagnostic criteria for depressive or anxiety disorder at baseline. Participants were randomized to the family meetings intervention (n = 96 or usual care (n = 96 condition. The intervention consisted of two individual sessions and four family meetings which occurred once every 2 to 3 months for a year. Outcome measures after 12 months were the incidence of a clinical depressive or anxiety disorder and change in depressive and anxiety symptoms (primary outcomes, caregiver burden and quality of life (secondary outcomes. Intention-to-treat as well as per protocol analyses were performed.A substantial number of caregivers (72/192 developed a depressive or anxiety disorder within 12 months. The intervention was not superior to usual care either in reducing the risk of disorder onset (adjusted IRR 0.98; 95% CI 0.69 to 1.38 or in reducing depressive (randomization-by-time interaction coefficient = -1.40; 95% CI -3.91 to 1.10 or anxiety symptoms (randomization-by-time interaction coefficient = -0.55; 95% CI -1.59 to 0.49. The intervention did not reduce caregiver burden or their health related quality of life.This study did not demonstrate preventive effects of family meetings on the mental health of family caregivers. Further research should determine whether this intervention might be more beneficial
Full Text Available Abstract Background Studies have shown that a proportion of children as young as two years are already overweight. This indicates that obesity prevention programs that commence as early as possible and are family-focused are needed. This Healthy Beginnings Trial aims to determine the efficacy of a community-based randomized controlled trial (RCT of a home visiting intervention in preventing the early onset of childhood overweight and obesity. The intervention will be conducted over the first two years of life to increase healthy feeding behaviours and physical activity, decrease physical inactivity, enhance parent-child interaction, and hence reduce overweight and obesity among children at 2 and 5 years of age in the most socially and economically disadvantaged areas of Sydney, Australia. Methods/design This RCT will be conducted with a consecutive sample of 782 first time mothers with their newborn children. Pregnant women who are expecting their first child, and who are between weeks 24 and 34 of their pregnancy, will be invited to participate in the trial at the antenatal clinic. Informed consent will be obtained and participants will then be randomly allocated to the intervention or the control group. The allocation will be concealed by sequentially numbered, sealed opaque envelopes containing a computer generated random number. The intervention comprises eight home visits from a specially trained community nurse over two years and pro-active telephone support between the visits. Main outcomes include a duration of breastfeeding measured at 6 and 12 months, b introduction of solids measured at 4 and 6 months, c nutrition, physical activity and television viewing measured at 24 months, and d overweight/obesity status at age 2 and 5 years. Discussion The results of this trial will ascertain whether the home based early intervention is effective in preventing the early onset of childhood overweight and obesity. If proved to be effective, it
Wasantha P. Jayawardene, MD, PhD
Full Text Available Empirical evidence suggested that mind-body interventions can be effectively delivered online. This study aimed to examine whether preventive online mindfulness interventions (POMI for non-clinical populations improve short- and long-term outcomes for perceived-stress (primary and mindfulness (secondary. Systematic search of four electronic databases, manuscript reference lists, and journal content lists was conducted in 2016, using 21 search-terms. Eight randomized controlled trials (RCTs evaluating effects of POMI in non-clinical populations with adequately reported perceived-stress and mindfulness measures pre- and post-intervention were included. Random-effects models utilized for all effect-size estimations with meta-regression performed for mean age and %females. Participants were volunteers (adults; predominantly female from academic, workplace, or community settings. Most interventions utilized simplified Mindfulness-Based Stress Reduction protocols over 2–12 week periods. Post-intervention, significant medium effect found for perceived-stress (g = 0.432, with moderate heterogeneity and significant, but small, effect size for mindfulness (g = 0.275 with low heterogeneity; highest effects were for middle-aged individuals. At follow-up, significant large effect found for perceived-stress (g = 0.699 with low heterogeneity and significant medium effect (g = 0.466 for mindfulness with high heterogeneity. No publication bias was found for perceived-stress; publication bias found for mindfulness outcomes led to underestimation of effects, not overestimation. Number of eligible RCTs was low with inadequate data reporting in some studies. POMI had substantial stress reduction effects and some mindfulness improvement effects. POMI can be a more convenient and cost-effective strategy, compared to traditional face-to-face interventions, especially in the context of busy, hard-to-reach, but digitally-accessible populations.
Tighe, Joseph; Shand, Fiona; Ridani, Rebecca; Mackinnon, Andrew; De La Mata, Nicole; Christensen, Helen
Rates of youth suicide in Australian Indigenous communities are 4 times the national youth average and demand innovative interventions. Historical and persistent disadvantage is coupled with multiple barriers to help seeking. Mobile phone applications offer the opportunity to deliver therapeutic interventions directly to individuals in remote communities. The pilot study aimed to evaluate the effectiveness of a self-help mobile app (ibobbly) targeting suicidal ideation, depression, psychological distress and impulsivity among Indigenous youth in remote Australia. Remote and very remote communities in the Kimberley region of North Western Australia. Indigenous Australians aged 18-35 years. 61 participants were recruited and randomised to receive either an app (ibobbly) which delivered acceptance-based therapy over 6 weeks or were waitlisted for 6 weeks and then received the app for the following 6 weeks. The primary outcome was the Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) to identify the frequency and intensity of suicidal ideation in the previous weeks. Secondary outcomes were the Patient Health Questionnaire 9 (PHQ-9), The Kessler Psychological Distress Scale (K10) and the Barratt Impulsivity Scale (BIS-11). Although preintervention and postintervention changes on the (DSI-SS) were significant in the ibobbly arm (t=2.40; df=58.1; p=0.0195), these differences were not significant compared with the waitlist arm (t=1.05; df=57.8; p=0.2962). However, participants in the ibobbly group showed substantial and statistically significant reductions in PHQ-9 and K10 scores compared with waitlist. No differences were observed in impulsivity. Waitlist participants improved after 6 weeks of app use. Apps for suicide prevention reduce distress and depression but do not show significant reductions on suicide ideation or impulsivity. A feasible and acceptable means of lowering symptoms for mental health disorders in remote communities is via
Berrouiguet, Sofian; Larsen, Mark Erik; Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe
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
Lim, Raymond B T; Cheung, Olive N Y; Tai, Bee Choo; Chen, Mark I-C; Chan, Roy K W; Wong, Mee Lian
We assessed the efficacy of a multicomponent culturally tailored HIV/STI prevention intervention programme on consistent condom use and STI incidence among foreign Thai and Vietnamese female entertainment workers (FEWs) in Singapore. We conducted a quasi-experimental pretest and post-test intervention trial with a comparison group. We recruited 220 participants (115 Vietnamese and 105 Thai) for the comparison group, followed by the intervention group (same number) from the same sites which were purposively selected after a 3-month interval period. Both groups completed a self-administered anonymous questionnaire and STI testing for cervical gonorrhoea and Chlamydia, as well as pharyngeal gonorrhoea at baseline and 6-week follow-up. The peer-led intervention consisted of behavioural (HIV/STI education and condom negotiation skills), biomedical (STI screening and treatment services) and structural components (access to free condoms). We used the mixed effects Poisson regression model accounting for clustering by establishment venue to compute the adjusted risk ratio (aRR) of the outcomes at follow-up. At follow-up, the intervention group was more likely than the comparison group to report consistent condom use for vaginal sex with paid (aRR 1.77; 95% CI 1.71 to 1.83) and casual (aRR 1.81; 95% CI 1.71 to 1.91) partners. For consistent condom use for oral sex, this was aRR 1.50; 95% CI 1.23 to 1.82 with paid and aRR 1.54; 95% CI 1.22 to 1.95 with casual partners. STI incidence at follow-up was significantly lower in the intervention (6.8 per 100 FEWs) than the comparison (14.8 per 100 FEWs) group (aRR 0.42; 95% CI 0.32 to 0.55). This trial was effective in promoting consistent condom use for vaginal and oral sex as well as reducing STI incidence among the foreign Thai and Vietnamese FEWs in Singapore. The feasibility of scaling up the interventions to all entertainment establishments in Singapore should be assessed. © Article author(s) (or their employer
Amirkhanian, Yuri A; Kelly, Jeffrey A; Takacs, Judit; McAuliffe, Timothy L; Kuznetsova, Anna V; Toth, Tamas P; Mocsonaki, Laszlo; DiFranceisco, Wayne J; Meylakhs, Anastasia
To test a novel social network HIV risk-reduction intervention for MSM in Russia and Hungary, where same-sex behavior is stigmatized and men may best be reached through their social network connections. A two-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling. St. Petersburg, Russia and Budapest, Hungary. Eighteen 'seeds' from community venues invited the participation of their MSM friends who, in turn, invited their own MSM friends into the study, a process that continued outward until eighteen three-ring sociocentric networks (mean size = 35 members, n = 626) were recruited. Empirically identified network leaders were trained and guided to convey HIV prevention advice to other network members. Changes in sexual behavior from baseline to 3-month and 12-month follow-up, with composite HIV/STD incidence, measured at 12 months to corroborate behavior changes. There were significant reductions between baseline, first follow-up, and second follow-up in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse (UAI) (P = 0.04); UAI with a nonmain partner (P = 0.04); and UAI with multiple partners (P = 0.002). The mean percentage of unprotected anal intercourse acts significantly declined (P = 0.001), as well as the mean number of UAI acts among men who initially had multiple partners (P = 0.05). Biological HIV/STD incidence was 15% in comparison condition networks and 9% in intervention condition networks. Even where same-sex behavior is stigmatized, it is possible to reach MSM and deliver HIV prevention through their social networks.
Verdurmen, Jacqueline E E; Koning, Ina M.; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E
Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention,
Verdurmen, J.E.E.; Koning, I.M.; Vollebergh, W.A.M.; Eijnden, R.J.J.M. van den; Engels, R.C.M.E.
Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m = 12.68 years, SD = 0.51) and their parents randomized over four conditions: parent intervention, student intervention,
Dongen, van E.J.I.; Duijzer, G.; Oord-Jansen, van S.J.; Beek, ter J.; Huijg, Johanna M.; Leerlooijer, J.N.; Hiddink, G.J.; Feskens, E.J.M.; Haveman-Nies, A.
Objective To investigate (i) how the SLIMMER intervention was delivered and received in Dutch primary health care and (ii) how this could explain intervention effectiveness.
Design A randomised controlled trial was conducted and subjects were randomly allocated to the intervention (10-month
Dean, Catherine M; Rissel, Chris; Sharkey, Michelle; Sherrington, Catherine; Cumming, Robert G; Barker, Ruth N; Lord, Stephen R; O'Rourke, Sandra D; Kirkham, Catherine
Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors. Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars) and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition. This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if found to be effective, has the potential to be implemented within
La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn
Background: Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the…
Full Text Available Abstract Background Early childhood caries (ECC is the most common dental disease among children, which can affect children’s primary teeth during their teething. This study evaluates an intervention for preventing early childhood caries in a pediatric population in Ahvaz, Iran. Method The population of this study (IRCT2017070210804N10 consists of 104 women with 12 to 36 months of age without dental caries referred to a health care center in Ahvaz, Iran. The children were randomly assigned to either an experimental or control group in equal numbers. First, the demographic information of participants was collected through a questionnaire containing components of perceived threat, health literacy, and oral health behaviors using a valid and reliable questionnaire. The ECC status of the children was established by a dentist. Control group received “standard well baby care”. The experimental group received standard well baby care in addition to educational interventions, including lecture and group discussion. After 6 months, the participant completed the questionnaire for the second time, and the children’s teeth were reexamined. Data were analyzed using SPSS version 15 at a significance level of p 0.05. However, after the intervention, a significant difference was observed between the perceived threats (41.15 ± 4.46 in the experimental group and 38.26 ± 4.21 in the control group, p = 0.001, health literacy (20.98 ± 2.15 in the experimental group and 19.76 ± 2.70 in the control group, p = 0.01, oral health behaviors (7.75 ± 2.30 in the experimental group and 6.15 ± 2.65 in the control group, p = 0.01, and the incidence of ECC (13% in the experimental group and 35% in the control group, p = 0.001. Conclusion This intervention had positive effects on the perceived threat, health literacy, and health behaviors; and the intervention could reduce the incidence of ECC. The finding of this study provided a suggestion
Fathi-Ashtiani, Ali; Ahmadi, Ahmad; Ghobari-Bonab, Bagher; Azizi, Mohammed Parsa; Saheb-Alzamani, Sayeh Moosavi
The current study was conducted to examine the effect of cognitive behavior therapy on the reduction postpartum mood disorder and increasing the self-esteem of at-risk Iranian mothers. In this quasi-experimental study, 135 at-risk mothers were selected from the population by means of cluster sampling and randomly assigned into one of two groups: Intervention (n = 64), or control (n = 71). The control group received usual medical care, and the intervention group received an eight sessions' cognitive behavior program during pregnancy. Assessments were administered at two time points (pretest at the beginning of the third trimester and posttest at 2 weeks postpartum). Beck anxiety, beck depression, Edinburgh postpartum depression, (PPD) Coopersmith self-esteem, and religious attitude questionnaire were used to collect data. The mean age of participants was 25.8 ± 3.7 years. One-third of them had either bachelor or higher degrees in education (33%). About two-third of participants were unemployment with similar distribution in both the groups (intervention = 80%, control = 83%). The majority (70%) of the participants had cesarean section deliveries. There were no statistically significant differences respects to sociodemographic characteristics between the control and intervention groups (P > 0.05). The multivariate analysis of covariance results showed that the average scores of PPD were reduced significantly in the intervention group (P self-esteem increased from 29.09 (SE = 3.51) to 31.81 (SE = 2.76), no change was statistically significant in comparison to the control group. According to the findings of the present study, cognitive behavior intervention is effective in reducing PPD in at-risk mothers.
Liu, Hui; Shen, Jun; Xiao, Lily Dongxia
Falls are highly prevalent in hospitalized older people. Although many factors contribute to this, registered nurses (RNs) lack of knowledge about how to prevent hospitalized older people falls was identified as one of the major factors. This study explored the effects of an educational intervention on improving knowledge level of RNs on prevention of falls in hospitalized older people. It was a randomized controlled trial. 374 RNs from 4 acute care hospitals in ChongQing were recruited to the study. Data were collected before the intervention and at the 3-month follow-up. After the intervention, knowledge scores increased significantly from baseline in the intervention group and significant differences were detected between the scores of the two groups at the 3-month follow-up. The results reflected that the educational intervention was an effective strategy for improving knowledge level of RNs on prevention of falls in hospitalized older people. Copyright © 2011 Elsevier Ltd. All rights reserved.
Stice, Eric; Presnell, Katherine; Gau, Jeff; Shaw, Heather
The authors investigated mediators hypothesized to account for the effects of 2 eating disorder prevention programs using data from 355 adolescent girls who were randomized to a dissonance or a healthy weight intervention or an active control condition. The dissonance intervention produced significant reductions in outcomes (body…
Bosi, Sandra; Gorini, Giuseppe; Tamelli, Marco; Monti, Claudia; Storani, Simone; Carreras, Giulia; Martini, Andrea; Allara, Elias; Angelini, Paola; Faggiano, Fabrizio
Few school programs are effective in preventing adolescents' tobacco smoking initiation. The "Lega contro i Tumori - Luoghi di Prevenzione" is a cluster randomized controlled trial designed to evaluate a school-based peer-led smoking prevention intervention with extracurricular activities for students aged 14-15 years. This paper presents the study design and the baseline characteristics of the study population. Twenty secondary schools located in the Reggio Emilia province took part in the study. Five schools were excluded because they already participated in smoking prevention interventions. The schools were randomized to control or intervention arms. The study population consisted of students attending the first grade. Components of the intervention included 1) the out-of-school "Smoking Prevention Tour" (SPT) at the "Luoghi di Prevenzione" Center, a 4-hour (4 sessions) extracurricular activity; 2) the "Smoke-free Schools" intervention, combining a life-skills-based peer-led intervention at school, an in-depth lesson on one of the SPT sessions, and enforcement surveillance of the school antismoking policy. Tobacco use was studied through a questionnaire administered before and 6 months after the intervention. Eleven high schools and 9 vocational secondary schools took part in the study for a total of 2,476 out of 3,050 eligible students (81.2%). The proportions of respondents in high schools and vocational secondary schools were 90.9% and 64.5%, respectively (P preventing smoking initiation.
Sherwood, Nancy E; Levy, Rona L; Langer, Shelby L; Senso, Meghan M; Crain, A Lauren; Hayes, Marcia G; Anderson, Julie D; Seburg, Elisabeth M; Jeffery, Robert W
Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a Contact Control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The Contact Control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. © 2013. Published by Elsevier Inc. All rights reserved.
Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.
Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490
A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial
Louise E. Kimball
Conclusion: Complex randomized, double-blind, multicenter interventional trials with treatment decisions made at a central coordinating site can be conducted safely and effectively according to Good Clinical Practice (GCP guidelines over a large geographic area.
Turawa, Eunice B; Musekiwa, Alfred; Rohwer, Anke C
Postpartum constipation, with symptoms such as pain or discomfort, straining, and hard stool, is a common condition affecting mothers. Haemorrhoids, pain at the episiotomy site, effects of pregnancy hormones and haematinics used in pregnancy can increase the risk of postpartum constipation. Eating a high-fibre diet and increasing fluid intake is usually encouraged, although laxatives are commonly used in relieving constipation. The effectiveness and safety of available interventions for preventing postpartum constipation needs to be ascertained. To evaluate the effectiveness and safety of interventions for preventing postpartum constipation. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015), Stellenbosch University database, ProQuest Dissertation and Theses database, World Health Organization International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov (30 April 2015) and reference lists of included studies. All randomised controlled trials (RCTs) comparing any intervention for preventing postpartum constipation versus another intervention, placebo or no intervention. Interventions could include pharmacological (e.g. laxatives) and non-pharmacological interventions (e.g. acupuncture, educational and behavioural interventions).We included quasi-randomised trials. Cluster-RCTs were eligible for inclusion but none were identified. Studies using a cross-over design were not eligible for inclusion in this review. Two review authors independently screened the results of the search to select potentially relevant studies, extracted data and assessed risk of bias. Results were pooled in a meta-analysis only where there was no substantial statistical heterogeneity. We included five trials (1208 postpartum mothers); four compared a laxative with placebo and one compared a laxative alone versus the same laxative plus a bulking agent in women who underwent surgical repair of third degree perineal tears. Trials were poorly
Guo, Jia; Chen, Jyu-Lin; Whittemore, Robin; Whitaker, Evans
Women with a history of gestational diabetes mellitus (GDM) are at a higher risk of developing type 2 diabetes. Several postpartum lifestyle intervention studies have been conducted for this high-risk group; however, the randomized clinical trials have not been evaluated systematically. Thus, the aim of this article is to evaluate the outcomes of clinical trials that focus on diabetes prevention among women with DGM. This systematic review utilized Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Chinese and US databases were searched. Randomized controlled trials of postpartum lifestyle interventions to prevent type 2 diabetes in women with prior GDM were reviewed. Outcomes included in this review are type 2 diabetes incidences, insulin insistence, and weight-related measures. The effect size of these outcomes in each study was computed. Data on intervention components were extracted, including type (in-person vs. technology-based), content (diet or physical activity or both), form (individual session vs. group session), duration, intensity, evaluation time point, and program delivery. A total of 12 studies met the inclusion criteria. The mean annual type 2 diabetes mellitus (T2DM) incidence of the intervention group was lower than that of the comparison group (6.0% vs. 9.3%), although there was no statistical difference between the two groups. About 50% of these studies and two-thirds of studies, respectively, reported a significant decrease in insulin resistance-related measures and weight-related measures in the intervention group compared with the comparison group. The median intervention duration and study length were 6 months. Postpartum lifestyle interventions can be effective in reducing T2DM development and insulin resistance, and decrease weight in women with GDM history, regardless of the intervention types (technology-based or in-person). Effective interventions typically include dietary changes while some physical
Martinez, Omar; Isabel Fernandez, M; Wu, Elwin; Carballo-Diéguez, Alex; Prado, Guillermo; Davey, Adam; Levine, Ethan; Mattera, Brian; Lopez, Nikki; Valentin, Omar; Murray, Ashley; Sutton, Madeline
Latino men who have sex with men (MSM) experienced a 13% increase in HIV diagnoses from 2010 to 2014, more than any other racial/ethnic subgroup of MSM in the United States. If current HIV diagnoses rates persist, about one in four Latino MSM in the United States will be diagnosed with HIV during their lifetime. Although some efficacious HIV prevention interventions for Latino MSM exist, none have focused on couples. This paper describes the protocol of a randomized controlled trial (RCT) to test the preliminary efficacy of a couple-based HIV prevention intervention that is culturally tailored for Latino men and their same-sex partners. The RCT will determine the preliminary efficacy of Connecting Latinos en Pareja (CLP) to increase the proportion of anal sex acts that are HIV protected (i.e., anal sex acts in which condoms, pre-exposure prophylaxis (PrEP), treatment as prevention (TasP), or a combination thereof, are used to reduce risk of HIV transmission). CLP builds upon previous couple-based interventions with white and black MSM by incorporating biomedical prevention techniques, such as PrEP and TasP, implementing a framework responsive to the couple's serostatus, and addressing the socio-cultural factors that influence HIV risk among Latino MSM. We also include input from community stakeholders, members of the target population, and a community advisory board as part of intervention development. Assessments will be conducted at baseline, and 3- and 6-months post-intervention to examine the intervention effects on outcomes (HIV-protected sex acts), and factors potentially mediating or moderating intervention effects. This paper describes an innovative RCT that incorporates multiple HIV prevention techniques for Latino MSM in couples, regardless of serostatus. The ongoing involvement of community stakeholders, members of the target population, and a community advisory board is emphasized, and plans for widespread dissemination and application of findings into
Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial).
Cockayne, Sarah; Rodgers, Sara; Green, Lorraine; Fairhurst, Caroline; Adamson, Joy; Scantlebury, Arabella; Corbacho, Belen; Hewitt, Catherine E; Hicks, Kate; Hull, Robin; Keenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony; Richardson, Zoe; Vernon, Wesley; Watson, Judith; Torgerson, David J
Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness. To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care. A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study. Nine NHS trusts in the UK and one site in Ireland. In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible. All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises. The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness. The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The
Merry, Sally; Stasiak, Karolina; McDowell, Heather; Doherty, Iain; Shepherd, Matthew; Dorey, Enid; Parag, Varsha; Ameratunga, Shanthi; Rodgers, Anthony
Background Prevention of the onset of depression in adolescence may prevent social dysfunction, teenage pregnancy, substance abuse, suicide, and mental health conditions in adulthood. New technologies allow delivery of prevention programs scalable to large and disparate populations. Objective To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents. We describe the development of the intervention and the results of participants’ self-reported satisfaction with the intervention. Methods The intervention was developed from 15 key messages derived from cognitive behavioral therapy (CBT). The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks, with a mixture of text, video, and cartoon messages and a mobile website. Delivery modalities were guided by social cognitive theory and marketing principles. The intervention was compared with an attention control program of the same number and types of messages on different topics. A double-blind randomized controlled trial was undertaken in high schools in Auckland, New Zealand, from June 2009 to April 2011. Results A total of 1348 students (13–17 years of age) volunteered to participate at group sessions in schools, and 855 were eventually randomly assigned to groups. Of these, 835 (97.7%) self-completed follow-up questionnaires at postprogram interviews on satisfaction, perceived usefulness, and adherence to the intervention. Over three-quarters of participants viewed at least half of the messages and 90.7% (379/418) in the intervention group reported they would refer the program to a friend. Intervention group participants said the intervention helped them to be more positive (279/418, 66.7%) and to get rid of negative thoughts (210/418, 50.2%)—significantly higher than proportions in the control group. Conclusions Key messages from CBT can be delivered by mobile phone, and young people report that these are helpful. Change in
Verdurmen, Jacqueline E E; Koning, Ina M; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E
To examine risk moderation of an alcohol intervention targeting parents and adolescents. A cluster randomized trial including 2937 Dutch early adolescents (m=12.68years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combined parent-student intervention, and control group. 152 classes of 19 high schools in The Netherlands (2006). Moderators at baseline (adolescent: gender, educational level and externalizing behavior; parent: educational level and heavy alcohol use) were used to examine the differential effects of the interventions on onset of (heavy) weekly drinking at 22-month follow-up. The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents, and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents (i.e. those attending lower levels of education and reporting higher levels of externalizing behavior). Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents, with an added effect on postponing heavy weekly drinking in high risk subgroups. Therefore, implementation of this intervention in the general population of schools in The Netherlands is advised. NTR649. Copyright © 2013 Elsevier Inc. All rights reserved.
Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.
Bryant, Maria; Burton, Wendy; Cundill, Bonnie; Farrin, Amanda J; Nixon, Jane; Stevens, June; Roberts, Kim; Foy, Robbie; Rutter, Harry; Hartley, Suzanne; Tubeuf, Sandy; Collinson, Michelle; Brown, Julia
Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot
Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a
Larsen, Kristian; Weidich, Flemming; Leboeuf-Yde, Charlotte
Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems. One review concludes that the former is clinically effective in relation to prevention, whereas the latter has been tested in only 1 randomized clinical trial, concluding that stress fractures could be prevented. To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible. Prospective, randomized, controlled intervention trial. One female and 145 male military conscripts (aged 18 to 24 years), representing 25% of all new conscripts in a Danish regiment. Health data were collected by questionnaires at initiation of the study and 3 months later. Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period. No intervention was provided for the control group. Differences between the 2 groups were tested with the chi-square test, and statistical significance was accepted at P biomechanic shoe orthoses. However, because care-seeking for lower extremity problems is rare, using this method of prevention in military conscripts would be too costly. We also noted that the choice of statistical approach determined the outcome.
Wolchik, Sharlene A; Sandler, Irwin N; Millsap, Roger E; Plummer, Brett A; Greene, Shannon M; Anderson, Edward R; Dawson-McClure, Spring R; Hipke, Kathleen; Haine, Rachel A
Compared with their peers with nondivorced parents, adolescents with divorced parents are more likely to have mental health problems, drop out of school, and become pregnant. The long-term effects of intervention programs for this population are unknown. To evaluate the long-term effectiveness of 2 programs designed to prevent mental health problems in children with divorced parents. Six-year follow-up of a randomized controlled trial of 2 intervention programs (mother program: 11 group and 2 individual sessions; mother plus child program: mother program and 11 group sessions for children) and a control condition (books on postdivorce adjustment), which was conducted in a large metropolitan US city from April 1998 through March 2000. A total of 218 families (91% of the original sample) with adolescents aged between 15 and 19 years were reinterviewed. Externalizing and internalizing problems, diagnosed mental disorders, drug and alcohol use, and number of sexual partners. Eleven percent of adolescents in the mother plus child program (95% confidence interval [CI], 3.8%-18.2%) had a 1-year prevalence of diagnosed mental disorder compared with 23.5% (95% CI, 13.8%-33.2%) of adolescents in the control program (P =.007). Adolescents in the mother plus child program had fewer sexual partners (mean [SE], 0.68 [0.16]) compared with adolescents in the control program (1.65 [0.37]; P =.01). Adolescents with higher initial mental health problems whose families were in the mother plus child program had lower externalizing problems (P =.007) and fewer symptoms of mental disorder (P =.02) compared with those in the control program. Compared with controls, adolescents whose mothers participated in the mother program and who had higher initial mental health problems had lower levels of externalizing problems (Pdivorced parents, the mother program and the mother plus child program reduced symptoms of mental disorder; rates of diagnoses of mental disorder; levels of externalizing
Rowe, Heather; Wynter, Karen; Lorgelly, Paula; Amir, Lisa H; Ranasinha, Sanjeeva; Proimos, Jenny; Cann, Warren; Hiscock, Harriet; Bayer, Jordana; Burns, Joanna; Ride, Jemimah; Bobevski, Irene; Fisher, Jane
Introduction Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and...
Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju
Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named "HAPPY ME," which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10-12 years of age using HAPPY ME. A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.
Background 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 (effectiveness of Cogmed in improving academic functioning 2 years’ post-intervention. Secondary objectives are to assess the effectiveness of Cogmed in improving working 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. Methods/Design 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. Discussion To our knowledge, this study will be
Whittaker, Robyn; Merry, Sally; Stasiak, Karolina; McDowell, Heather; Doherty, Iain; Shepherd, Matthew; Dorey, Enid; Parag, Varsha; Ameratunga, Shanthi; Rodgers, Anthony
Prevention of the onset of depression in adolescence may prevent social dysfunction, teenage pregnancy, substance abuse, suicide, and mental health conditions in adulthood. New technologies allow delivery of prevention programs scalable to large and disparate populations. To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents. We describe the development of the intervention and the results of participants' self-reported satisfaction with the intervention. The intervention was developed from 15 key messages derived from cognitive behavioral therapy (CBT). The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks, with a mixture of text, video, and cartoon messages and a mobile website. Delivery modalities were guided by social cognitive theory and marketing principles. The intervention was compared with an attention control program of the same number and types of messages on different topics. A double-blind randomized controlled trial was undertaken in high schools in Auckland, New Zealand, from June 2009 to April 2011. A total of 1348 students (13-17 years of age) volunteered to participate at group sessions in schools, and 855 were eventually randomly assigned to groups. Of these, 835 (97.7%) self-completed follow-up questionnaires at postprogram interviews on satisfaction, perceived usefulness, and adherence to the intervention. Over three-quarters of participants viewed at least half of the messages and 90.7% (379/418) in the intervention group reported they would refer the program to a friend. Intervention group participants said the intervention helped them to be more positive (279/418, 66.7%) and to get rid of negative thoughts (210/418, 50.2%)--significantly higher than proportions in the control group. Key messages from CBT can be delivered by mobile phone, and young people report that these are helpful. Change in clinician-rated depression symptom scores from baseline to 12
McElwaine Kathleen M
prior to and following the intervention with randomly selected samples of clinicians from each facility group to assess the reported provision of preventive care, and the acceptability of the practice change intervention and implementation. Discussion The study will provide novel evidence regarding the ability to increase clinician's routine provision of preventive care across a network of community health facilities. Trial registration Australian Clinical Trials Registry ACTRN12611001284954 Universal Trial Number (UTN U1111-1126-3465
Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Trial registration Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 PMID:24135085
Córdova, David; Mendoza Lua, Frania; Ovadje, Lauretta; Hong, Ethan; Castillo, Berenice; Salas-Wright, Christopher P
HIV/sexually transmitted infections (STIs) and drug abuse remain significant public health concerns in the United States, and African American and Hispanic youth are disproportionately affected. Although technology-based interventions are efficacious in preventing and reducing HIV/STI and licit/illicit drug use behaviors, relatively little is known regarding the state of the science of these interventions among African American and Hispanic youth. The aim of this review is to identify and examine randomized controlled trials (RCTs) of technology-based HIV/STI and/or drug abuse preventive interventions for African American and Hispanic youth. We searched electronic databases (ie, PubMed, Proquest, PsycINFO, Ebscohost, Google Scholar) to identify studies between January 2006 and October 2016. RCTs of technology-based interventions targeting African American and Hispanic youth HIV/STI risk behaviors, including sexual risk, licit and illicit drug use, and HIV/STI testing were included. Our search revealed a total of three studies that used an RCT design and included samples comprised of >50% African American and/or Hispanic youth. The follow-up assessments ranged from two weeks to six months and the number of participants in each trial ranged from 72 to 141. The three interventions were theory-driven, interactive, and tailored. The long-term effects of the interventions were mixed, and outcomes included reductions in sex partners, licit drug use, and condomless anal sex acts. Although technology-based interventions seem promising in the prevention of HIV/STI and drug abuse among African American and Hispanic youth, more research is needed. ©David Córdova, Frania Mendoza Lua, Lauretta Ovadje, Ethan Hong, Berenice Castillo, Christopher P Salas-Wright. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 13.12.2017.
Gilbert, Louisa; Hunt, Timothy; Primbetova, Sholpan; Terlikbayeva, Assel; Chang, Mingway; Wu, Elwin; McCrimmon, Tara; El-Bassel, Nabila
To evaluate the efficacy of a couple-based integrated HIV/HCV and overdose prevention intervention on non-fatal and fatal overdose and overdose prevention behaviors among people who use heroin or other opioids in Almaty, Kazakhstan. We selected 479 participants who reported lifetime heroin or opioid use from a sample of 600 participants (300 couples) enrolled in a randomized controlled trial (RCT) conducted between May 2009 and February 2013. Participants were randomized to either (1) a 5-session couple-based HIV/HCV and overdose prevention intervention condition or (2) a 5-session Wellness Promotion and overdose prevention comparison condition. We used multilevel mixed-effects model with modified Poisson regression to estimate effects of the intervention as risk ratios (RR) and the corresponding 95% CIs. About one-fifth (21.9%) of the sample reported that they had experienced an opioid overdose in the past 6 months at baseline. At the 12-month follow-up, both the intervention and comparison conditions reported significant reductions in non-fatal overdose and injection heroin/opioid use and significant increases in drug treatment attendance and naloxone use to prevent death from overdose. However, we found no differences between the study arms on any of these outcomes. There were three intervention condition participants (1.3%), compared to seven comparison condition participants (2.9%) who died from opioid overdose during the 12-month follow up period although this difference was not significant. There were no significant conditions on any outcomes: both conditions showed promising effects of reducing non-fatal overdose and overdose risks. Integrating overdose prevention into a couple-based HIV/HCV intervention may be an efficient strategy to target the syndemic of opioid overdose, HIV and HCV in Kazakhstan. Copyright © 2018 Elsevier B.V. All rights reserved.
Davis, Sally M; Myers, Orrin B; Cruz, Theresa H; Morshed, Alexandra B; Canaca, Glenda F; Keane, Patricia C; O'Donald, Elena R
We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2years to achieve. Copyright © 2016 Elsevier Inc. All rights reserved.
Chithambo, Taona P; Huey, Stanley J
The current study evaluated two web-based programs for eating disorder prevention in high-risk, predominantly ethnic minority women. Two hundred and seventy-one women with elevated weight concerns were randomized to Internet dissonance-based intervention (DBI-I), Internet cognitive-behavioral intervention (CBI-I), or no intervention (NI). Both interventions consisted of four weekly online sessions. Participants were assessed at pre- and post intervention. Outcome measures included eating pathology, body dissatisfaction, dieting, thin-ideal internalization, and depression. At postintervention, DBI-I and CBI-I led to greater reductions in body dissatisfaction, thin-ideal internalization, and depression than NI. In addition, CBI-I was effective at reducing dieting and composite eating pathology relative to NI. No outcome differences were found between the active conditions. Moderation analyses suggested that both active conditions were more effective for ethnic minorities than Whites relative to NI. Results suggest that both DBI-I and CBI-I are effective at reducing eating disorder risk factors in a high-risk, predominantly minority population relative to no intervention. © 2017 Wiley Periodicals, Inc.
Jelsma, Judith G. M.; van Poppel, Mireille N. M.; Galjaard, Sander; Desoye, Gernot; Corcoy, Rosa; Devlieger, Roland; van Assche, Andre; Timmerman, Dirk; Jans, Goele; Harreiter, Jurgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R.; Jensen, Dorte M.; Andersen, Liselotte
Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design Pregnant women at risk of GDM (BMI?29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose
Hye Jung Yang
Full Text Available Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference, body mass index (BMI percentiles (obesity rate, and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.
Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088
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.
Lehtisalo, Jenni; Ngandu, Tiia; Valve, Päivi; Antikainen, Riitta; Laatikainen, Tiina; Strandberg, Timo; Soininen, Hilkka; Tuomilehto, Jaakko; Kivipelto, Miia; Lindström, Jaana
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 (Pintervention group during the 2 years. Well-targeted dietary counselling may prevent age-related decline in diet quality and help in preventing cognitive decline.
Benjamin J Cowling
Full Text Available There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members.We conducted a cluster randomized controlled trial of households (composed of at least 3 members where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1 control or 2 surgical face masks or 3 hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms. We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable.The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008.ClinicalTrials.gov NCT00425893 HKClinicalTrials.com HKCTR-365.
Full Text Available Abstract Background Depressive and anxiety symptoms in older adults could develop into significant health problems with detrimental effects on quality of life and a possibly poor prognosis. Therefore, there is a need for preventive interventions which are at once effective, acceptable and economic affordable. Methods and design This paper describes the design of a study evaluating "The stories we live by", a preventive life-review group intervention, which was recently developed for adults of 55 years and over with depressive and anxiety symptoms. Both clinical and economic effectiveness will be evaluated in a pragmatic randomized controlled trial. The participants in the intervention condition will receive the 8-session preventive intervention. The participants in the control condition will have access to usual care. Clinical end-terms are depressive and anxiety symptoms, current major depressive episode, quality of life and positive mental health post-treatment (3 months after baseline and at follow-ups (6 and 12 months after baseline. Additional goals of this study are to identify groups for whom the intervention is particularly effective and to identify the therapeutic pathways that are vital in inducing clinical change. This will be done by analyzing if treatment response is moderated by demographics, personality, past major depressive episodes, important life events and chronically disease, and mediated by reminiscence functions, perceived control, automatic positive thoughts and meaning in life. Finally the cost-effectiveness of the intervention relative to care as usual will be assessed by computing incremental costs per case of depression and anxiety avoided (cost-effectiveness and per quality adjusted life year (QALY (cost utility. Discussion It is expected that both the life-review intervention and its evaluation will contribute to the existing body of knowledge in several ways. First, the intervention is unique in linking life
Musiat, Peter; Conrod, Patricia; Treasure, Janet; Tylee, Andre; Williams, Chris; Schmidt, Ulrike
promising way of preventing common mental disorders with a low-intensity intervention. ControlledTrials.com ISRCTN14342225.
Sathish, T; Oldenburg, B; Tapp, R J; Shaw, J E; Wolfe, R; Sajitha, B; D'Esposito, F; Absetz, P; Mathews, E; Zimmet, P Z; Thankappan, K R
To describe the baseline characteristics of participants in the Kerala Diabetes Prevention Program. The Kerala Diabetes Prevention Program is a cluster randomized controlled trial of lifestyle intervention for prevention of Type 2 diabetes mellitus in India. Participants in the study were those aged 30-60 years who had an Indian Diabetes Risk Score ≥ 60 and who were without Type 2 diabetes on oral glucose tolerance test. Data on demographic, lifestyle, clinical and biochemical characteristics were collected using standardized tools. A total of 2586 individuals were screened with the Indian Diabetes Risk Score, of these 1529 people (59.1%) had a score ≥ 60, of whom 1209 (79.1%) underwent an oral glucose tolerance test. A total of 202 individuals (16.7%) had undiagnosed Type 2 diabetes and were excluded, and the remaining 1007 individuals were enrolled in the trial (control arm, n = 507; intervention arm, n = 500). The mean participant age was 46.0 ± 7.5 years, and 47.2% were women. The mean Indian Diabetes Risk Score was 67.1 ± 8.4. More than two-thirds (69.0%) had prediabetes and 31.0% had normal glucose tolerance. The prevalence of cardiometabolic risk factors was high, including current tobacco use (34.4% in men), current alcohol use (39.3% in men), no leisure time exercise (98.0%), no daily intake of fruit and vegetables (78.7%), family history of diabetes (47.9%), overweight or obesity (68.5%), hypertension (22.3%) and dyslipidemia (85.4%). The Kerala Diabetes Prevention Program recruited participants using a diabetes risk score. A large proportion of the participants had prediabetes and there were high rates of cardiometabolic risk factors. The trial will evaluate the effectiveness of lifestyle intervention in a population selected on the basis of a diabetes risk score. © 2016 Diabetes UK.
Mackay, Bethany A; Shochet, Ian M; Orr, Jayne A
Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in schools with adolescents with ASD in years 6 and 7. Quantitative results showed significant intervention effects on parent reports of adolescent coping self-efficacy (maintained at 6 month follow-up) but no effect on depressive symptoms or mental health. Qualitative outcomes reflected perceived improvements from the intervention for adolescents' coping self-efficacy, self-confidence, social skills, and affect regulation. Converging results remain encouraging given this population's difficulties coping with adversity, managing emotions and interacting socially which strongly influence developmental outcomes.
Full Text Available Abstract Background Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'ALImentation et de l'Activité Physique trial aims to evaluate the effectiveness for these conditions of 3 health promotion strategies -- educational, screening and environmental -- applied singly or in combination in high schools over a 2-year intervention period. Methods PRALIMAP is a stratified 2 × 2 × 2 factorial cluster randomised controlled trial including 24 state high schools in Lorraine, northeastern France, in 2 waves: 8 schools in 2006 (wave 1 and 16 in 2007 (wave 2. Students entering the selected high schools in the 4 academic years from 2006 to 2009 are eligible for data collection. Interventional strategies are organized over 2 academic years. The follow-up consists of 3 visits: at the entry of grade 10 (T0, grade 11 (T1 and grade 12 (T2. At T0, 5,458 (85.7% adolescents participated. The educational strategy consists of nutritional lessons, working groups and a final party. The screening strategy consists in detecting overweight/obesity and eating disorders in adolescents and proposing, if necessary, an adapted care management program of 7 group educational sessions. The environmental strategy consists in improving dietary and physical activity offerings in high schools and facilities, especially catering. The main outcomes are body size evolution over time, nutritional behaviour and knowledge, health and quality of life. An evaluation process documents how each intervention strategy is implemented in the schools and estimates the dose of the intervention, allowing for a per protocol analysis after the main intention-to-treat analysis. Discussion PRALIMAP aims at improving the prevention and management of overweight and obesity in adolescents by translating current evidence into public health practice
Menz Hylton B
Full Text Available Abstract Background Falls in older people are a major public health problem, with at least one in three people aged over 65 years falling each year. There is increasing evidence that foot problems and inappropriate footwear increase the risk of falls, however no studies have been undertaken to determine whether modifying these risk factors decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people. Methods Three hundred community-dwelling men and women aged 65 years and over with current foot pain and an increased risk of falling will be randomly allocated to a control or intervention group. The "usual cae" control group will receive routine podiatry (i.e. nail care and callus debridement. The intervention group will receive usual care plus a multifaceted podiatry intervention consisting of: (i prefabricated insoles customised to accommodate plantar lesions; (ii footwear advice and assistance with the purchase of new footwear if current footwear is inappropriate; (iii a home-based exercise program to strengthen foot and ankle muscles; and (iv a falls prevention education booklet. Primary outcome measures will be the number of fallers, number of multiple fallers and the falls rate recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the Medical Outcomes Study Short Form 12 (SF-12, the Manchester Foot Pain and Disability Index, the Falls Efficacy Scale International, and a series of balance and functional tests. Data will be analysed using the intention to treat principle. Discussion This study is the first randomised trial to evaluate the efficacy of podiatry in improving balance and preventing falls. The trial has been pragmatically designed to ensure that the findings can be generalised to clinical practice. If
Cheung, Kei Long; Schwabe, Inga; Walthouwer, Michel J L; Oenema, Anke; Lechner, Lilian; de Vries, Hein
Computer-tailored programs may help to prevent overweight and obesity, which are worldwide public health problems. This study investigated (1) the 12-month effectiveness of a video- and text-based computer-tailored intervention on energy intake, physical activity, and body mass index (BMI), and (2) the role of educational level in intervention effects. A randomized controlled trial in The Netherlands was conducted, in which adults were allocated to a video-based condition, text-based condition, or control condition, with baseline, 6 months, and 12 months follow-up. Outcome variables were self-reported BMI, physical activity, and energy intake. Mixed-effects modelling was used to investigate intervention effects and potential interaction effects. Compared to the control group, the video intervention group was effective regarding energy intake after 6 months (least squares means (LSM) difference = -205.40, p = 0.00) and 12 months (LSM difference = -128.14, p = 0.03). Only video intervention resulted in lower average daily energy intake after one year (d = 0.12). Educational role and BMI did not seem to interact with this effect. No intervention effects on BMI and physical activity were found. The video computer-tailored intervention was effective on energy intake after one year. This effect was not dependent on educational levels or BMI categories, suggesting that video tailoring can be effective for a broad range of risk groups and may be preferred over text tailoring.
Kei Long Cheung
Full Text Available Computer-tailored programs may help to prevent overweight and obesity, which are worldwide public health problems. This study investigated (1 the 12-month effectiveness of a video- and text-based computer-tailored intervention on energy intake, physical activity, and body mass index (BMI, and (2 the role of educational level in intervention effects. A randomized controlled trial in The Netherlands was conducted, in which adults were allocated to a video-based condition, text-based condition, or control condition, with baseline, 6 months, and 12 months follow-up. Outcome variables were self-reported BMI, physical activity, and energy intake. Mixed-effects modelling was used to investigate intervention effects and potential interaction effects. Compared to the control group, the video intervention group was effective regarding energy intake after 6 months (least squares means (LSM difference = −205.40, p = 0.00 and 12 months (LSM difference = −128.14, p = 0.03. Only video intervention resulted in lower average daily energy intake after one year (d = 0.12. Educational role and BMI did not seem to interact with this effect. No intervention effects on BMI and physical activity were found. The video computer-tailored intervention was effective on energy intake after one year. This effect was not dependent on educational levels or BMI categories, suggesting that video tailoring can be effective for a broad range of risk groups and may be preferred over text tailoring.
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial
Suijker Jacqueline J
Full Text Available Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. Methods/Design In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC score (≥ 2. These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP. The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. Discussion This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. Trial registration NTR2653 Grant Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201
Chen, Ying-Yeh; Chen, Feng; Chang, Shu-Sen; Wong, Jacky; Yip, Paul S F
Charcoal-burning suicide has recently been spreading to many Asian countries. There have also been several cases involving this new method of suicide in Western countries. Restricting access to suicide means is one of the few suicide-prevention measures that have been supported by empirical evidence. The current study aims to assess the effectiveness of a community intervention program that restricts access to charcoal to prevent suicide in Taiwan. A quasi-experimental design is used to compare method-specific (charcoal-burning suicide, non-charcoal-burning suicide) and overall suicide rates in New Taipei City (the intervention site, with a population of 3.9 million) with two other cities (Taipei City and Kaohsiung City, the control sites, each with 2.7 million residents) before (Jan 1st 2009- April 30th 2012) and after (May 1st 2012-Dec. 31st 2013) the initiation of a charcoal-restriction program on May 1st 2012. The program mandates the removal of barbecue charcoal from open shelves to locked storage in major retail stores in New Taipei City. No such restriction measure was implemented in the two control sites. Generalized linear regression models incorporating secular trends were used to compare the changes in method-specific and overall suicide rates before and after the initiation of the restriction measure. A simulation approach was used to estimate the number of lives saved by the intervention. Compared with the pre-intervention period, the estimated rate reduction of charcoal-burning suicide in New Taipei City was 37% (95% CI: 17%, 50%) after the intervention. Taking secular trends into account, the reduction was 30% (95% CI: 14%, 44%). No compensatory rise in non-charcoal-burning suicide was observed in New Taipei City. No significant reduction in charcoal-burning suicide was observed in the other two control sites. The simulation approach estimated that 91 (95%CI [55, 128]) lives in New Taipei City were saved during the 20 months of the intervention. Our
Spink, Martin J; Menz, Hylton B; Fotoohabadi, Mohammad R; Wee, Elin; Landorf, Karl B; Hill, Keith D; Lord, Stephen R
To determine the effectiveness of a multifaceted podiatry intervention in preventing falls in community dwelling older people with disabling foot pain. Parallel group randomised controlled trial. University health sciences clinic in Melbourne, Australia. 305 community dwelling men and women (mean age 74 (SD 6) years) with disabling foot pain and an increased risk of falling. 153 were allocated to a multifaceted podiatry intervention and 152 to routine podiatry care, with 12 months' follow-up. Multifaceted podiatry intervention consisting of foot orthoses, advice on footwear, subsidy for footwear ($A100 voucher; £65; €74), a home based programme of foot and ankle exercises, a falls prevention education booklet, and routine podiatry care for 12 months. The control group received routine podiatry care for 12 months. Proportion of fallers and multiple fallers, falling rate, and injuries resulting from falls during follow-up. Overall, 264 falls occurred during the study. 296 participants returned all 12 calendars: 147 (96%) in the intervention group and 149 (98%) in the control group. Adherence was good, with 52% of the participants completing 75% or more of the requested three exercise sessions weekly, and 55% of those issued orthoses reporting wearing them most of the time. Participants in the intervention group (n=153) experienced 36% fewer falls than participants in the control group (incidence rate ratio 0.64, 95% confidence interval 0.45 to 0.91, P=0.01). The proportion of fallers and multiple fallers did not differ significantly between the groups (relative risk 0.85, 0.66 to 1.08, P=0.19 and 0.63, 0.38 to 1.04, P=0.07). One fracture occurred in the intervention group and seven in the control group (0.14, 0.02 to 1.15, P=0.07). Significant improvements in the intervention group compared with the control group were found for the domains of strength (ankle eversion), range of motion (ankle dorsiflexion and inversion/eversion), and balance (postural sway on the
Tan, Ai May; Lamontagne, Anthony D; Sarmugam, Rani; Howard, Peter
Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis
DiClemente, Ralph J.; Villamizar, Kira; Er, Deja L.; DeVarona, Martina; Taveras, Janelle; Painter, Thomas M.; Lang, Delia L.; Hardin, James W.; Ullah, Evelyn; Stallworth, JoAna; Purcell, David W.; Jean, Reynald
Objectives. We developed and assessed AMIGAS (Amigas, Mujeres Latinas, Inform andonos, Gui andonos, y Apoy andonos contra el SIDA [friends, Latina women, informing each other, guiding each other, and supporting each other against AIDS]), a culturally congruent HIV prevention intervention for Latina women adapted from SiSTA (Sistas Informing Sistas about Topics on AIDS), an intervention for African American women. Methods. We recruited 252 Latina women aged 18 to 35 years in Miami, Florida, in 2008 to 2009 and randomized them to the 4-session AMIGAS intervention or a 1-session health intervention. Participants completed audio computer-assisted self-interviews at baseline and follow-up. Results. Over the 6-month follow-up, AMIGAS participants reported more consistent condom use during the past 90 (adjusted odds ratio [AOR] = 4.81; P < .001) and 30 (AOR = 3.14; P < .001) days and at last sexual encounter (AOR = 2.76; P < .001), and a higher mean percentage condom use during the past 90 (relative change = 55.7%; P < .001) and 30 (relative change = 43.8%; P < .001) days than did comparison participants. AMIGAS participants reported fewer traditional views of gender roles (P = .008), greater self-efficacy for negotiating safer sex (P < .001), greater feelings of power in relationships (P = .02), greater self-efficacy for using condoms (P < .001), and greater HIV knowledge (P = .009) and perceived fewer barriers to using condoms (P < .001). Conclusions. Our results support the efficacy of this linguistically and culturally adapted HIV intervention among ethnically diverse, predominantly foreign-born Latina women. PMID:22021297
Anjali Sunil Kumar Mall
Full Text Available Background: Tobacco use among adolescence is one of the important preventable causes of death as well as a leading public health problem all over the world. The present study was conducted with the objective of studying the effect of peer-led interventions on tobacco use among adolescents. Materials and Methods: Twenty schools were randomly selected and ten schools each were identified as cluster for intervention and control groups. A total of 402 students in intervention group and 422 in control group were studied. Results: About 48% and 41% of adolescents were consuming smokeless tobacco in any form in the intervention and control groups, respectively. Prevalence of consumption of smokeless tobacco was significantly high among boys as compared to girls. Pan masala was the most common form of consumption. After conducting A Stop Smoking in School Trial-like peer-led intervention, a significant reduction in tobacco consumption of any form was observed in the intervention group (48%–36% during the follow-up (Z = 3.2, P < 0.01. A significant reduction in exposure to passive smoking in the intervention group (32%–29% was also observed. All the students smoking initially had stopped smoking at the end of the follow-up in both the groups. Conclusion: It was found that peer-led intervention was effective in reducing the consumption of smokeless tobacco in any form. The rate of reduction was more in the first follow-up as compared to the end of the intervention. Sustained intervention in the form of retraining is needed for the long-term effect.
Spink, Martin J; Menz, Hylton B; Lord, Stephen R
Falls in older people are a major public health problem, with at least one in three people aged over 65 years falling each year. There is increasing evidence that foot problems and inappropriate footwear increase the risk of falls, however no studies have been undertaken to determine whether modifying these risk factors decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people. Three hundred community-dwelling men and women aged 65 years and over with current foot pain and an increased risk of falling will be randomly allocated to a control or intervention group. The "usual cae" control group will receive routine podiatry (i.e. nail care and callus debridement). The intervention group will receive usual care plus a multifaceted podiatry intervention consisting of: (i) prefabricated insoles customised to accommodate plantar lesions; (ii) footwear advice and assistance with the purchase of new footwear if current footwear is inappropriate; (iii) a home-based exercise program to strengthen foot and ankle muscles; and (iv) a falls prevention education booklet. Primary outcome measures will be the number of fallers, number of multiple fallers and the falls rate recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the Medical Outcomes Study Short Form 12 (SF-12), the Manchester Foot Pain and Disability Index, the Falls Efficacy Scale International, and a series of balance and functional tests. Data will be analysed using the intention to treat principle. This study is the first randomised trial to evaluate the efficacy of podiatry in improving balance and preventing falls. The trial has been pragmatically designed to ensure that the findings can be generalised to clinical practice. If found to be effective, the multifaceted podiatry
Buller, David B.; Andersen, Peter A.; Walkosz, Barbara J.; Scott, Michael D.; Beck, Larry; Cutter, Gary R.
Introduction Exposure to solar ultraviolet radiation during recreation is a risk factor for skin cancer. A trial evaluating an intervention to promote advanced sun protection (sunscreen pre-application/reapplication; protective hats and clothing; use of shade) during vacations. Materials and Methods Adult visitors to hotels/resorts with outdoor recreation (i.e., vacationers) participated in a group-randomized pretest-posttest controlled quasi-experimental design in 2012–14. Hotels/resorts were pair-matched and randomly assigned to the intervention or untreated control group. Sun protection (e.g., clothing, hats, shade and sunscreen) was measured in cross-sectional samples by observation and a face-to-face intercept survey during two-day visits. Results Initially, 41 hotel/resorts (11%) participated but 4 dropped out before posttest. Hotel/resorts were diverse (employees=30 to 900; latitude=24o 78′ N to 50o 52′ N; elevation=2 ft. to 9,726 ft. above sea level), and had a variety of outdoor venues (beaches/pools, court/lawn games, golf courses, common areas, and chairlifts). At pretest, 4,347 vacationers were observed and 3,531 surveyed. More females were surveyed (61%) than observed (50%). Vacationers were mostly 35–60 years old, highly educated (college education = 68%) and non-Hispanic white (93%), with high-risk skin types (22%). Vacationers reported covering 60% of their skin with clothing. Also, 40% of vacationers used shade; 60% applied sunscreen; and 42% had been sunburned. Conclusions The trial faced challenges recruiting resorts but result show that the large, multi-state sample of vacationers were at high risk for solar UV exposure. PMID:26593781
Buller, David B; Andersen, Peter A; Walkosz, Barbara J; Scott, Michael D; Beck, Larry; Cutter, Gary R
Exposure to solar ultraviolet radiation during recreation is a risk factor for skin cancer. A trial evaluated an intervention to promote advanced sun protection (sunscreen pre-application/reapplication; protective hats and clothing; use of shade) during vacations. Adult visitors to hotels/resorts with outdoor recreation (i.e., vacationers) participated in a group-randomized pretest-posttest controlled quasi-experimental design in 2012-14. Hotels/resorts were pair-matched and randomly assigned to the intervention or untreated control group. Sun. protection (e.g., clothing, hats, shade and sunscreen) was measured in cross-sectional samples by observation and a face-to-face intercept survey during two-day visits. Initially, 41 hotel/resorts (11%) participated but 4 dropped out before posttest. Hotel/resorts were diverse (employees=30 to 900; latitude=24° 78' N to 50° 52' N; elevation=2ft. to 9726ft. above sea level), and had a variety of outdoor venues (beaches/pools, court/lawn games, golf courses, common areas, and chairlifts). At pretest, 4347 vacationers were observed and 3531 surveyed. More females were surveyed (61%) than observed (50%). Vacationers were mostly 35-60years old, highly educated (college education=68%) and non-Hispanic white (93%), with high-risk skin types (22%). Vacationers reported covering 60% of their skin with clothing. Also, 40% of vacationers used shade; 60% applied sunscreen; and 42% had been sunburned. The trial faced challenges recruiting resorts but result showed that the large, multi-state sample of vacationers were at high risk for solar UV exposure. Copyright © 2015 Elsevier Inc. All rights reserved.
Megan S Dunbar
Full Text Available Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ! was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control. The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the
Steinberg, Dori M; Levine, Erica L; Lane, Ilana; Askew, Sandy; Foley, Perry B; Puleo, Elaine; Bennett, Gary G
eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate self-monitoring. Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.
Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M
Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way m
Müller, Sina; Stice, Eric
To investigate factors hypothesized to moderate the effects of a dissonance-based eating disorder prevention program, including initial elevations in thin-ideal internalization, body dissatisfaction, eating disorders symptoms, and older participant age. Adolescent female high school and college students with body image concerns (N=977; M age=18.6) were randomized to a dissonance-based thin-ideal internalization reduction program or an assessment-only control condition in three prevention trials. The intervention produced (a) significantly stronger reductions in thin-ideal internalization for participants with initial elevations in thin-ideal internalization and a threshold/subthreshold DSM-5 eating disorder at baseline, (b) significantly greater reductions in eating disorder symptoms for participants with versus without a DSM-5 eating disorder at baseline, and (c) significantly stronger reductions in body dissatisfaction for late adolescence/young adulthood versus mid-adolescent participants. Baseline body dissatisfaction did not moderate the intervention effects. Overall, intervention effects tended to be amplified for individuals with initial elevations in risk factors and a DSM-5 eating disorder at baseline. Results suggest that this prevention program is effective for a broad range of individuals, but is somewhat more beneficial for the subgroups identified in the moderation analyses. Copyright © 2012 Elsevier Ltd. All rights reserved.
Walthouwer, Michel Jean Louis; Oenema, Anke; Lechner, Lilian; de Vries, Hein
Web-based computer-tailored interventions often suffer from small effect sizes and high drop-out rates, particularly among people with a low level of education. Using videos as a delivery format can possibly improve the effects and attractiveness of these interventions The main aim of this study was to examine the effects of a video and text version of a Web-based computer-tailored obesity prevention intervention on dietary intake, physical activity, and body mass index (BMI) among Dutch adults. A second study aim was to examine differences in appreciation between the video and text version. The final study aim was to examine possible differences in intervention effects and appreciation per educational level. A three-armed randomized controlled trial was conducted with a baseline and 6 months follow-up measurement. The intervention consisted of six sessions, lasting about 15 minutes each. In the video version, the core tailored information was provided by means of videos. In the text version, the same tailored information was provided in text format. Outcome variables were self-reported and included BMI, physical activity, energy intake, and appreciation of the intervention. Multiple imputation was used to replace missing values. The effect analyses were carried out with multiple linear regression analyses and adjusted for confounders. The process evaluation data were analyzed with independent samples t tests. The baseline questionnaire was completed by 1419 participants and the 6 months follow-up measurement by 1015 participants (71.53%). No significant interaction effects of educational level were found on any of the outcome variables. Compared to the control condition, the video version resulted in lower BMI (B=-0.25, P=.049) and lower average daily energy intake from energy-dense food products (B=-175.58, Pintervention (P=.018). The video version of the Web-based computer-tailored obesity prevention intervention was the most effective intervention and most
Full Text Available Abstract Background While the HIV epidemic is levelling off in sub-Saharan Africa, it remains at an unacceptably high level. Young people aged 15-24 years remain particularly vulnerable, resulting in a regional HIV prevalence of 1.4% in young men and 3.3% in young women. This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda on young people’s sexual behavior, HIV knowledge and attitudes. Methods In a non-randomized longitudinal controlled trial, fourteen schools were selected in two neighboring districts in Rwanda Bugesera (intervention and Rwamagana (control. Students (n = 1950 in eight intervention and six control schools participated in three surveys (baseline, six and twelve months in the intervention. Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score. Results The overall retention rate was 72%. Time trends in sexual risk behavior (being sexually active, sex in last six months, condom use at last sex were not significantly different in students from intervention and control schools, nor was the intervention associated with increased knowledge, perceived severity or perceived susceptibility. It did significantly reduce reported stigma. Conclusions Analyzing this and other interventions, we identified several reasons for the observed limited effectiveness of peer education: 1 intervention activities (spreading information are not tuned to objectives (changing behavior; 2 young people prefer receiving HIV information from other sources than peers; 3 outcome indicators are not adequate and the context of the relationship in which sex occurs and the context in which sex occurs is ignored. Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators’ role as focal points for sensitization and referral to experts and services. Finally, we argue that a
: This study suggests that a transdiagnostic web-based intervention for university students targeting underlying personality risk factors may be a promising way of preventing common mental disorders with a low-intensity intervention. TRIAL REGISTRATION: ControlledTrials.com ISRCTN14342225.
Cockayne, Sarah; Adamson, Joy; Corbacho Martin, Belen; Fairhurst, Caroline; Hewitt, Catherine; Hicks, Kate; Hull, Robin; Keenan, Anne Maree; Lamb, Sarah E; Loughrey, Lorraine; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David
Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. Current Controlled Trials ISRCTN68240461 assigned 01/07/2011. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a
Eaton, Lisa A; Kalichman, Seth C; Kalichman, Moira O; Driffin, Daniel D; Baldwin, Robert; Zohren, Larissa; Conway-Washington, Christopher
Novel interventions to address sexual risk taking and slow rates of STIs are urgently needed, in particular among black men who have sex with men (MSM) in the USA. Serosorting, or limiting condomless sex acts to partners of the same HIV status, is commonly practised among MSM, yet can lead to STI and remains largely unaddressed by public health agencies. A two-arm, randomised controlled trial was conducted from 2012 to 2015. This trial assessed the effects of a single-session, sexual partner selection and risk decision intervention (experimental arm) versus a single-session, Centers for Disease Control and Prevention-based, sexual risk reduction intervention (control arm) on psychosocial measures, sexual risk taking and STI. At study follow-ups, multiple beneficial changes were observed on sexual risk beliefs measures (ie, changes in serosorting and condom use beliefs, and HIV risk perceptions) and sexual risk taking among the experimental arm relative to the control arm. Overall main effects, however, of the intervention on STI outcomes on year-long follow-ups were non-significant. There was evidence for short-term effects on STI outcomes, and self-report of multiple STIs and STI symptoms demonstrated positive effects over the follow-up period. Brief interventions to address sexual risk taking can result in short-term beneficial outcomes and can be incorporated into currently existing infrastructure at healthcare agencies. Additional intervention will be necessary for demonstrating long-term results. NCT02128594. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Roy, Swapan Kumar; Jolly, Saira Parveen; Shafique, Sohana; Fuchs, George J; Mahmud, Zeba; Chakraborty, Barnali; Roy, Suchismita
As a result of inappropriate feeding, poor health and hygiene, and poor caring practices, the nutritional status of many young infants deteriorates with advancing age. To explore the effectiveness of a nutrition education package to prevent malnutrition among young children. A community-based, randomized, controlled trial was conducted among 605 normal and mildly malnourished children aged 6 to 9 months in 121 Community Nutrition Centers (CNCs) of the Bangladesh Integrated Nutrition Project (BINP) in four regions of Bangladesh from 2000 to 2002. The intervention group received weekly nutrition education based on the nutrition triangle concept of UNICEF for 6 months, whereas the control group received regular BINP services. Both groups were observed for a further 6 months to assess the sustainability of the effects. Information on socioeconomic status, feeding patterns, morbidity, and anthropometric features was collected. A significant increase in the frequency of complementary feeding was observed in the intervention group as compared with the control group, and the increase was sustained throughout the observation period. The intervention group had a higher weight gain than the control group after the end of the intervention (0.86 vs. 0.77 kg, p = 0.053) and after the end of the observation period (1.81 vs. 1.39 kg, p intervention group than in the control group after the end of the observations (88.9% vs. 61.5%, p Nutrition education successfully prevented malnutrition in all the areas. Variation in the outcome of nutrition education among the regions was observed. This culturally appropriate nutrition education package based on the nutrition triangle model effectively prevented growth faltering and malnutrition among young children.
Full Text Available Abstract Background Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches. Study Design A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16. The unit of allocation is year groups (n = 28 which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm. Discussion As of August 2010, all 28 year groups (n = 5023 had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011. Trial Registration ISRCTN19083628
Japan Diabetes Outcome Intervention Trial-1(J-DOIT1, a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment
Full Text Available Abstract Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM. To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1 is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters, formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups or control arm (21 clusters between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There
Abstract Background Maternal weight and maternal weight gain during pregnancy exert a significant influence on infant birth weight and the incidence of macrosomia. Fetal macrosomia is associated with an increase in both adverse obstetric and neonatal outcome, and also confers a future risk of childhood obesity. Studies have shown that a low glycaemic diet is associated with lower birth weights, however these studies have been small and not randomised 1 2 . Fetal macrosomia recurs in a second pregnancy in one third of women, and maternal weight influences this recurrence risk 3 . Methods\\/Design We propose a randomised control trial of low glycaemic index carbohydrate diet vs. no dietary intervention in the prevention of recurrence of fetal macrosomia. Secundigravid women whose first baby was macrosomic, defined as a birth weight greater than 4000 g will be recruited at their first antenatal visit. Patients will be randomised into two arms, a control arm which will receive no dietary intervention and a diet arm which will be commenced on a low glycaemic index diet. The primary outcome measure will be the mean birth weight centiles and ponderal indices in each group. Discussion Altering the source of maternal dietary carbohydrate may prove to be valuable in the management of pregnancies where there has been a history of fetal macrosomia. Fetal macrosomia recurs in a second pregnancy in one third of women. This randomised control trial will investigate whether or not a low glycaemic index diet can affect this recurrence risk. Current Controlled Trials Registration Number ISRCTN54392969
Full Text Available Abstract Background Pregnancy is a time of significant physiological and physical change for women. In particular, it is a time at which many women are at risk of gaining excessive weight. We describe the rationale and methods of the Health in Pregnancy and Post-birth (HIPP Study, a study which aims primarily to determine the effectiveness of a specialized health coaching (HC intervention during pregnancy, compared to education alone, in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth. A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth. Methods/Design The randomized controlled trial will be conducted with 220 women who have a BMI > 18.5 (American IOM cut-off for normal weight, are 18 years of age or older, English speaking, no history of disordered eating or diabetes and are less than 18 weeks gestation at recruitment. Women will be randomly allocated to either a specialized HC intervention group or an Education Alone group. Our specialized HC intervention has two components: (1 one-on-one sessions with a Health Coach, and (2 two by two hour educational group sessions led by a Health Coach. Women in the Education Alone group will receive two by two hour educational group sessions with no HC components. Body Mass Index, waist circumference, and psychological factors including motivation, readiness to change, symptoms of depression and anxiety, and body dissatisfaction will be assessed at baseline (14-16 weeks gestation, and again at follow-up: 32 weeks gestation, 6 weeks, 6 months and 12 months postpartum. Discussion Our study responds to the urgent need to design effective interventions in pregnancy to prevent excessive gestational weight gain and postpartum weight retention. Our pregnancy HC intervention is novel and innovative and has been designed to be easily adopted by health professionals
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial.
Suijker, Jacqueline J; Buurman, Bianca M; ter Riet, Gerben; van Rijn, Marjon; de Haan, Rob J; de Rooij, Sophia E; Moll van Charante, Eric P
Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC) score (≥ 2). These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP). The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. NTR2653 GRANT: Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201.
Faria, Bianca Lisa; Brieske, Christian M; Cosgarea, Ioana; Omlor, Albert J; Fries, Fabian N; de Faria, Christian Olber Moreira; Lino, Henrique Augusto; Oliveira, Ana Carla Cruz; Lisboa, Oscar Campos; Klode, Joachim; Schadendorf, Dirk; Bernardes-Souza, Breno; Brinker, Titus J
Most smokers start smoking during their early adolescence, often with the idea that smoking is glamorous; the dramatic health consequences are too far in the future to fathom. We recently designed and tested an intervention that takes advantage of the broad availability of mobile phones as well as adolescents' interest in their appearance. A free photoageing mobile app (Smokerface) was implemented by medical students in secondary schools via a novel method called mirroring. The pupils' altered three-dimensional selfies on tablets were 'mirrored' via a projector in front of their whole grade. This is the first randomised trial to measure the effectiveness of the mirroring approach on smoking behaviour in secondary schools. The mirroring intervention, which lasts 45 min, is implemented by Brazilian medical students in at least 35 secondary school classes with 21 participants each (at least 35 classes with 21 participants for control) in February 2018 in the city of Itauna, Brazil. External block randomisation via computer is performed on the class level with a 1:1 allocation. In addition to sociodemographic data, smoking behaviour is measured via a paper-pencil questionnaire before, 3 and 6 months postintervention plus a random carbon monoxide breathing test at baseline and end line. The primary outcome is cigarette smoking in the past week at 6 months follow-up. Smoking behaviour (smoking onset, quitting) and effects on the different genders are studied as secondary outcomes. Analysis is by intention to treat. Ethical approval is obtained from the ethics committee of the University of Itauna in Brazil. Results will be disseminated at conferences, in peer-reviewed journals, throughout the Education Against Tobacco network social media channels and on our websites. NCT03178227. © 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.
Pan, Kai-feng; Zhang, Lian; Gerhard, Markus; Ma, Jun-ling; Liu, Wei-dong; Ulm, Kurt; Wang, Jian-xi; Zhang, Lei; Zhang, Yang; Bajbouj, Monther; Zhang, Lan-fu; Li, Ming; Vieth, Michael; Liu, Rui-yong; Quante, Michael; Wang, Le-hua; Suchanek, Stepan; Zhou, Tong; Guan, Wei-xiang; Schmid, Roland; Classen, Meinhard; You, Wei-cheng
To clarify the full range of benefits and adverse consequences of Helicobacter pylori eradication as a strategy for gastric cancer prevention, the community-based intervention trial was launched in Linqu County, China. A total of 184,786 residents aged 25-54 years were enrolled in this trial and received (13)C-urea breath test. H. pylori positive participants were assigned into two groups, either receiving a 10-day quadruple anti-H. pylori treatment or lookalike placebos together with a single dosage of omeprazole and bismuth. The prevalence of H. pylori in trial participants was 57.6%. A total of 94,101 subjects completed the treatment. The overall H. pylori eradication rate was 72.9% in the active group. Gender, body mass index, history of stomach disease, baseline delta over baseline-value of (13)C-urea breath test, missed medication doses, smoking and drinking were independent predictors of eradication failure. The missed doses and high baseline delta over baseline-value were important contributors in men and women (all Ptrendhistory of stomach disease were significant predictors in women. The treatment failure rate increased up to 48.8% (OR 2.87, 95% CI 2.24 to 3.68) in men and 39.4% (OR 2.67, 95% CI 1.61 to 4.42) in women with multiple factors combined. This large community-based intervention trial to eradicate H. pylori is feasible and acceptable. The findings of this trial lead to a distinct evaluation of factors influencing eradication that should be generally considered for future eradication therapies. ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Fernández-Barrés, Sílvia; García-Barco, Montse; Basora, Josep; Martínez, Teresa; Pedret, Roser; Arija, Victoria
To assess the effect of a nutrition education intervention included in the Home Care Program for caregivers to prevent the increasing risk of malnutrition of dependent patients at risk of malnutrition. Randomized controlled multicenter trial of 6 months of duration and 12 months follow-up. 10 Primary Care Centers, Spain. Patients enrolled in the Home Care Program between January 2010 and March 2012, who were dependent and at risk of malnutrition, older than 65, and had caregivers (n=190). The nurses conducted initial educational intervention sessions for caregivers and then monitored at home every month for 6 months. The nutritional status was assessed using the Mini Nutritional Assessment test (primary outcome), diet, anthropometry, and biochemical parameters (albumin, prealbumin, hemoglobin and cholesterol). Other descriptive and outcome measures were recorded: current medical history, Activities of daily living (Barthel test), cognitive state (Pfeiffer test), and mood status (Yesavage test). All the measures were recorded in a schedule of 0-6-12 months. 173 individuals participated after exclusions (intervention n=101; control n=72). Mean age was 87.8±8.9years, 68.2% were women. Difference were found between the groups for Mini Nutritional Assessment test score change (repeated measures ANOVA, F=10.1; Pintervention improved the Mini Nutritional Assessment test score of the participants in the intervention group. The egg consumption (F=4.1; P=0.018), protein intake (F=3.0; P=0.050), polyunsaturated fatty acid intake (F=5.3; P=0.006), folate (F=3.3; P=0.041) and vitamin E (F=6.4; P=0.002) showed significant group×time interactions. A nutrition education intervention for caregivers halted the tendency of nutritional decline, and reduced the risk of malnutrition of older dependent patients. Clinical Trial Registration-URL: www.clinicaltrials.gov. Identifier: NCT01360775. Copyright © 2017 Elsevier Ltd. All rights reserved.
Kalichman, Seth C; Cherry, Chauncey; Kalichman, Moira O; Eaton, Lisa A; Kohler, James J; Montero, Catherine; Schinazi, Raymond F
We conducted a randomized clinical trial to test a mobile health behavioral intervention designed to enhance HIV treatment as prevention (B-TasP) by simultaneously increasing combination antiretroviral therapies (cART) adherence and improving the sexual health of people living with HIV. A cohort of sexually active men (n = 383) and women (n = 117) living with HIV were enrolled. Participants were baseline assessed and randomized to either (1) B-TasP adherence and sexual health intervention or (2) general health control intervention. Outcome measures included HIV RNA viral load, cART adherence monitored by unannounced pill counts, indicators of genital tract inflammation, and sexual behaviors assessed over 12 months. Eighty-six percent of the cohort was retained for 12-month follow-up. The B-TasP intervention demonstrated significantly lower HIV RNA, OR = 0.56, P = 0.01, greater cART adherence, Wald χ = 33.9, P = 0.01, and fewer indicators of genital tract inflammation, Wald χ = 9.36, P = 0.05, over the follow-up period. Changes in sexual behavior varied, with the B-TasP intervention showing lower rates of substance use in sexual contexts, but higher rates of condomless sex with non-HIV positive partners occurred in the context of significantly greater beliefs that cART reduces HIV transmission. Theory-based mobile health behavioral interventions can simultaneously improve cART adherence and sexual health in people living with HIV. Programs aimed to eliminate HIV transmission by reducing HIV infectiousness should be bundled with behavioral interventions to maximize their impact and increase their chances of success.
Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment.
Sakane, Naoki; Kotani, Kazuhiko; Takahashi, Kaoru; Sano, Yoshiko; Tsuzaki, Kokoro; Okazaki, Kentaro; Sato, Juichi; Suzuki, Sadao; Morita, Satoshi; Izumi, Kazuo; Kato, Masayuki; Ishizuka, Naoki; Noda, Mitsuhiko; Kuzuya, Hideshi
Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics
Amirkhanian, Yuri A.; Kelly, Jeffrey A.; Takacs, Judit; McAuliffe, Timothy L.; Kuznetsova, Anna V.; Toth, Tamas P.; Mocsonaki, Laszlo; DiFranceisco, Wayne J.; Meylakhs, Anastasia
Objective To test a novel social network HIV risk reduction intervention for MSM in Russia and Hungary, where same-sex behavior is stigmatized and men may best be reached through their social network connections. Design A 2-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling. Setting St. Petersburg, Russia and Budapest, Hungary. Participants 18 “seeds” from community venues invited the participation of their MSM friends who, in turn, invited their own MSM friends into the study, a process that continued outward until eighteen 3-ring sociocentric networks (mean size=35 members, n=626) were recruited. Intervention Empirically-identified network leaders were trained and guided to convey HIV prevention advice to other network members. Main Outcome and Measures Changes in sexual behavior from baseline to 3- and 12-month followup, with composite HIV/STD incidence measured at 12-months to corroborate behavior changes. Results There were significant reductions between baseline, first followup, and second followup in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse (P=.04); UAI with a nonmain partner (P=.04); and UAI with multiple partners (P=.002). The mean percentage of unprotected AI acts significantly declined (P=.001), as well as the mean number of UAI acts among men who initially had multiple partners (P=.05). Biological HIV/STD incidence was 15% in comparison condition networks and 9% in intervention condition networks. Conclusions Even where same-sex behavior is stigmatized, it is possible to reach MSM and deliver HIV prevention through their social networks. PMID:25565495
Delisle, Christine; Sandin, Sven; Forsum, Elisabet; Henriksson, Hanna; Trolle-Lagerros, Ylva; Larsson, Christel; Maddison, Ralph; Ortega, Francisco B; Ruiz, Jonatan R; Silfvernagel, Kristin; Timpka, Toomas; Löf, Marie
Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial. A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline). This novel study will evaluate the effectiveness of a mHealth program for
Summerbell, C D; Waters, E; Edmunds, L D; Kelly, S; Brown, T; Campbell, K J
Obesity prevention is an international public health priority. The prevalence of obesity and overweight is increasing in child populations throughout the world, impacting on short and long-term health. Obesity prevention strategies for children can change behaviour but efficacy in terms of preventing obesity remains poorly understood. To assess the effectiveness of interventions designed to prevent obesity in childhood through diet, physical activity and/or lifestyle and social support. MEDLINE, PsycINFO, EMBASE, CINAHL and CENTRAL were searched from 1990 to February 2005. Non-English language papers were included and experts contacted. Randomised controlled trials and controlled clinical trials with minimum duration twelve weeks. Two reviewers independently extracted data and assessed study quality. Twenty-two studies were included; ten long-term (at least 12 months) and twelve short-term (12 weeks to 12 months). Nineteen were school/preschool-based interventions, one was a community-based intervention targeting low-income families, and two were family-based interventions targeting non-obese children of obese or overweight parents. Six of the ten long-term studies combined dietary education and physical activity interventions; five resulted in no difference in overweight status between groups and one resulted in improvements for girls receiving the intervention, but not boys. Two studies focused on physical activity alone. Of these, a multi-media approach appeared to be effective in preventing obesity. Two studies focused on nutrition education alone, but neither were effective in preventing obesity. Four of the twelve short-term studies focused on interventions to increase physical activity levels, and two of these studies resulted in minor reductions in overweight status in favour of the intervention. The other eight studies combined advice on diet and physical activity, but none had a significant impact. The studies were heterogeneous in terms of study design
Bell, David L; Garbers, Samantha; Catallozzi, Marina; Hum, R Stanley; Nechitilo, Meredith; McKeague, Ian W; Koumans, Emilia H; House, L Duane; Rosenthal, Susan L; Gold, Melanie A
Despite recent declines, teen unintended pregnancy and sexually transmitted infections in the United States remain at levels higher than comparable nations. Initiatives to prevent teen pregnancy have focused primarily on female adolescents; how to effectively engage young men to reduce their risk of fathering a teen pregnancy has not been well studied. We proposed to adapt an innovative computer-assisted motivational interviewing (CAMI) intervention, originally designed and tested with young women, for use with young men, aged 15-24 years, to reduce their risk of fathering a teen pregnancy. This manuscript describes the design of a CAMI intervention for young men aimed at preventing teen pregnancy and improving fitness. This randomized controlled trial will recruit 945 sexually active young men between the ages of 15 and 24 years from three health centers in New York City. Participants will be assigned by permuted block randomization to two study arms: one aimed at reducing involvement in unintended teen pregnancy (CAMI-teen pregnancy prevention) and the other at improving overall fitness (CAMI-Fitness). Except for topic, both intervention arms will provide four sessions of Motivational Interviewing coaching and use a mobile app to track behavior and set goals. We will assess young men's sexual and reproductive health behaviors and fitness at baseline, 12, 24, 36, and 64 weeks using a mobile device app created for the study. Pending ongoing study. Results from the study are expected to enhance our understanding of the efficacy of CAMI to enhance young men's reproductive health and fitness behaviors. Copyright © 2017 Society for Adolescent Health and Medicine. All rights reserved.
Full Text Available Abstract Background Multi-level, longer-term obesity prevention interventions that focus on inequalities are scarce. Fun ‘n healthy in Moreland! aimed to improve child adiposity, school policies and environments, parent engagement, health behaviours and child wellbeing. Methods All children from primary schools in an inner urban, culturally diverse and economically disadvantaged area in Victoria, Australia were eligible for participation. The intervention, fun ‘n healthy in Moreland!, used a Health Promoting Schools Framework and provided schools with evidence, school research data and part time support from a Community Development Worker to develop health promoting strategies. Comparison schools continued as normal. Participants were not blinded to intervention status. The primary outcome was change in adiposity. Repeated cross-sectional design with nested longitudinal subsample. Results Students from twenty-four primary schools (clusters were randomised (aged 5–12 years at baseline. 1426 students from 12 intervention schools and 1539 students from 10 comparison schools consented to follow up measurements. Despite increased prevalence of healthy weight across all schools, after 3.5 years of intervention there was no statistically significant difference between trial arms in BMI z score post-intervention (Mean (sd: Intervention 0.68(1.16; Comparison: 0.72(1.12; Adjusted mean difference (AMD: -0.05, CI: -0.19 to 0.08, p = 0.44. Children from intervention schools consumed more daily fruit serves (AMD: 0.19, CI:0.00 to 0.37, p = 0.10, were more likely to have water (AOR: 1.71, CI:1.05 to 2.78, p = 0.03 and vegetables (AOR: 1.23, CI: 0.99 to 1.55, p = 0.07, and less likely to have fruit juice/cordial (AOR: 0.58, CI:0.36 to 0.93, p = 0.02 in school lunch compared to children in comparison schools. More intervention schools (8/11 had healthy eating and physical activity policies compared with comparison schools (2/9. Principals and
The Stepping Stones and Creating Futures intervention to prevent intimate partner violence and HIV-risk behaviours in Durban, South Africa: study protocol for a cluster randomized control trial, and baseline characteristics
Full Text Available Abstract Background Preventing intimate partner violence (IPV remains a global public health challenge. Studies suggest urban informal settlements have particularly high levels of IPV and HIV-prevalence and these settlements are rapidly growing. The current evidence base of effective approaches to preventing IPV recognizes the potential of combining economic strengthening and gender transformative interventions. However, few of these interventions have been done in urban informal settlements, and almost none have included men as direct recipients of these interventions. Methods Stepping Stones and Creating Futures intervention is a participatory gender transformative and livelihoods strengthening intervention. It is being evaluated through a cluster randomized control trial amongst young women and men (18–30 living in urban informal settlements in eThekwini Municipality, South Africa. The evaluation includes a qualitative process evaluation and cost-effectiveness analysis. A comparison of baseline characteristics of participants is also included. Discussion This is one of the first large trials to prevent IPV and HIV-vulnerability amongst young women and men in urban informal settlements. Given the mixed methods evaluation, the results of this trial have the ability to develop a stronger understanding of what works to prevent violence against women and the processes of change in interventions. Trial registration NCT03022370 . Registered 13 January 2017, retrospectively registered.
Buckland, Genevieve; Gonzalez, Carlos A
Consumption of olive oil within the Mediterranean diet has been long known to have many health benefits. However, only over the last decade has epidemiological research confirmed its protective role against developing several chronic diseases. The objective of this review was to give an overview of the state of art epidemiological evidence concerning the relationship between olive oil and key public health outcomes including mortality, CVD, diabetes, metabolic syndrome (MetS), obesity and cancer, with a particular focus on recent results from cohort studies and dietary intervention trials. Recent epidemiological research has shown that regular consumption of olive oil is associated with increased longevity. This benefit is partly due to the olive oil's unequivocal cardio-protective role. There is converging evidence on the benefits of olive oil for preventing several CVD risk factors, including diabetes, MetS and obesity. Olive oil is also implicated in preventing certain cancers, with the most promising findings for breast and digestive tract cancers, although the data are still not entirely consistent and mainly from case-control studies. These health benefits are supported by strong mechanistic evidence from experimental studies, demonstrating that specific components of olive oil have antihypertensive, antithrombotic, antioxidant, antiinflammatory and anticarcinogenic action. Despite the accumulating epidemiological research, there is still a lack of consistent results from high-quality studies for many health outcomes (i.e. certain cancers and metabolism-related disorders). Further research is mandatory, above all from prospective studies and randomised dietary intervention trials when feasible, to confirm some of the still potential health benefits.
Arenaza, Lide; Medrano, María; Amasene, María; Rodríguez-Vigil, Beatriz; Díez, Ignacio; Graña, Manuel; Tobalina, Ignacio; Maiz, Edurne; Arteche, Edurne; Larrarte, Eider; Huybrechts, Inge; Davis, Catherine L; Ruiz, Jonatan R; Ortega, Francisco B; Margareto, Javier; Labayen, Idoia
The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise. A total of 84 children, aged 8-12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry). Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity. ClinicalTrials.gov, ID: NCT03027726 . Registered on 16 January 2017.
Flierman, Monique; Koldewijn, Karen; Meijssen, Dominique; van Wassenaer-Leemhuis, Aleid; Aarnoudse-Moens, Cornelieke; van Schie, Petra; Jeukens-Visser, Martine
To evaluate the feasibility and potential efficacy of an age-appropriate additional parenting intervention for very preterm born toddlers. In a randomized controlled pilot study, 60 of 94 eligible very preterm born children who had received a responsive parenting intervention in their first year
De Young, Alexandra C; Haag, Ann-Christin; Kenardy, Justin A; Kimble, Roy M; Landolt, Markus A
Accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Around 10-30 % of young injured children will go on to develop post-traumatic stress disorder (PTSD) and other co-morbid conditions. Parents of injured children are also at risk of PTSD, and this is associated with short- and long-term consequences for their children's physical and psychological recovery. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. To address these gaps, researchers and psychologists in Australia and Switzerland have developed the Coping with Accident Reactions (CARE) programme, which is a two-session early intervention designed to prevent persistent PTSD reactions in young injured children screened as 'at risk'. Two separate international studies are being conducted to evaluate the effectiveness and feasibility of this programme. The study design for the two proposed studies will employ a randomised controlled trial design and children (aged 1-6 years) who are screened as at risk for PTSD 1 week after an unintentional injury, and their parents will be randomised to either (1) CARE intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks) and 3 and 6 months post-injury. This international collaboration provides an excellent opportunity to test the benefit of screening and providing early intervention to young children in two different countries and settings. It is expected that outcomes from this research will lead to significant original contributions to the scientific evidence base and clinical treatment and recovery of very young injured children. The Australian study was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN
Full Text Available Abstract Background The trend of increasing numbers of patients with type 2 diabetes emphasizes the need for active screening of high-risk individuals and intensive lifestyle modification (LSM. Methods/design The community-based Korean Diabetes Prevention Study (C-KDPS is a randomized controlled clinical trial to prevent type 2 diabetes by intensive LSM using a web-based program. The two public healthcare centers in Korea are involved, and 420 subjects are being recruited for 6 months and will be followed up for 22 months. The participants are allocated randomly to intensive LSM (18 individual sessions for 24 weeks and usual care (control group. The major goals of the C-KDPS lifestyle intervention program are: 1 a minimum of 5–7% loss of initial body weight in 6 months and maintenance of this weight loss, 2 increased physical activity (≥ 150 min/week of moderate intensity activity, 3 balanced healthy eating, and 4 quitting smoking and alcohol with stress management. The web-based program includes education contents, video files, visit schedules, and inter-communicable keeping track sites. Primary outcomes are the diagnoses of newly developed diabetes. A 75-g oral glucose tolerance test with hemoglobin A1c level determination and cardiovascular risk factor assessment is scheduled at 6, 12, 18, and 22 months. Discussion Active screening of high-risk individuals and an effective LSM program are an essential prerequisite for successful diabetes prevention. We hope that our C-KDPS program can reduce the incidence of newly developed type 2 diabetes and be implemented throughout the country, merging community-based public healthcare resources and a web-based system. Trial registration Clinical Research Information Service (CRIS, Republic of Korea (No. KCT0001981 . Date of registration; July 28, 2016.
Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.
Mahon, Susan; Krishnamurthi, Rita; Vandal, Alain; Witt, Emma; Barker-Collo, Suzanne; Parmar, Priya; Theadom, Alice; Barber, Alan; Arroll, Bruce; Rush, Elaine; Elder, Hinemoa; Dyer, Jesse; Feigin, Valery
Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management. Health Wellness Coaching is an innovative, patient-focused and cost-effective, multidimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes and has been shown to improve health and enhance well-being. Aims and/or hypothesis To determine the effectiveness of Health Wellness Coaching for primary stroke prevention in an ethnically diverse sample including Māori, Pacific Island, New Zealand European and Asian participants. Design A parallel, prospective, randomized, open-treatment, single-blinded end-point trial. Participants include 320 adults with absolute five-year cardiovascular disease risk ≥ 10%, calculated using the PREDICT web-based clinical tool. Randomization will be to Health Wellness Coaching or usual care groups. Participants randomized to Health Wellness Coaching will receive 15 coaching sessions over nine months. Study outcomes A substantial relative risk reduction of five-year cardiovascular disease risk at nine months post-randomization, which is defined as 10% relative risk reduction among those at moderate five-year cardiovascular disease risk (10-15%) and 25% among those at high risk (>15%). Discussion This clinical trial will determine whether Health Wellness Coaching is an effective intervention for reducing modifiable risk factors, and hence decrease the risk of stroke and cardiovascular disease.
Waters, Elizabeth; Gibbs, Lisa; Tadic, Maryanne; Ukoumunne, Obioha C; Magarey, Anthea; Okely, Anthony D; de Silva, Andrea; Armit, Christine; Green, Julie; O'Connor, Thea; Johnson, Britt; Swinburn, Boyd; Carpenter, Lauren; Moore, Graham; Littlecott, Hannah; Gold, Lisa
Multi-level, longer-term obesity prevention interventions that focus on inequalities are scarce. Fun 'n healthy in Moreland! aimed to improve child adiposity, school policies and environments, parent engagement, health behaviours and child wellbeing. All children from primary schools in an inner urban, culturally diverse and economically disadvantaged area in Victoria, Australia were eligible for participation. The intervention, fun 'n healthy in Moreland!, used a Health Promoting Schools Framework and provided schools with evidence, school research data and part time support from a Community Development Worker to develop health promoting strategies. Comparison schools continued as normal. Participants were not blinded to intervention status. The primary outcome was change in adiposity. Repeated cross-sectional design with nested longitudinal subsample. Students from twenty-four primary schools (clusters) were randomised (aged 5-12 years at baseline). 1426 students from 12 intervention schools and 1539 students from 10 comparison schools consented to follow up measurements. Despite increased prevalence of healthy weight across all schools, after 3.5 years of intervention there was no statistically significant difference between trial arms in BMI z score post-intervention (Mean (sd): Intervention 0.68(1.16); Comparison: 0.72(1.12); Adjusted mean difference (AMD): -0.05, CI: -0.19 to 0.08, p = 0.44). Children from intervention schools consumed more daily fruit serves (AMD: 0.19, CI:0.00 to 0.37, p = 0.10), were more likely to have water (AOR: 1.71, CI:1.05 to 2.78, p = 0.03) and vegetables (AOR: 1.23, CI: 0.99 to 1.55, p = 0.07), and less likely to have fruit juice/cordial (AOR: 0.58, CI:0.36 to 0.93, p = 0.02) in school lunch compared to children in comparison schools. More intervention schools (8/11) had healthy eating and physical activity policies compared with comparison schools (2/9). Principals and schools highly valued the approach as a catalyst
Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: study protocol for a randomised controlled trial.
Bolinski, Felix; Kleiboer, Annet; Karyotaki, Eirini; Bosmans, Judith E; Zarski, Anna-Carlotta; Weisel, Kiona K; Ebert, David D; Jacobi, Corinna; Cuijpers, Pim; Riper, Heleen
Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety. A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age ≥ 16 years) with subclinical symptoms of depression defined as a score ≥ 16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score ≥ 5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU. Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students. Dutch trial register, NTR 6562
Coyle, Karin K.; Kirby, Douglas B.; Robin, Leah E.; Banspach, Stephen W.; Baumler, Elizabeth; Glassman, Jill R.
This study evaluated All4You!, a theoretically based curriculum designed to reduce sexual risk behaviors associated with HIV, other STDs, and unintended pregnancy among students in alternative schools. The study featured a randomized controlled trial involving 24 community day schools in northern California. A cohort of 988 students was assessed…
Full Text Available Abstract Background Common low back pain represents a major public health problem in terms of its direct cost to health care and its socio-economic repercussions. Ten percent of individuals who suffer from low back pain evolve toward a chronic case and as such are responsible for 75 to 80% of the direct cost of low back pain. It is therefore imperative to highlight the predictive factors of low back pain chronification in order to lighten the economic burden of low back pain-related invalidity. Despite being particularly affected by low back pain, Hospices Civils de Lyon (HCL personnel have never been offered a specific, tailor-made treatment plan. The PRESLO study (with PRESLO referring to Secondary Low Back Pain Prevention, or in French, PREvention Secondaire de la LOmbalgie, proposed by HCL occupational health services and the Centre Médico-Chirurgical et de Réadaptation des Massues – Croix Rouge Française, is a randomized trial that aims to evaluate the feasibility and efficiency of a global secondary low back pain prevention program for the low back pain sufferers among HCL hospital personnel, a population at risk for recurrence and chronification. This program, which is based on the concept of physical retraining, employs a multidisciplinary approach uniting physical activity, cognitive education about low back pain and lumbopelvic morphotype analysis. No study targeting populations at risk for low back pain chronification has as yet evaluated the efficiency of lighter secondary prevention programs. Methods/Design This study is a two-arm parallel randomized controlled trial proposed to all low back pain sufferers among HCL workers, included between October 2008 and July 2011 and followed over two years. The personnel following their usual treatment (control group and those following the global prevention program in addition to their usual treatment (intervention group are compared in terms of low back pain recurrence and the
The Stepping Stones and Creating Futures intervention to prevent intimate partner violence and HIV-risk behaviours in Durban, South Africa: study protocol for a cluster randomized control trial, and baseline characteristics.
Gibbs, Andrew; Washington, Laura; Willan, Samantha; Ntini, Nolwazi; Khumalo, Thobani; Mbatha, Nompumelelo; Sikweyiya, Yandisa; Shai, Nwabisa; Chirwa, Esnat; Strauss, Michael; Ferrari, Giulia; Jewkes, Rachel
Preventing intimate partner violence (IPV) remains a global public health challenge. Studies suggest urban informal settlements have particularly high levels of IPV and HIV-prevalence and these settlements are rapidly growing. The current evidence base of effective approaches to preventing IPV recognizes the potential of combining economic strengthening and gender transformative interventions. However, few of these interventions have been done in urban informal settlements, and almost none have included men as direct recipients of these interventions. Stepping Stones and Creating Futures intervention is a participatory gender transformative and livelihoods strengthening intervention. It is being evaluated through a cluster randomized control trial amongst young women and men (18-30) living in urban informal settlements in eThekwini Municipality, South Africa. The evaluation includes a qualitative process evaluation and cost-effectiveness analysis. A comparison of baseline characteristics of participants is also included. This is one of the first large trials to prevent IPV and HIV-vulnerability amongst young women and men in urban informal settlements. Given the mixed methods evaluation, the results of this trial have the ability to develop a stronger understanding of what works to prevent violence against women and the processes of change in interventions. NCT03022370 . Registered 13 January 2017, retrospectively registered.
Välimäki, Maritta; Yang, Min; Normand, Sharon-Lise; Lorig, Kate R; Anttila, Minna; Lantta, Tella; Pekurinen, Virve; Adams, Clive E
People admitted to psychiatric hospitals with a diagnosis of schizophrenia may display behavioural problems. These may require management approaches such as use of coercive practices, which impact the well-being of staff members, visiting families and friends, peers, as well as patients themselves. Studies have proposed that not only patients' conditions, but also treatment environment and ward culture may affect patients' behaviour. Seclusion and restraint could possibly be prevented with staff education about user-centred, more humane approaches. Staff education could also increase collaboration between patients, family members and staff, which may further positively affect treatment culture and lower the need for using coercive treatment methods. This is a single-blind, two-arm cluster randomised controlled trial involving 28 psychiatric hospital wards across Finland. Units will be randomised to receive either a staff educational programme delivered by the team of researchers, or standard care. The primary outcome is the incidence of use of patient seclusion rooms, assessed from the local/national health registers. Secondary outcomes include use of other coercive methods (limb restraint, forced injection, and physical restraint), service use, treatment satisfaction, general functioning among patients, and team climate and employee turn-over (nursing staff). The study, designed in close collaboration with staff members, patients and their relatives, will provide evidence for a co-operative and user-centred educational intervention aiming to decrease the prevalence of coercive methods and service use in the units, increase the functional status of patients and improve team climate in the units. We have identified no similar trials. ClinicalTrials.gov NCT02724748 . Registered on 25 th of April 2016.
Joling, Karlijn J; Bosmans, Judith E; van Marwijk, Harm W J; van der Horst, Henriëtte E; Scheltens, Philip; MacNeil Vroomen, Janet L; van Hout, Hein P J
Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However, evidence about the cost-effectiveness of such interventions is scarce. The aim of this study was to evaluate the cost-effectiveness of a family meetings intervention for family caregivers of dementia patients in comparison with usual care over a period of 12 months. The economic evaluation was conducted from a societal perspective alongside a randomized trial of 192 primary caregivers with community-dwelling dementia patients. Outcome measures included the Quality Adjusted Life-Years (QALY) of caregivers and patients and the incidence of depression and anxiety disorders in caregivers. Missing cost and effect data were imputed using multiple imputations. Bootstrapping was used to estimate uncertainty around the cost-differences and the incremental cost-effectiveness ratio (ICER). The bootstrapped cost-effect pairs were plotted on a cost-effectiveness plane and used to estimate cost-effectiveness curves. No significant differences in costs and effects between the groups were found. At 12 months, total costs per patient and primary caregiver dyad were substantial: €77,832 for the intervention group and €75,201 for the usual care group (adjusted mean difference per dyad €4,149, 95% CI -13,371 to 21,956, ICER 157,534). The main cost driver was informal care (66% of total costs), followed by patients' day treatment and costs of hospital and long-term care facility admissions (23%). Based on the cost-effectiveness acceptability curves, the maximum probability that the intervention was considered cost-effective in comparison with usual care reached 0.4 for the outcome QALY per patient-caregiver dyad and 0.6 for the caregivers' incidence of depression and/or anxiety disorders regardless of
Fisker, Annette; Langberg, Henning; Petersen, Tom; Mortensen, Ole Steen
-statement in designing and reporting RCTs. This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion--both on the individual level and economic costs at community level. Short term results will be available in 2014.This study is approved by the Danish Regional Ethics Committee (J.nr: H-C-2008-112) and is registered at ClinicalTrials.gov: NCT01690234.
Full Text Available Background: More than 80% of bedridden patients develop bedsores in home care settings. Training of informal caregivers can significantly affect the quality of care to these patients. Objective: The objective of this study is to compare the effectiveness of two caregiver training strategies on prevention of bedsores among bedridden patients. Methods: The study was carried out in Chandigarh. The study center was at PGIMER, Chandigarh. Seventy-eight bedridden patients being taken care in their homes were identified. These were randomly allocated into two groups. Group A received Prevention Package I, i.e., self-instruction Manual (SIM, training, and counseling. Group B received Prevention Package 2, i.e., only SIM. All these patients were followed up periodically for 1 year. During each follow-up, patients were observed for bedsore development. Braden scale was used to assess the risk factors of bedsores. Katz scale was used to evaluate the level of functional dependence of patients. Descriptive statistics was used to analyze the data. Results: The percentage reduction of number of patients at risk of bedsore development as per various domains of Braden Scale was more in Group A as compared to Group B on each successive visit. There was 100% improvement in mobility level in the patients who were totally dependent in both the groups. However, in moderately dependant patients, the improvement in mobility level was more (87% in Group A as compared to Group B (75%. All the caregivers complied fully with instructions postintervention. Conclusion: Training of caregivers for the prevention of bedsores among the bedridden patients was effective in improving the practices of the caregivers and also in reducing the risk factors of bedsores. One-to-one training with SIM distribution yielded better results than the use of only SIM.
Denis, Angélique; Zelmar, Amélie; Le Pogam, Marie-Annick; Chaleat-Valayer, Emmanuelle; Bergeret, Alain; Colin, Cyrille
Common low back pain represents a major public health problem in terms of its direct cost to health care and its socio-economic repercussions. Ten percent of individuals who suffer from low back pain evolve toward a chronic case and as such are responsible for 75 to 80% of the direct cost of low back pain. It is therefore imperative to highlight the predictive factors of low back pain chronification in order to lighten the economic burden of low back pain-related invalidity. Despite being particularly affected by low back pain, Hospices Civils de Lyon (HCL) personnel have never been offered a specific, tailor-made treatment plan. The PRESLO study (with PRESLO referring to Secondary Low Back Pain Prevention, or in French, PREvention Secondaire de la LOmbalgie), proposed by HCL occupational health services and the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française, is a randomized trial that aims to evaluate the feasibility and efficiency of a global secondary low back pain prevention program for the low back pain sufferers among HCL hospital personnel, a population at risk for recurrence and chronification. This program, which is based on the concept of physical retraining, employs a multidisciplinary approach uniting physical activity, cognitive education about low back pain and lumbopelvic morphotype analysis. No study targeting populations at risk for low back pain chronification has as yet evaluated the efficiency of lighter secondary prevention programs. This study is a two-arm parallel randomized controlled trial proposed to all low back pain sufferers among HCL workers, included between October 2008 and July 2011 and followed over two years. The personnel following their usual treatment (control group) and those following the global prevention program in addition to their usual treatment (intervention group) are compared in terms of low back pain recurrence and the impairments measured at the beginning and the end of the study
Mackay, Bethany A.; Shochet, Ian M.; Orr, Jayne A.
Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in…
Whittaker, Robyn; Stasiak, Karolina; McDowell, Heather; Doherty, Iain; Shepherd, Matthew; Chua, Shireen; Dorey, Enid; Parag, Varsha; Ameratunga, Shanthi; Rodgers, Anthony; Merry, Sally
Depression often starts in adolescence making it an ideal time to intervene. We developed a universal cognitive behavioural therapy-based programme (MEMO CBT) to be delivered via multimedia mobile phone messages for teens. We conducted a prospective multicentre, randomised, placebo-controlled superiority trial in 15 high schools in Auckland, New Zealand, comparing MEMO CBT with a control programme [MEMO control] matched for intensity and type of message but with alternative content not targeting depression. The primary outcome was the change in score on the Children's Depression Rating Scale-Revised from baseline to 12 months. Secondary outcomes included the change in scores in the self-reported Reynold's Adolescent Depression Rating Scale-Second Edition, the Moods and Feelings Questionnaire, suicidal ideation using selected items from the Youth Risk Behaviour Survey, the Pediatric Quality of Life questionnaire, 12-month period prevalence of the diagnosis of depressive disorder using the Kiddie-Schedule for Affective Disorders and Schizophrenia, and students' ratings of their satisfaction with the programme. Eight hundred and fifty-five students (13-17 years old, mean 14.3 years) were randomly assigned to MEMO CBT (426) or to MEMO Control (429). Participants (68% female) had a mean CDRS-R at baseline of 21.5 (SD: 5). Overall 394 (93%) from the intervention group and 392 (91%) from the control group were followed up at 12 months. At the end of the intervention (approximately 9 weeks) the mean CDRS-R scores were 20.8 in the intervention group versus 20.4 in the control group, and at 12 months they were 22.4 versus 22.4 (p value for difference in change from baseline = 0.3). There was no obvious association between the amount of the intervention viewed by participants and outcomes. There was no evidence of benefit from the mobile phone CBT intervention compared with a control programme. Universal depression prevention remains a challenge. © 2017 Association
Handoll, Helen Hg; Rowe, Brian H; Quinn, Kathryn M; de Bie, Rob
Some sports, for example basketball and soccer, have a very high incidence of ankle injuries, mainly sprains. Consequently, ankle sprains are one of the most commonly treated injuries in acute care. To assess the effects of interventions used for the prevention of ankle ligament injuries or sprains in physically active individuals from adolescence to middle age. We searched the Cochrane Bone, Joint and Muscle Trauam Group's specialised register, MEDLINE, PubMed, EMBASE, CINAHL, the National Research Register and bibliographies of study reports. We also contacted colleagues and some trialists. The most recent search was conducted in July 2000. Randomised or quasi-randomised trials of interventions for the prevention of ankle sprains in physically active individuals from adolescence to middle age were included provided that ankle sprains were recorded. Interventions included use of modified footwear, external ankle supports, co-ordination training and health education. These could be applied as a supplement to treatment provided that prevention of re-injury was the primary objective. At least two reviewers independently assessed methodological quality and extracted data. Wherever possible, results of outcome measures were pooled and sub-grouped by history of previous sprain. Relative risks (RR) and 95% confidence intervals (95% CI) are reported for individual and pooled data. In this review update, a further nine new trials were included. Overall, 14 randomised trials with data for 8279 participants were included. Twelve trials involved active, predominantly young, adults participating in organised, generally high-risk, activities. The other two trials involved injured patients who had been active in sports before their injury. The prophylactic interventions under test included the application of an external ankle support in the form of a semi-rigid orthosis (three trials), air-cast brace (one trial) or high top shoes (one trial); ankle disk training; taping; muscle
Handoll, H H; Rowe, B H; Quinn, K M; de Bie, R
Some sports, for example basketball and soccer, have a very high incidence of ankle injuries, mainly sprains. Consequently, ankle sprains are one of the most commonly treated injuries in acute care. To assess the effects of interventions used for the prevention of ankle ligament injuries or sprains in physically active individuals from adolescence to middle age. We searched the Cochrane Musculoskeletal Injuries Group's specialised register, MEDLINE, PubMed, EMBASE, CINAHL, the National Research Register and bibliographies of study reports. We also contacted colleagues and some trialists. The most recent search was conducted in July 2000. Randomised or quasi-randomised trials of interventions for the prevention of ankle sprains in physically active individuals from adolescence to middle age were included provided that ankle sprains were recorded. Interventions included use of modified footwear, external ankle supports, co-ordination training and health education. These could be applied as a supplement to treatment provided that prevention of re-injury was the primary objective. At least two reviewers independently assessed methodological quality and extracted data. Wherever possible, results of outcome measures were pooled and sub-grouped by history of previous sprain. Relative risks (RR) and 95% confidence intervals (95% CI) are reported for individual and pooled data. In this review update, a further nine new trials were included. Overall, 14 randomised trials with data for 8279 participants were included. Twelve trials involved active, predominantly young, adults participating in organised, generally high-risk, activities. The other two trials involved injured patients who had been active in sports before their injury. The prophylactic interventions under test included the application of an external ankle support in the form of a semi-rigid orthosis (three trials), air-cast brace (one trial) or high top shoes (one trial); ankle disk training; taping; muscle
Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...... for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment...... element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have...
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial
Suijker, Jacqueline J; Buurman, Bianca M; ter Riet, Gerben; van Rijn, Marjon; de Haan, Rob J; de Rooij, Sophia E; Moll van Charante, Eric P
Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and n...
Carreras, G.; Bosi, S.; Angelini, P.; Gorini, G.
The aim of this study was to investigate factors mediating the effects of Luoghi di Prevenzione (LdP) smoking prevention intervention based on social competence and social influence approaches, and characterized by peer-led school-based interventions, out-of-school workshops, school lessons, and by enforcing the school anti-smoking policy.…
Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin).
Khera, Amit V; Demler, Olga V; Adelman, Steven J; Collins, Heidi L; Glynn, Robert J; Ridker, Paul M; Rader, Daniel J; Mora, Samia
Recent failures of drugs that raised high-density lipoprotein (HDL) cholesterol levels to reduce cardiovascular events in clinical trials have led to increased interest in alternative indices of HDL quality, such as cholesterol efflux capacity, and HDL quantity, such as HDL particle number. However, no studies have directly compared these metrics in a contemporary population that includes potent statin therapy and low low-density lipoprotein cholesterol. HDL cholesterol levels, apolipoprotein A-I, cholesterol efflux capacity, and HDL particle number were assessed at baseline and 12 months in a nested case-control study of the JUPITER trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin), a randomized primary prevention trial that compared rosuvastatin treatment to placebo in individuals with normal low-density lipoprotein cholesterol but increased C-reactive protein levels. In total, 314 cases of incident cardiovascular disease (CVD) (myocardial infarction, unstable angina, arterial revascularization, stroke, or cardiovascular death) were compared to age- and gender-matched controls. Conditional logistic regression models adjusting for risk factors evaluated associations between HDL-related biomarkers and incident CVD. Cholesterol efflux capacity was moderately correlated with HDL cholesterol, apolipoprotein A-I, and HDL particle number (Spearman r = 0.39, 0.48, and 0.39 respectively; P JUPITER, cholesterol efflux capacity was associated with incident CVD in individuals on potent statin therapy but not at baseline. For both baseline and on-statin analyses, HDL particle number was the strongest of 4 HDL-related biomarkers as an inverse predictor of incident events and biomarker of residual risk. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681. © 2017 American Heart Association, Inc.
Gao, Xiaoli; Lo, Edward Chin Man; McGrath, Colman; Ho, Samuel Mun Yin
Dental caries (tooth decay) is highly prevalent and is largely attributable to unhealthy self-care behaviors (diet and oral hygiene). The conventional (health) education (CE), focusing on disseminating information and giving normative advice, often fails to achieve sustained behavioral changes. This study incorporates two innovative elements into CE: (i) motivational interviewing (MI), a client-centered counseling for changing behaviors, and (ii) an interactive caries risk assessment (RA) tool, which is devised to facilitate dental counseling and may enhance MI in several ways. Through a randomized, controlled, evaluator-blinded trial, three intervention schemes (CE, CE+MI, and CE+MI+RA) will be compared for their effectiveness in eliciting dentally healthy behaviors and preventing caries in preschool children. This study targets 3-year-old children who are at a critical stage for embedding health habits. Children with unfavorable dental behaviors (insufficient toothbrushing and/or frequent snacking) and their parents will be recruited from 12 participating kindergartens. Parent-child dyads (n=690) will be randomly assigned into three groups. In the first group (CE), oral health information and advice will be delivered to parents through pamphlets. In the second group (CE+MI), in addition to the pamphlets, individual MI counseling with each parent will be performed by one of two trained dental hygienists. In the third group (CE+MI+RA), besides pamphlets and MI, interactive RA will be integrated into MI to motivate parents and facilitate their informed decision making and goal planning. At baseline and after 12 and 24 months, parents will complete a questionnaire and children will undergo a dental examination. The effectiveness of the intervention schemes will be compared over 12 and 24 months. The primary outcome will be caries increment in children and proportion of caries-free children. Secondary outcomes will be changes in parental efficacy for protecting
Oringanje, Chioma; Meremikwu, Martin M; Eko, Hokehe; Esu, Ekpereonne; Meremikwu, Anne; Ehiri, John E
Unintended pregnancy among adolescents represents an important public health challenge in high-income countries, as well as middle- and low-income countries. Numerous prevention strategies such as health education, skills-building and improving accessibility to contraceptives have been employed by countries across the world, in an effort to address this problem. However, there is uncertainty regarding the effects of these interventions, hence the need to review the evidence-base. To assess the effects of primary prevention interventions (school-based, community/home-based, clinic-based, and faith-based) on unintended pregnancies among adolescents. We searched all relevant studies regardless of language or publication status up to November 2015. We searched the Cochrane Fertility Regulation Group Specialised trial register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015 Issue 11), MEDLINE, EMBASE, LILACS, Social Science Citation Index and Science Citation Index, Dissertations Abstracts Online, The Gray Literature Network, HealthStar, PsycINFO, CINAHL and POPLINE and the reference lists of articles. We included both individual and cluster randomised controlled trials (RCTs) evaluating any interventions that aimed to increase knowledge and attitudes relating to risk of unintended pregnancies, promote delay in the initiation of sexual intercourse and encourage consistent use of birth control methods to reduce unintended pregnancies in adolescents aged 10 years to 19 years. Two authors independently assessed trial eligibility and risk of bias, and extracted data. Where appropriate, binary outcomes were pooled using a random-effects model with a 95% confidence interval (Cl). Where appropriate, we combined data in meta-analyses and assessed the quality of the evidence using the GRADE approach. We included 53 RCTs that enrolled 105,368 adolescents. Participants were ethnically diverse. Eighteen studies randomised individuals, 32
Khan, Salah Uddin; Gurley, Emily S.; Hossain, M. Jahangir; Nahar, Nazmun; Sharker, M. A. Yushuf; Luby, Stephen P.
Background Drinking raw date palm sap is a risk factor for human Nipah virus (NiV) infection. Fruit bats, the natural reservoir of NiV, commonly contaminate raw sap with saliva by licking date palm’s sap producing surface. We evaluated four types of physical barriers that may prevent bats from contacting sap. Methods During 2009, we used a crossover design and randomly selected 20 date palm sap producing trees and observed each tree for 2 nights: one night with a bamboo skirt intervention applied and one night without the intervention. During 2010, we selected 120 trees and randomly assigned four types of interventions to 15 trees each: bamboo, dhoincha (local plant), jute stick and polythene skirts covering the shaved part, sap stream, tap and collection pot. We enrolled the remaining 60 trees as controls. We used motion sensor activated infrared cameras to examine bat contact with sap. Results During 2009 bats contacted date palm sap in 85% of observation nights when no intervention was used compared with 35% of nights when the intervention was used [psap when the skirt did not entirely cover the sap producing surface. Therefore, in 2010 we requested the sap harvesters to use larger skirts. During 2010 bats contacted date palm sap [2% vs. 83%, psap in trees with bamboo (psap during one night (7%) with the jute stick skirt (psap producing areas of a tree effectively prevented bat-sap contact. Community interventions should promote applying these skirts to prevent occasional Nipah spillovers to human. PMID:22905160
Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.
Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important publ...
Richard, Edo; Andrieu, Sandrine; Solomon, Alina; Mangialasche, Francesca; Ahtiluoto, Satu; Moll van Charante, Eric P.; Coley, Nicola; Fratiglioni, Laura; Neely, Anna Stigsdotter; Vellas, Bruno; van Gool, Willem A.; Kivipelto, Miia
Recent epidemiological studies have indicated numerous associations between vascular and lifestyle related risk factors and incident dementia. However, evidence from randomised controlled trials (RCT) showing effectiveness of interventions aimed at these risk factors in preventing or postponing
Korte, J.; Bohlmeijer, Ernst Thomas; Smit, Filip
Background Depressive and anxiety symptoms in older adults could develop into significant health problems with detrimental effects on quality of life and a possibly poor prognosis. Therefore, there is a need for preventive interventions which are at once effective, acceptable and economic
Korte, J.; Bohlmeijer, E.; Smit, H.F.E.
Background: Depressive and anxiety symptoms in older adults could develop into significant health problems with detrimental effects on quality of life and a possibly poor prognosis. Therefore, there is a need for preventive interventions which are at once effective, acceptable and economic
Joling, Karlijn J.; Bosmans, Judith E.; van Marwijk, Harm W. J.; van der Horst, Henriëtte E.; Scheltens, Philip; MacNeil Vroomen, Janet L.; van Hout, Hein P. J.
Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However, evidence about
Joling, K.J.; Bosmans, J.E.; van Marwijk, H.W.J.; van der Horst, H.E.; Scheltens, P.; Vroomen, J.L.M.; van Hout, H.P.J.
Background: Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However,
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial
Suijker, Jacqueline J.; Buurman, Bianca M.; ter Riet, Gerben; van Rijn, Marjon; de Haan, Rob J.; de Rooij, Sophia E.; Moll van Charante, Eric P.
Background: Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this
Saraf, Deepika Singh; Gupta, Sanjeev Kumar; Pandav, Chandrakant S; Nongkinrih, Baridalyne; Kapoor, Suresh Kumar; Pradhan, Shishir Kumar; Krishnan, Anand
To assess the effectiveness of a multi-component school based intervention in improving knowledge and behavioral practices regarding diet, physical activity and tobacco use in middle schoolchildren of rural-Ballabgarh, North-India. A total of 40 middle schools were grouped into two, based on geographic proximity and randomly assigned to the intervention or control group in a cluster randomized controlled trial. The target population consisted of 2,348 children studying in 6th and 7th grades in these schools. The intervention consisted of a school component (policies), a classroom component (activities) and a family component [Information Education & Communication (IEC) material]. The main outcome measures were knowledge and behavioral changes in physical activity, diet and tobacco which were self- reported. Post-intervention, a significant number of intervention schools adopted the tobacco policy (16/19), physical activity policy (6/19) and healthy food policy (14/19) as compared to the control schools (n = 21). Knowledge about physical activity, diet and tobacco improved significantly in the intervention group as compared to the control group. Proportion of students attending Physical Training (PT) classes for five or more days in a week in the intervention group compared to the control group increased significantly (17.8%; p schools is feasible and effective in improving knowledge and behavioral practices of non-communicable diseases (NCD) risk factors in adolescents in rural India.
Lintvedt, Ove K; Griffiths, Kathleen M; Sørensen, Kristian; Østvik, Andreas R; Wang, Catharina E A; Eisemann, Martin; Waterloo, Knut
The Internet has the potential to increase the capacity and accessibility of mental health services. This study aimed to investigate whether an unguided Internet-based self-help intervention delivered without human support or guidance can reduce symptoms of depression in young people at risk of depression. The study also aimed to explore the usage of such sites in a real-life setting, to estimate the effects of the intervention for those who received a meaningful intervention dose and to evaluate user satisfaction. Young adults were recruited by means of a screening survey sent to all students at the University of Tromsø. Of those responding to the survey, 163 students (mean age 28.2 years) with elevated psychological distress were recruited to the trial and randomized to an Internet intervention condition or the waiting list control group. The Internet condition comprised a depression information website and a self-help Web application delivering automated cognitive behavioural therapy. The participants in the waiting list condition were free to access formal or informal help as usual. Two-thirds of the users who completed the trial initially reported an unmet need for help. The findings demonstrated that an unguided intervention was effective in reducing symptoms of depression and negative thoughts and in increasing depression literacy in young adults. Significant improvements were found at 2-month follow up. Internet-based interventions can be effective without tracking and thus constitute a minimal cost intervention for reaching a large number of people. User satisfaction among participants was high. Copyright © 2011 John Wiley & Sons, Ltd.
El-Bassel, Nabila; Jemmott, John B; Landis, J Richard; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Bellamy, Scarlett L
Human immunodeficiency virus (HIV) has disproportionately affected African Americans. Couple-level interventions may be a promising intervention strategy. To determine if a behavioral intervention can reduce HIV/sexually transmitted disease (STD) risk behaviors among African American HIV serodiscordant couples, a cluster randomized controlled trial (Eban) was conducted in Atlanta, Georgia; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania; with African American HIV serodiscordant heterosexual couples who were eligible if both partners were at least 18 years old and reported unprotected intercourse in the previous 90 days and awareness of each other's serostatus. One thousand seventy participants were enrolled (mean age, 43 years; 40% of male participants were HIV positive). Couples were randomized to 1 of 2 interventions: couple-focused Eban HIV/STD risk-reduction intervention or attention-matched individual-focused health promotion comparison. The primary outcomes were the proportion of condom-protected intercourse acts and cumulative incidence of STDs (chlamydia, gonorrhea, or trichomonas). Data were collected preintervention and postintervention, and at 6- and 12-month follow-ups. Data were analyzed for 535 randomized couples: 260 in the intervention group and 275 in the comparison group; 81.9% were retained at the 12-month follow-up. Generalized estimating equation analyses revealed that the proportion of condom-protected intercourse acts was larger among couples in the intervention group (0.77) than in the comparison group (0.47; risk ratio, 1.24; 95% confidence interval [CI], 1.09 to 1.41; P = .006) when adjusted for the baseline criterion measure. The adjusted percentage of couples using condoms consistently was higher in the intervention group (63%) than in the comparison group (48%; risk ratio, 1.45; 95% CI, 1.24 to 1.70; P STD incidence over the 12-month follow-up did not differ between couples in the intervention and comparison
Pontoppidan, Maiken W.
Background: Infancy is an important period in a child’s life, with rapid growth and development. Early experiences shape the developing brain, and adverse experiences can have both an immediate and lifelong impact on health and wellbeing. Parenting interventions offered to parents of newborns can....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...
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
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
Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia
Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.
Full Text Available Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER study population. Potential study participants (age 60–77 years, the dementia risk score ≥6 were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496, 48% (n = 2654 attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1. The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD age of the randomized participants was 69.4 (4.7 years, Mini-Mental State Examination 26.7 (2.0 points, systolic blood pressure 140.1 (16.2 mmHg, total serum cholesterol 5.2 (1.0 mmol/L for, and fasting glucose 6.1 (0.9 mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.
The effectiveness of smoking cessation, physical activity/diet and alcohol reduction interventions delivered by mobile phones for the prevention of non-communicable diseases: A systematic review of randomised controlled trials.
Palmer, Melissa; Sutherland, Jennifer; Barnard, Sharmani; Wynne, Aileen; Rezel, Emma; Doel, Andrew; Grigsby-Duffy, Lily; Edwards, Suzanne; Russell, Sophie; Hotopf, Ellie; Perel, Pablo; Free, Caroline
We conducted a systematic review to assess the effectiveness of smoking cessation, physical activity (PA), diet, and alcohol reduction interventions delivered by mobile technology to prevent non-communicable diseases (NCDs). We searched for randomised controlled trials (RCTs) of mobile-based NCD prevention interventions using MEDLINE, EMBASE, Global Health, CINAHL (Jan 1990-Jan 2016). Two authors extracted data. 71 trials were included: smoking cessation (n = 18); PA (n = 15), diet (n = 3), PA and diet (n = 25); PA, diet, and smoking cessation (n = 2); and harmful alcohol consumption (n = 8). 4 trials had low risk of bias. The effect of SMS-based smoking cessation support on biochemically verified continuous abstinence was pooled relative risk [RR] 2.19 [95% CI 1.80-2.68], I2 = 0%) and on verified 7 day point prevalence of smoking cessation was pooled RR 1.51 [95% CI 1.06-2.15], I2 = 0%, with no reported adverse events. There was no difference in peak oxygen intake at 3 months in a trial of an SMS-based PA intervention. The effect of SMS-based diet and PA interventions on: incidence of diabetes was pooled RR 0.67 [95% CI 0.49, 0.90], I2 = 0.0%; end-point weight was pooled MD -0.99Kg [95% CI -3.63, 1.64] I2 = 29.4%; % change in weight was pooled MD -3.1 [95%CI -4.86- -1.3] I2 0.3%; and on triglyceride levels was pooled MD -0.19 mmol/L [95% CI -0.29, -0.08], I2 = 0.0%. The results of other pooled analyses of the effect of SMS-based diet and PA interventions were heterogenous (I2 59-90%). The effects of alcohol reduction interventions were inconclusive. Smoking cessation support delivered by SMS increases quitting rates. Trials of PA interventions reporting outcomes ≥3 months showed no benefits. There were at best modest benefits of diet and PA interventions. The effects of the most promising SMS-based smoking, diet and PA interventions on morbidity and mortality in high-risk groups should be established in adequately powered RCTs.
The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity.
Lloyd, J; McHugh, C; Minton, J; Eke, H; Wyatt, K
Recruitment and retention of participants is crucial for statistical power and internal and external validity and participant engagement is essential for behaviour change. However, many school-based interventions focus on programme content rather than the building of supportive relationships with all participants and tend to employ specific standalone strategies, such as incentives, to improve retention. We believe that actively involving stakeholders in both intervention and trial design improves recruitment and retention and increases the chances of creating an effective intervention. The Healthy Lifestyles Programme, HeLP (an obesity prevention programme for children 9-10 years old) was developed using intervention mapping and involved extensive stakeholder involvement in both the design of the trial and the intervention to ensure that: (i) delivery methods were suitably engaging, (ii) deliverers had the necessary skills and qualities to build relationships and (iii) the intervention dovetailed with the National Curriculum. HeLP was a year-long intervention consisting of 4 multi-component phases using a range of delivery methods. We recruited 1324 children from 32 schools from the South West of England to a cluster-randomised controlled trial to determine the effectiveness of HeLP in preventing obesity. The primary outcome was change in body mass index standard deviation score (BMI SDS) at 24 months post randomisation. Secondary outcomes included additional anthropometric and behavioural (physical activity and diet) measures at 18 and 24 months. Anthropometric and behavioural measures were taken in 99%, 96% and 94% of children at baseline, 18 and 24 months, respectively, with no differential follow up between the control and intervention groups at each time point. All children participated in the programme and 92% of children and 77% of parents across the socio-economic spectrum were considered to have actively engaged with HeLP. We attribute our excellent
The effectiveness of smoking cessation, physical activity/diet and alcohol reduction interventions delivered by mobile phones for the prevention of non-communicable diseases: A systematic review of randomised controlled trials
Sutherland, Jennifer; Barnard, Sharmani; Wynne, Aileen; Rezel, Emma; Doel, Andrew; Grigsby-Duffy, Lily; Edwards, Suzanne; Russell, Sophie; Hotopf, Ellie; Perel, Pablo; Free, Caroline
Background We conducted a systematic review to assess the effectiveness of smoking cessation, physical activity (PA), diet, and alcohol reduction interventions delivered by mobile technology to prevent non-communicable diseases (NCDs). Methods We searched for randomised controlled trials (RCTs) of mobile-based NCD prevention interventions using MEDLINE, EMBASE, Global Health, CINAHL (Jan 1990–Jan 2016). Two authors extracted data. Findings 71 trials were included: smoking cessation (n = 18); PA (n = 15), diet (n = 3), PA and diet (n = 25); PA, diet, and smoking cessation (n = 2); and harmful alcohol consumption (n = 8). 4 trials had low risk of bias. The effect of SMS-based smoking cessation support on biochemically verified continuous abstinence was pooled relative risk [RR] 2.19 [95% CI 1.80–2.68], I2 = 0%) and on verified 7 day point prevalence of smoking cessation was pooled RR 1.51 [95% CI 1.06–2.15], I2 = 0%, with no reported adverse events. There was no difference in peak oxygen intake at 3 months in a trial of an SMS-based PA intervention. The effect of SMS-based diet and PA interventions on: incidence of diabetes was pooled RR 0.67 [95% CI 0.49, 0.90], I2 = 0.0%; end-point weight was pooled MD -0.99Kg [95% CI -3.63, 1.64] I2 = 29.4%; % change in weight was pooled MD -3.1 [95%CI -4.86- -1.3] I2 0.3%; and on triglyceride levels was pooled MD -0.19 mmol/L [95% CI -0.29, -0.08], I2 = 0.0%. The results of other pooled analyses of the effect of SMS-based diet and PA interventions were heterogenous (I2 59–90%). The effects of alcohol reduction interventions were inconclusive. Conclusions Smoking cessation support delivered by SMS increases quitting rates. Trials of PA interventions reporting outcomes ≥3 months showed no benefits. There were at best modest benefits of diet and PA interventions. The effects of the most promising SMS-based smoking, diet and PA interventions on morbidity and mortality in high-risk groups should be established in adequately
This article examines the causes of pressure ulcers and provides an overview of the best advice available in preventing them in the clinical setting. This should enable nurses to provide more effective interventions for preventing patients from developing pressure ulcers.
Bogaerts, Annick; Ameye, Lieveke; Bijlholt, Margriet; Amuli, Kelly; Heynickx, Dorine; Devlieger, Roland
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
van der Molen, Henk F; Basnet, Prativa; Hoonakker, Peter Lt; Lehtola, Marika M; Lappalainen, Jorma; Frings-Dresen, Monique Hw; Haslam, Roger; Verbeek, Jos H
Construction workers are frequently exposed to various types of injury-inducing hazards. There are a number of injury prevention interventions, yet their effectiveness is uncertain. To assess the effects of interventions for preventing injuries in construction workers. We searched the Cochrane Injuries Group's specialised register, CENTRAL (issue 3), MEDLINE, Embase and PsycINFO up to April 2017. The searches were not restricted by language or publication status. We also handsearched the reference lists of relevant papers and reviews. Randomised controlled trials, controlled before-after (CBA) studies and interrupted time-series (ITS) of all types of interventions for preventing fatal and non-fatal injuries among workers at construction sites. Two review authors independently selected studies, extracted data and assessed their risk of bias. For ITS studies, we re-analysed the studies and used an initial effect, measured as the change in injury rate in the year after the intervention, as well as a sustained effect, measured as the change in time trend before and after the intervention. Seventeen studies (14 ITS and 3 CBA studies) met the inclusion criteria in this updated version of the review. The ITS studies evaluated the effects of: introducing or changing regulations that laid down safety and health requirements for the construction sites (nine studies), a safety campaign (two studies), a drug-free workplace programme (one study), a training programme (one study), and safety inspections (one study) on fatal and non-fatal occupational injuries. One CBA study evaluated the introduction of occupational health services such as risk assessment and health surveillance, one evaluated a training programme and one evaluated the effect of a subsidy for upgrading to safer scaffoldings. The overall risk of bias of most of the included studies was high, as it was uncertain for the ITS studies whether the intervention was independent from other changes and thus could be
Preventing Australian football injuries with a targeted neuromuscular control exercise programme: comparative injury rates from a training intervention delivered in a clustered randomised controlled trial.
Finch, Caroline F; Twomey, Dara M; Fortington, Lauren V; Doyle, Tim L A; Elliott, Bruce C; Akram, Muhammad; Lloyd, David G
Exercise-based training programmes are commonly used to prevent sports injuries but programme effectiveness within community men's team sport is largely unknown. To present the intention-to-treat analysis of injury outcomes from a clustered randomised controlled trial in community Australian football. Players from 18 male, non-elite, community Australian football clubs across two states were randomly allocated to either a neuromuscular control (NMC) (intervention n=679 players) or standard-practice (control n=885 players) exercise training programme delivered as part of regular team training sessions (2× weekly for 8-week preseason and 18-week regular-season). All game-related injuries and hours of game participation were recorded. Generalised estimating equations, adjusted for clustering (club unit), were used to compute injury incidence rates (IIRs) for all injuries, lower limb injuries (LLIs) and knee injuries sustained during games. The IIRs were compared across groups with cluster-adjusted Injury Rate Ratios (IRRs). Overall, 773 game injuries were recorded. The lower limb was the most frequent body region injured, accounting for 50% of injuries overall, 96 (12%) of which were knee injuries. The NMC players had a reduced LLI rate compared with control players (IRR: 0.78 (95% CI 0.56 to 1.08), p=0.14.) The knee IIR was also reduced for NMC compared with control players (IRR: 0.50 (95% CI 0.24 to 1.05), p=0.07). These intention-to-treat results indicate that positive outcomes can be achieved from targeted training programmes for reducing knee and LLI injury rates in men's community sport. While not statistically significant, reducing the knee injury rate by 50% and the LLI rate by 22% is still a clinically important outcome. Further injury reductions could be achieved with improved training attendance and participation in the programme. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to
Newcomb, Michael E; Macapagal, Kathryn R; Feinstein, Brian A; Bettin, Emily; Swann, Gregory; Whitton, Sarah W
Young men who have sex with men are at high risk for HIV, and most new HIV infections occur in serious relationships. This pilot study assessed the feasibility, acceptability and preliminary efficacy of the 2GETHER couples-based HIV prevention and relationship education intervention for young same-sex male couples. We enrolled 57 young male couples (N = 114) into a four-session hybrid group and individual intervention. We assessed acceptability via post-session surveys and exit interviews, and we examined preliminary efficacy at a two week posttest. The vast majority of participants (93%) reported exclusively positive impressions of 2GETHER, and all components received high mean ratings. We observed decreases in HIV risk behavior, increases in information, motivation and behavioral skills related to HIV prevention, and improvement in relationship investment between pretest and posttest. Integrating relationship education and sexual health programming may be an effective way to reduce HIV transmissions in young male couples.
José Rodríguez Cristóbal Juan
Full Text Available Abstract Background We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. Results This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA in l'Hospitalet de Llobregat (Barcelona and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl, cholesterol The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. Conclusion Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. Trial Registration ClinicalTrials.gov: NCT01089530
Bonell, Chris; Maisey, Ruth; Speight, Svetlana; Purdon, Susan; Keogh, Peter; Wollny, Ivonne; Sorhaindo, Annik; Wellings, Kaye
We conducted an independent evaluation of the "Teens and Toddlers" intervention. Our randomized trial examined effects on self-reported last sex without contraception, >1 episode of sex without contraception in previous 3 months, expectation of teenage parenthood and youth development score, plus secondary outcomes among 449 at-risk girls age 13/14 in England. The intervention involves 18-20 weekly sessions in pre-school nurseries. Response rates were 95% post-intervention and 91% one year later. At follow-up two, there was no evidence of intervention benefits for primary outcomes and a positive impact for our secondary outcome, low self-esteem. At follow-up one, there was no evidence of benefits for our primary outcomes but evidence of benefits for our secondary outcomes: low self-esteem; low sexual health knowledge; and difficulty discussing the contraceptive pill. The intervention should be refined, with a clearer logic model and more emphasis on sex education, and re-evaluated. Copyright © 2013 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.
Higashiguchi, Takashi; Ohara, Hiroshi; Kamakura, Yayoi; Kikutani, Takeshi; Kuzuya, Masafumi; Enoki, Hiromi; Sanada, Hiromi; Matsuzaki, Masami; Maruyama, Michio
Aspiration pneumonia is a common cause of death among the elderly (≥90-year-old) in nursing homes. Studies suggest that its incidence could be reduced by oral care interventions. We aimed to evaluate the efficacy of a new oral care intervention: wiping plus oral nutritional supplements (ONS). This prospective observational study was conducted in 252 patients (age 88.0 ± 6.5 years) in 75 nursing homes, rehabilitation hospitals, and other care facilities. Patients were randomly divided into an intervention group (n = 74) and a control group (n = 107), whose members received conventional oral care. Body mass index, activities of daily living (Barthel index), and complete blood count and biochemistry parameters were measured at 2, 4, 6, and 8 months. The cumulative incidence of pneumonia at 8 months tended to be lower in the intervention than in the control group (7.8 vs. 17.7%, p = 0.056) and was significantly lower for men in the intervention group (p = 0.046). Our new intervention "wiping plus providing ONS" method appears to help prevent aspiration pneumonia, thereby reducing mortality risk. In this study, we disseminate information on how this method is used in Japan. © 2017 S. Karger AG, Basel.
Baker, Philip R A; Francis, Daniel P; Hairi, Noran N; Othman, Sajaratulnisah; Choo, Wan Yuen
Maltreatment of older people (elder abuse) includes psychological, physical, sexual abuse, neglect and financial exploitation. Evidence suggests that 10% of older adults experience some form of abuse, and only a fraction of cases are actually reported or referred to social services agencies. Elder abuse is associated with significant morbidity and premature mortality. Numerous interventions have been implemented to address the issue of elder maltreatment. It is, however, unclear which interventions best serve to prevent or reduce elder abuse. The objective of this review was to assess the effectiveness of primary, secondary and tertiary intervention programmes used to reduce or prevent abuse of the elderly in their own home, in organisational or institutional and community settings. The secondary objective was to investigate whether intervention effects are modified by types of abuse, types of participants, setting of intervention, or the cognitive status of older people. We searched 19 databases (AgeLine, CINAHL, Psycinfo, MEDLINE, Embase, Proquest Central, Social Services Abstracts, ASSIA, Sociological Abstracts, ProQuest Dissertations & Theses Global, Web of Science, LILACS, EPPI, InfoBase, CENTRAL, HMIC, Opengrey and Zetoc) on 12 platforms, including multidisciplinary disciplines covering medical, health, social sciences, social services, legal, finance and education. We also browsed related organisational websites, contacted authors of relevant articles and checked reference lists. Searches of databases were conducted between 30 August 2015 and 16 March 2016 and were not restricted by language. We included randomised controlled trials (RCTs), cluster-randomised trials, and quasi-RCTs, before-and-after studies, and interrupted time series. Only studies with at least 12 weeks of follow-up investigating the effect of interventions in preventing or reducing abuse of elderly people and those who interact with the elderly were included. Two review authors
Delisle, Christine; Sandin, Sven; Forsum, Elisabet; Henriksson, Hanna; Trolle-Lagerros, Ylva; Larsson, Christel; Maddison, Ralph; Ortega, Francisco B.; Ruiz, Jonatan R.; Silfvernagel, Kristin; Timpka, Toomas; Löf, Marie
Background: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodol...
Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert
Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.
Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte
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
Vass, Mikkel; Avlund, Kirsten; Hendriksen, Carsten
of municipality employees) was done at municipality level. In total 5,788 home-dwelling 75- and 80-year-olds living in these municipalities were invited to participate in the study. Written consent was obtained from 4,060 persons (participation rate 71%). RESULTS: During five-year follow-up non-participants had...... declined (non-participants) to join a controlled feasibility trial, and to describe and evaluate defined subgroups of non-participants. METHODS: Prospective controlled three-year intervention study (1999-2001) in 34 Danish municipalities with five-year follow-up. Randomization and intervention (education...... a higher mortality rate (survival analysis risk ratio RR = 1.5, 95% CI = 1.3-1.7, prate of nursing home admissions (RR = 1.7, 95% CI = 1.3-2.1, p
PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial
Full Text Available Type-2 diabetes (T2D is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand. Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6 years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.
PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial.
Fogelholm, Mikael; Larsen, Thomas Meinert; Westerterp-Plantenga, Margriet; Macdonald, Ian; Martinez, J Alfredo; Boyadjieva, Nadka; Poppitt, Sally; Schlicht, Wolfgang; Stratton, Gareth; Sundvall, Jouko; Lam, Tony; Jalo, Elli; Christensen, Pia; Drummen, Mathijs; Simpson, Elizabeth; Navas-Carretero, Santiago; Handjieva-Darlenska, Teodora; Muirhead, Roslyn; Silvestre, Marta P; Kahlert, Daniela; Pastor-Sanz, Laura; Brand-Miller, Jennie; Raben, Anne
Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand). Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6) years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.
Full Text Available Kazumi Asakawa1, Katsuhiro Koyama2, Zentaro Yamagata31Department of Fundamental and Clinical Nursing, 2Department of Health and Physical Education, 3Department of Health Science, University of Yamanashi, Chuo, Yamanashi, JapanBackground: The objective of this study was to determine whether or not educational intervention using the Internet, to prevent osteoporosis, is able to increase bone strength in young women.Methods: Subjects were 253 healthy female university and junior college students aged 18–25 years. After initial measurements of bone stiffness index, a bone formation marker, and a bone absorption marker, the minimization method was used to allocate the subjects to an intervention group (n = 126 or a control group (n = 127 according to whether the measurements were above or below average. Subjects in the intervention group were instructed to perform osteoporosis prevention activities, ie, jump on the spot as high as possible ten times per day and increase calcium intake by 300 mg per day to a total of 800 mg or more per day on average. In addition, they were instructed to report the implementation status of the recommended measures via email. The researcher sent out information on osteoporosis and preventive behaviors to the subjects five times via email.Results: A total of 182 subjects, comprising 87 (69.0% in the intervention group and 95 (74.8% in the control group, underwent remeasurement 6 months later. Of the subjects in the intervention group, 54 (42.9% reported their daily additional calcium intake amount and number of jumps via email. The mean amount of additional calcium taken was 216.3 ± 85.9 mg per day, and mean number of jumps performed was 6.4 ± 4.2 per day. Subjects in the intervention group were further divided into an implementation group (n = 54, consisting of subjects who sent in reports and a nonimplementation group (n = 72 who did not. No significant difference was found among the groups for rate of change in
Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam.
Kajula, Lusajo; Balvanz, Peter; Kilonzo, Mrema Noel; Mwikoko, Gema; Yamanis, Thespina; Mulawa, Marta; Kajuna, Deus; Hill, Lauren; Conserve, Donaldson; Reyes, Heathe Luz McNaughton; Leatherman, Sheila; Singh, Basant; Maman, Suzanne
Intimate partner violence (IPV) and sexually transmitted infections (STIs), including HIV, remain important public health problems with devastating health effects for men and women in sub-Saharan Africa. There have been calls to engage men in prevention efforts, however, we lack effective approaches to reach and engage them. Social network approaches have demonstrated effective and sustained outcomes on changing risk behaviors in the U.S. Our team has identified and engaged naturally occurring social networks comprised mostly of young men in Dar es Salaam in an intervention designed to jointly reduce STI incidence and the perpetration of IPV. These stable networks are locally referred to as "camps." In a pilot study we demonstrated the feasibility and acceptability of a combined microfinance and peer health leadership intervention within these camp-based peer networks. We are implementing a cluster-randomized trial to evaluate the efficacy of an intervention combining microfinance with health leadership training in 60 camps in Dar es Salaam, Tanzania. Half of the camps have been randomized to the intervention arm, and half to a control arm. The camps in the intervention arm will receive a combined microfinance and health leadership intervention for a period of two years. The camps in the control arm will receive a delayed intervention. We have enrolled 1,258 men across the 60 study camps. Behavioral surveys will be conducted at baseline, 12-months post intervention launch and 30-month post intervention launch and biological samples will be drawn to test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) at baseline and 30-months. The primary endpoints for assessing intervention impact are IPV perpetration and STI incidence. This is the first cluster-randomized trial targeting social networks of men in sub-Saharan Africa that jointly addresses HIV and IPV perpetration and has both biological and behavioral endpoints. Effective
Ott, Mary A; Alexander, Andreia B; Lally, Michelle; Steever, John B; Zimet, Gregory D
Adolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry a possibility of harm, requiring investigators to take additional precautions. Of particular concern is preventive misconception, or the overestimation of personal protection that is afforded by enrolment in a prevention intervention trial. As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their understanding and opinions related to enrolment in a HIV vaccine trial. A grounded theory analysis looked for shared concepts, and focused on the content and process of adolescent participants' understanding of HIV vaccination and the components of preventive misconception, including experiment, placebo and randomisation. Across interviews, adolescents demonstrated active processing of information, in which they questioned the interviewer, verbally worked out their answers based upon information provided, and corrected themselves. We observed a wide variety of understanding of research concepts. While most understood experiment and placebo, fewer understood randomisation. All understood the need for safer sex even if they did not understand the more basic concepts. Education about basic concepts related to clinical trials, time to absorb materials and assessment of understanding may be necessary in future biomedical prevention trials.
Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial.
Choko, Augustine T; Fielding, Katherine; Stallard, Nigel; Maheswaran, Hendramoorthy; Lepine, Aurelia; Desmond, Nicola; Kumwenda, Moses K; Corbett, Elizabeth L
Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women. A phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic (ANC) days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing) or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders. Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity. This trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying
Development and evaluation of the efficacy of a web-based 'social norms'-intervention for the prevention and reduction of substance use in a cluster-controlled trial conducted at eight German universities.
Helmer, Stefanie M; Muellmann, Saskia; Zeeb, Hajo; Pischke, Claudia R
Previous research suggests that perceptions of peer substance use are associated with personal use. Specifically, overestimating use in the peer group is predictive of higher rates of personal substance use. 'Social norms'-interventions are based on the premise that changing these misperceived social norms regarding substance use by providing feedback on actual norms is associated with a reduction in personal substance use. Studies conducted in the U.S.A. suggest that 'social norms'-feedback is an effective strategy for reducing substance use among university students. It is unknown whether the effects of a 'social norms'-feedback on substance use can be replicated in a sample of German university students. The objective of this article is to describe the study design and aims of the 'INternet-based Social norms-Intervention for the prevention of substance use among Students' (INSIST)-study, a cluster-controlled trial examining the effects of a web-based 'social norms'- intervention in students enrolled at four intervention universities with those enrolled at four delayed intervention control universities. The INSIST-study is funded by the German Federal Ministry of Health. Eight universities in four regions in Germany will take part in the study, four serving as intervention and four as delayed intervention control universities (randomly selected within a geographic region). Six hundred students will be recruited at each university and will be asked to complete a web-based survey assessing personal and perceived substance use/attitudes towards substance use at baseline. These data will be used to develop the web-based 'social norms'-feedback tailored to gender and university. Three months after the baseline survey, students at intervention universities will receive the intervention. Two months after the launch of the intervention, students of all eight universities will be asked to complete the follow-up questionnaires to assess changes in perceptions of
Walker, Dilys; Gutierrez, Juan Pablo; Torres, Pilar; Bertozzi, Stefano M
OBJECTIVE: To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception. DESIGN: Cluster randomised controlled trial. SETTING: 40 public high schools in the state of Morelos, Mexico. PARTICIPANTS: 10 954 first year high school students. INTERVENTION: Schools were randomised to one of three arms: an HIV prevention course that promoted condom use, the same course with emergency contr...
Muktabhant, Benja; Lumbiganon, Pisake; Ngamjarus, Chetta; Dowswell, Therese
Background Excessive weight gain during pregnancy is associated with multiple maternal and neonatal complications. However, interventions to prevent excessive weight gain during pregnancy have not been adequately evaluated. Objectives To evaluate the effectiveness of interventions for preventing excessive weight gain during pregnancy and associated pregnancy complications. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (20 October 2011) and MEDLINE (1966 to 20 October 2011). Selection criteria All randomised controlled trials and quasi-randomised trials of interventions for preventing excessive weight gain during pregnancy. Data collection and analysis We assessed for inclusion all potential studies we identified as a result of the search strategy. At least two review authors independently assessed trial quality and extracted data. We resolved discrepancies through discussion. We have presented results using risk ratio (RR) for categorical data and mean difference for continuous data. We analysed data using a fixed-effect model. Main results We included 28 studies involving 3976 women; 27 of these studies with 3964 women contributed data to the analyses. Interventions focused on a broad range of interventions. However, for most outcomes we could not combine data in a meta-analysis, and where we did pool data, no more than two or three studies could be combined for a particular intervention and outcome. Overall, results from this review were mainly not statistically significant, and where there did appear to be differences between intervention and control groups, results were not consistent. For women in general clinic populations one (behavioural counselling versus standard care) of three interventions examined was associated with a reduction in the rate of excessive weight gain (RR 0.72, 95% confidence interval 0.54 to 0.95); for women in high-risk groups no intervention appeared to reduce excess weight gain. There were
Full Text Available Abstract Background Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents’ physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. Methods/Design The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic status that is below the state average. Five schools will be allocated to receive an intervention based on the Health Promoting Schools framework, and will be supported by a part-time physical activity consultant placed in intervention schools who will implement a range of intervention adoption strategies. Study measures will be taken at baseline when students are in Year 7 (12–13 years and again after 12- and 24-months. The primary outcome, minutes of moderate- to-vigorous- intensity physical activity per day and percentage of time in moderate- to vigorous-intensity physical activity (MVPA, will be objectively assessed using accelerometers (Actigraph GT3x+. Group allocation and intervention delivery will commence after baseline data collection. The intervention will continue during school terms through to 24-month follow-up. Discussion The study will provide evidence regarding the effectiveness of a multi-component school-based intervention that includes an in-school physical activity consultant targeting the physical activity levels of adolescents in disadvantaged Australian secondary schools. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000382875.
Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63
An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial.
Hayek, Adina; Joshi, Rohina; Usherwood, Tim; Webster, Ruth; Kaur, Baldeep; Saini, Bandana; Armour, Carol; Krass, Ines; Laba, Tracey-Lea; Reid, Christopher; Shiel, Louise; Hespe, Charlotte; Hersch, Fred; Jan, Stephen; Lo, Serigne; Peiris, David; Rodgers, Anthony; Patel, Anushka
Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities; availability of a range of CVD polypills (fixed-dose combinations of two blood pressure lowering agents, a statin ± aspirin) for prescription when appropriate; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification. Following a systematic development process, the intervention will be evaluated in a pragmatic cluster randomized controlled trial including 70 general practices for a median period of 18 months. The 35 general practices in the intervention group will work with a nominated partner pharmacy, whereas those in the control group will provide usual care without access to the intervention tools. The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels at the study end. The outcomes will be analyzed using data from electronic medical records, utilizing a validated extraction tool. Detailed process and economic evaluations will also be performed. The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients, pharmacists, and general practitioners (GPs) for CVD prevention. Australian New Zealand Clinical Trials Registry ACTRN12616000233426.
Baker-Henningham, H; Walker, S
Based on extensive piloting work, we adapted the Incredible Years (IY) teacher-training programme to the Jamaican preschool setting and evaluated this adapted version through a cluster-randomised trial. Twenty-four community preschools in Kingston, Jamaica were randomly assigned to intervention (12 schools, 37 teachers) or control (12 schools, 36 teachers). The intervention involved training teachers in classroom management through eight full-day training workshops and four individual 1-h in-class support sessions. Outcome measurements included direct observation of teachers' positive and negative behaviours to the whole class and to high-risk children and four observer ratings: two measures of class-wide child behaviour and two measures of classroom atmosphere. Measures were repeated at a six-month follow-up. Significant benefits of intervention were found for teachers' positive [effect size (ES) = 3.35] and negative (ES = 1.29) behaviours to the whole class and to high-risk children (positive: ES = 0.83; negative: ES = 0.50) and for observer ratings of class-wide child behaviour (ES = 0.73), child interest and enthusiasm (ES = 0.98), teacher warmth (ES = 2.03) and opportunities provided to share and help (ES = 5.72). At 6-month follow-up, significant benefits of intervention were sustained: positive behaviours (ES = 2.70), negative behaviours (ES = 0.98), child behaviour (ES = 0.50), child interest and enthusiasm (ES = 0.78), teacher warmth (ES = 0.91), opportunities to share and help (ES = 1.42). The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up. Benefits were of a similar magnitude to those found in a pilot study of the minimally adapted version that required significantly more in-class support for teachers.
Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers
Ride, Jemimah; Rowe, Heather; Wynter, Karen; Fisher, Jane; Lorgelly, Paula
Introduction Postnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers. Methods and analysis The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial. Ethics and dissemination Approval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012. Trial registration number The trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796). PMID:25280810
Sampselle, Carolyn M; Newman, Diane K; Miller, Janis M; Kirk, Keri; DiCamillo, Mary Ann; Wagner, Todd H; Raghunathan, Trivellor E; Diokno, Ananias C
We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.
Leathem, Claire S
BACKGROUND: Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers\\' and participants\\' experiences of its implementation and to inform future strategies to maximise recruitment and retention. METHODS: In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. RESULTS: We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners\\' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. CONCLUSION: Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A
Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care
Full Text Available Abstract Background Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention. Methods In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. Results We achieved high retention rates for practices (100% and for patients (85% over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Conclusion Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT
Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population
Latkin, Carl A.; Kukhareva, Polina V.; Malov, Sergey V.; Batluk, Julia V.; Shaboltas, Alla V.; Skochilov, Roman V.; Sokolov, Nicolay V.; Verevochkin, Sergei V.; Hudgens, Michael G.; Kozlov, Andrei P.
We evaluated the efficacy of a peer-educator network intervention as a strategy to reduce HIV acquisition among injection drug users (IDUs) and their drug and/or sexual networks. A randomized controlled trial was conducted in St. Petersburg, Russia among IDU index participants and their risk network participants. Network units were randomized to the control or experimental intervention. Only the experimental index participants received training sessions to communicate risk reduction techniques to their network members. Analysis includes 76 index and 84 network participants who were HIV uninfected. The main outcome measure was HIV sero-conversion. The incidence rates in the control and experimental groups were 19.57 (95 % CI 10.74–35.65) and 7.76 (95 % CI 3.51–17.19) cases per 100 p/y, respectively. The IRR was 0.41 (95 % CI 0.15–1.08) without a statistically significant difference between the two groups (log rank test statistic X2 = 2.73, permutation p value = 0.16). Retention rate was 67 % with a third of the loss due to incarceration or death. The results show a promising trend that this strategy would be successful in reducing the acquisition of HIV among IDUs. PMID:23881187
Han, Liyuan; Ma, Wenjie; Sun, Dianjianyi; Heianza, Yoriko; Wang, Tiange; Zheng, Yan; Huang, Tao; Duan, Donghui; Bray, J George A; Champagne, Catherine M; Sacks, Frank M; Qi, Lu
Background: Coffee consumption has been associated with glucose metabolism and risk of type 2 diabetes. Objective: We examined whether the genetic variation determining habitual coffee consumption affected glycemic changes in response to weight-loss dietary intervention. Design: A genetic risk score (GRS) was calculated based on 8 habitual coffee consumption-associated single nucleotide polymorphisms. We used general linear models to test changes in glycemic traits in groups randomly assigned to high- and low-fat diets according to tertiles of the GRS. Results: We observed significant interactions between the GRS and low compared with high dietary fat intake on 6-mo changes in fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) ( P -interaction = 0.023 and 0.022, respectively), adjusting for age, sex, race, physical activity, smoking, alcohol, seasonal variation, and baseline values of the respective outcomes. Participants with a higher GRS of habitual coffee consumption showed a greater reduction in fasting insulin and a marginally greater decrease in HOMA-IR in the low-fat diet intervention group. Conclusions: Our data suggest that participants with genetically determined high coffee consumption may benefit more by eating a low-fat diet in improving fasting insulin and HOMA-IR in a short term. This trial was registered at clinicaltrials.gov as NCT00072995 and NCT03258203. © 2017 American Society for Nutrition.
Full Text Available Telephone-delivered interventions do not require frequent clinic visits, literacy, or costly technology and thus may represent promising approaches to promoting physical activity in the Deep South, a largely rural U.S. region, with generally lower physical activity, income, and education levels. Building on past Interactive Voice Response (IVR system-based HIV studies and extensive formative research (11 focus groups on physical activity intervention needs/preferences in the Deep South, the resulting IVR-supported physical activity intervention is now being tested in a randomized controlled trial with a waitlist control. The sample (n = 63 includes mostly obese (Mean BMI = 30.1 adults (Mean age = 43 years in Birmingham, AL. Both genders (55.6% male and African Americans (58.7% are well-represented. Most participants reported at least some college (92%, full time employment (63.5%, and household income <$50,000 per year (61.9%. Baseline physical activity (Mean = 39.6 min/week, SD = 56.4, self-efficacy, self-regulation, and social support were low. However, high physical activity enjoyment and outcome expectations bode well. Self-report physical activity was associated with physical activity enjoyment (r = 0.36 and social support (friends r = 0.25, p's < 0.05 at baseline. Consequently, these may be important variables to emphasize in our program. Depression and anxiety were negatively correlated with some early indicators of behavior change (e.g., physical activity self-regulation; r's = -0.43 and −0.46, respectively, p's < 0.01 and thus may require additional attention. Such technology-supported strategies have great potential to reach underserved populations and address physical activity-related health disparities in this region.
Creanor, Siobhan; Lloyd, Jenny; Hillsdon, Melvyn; Dean, Sarah; Green, Colin; Taylor, Rod S; Ryan, Emma; Wyatt, Katrina
The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9-10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. The HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses. International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706 . Registered on 1 May 2012.
The effect of a sports chiropractic manual therapy intervention on the prevention of back pain, hamstring and lower limb injuries in semi-elite Australian Rules footballers: a randomized controlled trial
Full Text Available Abstract Background Hamstring injuries are the most common injury in Australian Rules football. It was the aims to investigate whether a sports chiropractic manual therapy intervention protocol provided in addition to the current best practice management could prevent the occurrence of and weeks missed due to hamstring and other lower-limb injuries at the semi-elite level of Australian football. Methods Sixty male subjects were assessed for eligibility with 59 meeting entry requirements and randomly allocated to an intervention (n = 29 or control group (n = 30, being matched for age and hamstring injury history. Twenty-eight intervention and 29 control group participants completed the trial. Both groups received the current best practice medical and sports science management, which acted as the control. Additionally, the intervention group received a sports chiropractic intervention. Treatment for the intervention group was individually determined and could involve manipulation/mobilization and/or soft tissue therapies to the spine and extremity. Minimum scheduling was: 1 treatment per week for 6 weeks, 1 treatment per fortnight for 3 months, 1 treatment per month for the remainder of the season (3 months. The main outcome measure was an injury surveillance with a missed match injury definition. Results After 24 matches there was no statistical significant difference between the groups for the incidence of hamstring injury (OR:0.116, 95% CI:0.013-1.019, p = 0.051 and primary non-contact knee injury (OR:0.116, 95% CI:0.013-1.019, p = 0.051. The difference for primary lower-limb muscle strains was significant (OR:0.097, 95%CI:0.011-0.839, p = 0.025. There was no significant difference for weeks missed due to hamstring injury (4 v14, χ2:1.12, p = 0.29 and lower-limb muscle strains (4 v 21, χ2:2.66, p = 0.10. A significant difference in weeks missed due to non-contact knee injury was noted (1 v 24, χ2:6.70, p = 0.01. Conclusions This study
Keall, Michael D; Pierse, Nevil; Howden-Chapman, Philippa; Cunningham, Chris; Cunningham, Malcolm; Guria, Jagadish; Baker, Michael G
Despite the considerable injury burden attributable to falls at home among the general population, few effective safety interventions have been identified. We tested the safety benefits of home modifications, including handrails for outside steps and internal stairs, grab rails for bathrooms, outside lighting, edging for outside steps, and slip-resistant surfacing for outside areas such as decks and porches. We did a single-blind, cluster-randomised controlled trial of households from the Taranaki region of New Zealand. To be eligible, participants had to live in an owner-occupied dwelling constructed before 1980 and at least one member of every household had to be in receipt of state benefits or subsidies. We randomly assigned households by electronic coin toss to either immediate home modifications (treatment group) or a 3-year wait before modifications (control group). Household members in the treatment group could not be masked to their assigned status because modifications were made to their homes. The primary outcome was the rate of falls at home per person per year that needed medical treatment, which we derived from administrative data for insurance claims. Coders who were unaware of the random allocation analysed text descriptions of injuries and coded injuries as all falls and injuries most likely to be affected by the home modifications tested. To account for clustering at the household level, we analysed all injuries from falls at home per person-year with a negative binomial generalised linear model with generalised estimating equations. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000779279. Of 842 households recruited, 436 (n=950 individual occupants) were randomly assigned to the treatment group and 406 (n=898 occupants) were allocated to the control group. After a median observation period of 1148 days (IQR 1085-1263), the crude rate of fall injuries per
Intervention studies This dissertation describes three trials in which the effectiveness of three preventive interventions for youth were tested in the Netherlands. The interventions aim to improve the social and emotional development of children in elementary school (PATHS), reduce alcohol use and
Implementing prevention interventions for non-communicable diseases within the Primary Health Care system in the Federal Capital Territory, Nigeria. ... Conclusion: The capacity of the PHC system to implement NCDs interventions is weak, necessitating a need to strengthen coordination, partnership and funding for better ...
Bauer, Andrea; Schmitt, Jochen; Bennett, Cathy; Coenraads, Pieter-Jan; Elsner, Peter; English, John; Williams, Hywel C.
Background Occupational irritant hand dermatitis (OIHD) is an important cause of discomfort in the working population. Different preventive measures are in place but it is not clear how effective these are. Objectives To assess the effect of interventions for preventing OIHD in healthy people who
A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.
Ngandu, Tiia; Lehtisalo, Jenni; Solomon, Alina; Levälahti, Esko; Ahtiluoto, Satu; Antikainen, Riitta; Bäckman, Lars; Hänninen, Tuomo; Jula, Antti; Laatikainen, Tiina; Lindström, Jaana; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Peltonen, Markku; Rauramaa, Rainer; Stigsdotter-Neely, Anna; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia
Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies. In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a proof-of-concept randomised controlled trial, we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population. In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys. Inclusion criteria were CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age. We randomly assigned participants in a 1:1 ratio to a 2 year multidomain intervention (diet, exercise, cognitive training, vascular risk monitoring), or a control group (general health advice). Computer-generated allocation was done in blocks of four (two individuals randomly allocated to each group) at each site. Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation. The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery (NTB) Z score. Analysis was by modified intention to treat (all participants with at least one post-baseline observation). This trial is registered at ClinicalTrials.gov, number NCT01041989. Between Sept 7, 2009, and Nov 24, 2011, we screened 2654 individuals and randomly assigned 1260 to the intervention group (n=631) or control group (n=629). 591 (94%) participants in the intervention group and 599 (95%) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis. Estimated mean change in NTB total Z score at 2 years was 0·20 (SE 0·02, SD 0·51) in the intervention group and 0·16 (0·01, 0·51) in the control group. Between-group difference in the change of NTB
Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial.
Lanhers, Charlotte; Pereira, Bruno; Gay, Chloé; Hérisson, Christian; Levyckyj, Christine; Dupeyron, Arnaud; Coudeyre, Emmanuel
Musculoskeletal disorders (MSDs) constitute a major occupational health problem in the working population, substantially impacting the quality of life of employees. They also cause considerable economic cost to the healthcare system, with, notably, the reimbursement of treatments and compensation for lost income. MSDs manifest as localized pain or functional difficulty in one or more anatomical areas, such as the cervical spine, shoulder, elbow, hand, and wrist. Although prevalence varies depending on the region considered and the method of assessment, a prevalence of 30% is found in different epidemiological studies. The disease needs to be prevented, not only for medical and economic reasons, but also for legal reasons, owing to the requirement of assessing occupational risks. The strategy envisaged may thus revolve around active, multimodal prevention that has employees fully involved at the heart of their care. Although physical exercise is widely recommended, few studies with a good level of evidence have enabled us to base a complete, well-constructed intervention on exercise that can be offered as secondary prevention in these disorders. A prospective, multicenter, comparative (intervention arm vs. control arm), randomized (immediate vs. later treatment) study using Zelen's design. This study falls under active prevention of MSDs of the upper extremities (UE-MSDs). Participants are workers aged between 18 and 65 years with latent or symptomatic MSDS, with any type of job or workstation, with or without an history of sick leave. The primary aim is to show the superiority at 3 months of a combination of spa therapy, exercise, and self-management workshops for 6 days over usual care in the management of MSDs in terms of employee functional capacity in personal and professional daily life. Secondary aims are to assess the benefit of the intervention in terms of pain, quality of life, and accumulated duration of sick leave. This randomized controlled trial is
Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.
Leathem, Claire S; Cupples, Margaret E; Byrne, Mary C; O'Malley, Mary; Houlihan, Ailish; Murphy, Andrew W; Smith, Susan M
Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention. In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress
Andrieu, S.; Coley, N.; Aisen, P.; Carrillo, M.C.; DeKosky, S.; Durga, J.; Fillit, H.; Frisoni, G.B.; Froelich, L.; Gauthier, S.; Jones, R.; Jonsson, L.; Khachaturian, Z.; Morris, J.C.; Orgogozo, J.M.; Ousset, P.J.; Robert, P.; Salmon, E.; Sampaio, C.; Verhey, F.; Wilcock, G.; Vellas, B.
The prevention of neurodegenerative dementias, such as Alzheimer's disease, is a public health priority. Due to the large numbers of affected patients, even interventions bringing about a relatively small delay in disease onset could have large public health effects. Randomized controlled trials
Schwingshackl, L; Lampousi, A-M; Portillo, M P; Romaguera, D; Hoffmann, G; Boeing, H
Olive oil (OO) as food is composed mainly of fatty acids and bioactive compounds depending from the extraction method. Both had been discussed as health promoting with still open questions. Thus, we conducted a meta-analysis to illustrate the impact of this food on type 2 diabetes (T2D) by investigating the association between OO intake and risk of T2D, and the effect of OO intake in the management of T2D. Searches were performed in PubMed, Cochrane Library and google scholar. First, we conducted a random effect meta-analysis of prospective cohort studies and trials investigating the association between OO and risk of T2D. Second, a meta-analysis was performed to detect the effects of olive oil on glycemic control in patients with T2D. Four cohort studies including 15 784 T2D cases and 29 trials were included in the meta-analysis. The highest OO intake category showed a 16% reduced risk of T2D (RR: 0.84; 95% CI: 0.77, 0.92) compared with the lowest. However, we observed evidence for a nonlinear relationship. In T2D patients OO supplementation resulted in a significantly more pronounced reduction in HbA1c (MD: -0.27%; 95% CI: -0.37, -0.17) and fasting plasma glucose (MD: -0.44 mmol l -1 ; 95% CI -0.66, -0.22) as compared with the control groups. This meta-analysis provides evidence that the intake of OO could be beneficial for the prevention and management of T2D. This conclusion regards OO as food, and might not been valid for single components comprising this food.
Peters, Janne A; Zwerver, Johannes; Diercks, Ronald L; Elferink-Gemser, Marije T; van den Akker-Scheek, Inge
Tendinopathy, the most prevalent tendon disorder which is considered as the clinical diagnosis of pain and dysfunction, is common in sports and its prevalence is ever-increasing. Despite the lack of clarity about risk factors, various preventive interventions for tendinopathy have been investigated. The main objective of this study is to review current preventive interventions for tendinopathy in the major regions: ankle, knee, hip, groin, shoulder and elbow. A systematic literature search was conducted. The PubMed and Embase databases were explored to identify articles that met the inclusion criteria. The included studies were assessed on methodological quality and data was summarized. Ten articles were included that describe a wide variety of preventive interventions. These were divided into three categories: stretch and exercise interventions, shoe adaptations and other interventions. The methodological quality of the studies was moderate to high. Three out of ten studies showed a significant beneficial result. There is limited evidence that a long-term intervention including balance training is effective in the prevention of patellar and Achilles tendinopathy. Shoe adaptations in the form of shock absorbing insoles could have a preventive effect on Achilles tendinopathy. Hormone replacement therapy seems to reduce the risk for structural Achilles tendon changes in active post-menopausal women. No evidence was found for a positive effect of stretching exercises. Prophylactic eccentric training and stretching can increase the risk of injury in asymptomatic players with patellar tendon abnormalities. A limited amount of studies was available and more research is needed on (multifactorial) etiology, risk factors and preventive interventions. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.
Tiedemann, Anne; Paul, Serene; Ramsay, Elisabeth; O'Rourke, Sandra D; Chamberlain, Kathryn; Kirkham, Catherine; Merom, Dafna; Fairhall, Nicola; Oliveira, Juliana S; Hassett, Leanne; Sherrington, Catherine
Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establish the impact of a combined physical activity and fall prevention intervention compared to an advice brochure on objectively measured physical activity participation and mobility-related goal attainment among people aged 60+. A randomised controlled trial involving 130 consenting community-dwelling older people will be conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall prevention brochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fall prevention intervention enhanced with health coaching and a pedometer. Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured at both six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meeting the physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers to physical activity participation will be measured 6 months after randomisation. General linear models will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified
Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.
Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike
This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered
Awa, Wendy L; Plaumann, Martina; Walter, Ulla
To evaluate the effectiveness of intervention programs at the workplace or elsewhere aimed at preventing burnout, a leading cause of work related mental health impairment. A systematic search of burnout intervention studies was conducted in the databases Medline, PsycINFO and PSYNDEX from 1995 to 2007. Data was also extracted from papers found through a hand search. A total of 25 primary intervention studies were reviewed. Seventeen (68%) were person-directed interventions, 2 (8%) were organization-directed and 6 (24%) were a combination of both interventions types. Eighty percent of all programs led to a reduction in burnout. Person-directed interventions reduced burnout in the short term (6 months or less), while a combination of both person- and organization-directed interventions had longer lasting positive effects (12 months and over). In all cases, positive intervention effects diminished in the course of time. Intervention programs against burnout are beneficial and can be enhanced with refresher courses. Better implemented programs including both person- and organization-directed measures should be offered and evaluated. A combination of both intervention types should be further investigated, optimized and practiced. Institutions should recognize the need for and make burnout intervention programs available to employees. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.
Manuel, Celie; Jørgensen, Anne-Marie Klint
This review centers on evaluations of youth crime prevention interventions published between 2008 and 2012. The aim of the review is to bring forward the newest information to supplement existing knowledge about crime preventive methods targeting youth. The review lists 56 studies, all targeting 12...... produced for TrygFonden and the Danish Crime Prevention Council TrygFonden and The Danish Crime Prevention Council have entered into an ambitious collaboration. The objective of this collaboration is to reduce crime and increase the feeling of security in Denmark by engaging citizens and creating new...
Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial.
Mora, Samia; Caulfield, Michael P; Wohlgemuth, Jay; Chen, Zhihong; Superko, H Robert; Rowland, Charles M; Glynn, Robert J; Ridker, Paul M; Krauss, Ronald M
Cardiovascular disease (CVD) can occur in individuals with low low-density lipoprotein (LDL) cholesterol (LDL-C). We investigated whether detailed measures of LDL subfractions and other lipoproteins can be used to assess CVD risk in a population with both low LDL-C and high C-reactive protein who were randomized to high-intensity statin or placebo. In 11 186 Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) participants, we tested whether lipids, apolipoproteins, and ion mobility-measured particle concentrations at baseline and after random allocation to rosuvastatin 20 mg/d or placebo were associated with first CVD events (n=307) or CVD/all-cause death (n=522). In placebo-allocated participants, baseline LDL-C was not associated with CVD (adjusted hazard ratio [HR] per SD, 1.03; 95% confidence interval [CI], 0.88-1.21). In contrast, associations with CVD events were observed for baseline non-high-density lipoprotein (HDL) cholesterol (HR, 1.18; 95% CI, 1.01-1.38), apolipoprotein B (HR, 1.28; 95% CI, 1.11-1.48), and ion mobility-measured non-HDL particles (HR, 1.19; 95% CI, 1.05-1.35) and LDL particles (HR, 1.21; 95% CI, 1.07-1.37). Association with CVD events was also observed for several LDL and very-low-density lipoprotein subfractions but not for ion mobility-measured HDL subfractions. In statin-allocated participants, CVD events were associated with on-treatment LDL-C, non-HDL cholesterol, and apolipoprotein B; these were also associated with CVD/all-cause death, as were several LDL and very-low-density lipoprotein subfractions, albeit with a pattern of association that differed from the baseline risk. In JUPITER, baseline LDL-C was not associated with CVD events, in contrast with significant associations for non-HDL cholesterol and atherogenic particles: apolipoprotein B and ion mobility-measured non-HDL particles, LDL particles, and select subfractions of very-low-density lipoprotein particles and
Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient's caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial.
Mendyk, Anne-Marie; Duhamel, Alain; Bejot, Yannick; Leys, Didier; Derex, Laurent; Dereeper, Olivier; Detante, Olivier; Garcia, Pierre-Yves; Godefroy, Olivier; Montoro, Francisco Macian; Neau, Jean-Philippe; Richard, Sébastien; Rosolacci, Thierry; Sibon, Igor; Sablot, Denis; Timsit, Serge; Zuber, Mathieu; Cordonnier, Charlotte; Bordet, Régis
Setting up a follow-up secondary prevention program after stroke is difficult due to motor and cognitive impairment, but necessary to prevent recurrence and improve patients' quality of life. To involve a referent nurse and a caregiver from the patient's social circle in nurse-led multimodal and long-term management of risk factors after stroke could be an advantage due to their easier access to the patient and family. The aim of this study is to compare the benefit of optimized follow up by nursing personnel from the vascular neurology department including therapeutic follow up, and an interventional program directed to the patient and a caregiving member of their social circle, as compared with typical follow up in order to develop a specific follow-up program of secondary prevention of stroke. The design is a randomized, controlled, clinical trial conducted in the French Stroke Unit of the Strokavenir network. In total, 410 patients will be recruited and randomized in optimized follow up or usual follow up for 2 years. In both group, patients will be seen by a neurologist at 6, 12 and 24 months. The optimized follow up will include follow up by a nurse from the vascular neurology department, including therapeutic follow up, and a training program on secondary prevention directed to the patient and a caregiving member of their social circle. After discharge, a monthly telephone interview, in the first year and every 3 months in the second year, will be performed by the nurse. At 6, 12 and 24 month, the nurse will give the patient and caregiver another training session. Usual follow up is only done by the patient's general practitioner, after classical information on secondary prevention of risk factors during hospitalization. The primary outcome measure is blood pressure measured after the first year of follow up. Blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomized. Secondary endpoints are
Paul, Amy; Merritt, Maria W; Sugarman, Jeremy
Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
du Roscoät, E; Beck, F
This review focuses on interventions to prevent suicide. It excludes psychotherapy evaluations and pharmaceutical clinical trials. The aim of this article is to provide useful input to the reflection on and the development of actions for professionals who may be concerned by suicide prevention. This research is based on 41 published evaluation studies presenting results on at least one of the three following outcomes: completed suicides, suicide attempts, and suicidal ideations. These studies have been classified into seven categories of preventive action. According to data from the literature selected for our analysis, the three most efficient categories of intervention seem to be the limitation of access to lethal means, the preservation of contact with the patients hospitalized for a suicide attempt after hospitalization, and the implementation of emergency call centers. The four other categories of intervention examined in this study - the training of general practitioners, the reorganization of care, programs in schools, and information campaigns - have not yet shown sufficient proof of their efficacy. Nevertheless, these interventions, under certain conditions, can also contribute significantly to the prevention of suicide. The majority of effective interventions minister to people already suffering from psychological disorders, but health promotion initiatives prior to situations of psychological disorders also deserve to be considered, in particular the implementation of services for the isolated elderly. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
Stuart, Elizabeth A; Perry, Deborah F; Le, Huynh-Nhu; Ialongo, Nicholas S
Individuals not fully complying with their assigned treatments is a common problem encountered in randomized evaluations of behavioral interventions. Treatment group members rarely attend all sessions or do all "required" activities; control group members sometimes find ways to participate in aspects of the intervention. As a result, there is often interest in estimating both the effect of being assigned to participate in the intervention, as well as the impact of actually participating and doing all of the required activities. Methods known broadly as "complier average causal effects" (CACE) or "instrumental variables" (IV) methods have been developed to estimate this latter effect, but they are more commonly applied in medical and treatment research. Since the use of these statistical techniques in prevention trials has been less widespread, many prevention scientists may not be familiar with the underlying assumptions and limitations of CACE and IV approaches. This paper provides an introduction to these methods, described in the context of randomized controlled trials of two preventive interventions: one for perinatal depression among at-risk women and the other for aggressive disruptive behavior in children. Through these case studies, the underlying assumptions and limitations of these methods are highlighted.
Implementing a patient education intervention about Methicillin-resistant Staphylococcus aureus prevention and effect on knowledge and behavior in veterans with spinal cord injuries and disorders: a pilot randomized controlled trial.
Evans, Charlesnika T; Hill, Jennifer N; Guihan, Marylou; Chin, Amy; Goldstein, Barry; Richardson, Michael S A; Anderson, Vicki; Risa, Kathleen; Kellie, Susan; Cameron, Kenzie A
To assess the feasibility and effect of a nurse-administered patient educational intervention about Methicillin-resistant Staphylococcus aureus (MRSA) prevention on knowledge and behavior of Veterans with spinal cord injuries and disorders (SCI/D). Blinded, block-randomized controlled pilot trial. Two Department of Veterans Affairs (VA) SCI Centers. Veterans were recruited March-September 2010 through referral by a healthcare provider from inpatient, outpatient, and residential care settings. Thirty participants were randomized to the nurse-administered intervention and 31 to the usual care group. The intervention included a brochure and tools to assist nurses in conducting the education. Pre- and post-intervention measurement of knowledge and behaviors related to MRSA and prevention strategies and feasibility measures related to implementation. Participants were primarily male (95.1%), white (63.9%), with tetraplegia (63.9%) and mean age and duration of injury of 64.3 and 20.5 years, respectively. The intervention groups mean knowledge score significantly increased between pre- and post-test (mean change score = 1.70, 95% confidence interval, CI 0.25-3.15) while the usual care groups score did not significantly change (mean change score = 1.45, 95% CI -0.08-2.98). However, the mean knowledge change between intervention and usual care groups was not significantly different (P = 0.81). Overall behavior scores did not significantly differ between treatment groups; however, the intervention group was more likely to report intentions to clean hands (90.0% vs. 64.5%, P = 0.03) and asking providers about MRSA status (46.7% vs. 16.1%, P = 0.01). Nurse educators reported that the quality of the intervention was high and could be implemented in clinical care. A targeted educational strategy is feasible to implement in SCI/D clinical practices and may improve some participants' knowledge about MRSA and increase intentions to improve hand hygiene and engagement with providers
Intervention studies This dissertation describes three trials in which the effectiveness of three preventive interventions for youth were tested in the Netherlands. The interventions aim to improve the social and emotional development of children in elementary school (PATHS), reduce alcohol use and mental health problems in students in secondary education (Preventure), and empower adolescent second generation migrants (POWER). The results revealed no effectiveness of the PATHS intervention, w...
A workplace exercise versus health promotion intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel: protocol of a cluster-randomised controlled trial.
Johnston, V; O'Leary, S; Comans, T; Straker, L; Melloh, M; Khan, A; Sjøgaard, G
Non-specific neck pain is a major burden to industry, yet the impact of introducing a workplace ergonomics and exercise intervention on work productivity and severity of neck pain in a population of office personnel is unknown. Does a combined workplace-based best practice ergonomic and neck exercise program reduce productivity losses and risk of developing neck pain in asymptomatic workers, or decrease severity of neck pain in symptomatic workers, compared to a best practice ergonomic and general health promotion program? Prospective cluster randomised controlled trial. Office personnel aged over 18 years, and who work>30 hours/week. Individualised best practice ergonomic intervention plus 3×20 minute weekly, progressive neck/shoulder girdle exercise group sessions for 12 weeks. Individualised best practice ergonomic intervention plus 1-hour weekly health information sessions for 12 weeks. Primary (productivity loss) and secondary (neck pain and disability, muscle performance, and quality of life) outcome measures will be collected using validated scales at baseline, immediate post-intervention and 12 months after commencement. 640 volunteering office personnel will be randomly allocated to either an intervention or control arm in work group clusters. Analysis will be on an 'intent-to-treat' basis and per protocol. Multilevel, generalised linear models will be used to examine the effect of the intervention on reducing the productivity loss in dollar units (AUD), and severity of neck pain and disability. The findings of this study will have a direct impact on policies that underpin the prevention and management of neck pain in office personnel. Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Suzuki, T; Makizako, H; Doi, T; Park, H; Lee, S; Tsutsumimoto, K; Umemura, K; Maki, Y; Shimada, H
Population aging is accelerating, with prolonged life expectancy and a decrease in birth rate. As age is a significant risk factor for dementia, we are confronted with an ever-increasing prevalence of mild cognitive impairment (MCI)/dementia. Thus, the Japanese National Center for Geriatrics and Gerontology launched a project to promote community-based research, including the development of an effective screening system for high-risk groups and intervention for dementia prevention. This review introduces the project, the Obu Study of Health Promotion for the Elderly, with the following strategic triad: 1) Identification of the target population by population screening; we regarded patients with MCI as the target population, and developed a screening test battery to identify MCI in a population screening setting. 2) Scientific evaluation of community-based intervention; we developed an interventional method combining exercise and cognitive training ("cognicise"). In practical settings, "cognicise" is programmed into multicomponent exercise intervention, which was reported to have benefits of cognitive improvement and reduction of brain atrophy based on randomized controlled trials. 3) Standardization of the methods of population screening and community-based intervention for evidence-based policy making and widespread implementation. Dementia prevention, or at least delaying the onset of dementia and/or stopping/slowing the progression of dementia, should benefit the whole society as well as individuals. It is our continuing challenge to improve the screening system and community-based intervention for dementia prevention through accumulation of evidence.
Esther Quirós Abajo
Eating Disorders are an important health problem of our society because of their rising incidence in the last years, as well as their high cost in terms of Public Health. Nowadays the best option to face this problem is through prevention. The objective of the present work is to evaluate if a Web nursing intervention based on Cognitive-Behavioural Therapy can prevent Eating Disorders by reducing risk factors in 15 to 18 years old women.Methodology: It is a randomized clinical trial in which t...
Langer, Gero; Fink, Astrid
ulcer development (pooled RR 0.86; 95% CI 0.73 to 1.00; P value 0.05; I(2) = 13%, random effects). This outcome is at unclear or high risk of bias.Fourteen trials evaluated the effects of nutritional supplements on the healing of existing pressure ulcers: seven trials examined mixed nutritional supplements, three the effects of proteins, two trials examined zinc, and two studies examined ascorbic acid. The included trials were heterogeneous with regard to participants, interventions, comparisons and outcomes and meta-analysis was not appropriate. There was no clear evidence of an improvement in pressure ulcer healing from the nutritional supplements evaluated in any of these individual studies. There is currently no clear evidence of a benefit associated with nutritional interventions for either the prevention or treatment of pressure ulcers. Further trials of high methodological quality are necessary.
Benwell, Ann Fenger
A growing body of literature emphasizes the importance of using both quantitative and qualitative methods to investigate the wide range of aspects which hinder or promote the success of health interventions. The pilot phase of this study highlights how mixed-method approaches can be strengthened ...... to investigate factors associated with multi-level obesity prevention....
Peters, Janne A; Zwerver, Johannes; Diercks, Ronald L; Elferink-Gemser, Marije T; van den Akker-Scheek, Inge
Objectives: Tendinopathy, the most prevalent tendon disorder which is considered as the clinical diagnosis of pain and dysfunction, is common in sports and its prevalence is ever-increasing. Despite the lack of clarity about risk factors, various preventive interventions for tendinopathy have been
van Dijken, M.W.; Stams, Geert-Jan; de Winter, M.
Despite the many efforts taken to prevent child maltreatment, this continues to be a significant worldwide problem. Interventions predominantly focus on ‘at risk’ populations and individual characteristics of the victim or abuser, but is that enough? The present review was designed to examine the
Huisman, A.; Pirkis, J; Robinson, J.
Background: Despite the growing strength of the field of suicidology, various commentators have recently noted that insufficient effort is being put into intervention research, and that this is limiting our knowledge of which suicide prevention strategies might be the most effective. Aims: To
Interventions for Violence Prevention among Young Female Hawkers in Motor Parks in South-Western Nigeria: A Review of Effectiveness. ... Findings show that they had greater knowledge of the different types of violence (p < 0.05), were more aware of their vulnerability to violence (99.4% after compared to 82.7% before ...
Children with Elevated Psychosocial Risk Load Benefit Most from a Family-Based Preventive Intervention: Exploratory Differential Analyses from the German "Strengthening Families Program 10-14" Adaptation Trial.
Bröning, Sonja; Baldus, Christiane; Thomsen, Monika; Sack, Peter-Michael; Arnaud, Nicolas; Thomasius, Rainer
While the effectiveness of substance use prevention programs such as the Strengthening Families Program 10-14 (SFP) has been demonstrated in the USA, European SFP adaptations have not replicated these sizable effects. Following the rationale of the risk moderation hypothesis positing that elevated risk groups may benefit more from a preventive intervention than lower-risk groups, we reanalyzed evaluation data from a randomized controlled trial testing the adapted German version of SFP (SFP-D). We hypothesized a differential impact of risk status on intervention results. The study employed a minimal control condition. Of the N = 292 participating children, 73.5% qualified as at-risk because they lived in a deprived urban district, and 26.5% qualified as high risk because they additionally scored as "difficult" in the German Strengths and Difficulty Questionnaire (parents' reports using gender- and age-specific German norms). Outcomes were children's self-reports on substance use, mental health, family functioning, and quality of life. Data were analyzed with repeated measures linear mixed models and relative risk analyses. The high-risk group in the SFP-D condition achieved the best results compared with all other groups, especially in mental health and quality of life. Relative risk analyses on tobacco [alcohol] abstinence showed that an additional percentage of 29.8% [16.0%] of high-risk children in nonabstinent controls would have remained abstinent if they had participated in SFP-D. We conclude that risk load influences the impact of substance use prevention programs and discuss to what extent differential analyses can add value to prevention research.
The effect of a sports chiropractic manual therapy intervention on the prevention of back pain, hamstring and lower limb injuries in semi-elite Australian Rules footballers: a randomized controlled trial.
Hoskins, Wayne; Pollard, Henry
Hamstring injuries are the most common injury in Australian Rules football. It was the aims to investigate whether a sports chiropractic manual therapy intervention protocol provided in addition to the current best practice management could prevent the occurrence of and weeks missed due to hamstring and other lower-limb injuries at the semi-elite level of Australian football. Sixty male subjects were assessed for eligibility with 59 meeting entry requirements and randomly allocated to an intervention (n = 29) or control group (n = 30), being matched for age and hamstring injury history. Twenty-eight intervention and 29 control group participants completed the trial. Both groups received the current best practice medical and sports science management, which acted as the control. Additionally, the intervention group received a sports chiropractic intervention. Treatment for the intervention group was individually determined and could involve manipulation/mobilization and/or soft tissue therapies to the spine and extremity. Minimum scheduling was: 1 treatment per week for 6 weeks, 1 treatment per fortnight for 3 months, 1 treatment per month for the remainder of the season (3 months). The main outcome measure was an injury surveillance with a missed match injury definition. After 24 matches there was no statistical significant difference between the groups for the incidence of hamstring injury (OR:0.116, 95% CI:0.013-1.019, p = 0.051) and primary non-contact knee injury (OR:0.116, 95% CI:0.013-1.019, p = 0.051). The difference for primary lower-limb muscle strains was significant (OR:0.097, 95%CI:0.011-0.839, p = 0.025). There was no significant difference for weeks missed due to hamstring injury (4 v 14, chi2:1.12, p = 0.29) and lower-limb muscle strains (4 v 21, chi2:2.66, p = 0.10). A significant difference in weeks missed due to non-contact knee injury was noted (1 v 24, chi2:6.70, p = 0.01). This study demonstrated a trend towards lower limb injury prevention
Verbeek, Jos H.; Kateman, Erik; Morata, Thais C.; Dreschler, Wouter A.; Mischke, Christina
To assess the effectiveness of interventions for preventing occupational noise exposure or hearing loss compared to no intervention or alternative interventions. We searched biomedical databases up to 25 January 2012 for randomized controlled trials (RCT), controlled before-after studies and
Dawson, Liza; Zwerski, Sheryl
This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
Richard, Edo; Andrieu, Sandrine; Solomon, Alina; Mangialasche, Francesca; Ahtiluoto, Satu; Moll van Charante, Eric P; Coley, Nicola; Fratiglioni, Laura; Neely, Anna Stigsdotter; Vellas, Bruno; van Gool, Willem A; Kivipelto, Miia
Recent epidemiological studies have indicated numerous associations between vascular and lifestyle related risk factors and incident dementia. However, evidence from randomised controlled trials (RCT) showing effectiveness of interventions aimed at these risk factors in preventing or postponing dementia onset is still lacking. Three large RCTs on multi-component interventions to prevent dementia (preDIVA, FINGER, MAPT) have been initiated in Europe to address these issues. Irrespective of some methodological differences, all three studies target cardiovascular and lifestyle related risk factors. Collaboration within the newly founded 'European Dementia Prevention Initiative' (EDPI) will allow for a comprehensive exploration of optimal target population, intervention and outcome measures, which are currently unknown. Combining data of the ongoing studies and running simulation analyses will facilitate determining the optimal design including accurate sample-size calculations for future multi-national clinical trials on dementia prevention. Interventions aiming at dementia prevention should be pragmatic and easy to implement on a large scale in different health care systems, without generating high additional costs or burden on participants or physicians. As the optimal age for intervention precedes the optimal age for outcome assessment, traditional trial designs might lead to suboptimal timing of either of the two. Separation of intervention and outcome assessment in time is a potential solution, but requires studies with very long follow-up. International collaboration of research groups with experience in dementia prevention studies and well-organised logistics for these major projects is pivotal to success for future large-scale dementia prevention studies. Founding of EDPI is an important first step in this direction. Copyright © 2012 Elsevier B.V. All rights reserved.
Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).
Towfighi, Amytis; Cheng, Eric M; Ayala-Rivera, Monica; McCreath, Heather; Sanossian, Nerses; Dutta, Tara; Mehta, Bijal; Bryg, Robert; Rao, Neal; Song, Shlee; Razmara, Ali; Ramirez, Magaly; Sivers-Teixeira, Theresa; Tran, Jamie; Mojarro-Huang, Elizabeth; Montoya, Ana; Corrales, Marilyn; Martinez, Beatrice; Willis, Phyllis; Macias, Mireya; Ibrahim, Nancy; Wu, Shinyi; Wacksman, Jeremy; Haber, Hilary; Richards, Adam; Barry, Frances; Hill, Valerie; Mittman, Brian; Cunningham, William; Liu, Honghu; Ganz, David A; Factor, Diane; Vickrey, Barbara G
Recurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population. In this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial
van Wier, Marieke F; Lakerveld, Jeroen; Bot, Sandra D M; Chinapaw, Mai J M; Nijpels, Giel; van Tulder, Maurits W
BACKGROUND: Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases, addressing 'real-world' implementation, are needed. This study examines the cost-effectiveness of a primary care intervention from a societal perspective, compared with provision of
Palmer, Shawna L; Leigh, Laurie; Ellison, Susan C; Onar-Thomas, Arzu; Wu, Shengjie; Qaddoumi, Ibrahim; Armstrong, Gregory T; Wright, Karen; Wetmore, Cynthia; Broniscer, Alberto; Gajjar, Amar
To investigate the feasibility of a computer-based reading intervention completed by patients diagnosed with a brain tumor. Patients were randomized to the intervention (n = 43) or standard of care group (n = 38). The intervention consisted of 30 sessions using Fast ForWord® exercises in a game-like format. Change in reading decoding scores over time since diagnosis was examined. Gender, race, parent education, parent marital status, and age at diagnosis were examined as covariates. 17 patients (39.5%) were able to complete the target goal of 30 intervention sessions. Females had significantly greater training time than males (p = .022). Age at diagnosis was associated with average training time/session for females (r = .485, p = .041). No significant differences were found in reading scores between the randomized groups. The study was well accepted by families and adherence by patients undergoing radiation therapy for medulloblastoma was moderate. Suggestions for improved methodology are discussed.
Jahanfar, Shayesteh; Howard, Louise M; Medley, Nancy
Domestic violence during pregnancy is a major public health concern. This preventable risk factor threatens both the mother and baby. Routine perinatal care visits offer opportunities for healthcare professionals to screen and refer abused women for effective interventions. It is, however, not clear which interventions best serve mothers during pregnancy and postpartum to ensure their safety. To examine the effectiveness and safety of interventions in preventing or reducing domestic violence against pregnant women. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 July 2014), scanned bibliographies of published studies and corresponded with investigators. We included randomised controlled trials (RCTs) including cluster-randomised trials, and quasi-randomised controlled trials (e.g. where there was alternate allocation) investigating the effect of interventions in preventing or reducing domestic violence during pregnancy. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We included 10 trials with a total of 3417 women randomised. Seven of these trials, recruiting 2629 women, contributed data to the review. However, results for all outcomes were based on single studies. There was limited evidence for the primary outcomes of reduction of episodes of violence (physical, sexual, and/or psychological) and prevention of violence during and up to one year after pregnancy (as defined by the authors of trials). In one study, women who received the intervention reported fewer episodes of partner violence during pregnancy and in the postpartum period (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.43 to 0.88, 306 women, moderate quality). Groups did not differ for Conflict Tactics Score - the mean partner abuse scores in the first three months postpartum (mean difference (MD) 4.20 higher, 95% CI -10.74 to 19.14, one study, 46 women, very low quality). The Current
Rationale and study protocol for the 'active teen leaders avoiding screen-time' (ATLAS) group randomized controlled trial: an obesity prevention intervention for adolescent boys from schools in low-income communities.
Smith, Jordan J; Morgan, Philip J; Plotnikoff, Ronald C; Dally, Kerry A; Salmon, Jo; Okely, Anthony D; Finn, Tara L; Babic, Mark J; Skinner, Geoff; Lubans, David R
The negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are 'at risk' of obesity. The aim of this paper is to report the rationale and study protocol for the 'Active Teen Leaders Avoiding Screen-time' (ATLAS) obesity prevention intervention for adolescent boys living in low-income communities. The ATLAS intervention will be evaluated using a cluster randomized controlled trial in 14 secondary schools in the state of New South Wales (NSW), Australia (2012 to 2014). ATLAS is an 8-month multi-component, school-based program informed by self-determination theory and social cognitive theory. The intervention consists of teacher professional development, enhanced school-sport sessions, researcher-led seminars, lunch-time physical activity mentoring sessions, pedometers for self-monitoring, provision of equipment to schools, parental newsletters, and a smartphone application and website. Assessments were conducted at baseline and will be completed again at 9- and 18-months from baseline. Primary outcomes are body mass index (BMI) and waist circumference. Secondary outcomes include BMI z-scores, body fat (bioelectrical impedance analysis), physical activity (accelerometers), muscular fitness (grip strength and push-ups), screen-time, sugar-sweetened beverage consumption, resistance training skill competency, daytime sleepiness, subjective well-being, physical self-perception, pathological video gaming, and aggression. Hypothesized mediators of behavior change will also be explored. ATLAS is an innovative school-based intervention designed to improve the health behaviors and related outcomes of adolescent males in low-income communities. Copyright © 2013 Elsevier Inc. All rights reserved.
Lee, Ming-Shinn; Zi-Pei, Wu; Svanström, Leif; Dalal, Koustuv
This study aimed to explore the effectiveness of the cyber bullying prevention WebQuest course implementation. The study adopted the quasi-experimental design with two classes made up of a total of 61 junior high school students of seventh grade. The study subjects comprised of 30 students from the experimental group and 31 students from the control group. The experimental group received eight sessions (total 360 minutes) of the teaching intervention for four consecutive weeks, while the control group did not engage in any related courses. The self-compiled questionnaire for the student's knowledge, attitudes, and intentions toward cyber bullying prevention was adopted. Data were analysed through generalized estimating equations to understand the immediate results on the student's knowledge, attitudes, and intentions after the intervention. The results show that the WebQuest course immediately and effectively enhanced the knowledge of cyber bullying, reduced the intentions, and retained the effects after the learning. But it produced no significant impact on the attitude toward cyber bullying. The intervention through this pilot study was effective and positive for cyber bulling prevention. It was with small number of students. Therefore, studies with large number of students and long experimental times, in different areas and countries are warranted.
Full Text Available BACKGROUND: This study aimed to explore the effectiveness of the cyber bullying prevention WebQuest course implementation. METHODOLOGY/FINDINGS: The study adopted the quasi-experimental design with two classes made up of a total of 61 junior high school students of seventh grade. The study subjects comprised of 30 students from the experimental group and 31 students from the control group. The experimental group received eight sessions (total 360 minutes of the teaching intervention for four consecutive weeks, while the control group did not engage in any related courses. The self-compiled questionnaire for the student's knowledge, attitudes, and intentions toward cyber bullying prevention was adopted. Data were analysed through generalized estimating equations to understand the immediate results on the student's knowledge, attitudes, and intentions after the intervention. The results show that the WebQuest course immediately and effectively enhanced the knowledge of cyber bullying, reduced the intentions, and retained the effects after the learning. But it produced no significant impact on the attitude toward cyber bullying. CONCLUSIONS/SIGNIFICANCE: The intervention through this pilot study was effective and positive for cyber bulling prevention. It was with small number of students. Therefore, studies with large number of students and long experimental times, in different areas and countries are warranted.
The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories
Fiellin, Lynn E; Kyriakides, Tassos C; Hieftje, Kimberly D; Pendergrass, Tyra M; Duncan, Lindsay R; Dziura, James D; Sawyer, Benjamin G; Fiellin, David A
Background To address the need for risk behavior reduction and HIV prevention interventions that capture adolescents “where they live,” we created a tablet-based videogame to teach skills and knowledge and influence psychosocial antecedents for decreasing risk and preventing HIV infection in minority youth in schools, after-school programs, and summer camps. Methods We developed PlayForward: Elm City Stories over a 2-year period, working with researchers, commercial game designers, and staff and teens from community programs. The videogame PlayForward provides an interactive world where players, using an avatar, “travel” through time, facing challenges such as peer pressure to drink alcohol or engage in risky sexual behaviors. Players experience how their choices affect their future and then are able to go back in time and change their choices, creating different outcomes. A randomized controlled trial was designed to evaluate the efficacy of PlayForward. Participants were randomly assigned to play PlayForward or a set of attention/time control games on a tablet at their community-based program. Assessment data were collected during face-to-face study visits and entered into a web-based platform and unique real-time “in-game” PlayForward data were collected as players engaged in the game. The innovative methods of this randomized controlled trial are described. We highlight the logistical issues of conducting a large-scale trial using mobile technology such as the iPad®, and collecting, transferring, and storing large amounts of in-game data. We outline the methods used to analyze the in-game data alone and in conjunction with standardized assessment data to establish correlations between behaviors during gameplay and those reported in real life. We also describe the use of the in-game data as a measure of fidelity to the intervention. Results In total, 333 boys and girls, aged 11–14 years, were randomized over a 14-month period: 166 were assigned to
Cost-effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: design of a cluster-randomized controlled trial.
van Dijk, Susan E M; Pols, Alide D; Adriaanse, Marcel C; Bosmans, Judith E; Elders, Petra J M; van Marwijk, Harm W J; van Tulder, Maurits W
Co-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and/or coronary heart disease and this negatively impacts quality of life. Subthreshold depression is the most important risk factor for the development of major depression. Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care, there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder. Nurse led stepped-care is a promising way to accomplish this. The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and/or coronary heart disease in primary care who also have subthreshold depressive symptoms. An economic evaluation will be conducted alongside a cluster-randomized controlled trial in approximately thirty general practices in the Netherlands. Randomization takes place at the level of participating practice nurses. We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual. The stepped-care program consists of four sequential but flexible treatment steps: 1) watchful waiting, 2) guided self-help treatment, 3) problem solving treatment and 4) referral to the general practitioner. The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview. Secondary outcomes include severity of depressive symptoms, quality of life, anxiety and physical outcomes. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline and 3, 6, 9 and 12 months. The intervention being investigated is expected
Conclusion: The results suggest that chest vibration may contribute to expectoration and thus improve lung collapse among ventilated patients in an ICU. Chest vibration nursing intervention is a safe and effective alternative pulmonary clearance method and can be used on patients who are on ventilators in ICUs.
Lakerveld, Jeroen; Bot, Sandra D M; van der Ploeg, Hidde P; Nijpels, Giel
This study set out to assess the short- and long-term effects of a primary care-based lifestyle intervention on different domains of leisure-time sedentary behaviors in Dutch adults at risk of type 2 diabetes and cardiovascular diseases. Between 2007 and 2009, adults (n=622) at risk were randomly assigned to a counseling intervention aimed at adopting healthy lifestyle behaviors, or a control group that only received health brochures. Follow-up measures were done after 6, 12 and 24months. Linear regression analysis was used to examine between-group differences in self-report minutes per day sedentary behaviors, adjusted for baseline values. Stratified analyses were performed for sex and educational attainment. Seventy-nine percent (n=490) of participants completed the last follow-up. Mean baseline sedentary behaviors were 254.6min per day (SD=136.2). Intention-to-treat analyses showed no significant differences in overall or domain-specific sedentary behaviors between the two groups at follow-up. Stratified analyses for educational attainment revealed a small and temporary between-group difference in favor of the intervention group, in those who finished secondary school. A primary care-based general lifestyle intervention was not more effective in reducing leisure-time sedentary behaviors than providing brochures in adults at risk for chronic diseases. Copyright © 2013 Elsevier Inc. All rights reserved.
Lakerveld, J.; Bot, S.D.M.; van der Ploeg, H.P.; Nijpels, G.
Objective: This study set out to assess the short- and long-term effects of a primary care-based lifestyle intervention on different domains of leisure-time sedentary behaviors in Dutch adults at risk of type 2 diabetes and cardiovascular diseases. Methods: Between 2007 and 2009, adults (n=622) at
Pratt, B M; Woolfenden, S R
/or electronic mail. Randomised controlled trials (RCT) with a major focus on eating disorder prevention programs for children and adolescents, where there is no known DSM-IV diagnosis of an eating disorder, are eligible for inclusion in the review. Trials must include a control group and at least one objective outcome measure (eg. BMI) or a standardised psychological measure used with the intervention and control group, pre- and post-intervention. A total of 1379 titles have been identified through the search to date. 13 studies were located that reported use of a randomised controlled trial methodology and were critically appraised by two independent reviewers. Five (5) studies were excluded as data were not reported in a useable form or useable data could not be obtained from the trial authors, one dissertation could not be obtained, one study had no "true" no-treatment or usual treatment control group, and one study did not use a pre-test outcome measure. Eight (8) studies met the selection criteria outlined above. Only one of eight pooled comparisons of two or more studies using similar outcome measures and similar intervention types demonstrated the statistically significant effect of a particular type of eating disorder prevention program for children and adolescents. Combined data from two eating disorder prevention programs based on a media literacy and advocacy approach indicate a reduction in the internalisation or acceptance of societal ideals relating to appearance at a 3- to 6-month follow-up (Kusel, unpublished; Neumark-Sztainer2000) [SMD -0.28, -0.51 to -0.05, 95% CI]. However, there is insufficient evidence to conclude that this approach also demonstrated a significant impact on awareness of societal standards relating to appearance. There is insufficient evidence to support the effect of four programs designed to address eating attitudes and behaviours and other adolescent issues on body weight, eating disorder symptoms, associated eating disorder
Morales, Eduardo S
Translation from research to practice faces numerous problems that include replicating effectiveness, fidelity to the protocol and processes, and adaptations to different types of target populations. Working collaboratively with existing service providers can speed up the time for development and can ease the implementation of empirical randomized trials. Contextual community prevention theory is an innovative approach that focuses on changing behaviors of community members by creating a visible institutional presence that draws and pulls the targeted population into the organization's activities and interventions. The result is an institution or organization within the community that provides a new active and dynamic context, engaging its community members into its activities, interventions, and functions. An HIV prevention program developed collaboratively from the ground up for Latino gay/bisexual men is presented. Results from the program evaluation efforts across the years suggest promise for testing its efficacy through a randomized trial. HIV prevention efforts need to develop dynamic support systems within communities where these men have ownership, have control, and feel safe; otherwise HIV infection rates in this population will increase. Copyright 2009 by the American Psychological Association
Fisker, Annette; Langberg, Henning; Petersen, Tom; Mortensen, Ole Steen
Background Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effec...
J Gordon Millichap
Full Text Available As part of an International Pediatric Stroke Study launched in 2002, the Stroke Prevention Trial in Sickle Cell Anemia (STOP reports a reduction in the number of overt clinical strokes in children with critically high transcranial Doppler velocities (>200 cm/sec who were regularly transfused.
Becker, Annette; Angerer, Peter; Müller, Andreas
Research shows that psychosocial factors play a significant role on the emergence of musculoskeletal complaints (MSC). The aim of this study was to determine whether a coaching intervention which was focussed on enabling better strategies for coping with work stressors is superior to physiotherapy alone in the reduction of MSC. 68 nurses were randomized to an intervention group (IG, n = 34) or a control group (CG, n = 34). The IG and CG completed a weekly individual physiotherapy unit (10 weeks). Additionally, the IG passed five coaching sessions (fortnightly), plus one opening and one closing session. The primary outcome was MSC, secondary outcomes were work ability and work-related wellbeing. Outcomes were obtained by physical examinations and questionnaires. Data were analyzed by t-test, Chi-Square test, ANOVA with repeated measurements, and multilevel analyzes. In respect of MSC, the IG compared to the CG showed a significant improvement in the pain severity of everyday movements, and trends towards an improvement of movement in the vertebral column as well as a reduction of the pain severity due to maximum degree movements. No effects were observed in respect to muscle strengths, and restrictions of everyday activities. The IG exhibited a significant improvement of work ability in reference to the physical working demands, and work-related wellbeing. Analysis indicates that improvements in the IG increased further in the 12 weeks after the intervention. The results suggest that the coaching, beyond physiotherapy, can support the reduction of MSC, the improvement of work ability and work-related wellbeing.
Verbeek, Jos H.; Kateman, Erik; Morata, Thais C.; Dreschler, Wout; Sorgdrager, Bas
BACKGROUND: Millions of workers worldwide are exposed to noise levels that increase their risk of hearing impairment. Little is known about the effectiveness of hearing loss prevention interventions. OBJECTIVES: To assess the effectiveness of non-pharmaceutical interventions for preventing
Verbeek, Jos H.; Kateman, Erik; Morata, Thais C.; Dreschler, Wouter A.; Mischke, Christina
Background Millions of workers worldwide are exposed to noise levels that increase their risk of hearing impairment. Little is known about the effectiveness of hearing loss prevention interventions. Objectives To assess the effectiveness of non-pharmaceutical interventions for preventing
Gewandter, Jennifer S.; Dworkin, Robert H.; Turk, Dennis C.; Farrar, John T.; Fillingim, Roger B.; Gilron, Ian; Markman, John D.; Oaklander, Anne Louise; Polydefkis, Michael J.; Raja, Srinivasa N.; Robinson, James P.; Woolf, Clifford J.; Ziegler, Dan; Ashburn, Michael A.; Burke, Laurie B.; Cowan, Penney; George, Steven Z.; Goli, Veeraindar; Graff, Ole X.; Iyengar, Smriti; Jay, Gary W.; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A.; Kopecky, Ernest A.; Malamut, Richard; McDermott, Michael P.; Palmer, Pamela; Rappaport, Bob A.; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A.
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (i.e., chronic post-surgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (i.e., surgery, viral infection, injury, and toxic/noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials. PMID:25887465
Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.
Christakis, Dimitri A; Zimmerman, Frederick J; Rivara, Frederick P; Ebel, Beth
Innovations to improve the delivery of pediatric preventive care are needed. We enrolled children, 0 to 11 years of age, into a factorial, randomized, controlled trial of a tailored, evidence-based, Web site (MyHealthyChild) that provided information on prevention topics before a scheduled well-child visit. There were 2 components of the intervention, namely, parental Web content and provider notification. Parental Web content provided information to parents about prevention topics; provider notification communicated to physicians topics that were of interest to parents. We assigned 887 children randomly to 4 groups (usual care, content only, content and notification, or notification only). Outcomes were determined with telephone follow-up surveys conducted 2 to 4 weeks after the visit. Poisson regression analysis was used to determine the independent effects of each intervention on the number of topics discussed and the number of preventive practices implemented. Parents in the notification/content group and in the notification-only group reported discussing more MyHealthyChild topics with their provider. Parents in the notification/content group and in the content-only group reported implementing more MyHealthyChild topic suggestions (such as use of a safety device). A Web-based intervention can activate parents to discuss prevention topics with their child's provider. Delivery of tailored content can promote preventive practices.
White, Wendi E; Carmody, Dianne
Facebook, Twitter, and other social networking sites have changed the way we interact online. Technological advances have also facilitated the emergence of cyberstalking and online harassment, a growing issue on college campuses. This study utilizes focus group data to examine college students' experiences with online harassment and cyberstalking. Students voiced concerns with online tracking, falsifying identities, and harassment. They also noted that incoming first-year students and those negotiating some of their first romantic relationships are especially vulnerable. In addition, students were asked to propose appropriate prevention, education, and intervention strategies at the college level. Surprisingly, many students recommended offline programs to battle this online problem. © The Author(s) 2016.
Esther Quirós Abajo
Full Text Available Eating Disorders are an important health problem of our society because of their rising incidence in the last years, as well as their high cost in terms of Public Health. Nowadays the best option to face this problem is through prevention. The objective of the present work is to evaluate if a Web nursing intervention based on Cognitive-Behavioural Therapy can prevent Eating Disorders by reducing risk factors in 15 to 18 years old women.Methodology: It is a randomized clinical trial in which the experimental group will receive the Web nursing intervention and the control group will not receive any kind of preventive intervention related to Eating Disorders. The study will be developed in six Secondary Education Institutes of the areas 9 and 10 of Madrid Community. Women at risk will be selected by the Body Shape Questionnaire (BSQ. Risk factors such as body image dissatisfaction, eating and depressive symptoms will be evaluated. Measurements will be, besides BSQ, the Body Attitudes Test (BAT, the Eating Disorders Inventory (EDI, the Eating Attitudes Test (EAT and the Beck Depression Inventory (BDI.
Sagarra, R; Costa, B; Cabré, J J; Solà-Morales, O; Barrio, F
Transferring the results from clinical trials on type 2 diabetes prevention is the objective of the Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional intervention (DE-PLAN) project in Catalonia, whose cost-effectiveness analysis is now presented. A prospective cohort study was performed in primary care involving individuals without diagnosed diabetes aged 45-75 years (n=2054) screened using the questionnaire Finnish Diabetes Risk Score (FINDRISC) and a subsequent oral glucose tolerance test. Where feasible, high-risk individuals who were identified (n=552) were allocated sequentially to standard care (n=219), a group-based (n=230) or an individual-level (n=103) intensive (structured programme of six hours using specific teaching techniques) lifestyle intervention (n=333). The primary outcome was the development of diabetes (WHO). We evaluated the cost of resources used with comparison of standard care and the intervention groups in terms of effectiveness and quality of life (15D questionnaire). After 4.2-year median follow-up, the cumulative incidences were 18.3% (14.3-22.9%) in the intensive intervention group and 28.8% (22.9-35.3%) in the standard care group (36.5% relative-risk-reduction). The corresponding 4-year HR was 0.64 (0.47-0.87; P<.004). The incremental cost induced by intensive intervention compared with the standard was 106€ per participant in the individual level and 10€ in the group-based intervention representing 746€ and 108€ per averted case of diabetes, respectively. The estimated incremental cost-utility ratio was 3243€ per quality-adjusted life-years gained. The intensive lifestyle intervention delayed the development of diabetes and was efficient in economic analysis. Copyright © 2013 Elsevier España, S.L. All rights reserved.
Atkinson, Ross A; Cullum, Nicky A
Narrative review. Pressure ulcers are a common complication in people with reduced sensation and limited mobility, occurring frequently in those who have sustained spinal cord injury. This narrative review summarises the evidence relating to interventions for the prevention and treatment of pressure ulcers, in particular from Cochrane systematic reviews. It also aims to highlight the degree to which people with spinal cord injury have been included as participants in randomised controlled trials included in Cochrane reviews of such interventions. Global. The Cochrane library (up to July 2017) was searched for systematic reviews of any type of intervention for the prevention or treatment of pressure ulcers. A search of PubMed (up to July 2017) was undertaken to identify other systematic reviews and additional published trial reports of interventions for pressure ulcer prevention and treatment. The searches revealed 38 published systematic reviews (27 Cochrane and 11 others) and 6 additional published trial reports. An array of interventions is available for clinical use, but few have been evaluated adequately in people with SCI. The effects of most interventions for preventing and treating pressure ulcers in people with spinal cord injury are highly uncertain. Existing evaluations of pressure ulcer interventions include very few participants with spinal cord injury. Subsequently, there is still a need for high-quality randomised trials of such interventions in this patient population.
Clasen, Thomas F; Alexander, Kelly T; Sinclair, David; Boisson, Sophie; Peletz, Rachel; Chang, Howard H; Majorin, Fiona; Cairncross, Sandy
Background Diarrhoea is a major cause of death and disease, especially among young children in low-income countries. In these settings, many infectious agents associated with diarrhoea are spread through water contaminated with faeces. In remote and low-income settings, source-based water quality improvement includes providing protected groundwater (springs, wells, and bore holes), or harvested rainwater as an alternative to surface sources (rivers and lakes). Point-of-use water quality improvement interventions include boiling, chlorination, flocculation, filtration, or solar disinfection, mainly conducted at home. Objectives To assess the effectiveness of interventions to improve water quality for preventing diarrhoea. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register (11 November 2014), CENTRAL (the Cochrane Library, 7 November 2014), MEDLINE (1966 to 10 November 2014), EMBASE (1974 to 10 November 2014), and LILACS (1982 to 7 November 2014). We also handsearched relevant conference proceedings, contacted researchers and organizations working in the field, and checked references from identified studies through 11 November 2014. Selection criteria Randomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies (CBA) comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults. Data collection and analysis Two review authors independently assessed trial quality and extracted data. We used meta-analyses to estimate pooled measures of effect, where appropriate, and investigated potential sources of heterogeneity using subgroup analyses. We assessed the quality of evidence using the GRADE approach. Main results Forty-five cluster-RCTs, two quasi-RCTs, and eight CBA studies, including over 84,000 participants, met the inclusion criteria. Most included studies were conducted in low- or middle-income countries (LMICs) (50 studies) with
Gillen, Patricia A; Sinclair, Marlene; Kernohan, W George; Begley, Cecily M; Luyben, Ans G
Bullying has been identified as one of the leading workplace stressors, with adverse consequences for the individual employee, groups of employees, and whole organisations. Employees who have been bullied have lower levels of job satisfaction, higher levels of anxiety and depression, and are more likely to leave their place of work. Organisations face increased risk of skill depletion and absenteeism, leading to loss of profit, potential legal fees, and tribunal cases. It is unclear to what extent these risks can be addressed through interventions to prevent bullying. To explore the effectiveness of workplace interventions to prevent bullying in the workplace. We searched: the Cochrane Work Group Trials Register (August 2014); Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, issue 1); PUBMED (1946 to January 2016); EMBASE (1980 to January 2016); PsycINFO (1967 to January 2016); Cumulative Index to Nursing and Allied Health Literature (CINAHL Plus; 1937 to January 2016); International Bibliography of the Social Sciences (IBSS; 1951 to January 2016); Applied Social Sciences Index and Abstracts (ASSIA; 1987 to January 2016); ABI Global (earliest record to January 2016); Business Source Premier (BSP; earliest record to January 2016); OpenGrey (previously known as OpenSIGLE-System for Information on Grey Literature in Europe; 1980 to December 2014); and reference lists of articles. Randomised and cluster-randomised controlled trials of employee-directed interventions, controlled before and after studies, and interrupted time-series studies of interventions of any type, aimed at preventing bullying in the workplace, targeted at an individual employee, a group of employees, or an organisation. Three authors independently screened and selected studies. We extracted data from included studies on victimisation, perpetration, and absenteeism associated with workplace bullying. We contacted study authors to gather additional data. We used the
Full Text Available BACKGROUND: Prevention of childhood obesity is an international public health priority given the significant impact of obesity on acute and chronic diseases, general health, development and well-being. The international evidence base for strategies that governments, communities and families can implement to prevent obesity, and promote health, has been accumulating but remains unclear. OBJECTIVE: This review primarily aims to update the previous Cochrane review of childhood obesity prevention research and determine the effectiveness of evaluated interventions intended to prevent obesity in children, assessed by change in Body Mass Index (BMI. Secondary aims were to examine the characteristics of the programs and strategies to answer the questions "What works for whom, why and for what cost?" METHODS: Search methods: The searches were re-run in CENTRAL, MEDLINE, EMBASE, PsychINFO and CINAHL in March 2010 and searched relevant websites. Non-English language papers were included and experts were contacted. Selection criteria: The review includes data from childhood obesity prevention studies that used a controlled study design (with or without randomisation. Studies were included if they evaluated interventions, policies or programs in place for twelve weeks or more. If studies were randomized at a cluster level, six clusters were required. Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias of included studies. Data was extracted on intervention implementation, cost, equity and outcomes. Outcome measures were grouped according to whether they measured adiposity, physical activity (PA-related behaviours or diet-related behaviours. Adverse outcomes were recorded. A meta-analysis was conducted using available BMI or standardized BMI (zBMI score data with subgroup analysis by age group (0-5, 6-12, 13-18 years, corresponding to stages of developmental and childhood settings. MAIN RESULTS: This
Marchand, Erica; Stice, Eric; Rohde, Paul; Becker, Carolyn Black
Efficacy trials test whether interventions work under optimal, highly controlled conditions whereas effectiveness trials test whether interventions work with typical clients and providers in real-world settings. Researchers, providers, and funding bodies have called for more effectiveness trials to understand whether interventions produce effects under ecologically valid conditions, which factors predict program effectiveness, and what strategies are needed to successfully implement programs ...
Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D.
Background: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes.Methods/Design: The original...
Auvert, Bertran; Sitta, Rémi; Zarca, Kevin; Mahiane, Séverin Guy; Pretorius, Carel; Lissouba, Pascale
Randomized controlled trials (RCTs) for the prevention of HIV heterosexual acquisition are usually conducted among adult African populations with high heterogeneity in individual risk of infection. The objectives were to (a) review how this heterogeneity has been considered when designing and interpreting such RCTs, (b) evaluate its effect on the findings and the statistical power of these trials, and (c) assess the potential advantages of using the crossover design with single failure-time endpoint. Individual-level HIV prevention RCTs conducted in Africa and published in the period 1998-2008 were reviewed. Using Monte Carlo simulations and statistical calculations, we assessed the effect of heterogeneity on the findings and the statistical power of HIV prevention RCTs. All reviewed RCTs used the parallel design. The heterogeneity in individual risk of infection within study sites was not used for stratification nor generally considered in the design and interpretation of RCTs. Simulations showed that in the context of high HIV incidence, high heterogeneity can lead to a substantial underestimation of the impact of an intervention and reduced statistical power. Calculations demonstrated that the crossover design allowed for similar or better estimation and statistical power. The crossover design has the ethical advantage of sharing the potential benefits and risks of the intervention between participants. Only trials with two treatment arms and two follow-up periods were modeled. The baseline risk of infection of each participant was assumed to be constant over time and HIV status was assessed at the end of each follow-up period. The heterogeneity in individual risk of HIV infection is an underestimated problem which should be taken into account when designing and interpreting RCTs that test prevention methods of HIV heterosexual acquisition in adult African populations with high HIV incidence. When the effects of tested interventions are rapidly reversible, the
Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.
Woelk, Godfrey B; Kieffer, Mary Pat; Walker, Damilola; Mpofu, Daphne; Machekano, Rhoderick
Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. Implementation of the protocol necessitated changes in the
Amos, Taryn; Stein, Dan J; Ipser, Jonathan C
Post-traumatic stress disorder (PTSD) is a debilitating disorder which, after a sufficient delay, may be diagnosed amongst individuals who respond with intense fear, helplessness or horror to traumatic events. There is some evidence that the use of pharmacological interventions immediately after exposure to trauma may reduce the risk of developing of PTSD. To assess the effects of pharmacological interventions for the prevention of PTSD in adults following exposure to a traumatic event. We searched the Cochrane Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR-Studies and CCDANCTR-References) (to 14 February 2014). This register contains relevant reports of randomised controlled trials from the following bibliographic databases: CENTRAL (all years); EMBASE (1974 to date); MEDLINE (1950 to date) and PsycINFO (1967 to date). We identified unpublished trials by searching the National Institute of Health (NIH) Reporter, the metaRegister of Controlled Trials database (mRCT) and the WHO International Clinical Trials Registry Platform (to December 2013). We scanned the reference lists of articles for additional studies. We placed no constraints on language and setting. We restricted studies to randomised controlled trials (RCTs) of pharmacological interventions compared with placebo for the prevention of PTSD in adults. Two authors (TA and JI) independently assessed trials for eligibility and inclusion based on the review selection criteria. We independently extracted sample, methodological, outcome and 'Risk of bias' data, as well as the number of side effects, from each trial and entered these into a customised data extraction form. We contacted investigators for missing information. We calculated summary statistics for continuous and dichotomous variables (if provided). We did not undertake subgroup analyses due to the small number of included studies. We included nine short-term RCTs (duration 12 weeks or less) in the analysis (345 participants
Gale, E A M; Bingley, P J; Emmett, C L
to assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done...
Rosuvastatin for Primary Prevention Among Individuals With Elevated High-Sensitivity C-Reactive Protein and 5% to 10% and 10% to 20% 10-Year Risk Implications of the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial for "Intermediate Risk"
Ridker, Paul M.; Macfadyen, Jean G.; Nordestgaard, Børge G.; Koenig, Wolfgang; Kastelein, John J. P.; Genest, Jacques; Glynn, Robert J.
Background-Recent primary prevention guidelines issued in Canada endorse the use of statin therapy among individuals at "intermediate risk" who have elevated levels of high-sensitivity C-reactive protein (hsCRP). However, trial data directly addressing whether this recommendation defines a patient
Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L
Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.
Krishnaratne, Shari; Hensen, Bernadette; Cordes, Jillian; Enstone, Joanne; Hargreaves, James R
Much progress has been made in interventions to prevent HIV infection. However, development of evidence-informed prevention programmes that translate the efficacy of these strategies into population effect remain a challenge. In this systematic review, we map current evidence for HIV prevention against a new classification system, the HIV prevention cascade. We searched for systematic reviews on the effectiveness of HIV prevention interventions published in English from Jan 1, 1995, to July, 2015. From eligible reviews, we identified primary studies that assessed at least one of: HIV incidence, HIV prevalence, condom use, and uptake of HIV testing. We categorised interventions as those seeking to increase demand for HIV prevention, improve supply of HIV prevention methods, support adherence to prevention behaviours, or directly prevent HIV. For each specific intervention, we assigned a rating based on the number of randomised trials and the strength of evidence. From 88 eligible reviews, we identified 1964 primary studies, of which 292 were eligible for inclusion. Primary studies of direct prevention mechanisms showed strong evidence for the efficacy of pre-exposure prophylaxis (PrEP) and voluntary medical male circumcision. Evidence suggests that interventions to increase supply of prevention methods such as condoms or clean needles can be effective. Evidence arising from demand-side interventions and interventions to promote use of or adherence to prevention tools was less clear, with some strategies likely to be effective and others showing no effect. The quality of the evidence varied across categories. There is growing evidence to support a number of efficacious HIV prevention behaviours, products, and procedures. Translating this evidence into population impact will require interventions that strengthen demand for HIV prevention, supply of HIV prevention technologies, and use of and adherence to HIV prevention methods. Bill & Melinda Gates Foundation
Walker, Dilys; Gutierrez, Juan Pablo; Torres, Pilar; Bertozzi, Stefano M
To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception. Cluster randomised controlled trial. 40 public high schools in the state of Morelos, Mexico. 10 954 first year high school students. Schools were randomised to one of three arms: an HIV prevention course that promoted condom use, the same course with emergency contraception as back-up, or the existing sex education course. Self administered anonymous questionnaires were completed at baseline, four months, and 16 months. Students at intervention schools received a 30 hour course (over 15 weeks) on HIV prevention and life skills, designed in accordance with guidelines of the joint United Nations programme on HIV/AIDS. Two extra hours of education on emergency contraception were given to students in the condom promotion with contraception arm. Primary outcome measure was reported condom use. Other outcomes were reported sexual activity; knowledge and attitudes about HIV and emergency contraception; and attitudes and confidence about condom use. Intervention did not affect reported condom use. Knowledge of HIV improved in both intervention arms and knowledge of emergency contraception improved in the condom promotion with contraception arm. Reported sexual behaviour was similar in the intervention arms and the control group. A rigorously designed, implemented, and evaluated HIV education course based in public high schools did not reduce risk behaviour, so such courses need to be redesigned and evaluated. Addition of emergency contraception did not decrease reported condom use or increase risky sexual behaviour but did increase reported use of emergency contraception.
Canada-Africa Prevention Trials Network : Building African Capacity for HIV/AIDS Prevention Trials. The Canada-Africa Prevention Trials Network (CAPT Network) was formed through a capacity building grant from the Global Health Research Initiative (GHRI). The Network comprises eight African centres (four in Uganda, ...
Canada-Africa Prevention Trials Network : Building African Capacity for HIV/AIDS Prevention Trials. The Canada-Africa Prevention Trials Network (CAPT Network) was formed through a capacity building grant from the Global Health Research Initiative (GHRI). The Network comprises eight African centres (four in Uganda, ...
Developmental Implications of HIV Prevention during Adolescence: Examination of the Long-Term Impact of HIV Prevention Interventions Delivered in Randomized Controlled Trials in Grade Six and in Grade 10
Dinaj-Koci, Veronica; Chen, Xinguang; Deveaux, Lynette; Lunn, Sonja; Li, Xiaoming; Wang, Bo; Braithwaite, Nanika; Marshall, Sharon; Gomez, Perry; Stanton, Bonita
Dramatic changes occur in abstract reasoning, physical maturation, familial relationships and risk exposure during adolescence. It is probable that delivery of behavioral interventions addressing decision-making during the preadolescent period and later in adolescence would result in different impacts. We evaluated the intervention effects of an…
Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard
interventions post-surgery. Prostate Cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.
Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: study protocol for a randomised controlled trial
Bolinski, F.; Kleiboer, A.M.; Karyotaki, E.; Bosmans, J.E.; Zarski, A.C.; Weisel, K.K.; Ebert, David D.; Jacobi, Corinna; Cuijpers, Pim; Riper, M.M.
Background Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a
An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial
Hayek, Adina; Joshi, Rohina; Usherwood, Tim; Webster, Ruth; Kaur, Baldeep; Saini, Bandana; Armour, Carol; Krass, Ines; Laba, Tracey-Lea; Reid, Christopher; Shiel, Louise; Hespe, Charlotte; Hersch, Fred; Jan, Stephen; Lo, Serigne
Background Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general p...
Clasen, Thomas F; Alexander, Kelly T; Sinclair, David; Boisson, Sophie; Peletz, Rachel; Chang, Howard H; Majorin, Fiona; Cairncross, Sandy
Diarrhoea is a major cause of death and disease, especially among young children in low-income countries. In these settings, many infectious agents associated with diarrhoea are spread through water contaminated with faeces.In remote and low-income settings, source-based water quality improvement includes providing protected groundwater (springs, wells, and bore holes), or harvested rainwater as an alternative to surface sources (rivers and lakes). Point-of-use water quality improvement interventions include boiling, chlorination, flocculation, filtration, or solar disinfection, mainly conducted at home. To assess the effectiveness of interventions to improve water quality for preventing diarrhoea. We searched the Cochrane Infectious Diseases Group Specialized Register (11 November 2014), CENTRAL (the Cochrane Library, 7 November 2014), MEDLINE (1966 to 10 November 2014), EMBASE (1974 to 10 November 2014), and LILACS (1982 to 7 November 2014). We also handsearched relevant conference proceedings, contacted researchers and organizations working in the field, and checked references from identified studies through 11 November 2014. Randomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies (CBA) comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults. Two review authors independently assessed trial quality and extracted data. We used meta-analyses to estimate pooled measures of effect, where appropriate, and investigated potential sources of heterogeneity using subgroup analyses. We assessed the quality of evidence using the GRADE approach. Forty-five cluster-RCTs, two quasi-RCTs, and eight CBA studies, including over 84,000 participants, met the inclusion criteria. Most included studies were conducted in low- or middle-income countries (LMICs) (50 studies) with unimproved water sources (30 studies) and unimproved or unclear sanitation (34 studies). The primary
Shepherd, Emily; Gomersall, Judith C; Tieu, Joanna; Han, Shanshan; Crowther, Caroline A; Middleton, Philippa
Gestational diabetes mellitus (GDM) is associated with a wide range of adverse health consequences for women and their infants in the short and long term. With an increasing prevalence of GDM worldwide, there is an urgent need to assess strategies for GDM prevention, such as combined diet and exercise interventions. This is an update of a Cochrane review that was first published in 2015. To assess the effects of diet interventions in combination with exercise interventions for pregnant women for preventing GDM, and associated adverse health consequences for the mother and her infant/child. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 November 2016) and reference lists of retrieved studies. We included randomised controlled trials (RCTs) and cluster-RCTs, comparing combined diet and exercise interventions with no intervention (i.e. standard care), that reported on GDM diagnosis as an outcome. Quasi-RCTs were excluded. Cross-over trials were not eligible for inclusion. We planned to include RCTs comparing two or more different diet/exercise interventions, however none were identified. Two review authors independently assessed study eligibility, extracted data, assessed the risk of bias of the included trials and assessed quality of evidence for selected maternal and infant/child outcomes using the GRADE approach. We checked data for accuracy. In this update, we included 23 RCTs (involving 8918 women and 8709 infants) that compared combined diet and exercise interventions with no intervention (standard care). The studies varied in the diet and exercise programs evaluated and health outcomes reported. None reported receiving funding from a drug manufacturer or agency with interests in the results. Overall risk of bias was judged to be unclear due to the lack of methodological detail reported. Most studies were undertaken in high-income countries.For our primary review outcomes, there was a possible reduced risk of GDM in the diet and
Tickle, M; O'Neill, C; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Worthington, H V
We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once
To determine what secondary schoolchildren in Jordan want from overweight and obesity intervention strategies and prevention programmes. A school-based, cross-sectional study using a quantitative design was carried out during October 2014. The participants were secondary schoolchildren in grades 11 and 12. Data were analysed using SPSS program version 17. Percentages, standard deviations and means were computed. The main suggestions were for programmes at school, during school hours (n=962, 85.4%), followed by one that involved family and friends (n=951, 84.5%), and a programme at a convenient time free of charge (n=919, 81.6%). The students also suggested many strategies to tackle overweight and obesity, such as: taking more physical exercise (n=925, 82.1%), increasing consumption of more fruit and vegetables (n=712, 63.2%) eating less fast food (n=689, 61.2%). Schools, families, health providers and community organisations should encourage students to adopt healthy lifestyles, and facilitate their selection and participation in health programmes.
Oti, Samuel O.; van de Vijver, Steven J. M.; Kyobutungi, Catherine; Gomez, Gabriela B.; Agyemang, Charles; Moll van Charante, Eric P.; Brewster, Lizzy M.; Hendriks, Marleen E.; Schultsz, Constance; Ettarh, Remare; Ezeh, Alex; Lange, Joep
The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the
Randomized controlled trial of primary care physician motivational interviewing versus brief advice to engage adolescents with an Internet-based depression prevention intervention: 6-month outcomes and predictors of improvement
Hoek, W.; Marko, M.; Fogel, J.; Schuurmans, J.; Gladstone, T.; Bradford, N.; Domanico, R.; Fagan, B.; Bell, C.; Reinecke, M.A.; van Voorhees, B.
We believe that primary care physicians could play a key role in engaging youth with a depression prevention intervention. We developed CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral and Interpersonal Training), which is an adolescent Internet-based behavior change model. We
Carson, Kristin V; Ameer, Faisal; Sayehmiri, Kourosh; Hnin, Khin; van Agteren, Joseph Em; Sayehmiri, Fatemeh; Brinn, Malcolm P; Esterman, Adrian J; Chang, Anne B; Smith, Brian J
Mass media interventions can be used as a way of delivering preventive health messages. They have the potential to reach and modify the knowledge, attitudes and behaviour of a large proportion of the community. To assess the effects of mass media interventions on preventing smoking in young people, and whether it can reduce smoking uptake among youth (under 25 years), improve smoking attitudes, intentions and knowledge, improve self-efficacy/self-esteem, and improve perceptions about smoking, including the choice to follow positive role models. We searched the Cochrane Tobacco Addiction Group Specialized Register, with additional searches of MEDLINE and Embase in June 2016. This is an update of a review first published in 1998. Randomized trials, controlled trials without randomization and interrupted time-series studies that assessed the effect of mass media campaigns (defined as channels of communication such as television, radio, newspapers, social media, billboards, posters, leaflets or booklets intended to reach large numbers of people and which are not dependent on person-to-person contact) in influencing the smoking behaviour (either objective or self-reported) of young people under the age of 25 years. We define smoking behaviour as the presence or absence of tobacco smoking or other tobacco use, or both, and the frequency of tobacco use. Eligible comparators included education or no intervention. Two review authors independently extracted information relating to the characteristics and the content of media interventions, participants, outcomes, methods of the study and risks of bias. We combined studies using qualitative narrative synthesis. We assessed the risks of bias for each study using the Cochrane 'Risk of bias' tool, alongside additional domains to account for the nature of the intervention. We assessed the quality of evidence contributing to outcomes using GRADE. We identified eight eligible studies reporting information about mass media smoking
Full Text Available Abstract Background Blood pressure (BP within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. Methods This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. Discussion The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe
DeBar, Lynn L; Ritenbaugh, Cheryl; Vuckovic, Nancy; Stevens, Victor J; Aickin, Mikel; Elliot, Diane; Moe, Esther; Orwoll, Eric; Ernst, Denise; Irving, Lori M
This paper describes decisions about the experimental design for the Youth, Osteoporosis, and Understanding Total Health Project (YOUTH), a trial designed to test the efficacy of a health plan-based lifestyle intervention for increasing bone mineral density among adolescent women 14 to 16 years of age. This randomized controlled trial recruited adolescent women who were at higher risk for developing osteoporosis (body mass index 16-23) from a large HMO in the Pacific Northwest. The intervention focused on improving diet (high calcium foods, fruits, and vegetables) and increasing physical activity (high impact and spinal motion). The intervention included both group and individual activities. The primary endpoint in the study was total bone mineral density as measured by dual-energy X-ray absorptiometry (DEXA). Baseline data were collected on the trial cohort of 228 adolescent women and their families. This paper discusses how researchers met the following challenges in designing and implementing the trial: determining appropriate dietary and exercise targets to affect bone mineral density in adolescents; choosing suitable assessments; and developing an intervention well suited for implementation in a non-school (health plan) setting. We also discuss the rationale for the specific study population chosen (females, younger adolescents). The YOUTH project is one of very few preventive research interventions with adolescents conducted in a health plan setting. Many of the recruitment and intervention strategies used in this trial may be appropriate for adoption in other health plan-based prevention studies.
Beishuizen, Cathrien R L; Coley, Nicola; Moll van Charante, Eric P; van Gool, Willem A; Richard, Edo; Andrieu, Sandrine
To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. Secondary analysis. One hundred sixteen general practices in the Netherlands. Community-dwelling individuals aged 70 to 78 (N = 2,994). Nurse-led multidomain intervention targeting cardiovascular risk factors to prevent dementia. The associations between participant baseline sociodemographic (age, sex, education), clinical (medical history, disability, cardiovascular risk), neuropsychiatric (depressive symptoms (Geriatric Depression Scale-15), and cognitive (Mini-Mental State Examination)) characteristics and dropout from the trial and nonadherence to the trial intervention were explored using multilevel logistic regression models. Older age, poorer cognitive function, more symptoms of depression, and greater disability were the most important determinants of dropout of older people. The presence of cardiovascular risk factors was not associated with dropout but was associated with nonadherence. Being overweight was a risk factor for nonadherence, whereas people with high blood pressure or a low level of physical exercise adhered better to the intervention. The association between poorer cognitive function and symptoms of depression and dropout was stronger in the control group than in the intervention group, and vice versa for increased disability. In a large dementia prevention trial with 6-year follow-up, dropout was associated with older age, poorer cognitive function, symptoms of depression, and disability at baseline. These findings can help to guide the design of future dementia prevention trials in older adults. The associations found between cardiovascular risk factors and nonadherence need to be confirmed in other older populations receiving cardiovascular prevention interventions
Shamliyan, Tatyana A; Wyman, Jean F; Ping, Ryan; Wilt, Timothy J; Kane, Robert L
Urinary incontinence (UI) in community-dwelling men affects quality of life and increases the risk of institutionalization. Observational studies and randomized, controlled trials published in English from 1990 to November 2007 on the epidemiology and prevention of UI were identified in several databases to abstract rates and adjusted odds ratios (OR) of incontinence, calculate absolute risk difference (ARD) after clinical interventions, and synthesize evidence with random-effects models. Of 1083 articles identified, 126 were eligible for analysis. Pooled prevalence of UI increased with age to 21% to 32% in elderly men. Poor general health, comorbidities, severe physical limitations, cognitive impairment, stroke (pooled OR 1.54; 95% confidence interval [CI], 1.14-2.1), urinary tract infections (pooled OR 3.49; 95% CI, 2.33-5.23), prostate diseases, and diabetes (pooled OR 1.36; 95% CI, 1.14-1.61) were associated with UI. Treatment with tolterodine alone (ARD 0.17; 95% CI, 0.02-0.32) or combined with tamsulosin (ARD 0.17; 95% CI, 0.08-0.25) resulted in greater self-reported benefit compared with placebo. Radical prostatectomy or radiotherapy for prostate cancer compared with watchful waiting increased UI. Short-term prevention of UI with pelvic floor muscle rehabilitation after prostatectomy was not consistently seen across randomized, controlled trials. The prevalence of incontinence increased with age and functional dependency. Stroke, diabetes, poor general health, radiation, and surgery for prostate cancer were associated with UI in community-dwelling men. Men reported overall benefit from drug treatments. Limited evidence of preventive effects of pelvic floor rehabilitation requires future investigation.
Shih, Sophy T.F.; Davis-Lameloise, Nathalie; Janus, Edward D.
Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58......% for high-risk individuals. Methods/Design: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention...... group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone...
This article presents a systematic review of school-based cyberbullying prevention and intervention programs. Research presenting empirical evidence about the effectiveness of a school-based cyberbullying prevention or intervention program published before August 2016 was searched. Seventeen studies were obtained and reviewed. The findings showed…
Fellmeth, Gracia; Heffernan, Catherine; Nurse, Joanna; Habibula, Shakiba; Sethi, Dinesh
Objectives: To assess the efficacy of educational and skills-based interventions to prevent relationship and dating violence in adolescents and young adults. Methods: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, and other databases for randomized, cluster-randomized, and quasi-randomized…
Study protocol for "Moving Bright, Eating Smart"- A phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors.
Ho, Judy W C; Lee, Antoinette M; Macfarlane, Duncan J; Fong, Daniel Y T; Leung, Sharron; Cerin, Ester; Chan, Wynnie Y Y; Leung, Ivy P F; Lam, Sharon H S; Taylor, Aliki J; Cheng, Kar-keung
Colorectal cancer is the second most common cancer and cancer-killer in Hong Kong with an alarming increasing incidence in recent years. The latest World Cancer Research Fund report concluded that foods low in fibre, and high in red and processed meat cause colorectal cancer whereas physical activity protects against colon cancer. Yet, the influence of these lifestyle factors on cancer outcome is largely unknown even though cancer survivors are eager for lifestyle modifications. Observational studies suggested that low intake of a Western-pattern diet and high physical activity level reduced colorectal cancer mortality. The Theory of Planned Behaviour and the Health Action Process Approach have guided the design of intervention models targeting a wide range of health-related behaviours. We aim to demonstrate the feasibility of two behavioural interventions intended to improve colorectal cancer outcome and which are designed to increase physical activity level and reduce consumption of a Western-pattern diet. This three year study will be a multicentre, randomised controlled trial in a 2x2 factorial design comparing the "Moving Bright, Eating Smart" (physical activity and diet) programme against usual care. Subjects will be recruited over a 12-month period, undertake intervention for 12 months and followed up for a further 12 months. Baseline, interim and three post-intervention assessments will be conducted.Two hundred and twenty-two colorectal cancer patients who completed curative treatment without evidence of recurrence will be recruited into the study. Primary outcome measure will be whether physical activity and dietary targets are met at the end of the 12-month intervention. Secondary outcome measures include the magnitude and mechanism of behavioural change, the degree and determinants of compliance, and the additional health benefits and side effects of the intervention. The results of this study will establish the feasibility of targeting the two
Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial.
Moppett, Iain Keith; White, Stuart; Griffiths, Richard; Buggy, Donal
Hypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control. We are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence. This is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity
Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia
Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…
O'Brien, James; Finch, Caroline F
Recently, the use of specific exercise programmes to prevent musculoskeletal injuries in team ball sports has gained considerable attention, and the results of large-scale, randomised controlled trials have supported their efficacy. To enhance the translation of these interventions into widespread use, research trials must be reported in a way that allows the players, staff and policymakers associated with sports teams to implement these interventions effectively. In particular, information is needed on core implementation components, which represent the essential and indispensable aspects of successful implementation. To assess the extent to which team ball sport injury prevention trial reports have reported the core implementation components of the intervention, the intervention target and the use of any delivery agents (ie, staff or other personnel delivering the intervention). To summarise which specific types of intervention, intervention target and delivery agents are reported. To develop consensus between reviewers on the reporting of these components. Six electronic databases were systematically searched for English-language, peer-reviewed papers on injury prevention exercise programme (IPEP) trials in team ball sports. The reporting of all eligible trials was assessed by two independent reviewers. The reporting of the three core implementation components were coded as 'yes', 'no' or 'unclear'. For cases coded as 'yes', the specific types of interventions, intervention targets and delivery agents were extracted and summarised. The search strategy identified 52 eligible trials. The intervention and the intervention target were reported in all 52 trials. The reporting of 25 trials (48%) specified the use of delivery agents, the reporting of three trials (6%) specified not using delivery agents, and in the reporting of the remaining 24 trials (46%) the use of delivery agents was unclear. The reported intervention type was an IPEP alone in 43 trials (83
Lodi, Giovanni; Franchini, Roberto; Warnakulasuriya, Saman; Varoni, Elena Maria; Sardella, Andrea; Kerr, Alexander R; Carrassi, Antonio; MacDonald, L C I; Worthington, Helen V
participants because drop-out rates were similar between treatment and control groups. Surgical treatment for oral leukoplakia has not been assessed in an RCT that included a no treatment or placebo comparison. Nor has cessation of risk factors such as smoking been assessed. The available evidence on medical and complementary interventions for treating people with leukoplakia is very limited. We do not currently have evidence of a treatment that is effective for preventing the development of oral cancer. Treatments such as vitamin A and beta carotene may be effective in healing oral lesions, but relapses and adverse effects are common. Larger trials of longer duration are required to properly evaluate the effects of leukoplakia treatments on the risk of developing oral cancer. High-quality research is particularly needed to assess surgical treatment and to assess the effects of risk factor cessation in people with leukoplakia.
Tso, Lai Sze; Tang, Weiming; Li, Haochu; Yan, H Yanna; Tucker, Joseph D
Persistent new HIV infections and risky behaviors underscore the need for enhanced HIV prevention. Social media interventions may promote safe sexual behaviors, increase HIV testing uptake, and promote safe injection behaviors. This review discusses how social media interventions tap into the wisdom of crowds through crowdsourcing, build peer-mentored communities, and deliver interventions through social networks. Social media HIV prevention interventions are constrained by ethical issues, low social media usage among some key populations, and implementation issues. Comprehensive measurement of social media interventions to prevent HIV is necessary, but requires further development of metrics.
Dalal, Adam; Eskin-Schwartz, Marina; Mimouni, Daniel; Ray, Sujoy; Days, Walford; Hodak, Emmilia; Leibovici, Leonard; Paul, Mical
Erysipelas and cellulitis (hereafter referred to as 'cellulitis') are common bacterial skin infections usually affecting the lower extremities. Despite their burden of morbidity, the evidence for different prevention strategies is unclear. To assess the beneficial and adverse effects of antibiotic prophylaxis or other prophylactic interventions for the prevention of recurrent episodes of cellulitis in adults aged over 16. We searched the following databases up to June 2016: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and LILACS. We also searched five trials registry databases, and checked reference lists of included studies and reviews for further references to relevant randomised controlled trials (RCTs). We searched two sets of dermatology conference proceedings, and BIOSIS Previews. Randomised controlled trials evaluating any therapy for the prevention of recurrent cellulitis. Two authors independently carried out study selection, data extraction, assessment of risks of bias, and analyses. Our primary prespecified outcome was recurrence of cellulitis when on treatment and after treatment. Our secondary outcomes included incidence rate, time to next episode, hospitalisation, quality of life, development of resistance to antibiotics, adverse reactions and mortality. We included six trials, with a total of 573 evaluable participants, who were aged on average between 50 and 70. There were few previous episodes of cellulitis in those recruited to the trials, ranging between one and four episodes per study.Five of the six included trials assessed prevention with antibiotics in participants with cellulitis of the legs, and one assessed selenium in participants with cellulitis of the arms. Among the studies assessing antibiotics, one study evaluated oral erythromycin (n = 32) and four studies assessed penicillin (n = 481). Treatment duration varied from six to 18 months, and two studies
Moessner, Markus; Minarik, Carla; Ozer, Fikret; Bauer, Stephanie
Only little is known about costs and effects (i.e., success) of dissemination strategies, although cost-effective dissemination strategies are crucial for the transfer of interventions into routine care. This study investigates the effects and cost-effectiveness of five school-based dissemination strategies for an Internet-based intervention for the prevention and early intervention of eating disorders. Three-hundred ninety-five schools were randomly assigned to one of five dissemination strategies. Strategies varied with respect to intensity from only sending advertisement materials and asking the school to distribute them among students to organizing presentations and workshops at schools. Effects were defined as the number of page visits, the number of screenings conducted, and the number of registrations to the Internet-based intervention. More expensive strategies proved to be more cost-effective. Cost per page visit ranged from 2.83€ (introductory presentation plus workshop) to 20.37€ (dissemination by student representatives/peers). Costs per screening ranged from 3.30€ (introductory presentation plus workshop) to 75.66€ (dissemination by student representatives/peers), and costs per registration ranged from 6.86€ (introductory presentation plus workshop) to 431.10€ (advertisement materials only). Dissemination of an Internet-based intervention for prevention and early intervention is challenging and expensive. More intense, expensive strategies with personal contact proved to be more cost-effective. The combination of an introductory presentation on eating disorders and a workshop in the high school was most effective and had the best cost-effectiveness ratio. The sole distribution of advertisement materials attracted hardly any participants to the Internet-based program.
Christensen, Helen; Batterham, Philip J; O'Dea, Bridianne
Many people at risk of suicide do not seek help before an attempt, and do not remain connected to health services following an attempt. E-health interventions are now being considered as a means to identify at-risk individuals, offer self-help through web interventions or to deliver proactive interventions in response to individuals' posts on social media. In this article, we examine research studies which focus on these three aspects of suicide and the internet: the use of online screening for suicide, the effectiveness of e-health interventions aimed to manage suicidal thoughts, and newer studies which aim to proactively intervene when individuals at risk of suicide are identified by their social media postings. We conclude that online screening may have a role, although there is a need for additional robust controlled research to establish whether suicide screening can effectively reduce suicide-related outcomes, and in what settings online screening might be most effective. The effectiveness of Internet interventions may be increased if these interventions are designed to specifically target suicidal thoughts, rather than associated conditions such as depression. The evidence for the use of intervention practices using social media is possible, although validity, feasibility and implementation remains highly uncertain.
Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C
Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates
Pittas, Anastassios G
Type 2 diabetes is a chronic disease associated with significant morbidity and mortality that is increasing in prevalence worldwide. Although our current methods for treating type 2 diabetes and its complications have improved, prevention of the disease is preferable, Epidemiologic data suggest that most cases of type 2 diabetes could be attributed to habits and forms of modifiable behavior. Recent evidence from randomized controlled trials has confirmed that lifestyle plays a central role in diabetes prevention. However, the optimal prevention strategy remains to be determined. This review presents the evidence for dietary components that may modify diabetes risk and suggests nutritional interventions that may be of benefit in preventing the disease.
Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee
The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.
ICARUSS, the Integrated Care for the Reduction of Secondary Stroke trial: rationale and design of a randomized controlled trial of a multimodal intervention to prevent recurrent stroke in patients with a recent cerebrovascular event, ACTRN = 12611000264987.
Joubert, J; Davis, S M; Hankey, G J; Levi, C; Olver, J; Gonzales, G; Donnan, G A
The majority of strokes, both ischaemic and haemorrhagic, are attributable to a relatively small number of risk factors which are readily manageable in primary care setting. Implementation of best-practice recommendations for risk factor management is calculated to reduce stroke recurrence by around 80%. However, risk factor management in stroke survivors has generally been poor at primary care level. A model of care that supports long-term effective risk factor management is needed. To determine whether the model of Integrated Care for the Reduction of Recurrent Stroke (ICARUSS) will, through promotion of implementation of best-practice recommendations for risk factor management reduce the combined incidence of stroke, myocardial infarction and vascular death in patients with recent stroke or transient ischaemic attack (TIA) of the brain or eye. A prospective, Australian, multicentre, randomized controlled trial. Academic stroke units in Melbourne, Perth and the John Hunter Hospital, New South Wales. 1000 stroke survivors recruited as from March 2007 with a recent (system (IVRS). Exposure to the ICARUSS model of integrated care or usual care. The composite of stroke, MI or death from any vascular cause, whichever occurs first. Risk factor management in the community, depression, quality of life, disability and dementia. With 1000 patients followed up for a median of one-year, with a recurrence rate of 7-10% per year in patients exposed to usual care, the study will have at least 80% power to detect a significant reduction in primary end-points The ICARUSS study aims to recruit and follow up patients between 2007 and 2013 and demonstrate the effectiveness of exposure to the ICARUSS model in stroke survivors to reduce recurrent stroke or vascular events and promote the implementation of best practice risk factor management at primary care level. © 2015 World Stroke Organization.
Lerch, C; Meissner, T
Nutritional rickets is a disease of growing children leading to bone deformities, bone pain, convulsions or delayed motor development. Today, high-incidence of nutritional rickets is mainly found in low-income countries. To assess the effects of various interventions on the prevention of nutritional rickets in term born children. Studies were obtained from computerised searches of The Cochrane Library, MEDLINE, EMBASE, LILACS and reference lists of relevant articles. We contacted authors of studies or reviews to obtain further studies. Studies were included if they were randomised controlled clinical trials, controlled clinical trials or prospective cohort studies comparing any intervention for the prevention of nutritional rickets in term born children with placebo or no intervention. Minimum duration of the intervention was three months for children under 12 months or six months for children over 12 months. Two authors independently extracted data and assessed study quality. Authors of studies were contacted to obtain missing information. Four studies enrolled approximately 1700 participants. Trials lasted between nine months to two years. Three studies were randomised controlled trials, two of which showed a cluster randomised design; one trial probably was a controlled trial with researcher controlled group assignment. In children up to three years of age in Turkey, Vitamin D compared to no intervention showed a relative risk of 0.04 (95% confidence interval (CI) 0 to 0.71). Despite a marked non-compliance, a Chinese trial in children up to three years of age comparing a combined intervention of supplementation of vitamin D, calcium and nutritional counseling showed a relative risk of 0.76 (95% CI 0.61 to 0.95) compared to no intervention. In two studies conducted in older children in China and in France no rickets occurred in both the intervention and control group. There a only few studies on the prevention of nutritional rickets in term born children. Until
Howe, George W.; Beach, Steven R. H.; Brody, Gene H.; Wyman, Peter A.
In this paper we present and discuss a novel research approach, the baseline target moderated mediation (BTMM) design, that holds substantial promise for advancing our understanding of how genetic research can inform prevention research. We first discuss how genetically informed research on developmental psychopathology can be used to identify potential intervention targets. We then describe the BTMM design, which employs moderated mediation within a longitudinal study to test whether baseline levels of intervention targets moderate the impact of the intervention on change in that target, and whether change in those targets mediates causal impact of preventive or treatment interventions on distal health outcomes. We next discuss how genetically informed BTMM designs can be applied to both microtrials and full-scale prevention trials. We use simulated data to illustrate a BTMM, and end with a discussion of some of the advantages and limitations of this approach. PMID:26779062
George W. Howe
Full Text Available In this paper we present and discuss a novel research approach, the baseline target moderated mediation (BTMM design, that holds substantial promise for advancing our understanding of how genetic research can inform prevention research. We first discuss how genetically informed research on developmental psychopathology can be used to identify potential intervention targets. We then describe the BTMM design, which employs moderated mediation within a longitudinal study to test whether baseline levels of intervention targets moderate the impact of the intervention on change in that target, and whether change in those targets mediates causal impact of preventive or treatment interventions on distal health outcomes. We next discuss how genetically informed BTMM designs can be applied to both microtrials and full-scale prevention trials. We end with a discussion of some of the advantages and limitations of this approach.
El-Jardali, Fadi; Akl, Elie A; Fadlallah, Racha; Oliver, Sandy; Saleh, Nadine; El-Bawab, Lamya; Rizk, Rana; Farha, Aida; Hamra, Rasha
Drug counterfeiting has serious public health and safety implications. The objective of this study was to systematically review the evidence on the effectiveness of interventions to combat or prevent drug counterfeiting. We searched multiple electronic databases and the grey literature up to March 2014. Two reviewers completed, in duplicate and independently, the study selection, data abstraction and risk of bias assessment. We included randomised trials, non-randomised studies, and case studies examining any intervention at the health system-level to combat or prevent drug counterfeiting. Outcomes of interest included changes in failure rates of tested drugs and changes in prevalence of counterfeit medicines. We excluded studies that focused exclusively on substandard, degraded or expired drugs, or that focused on medication errors. We assessed the risk of bias in each included study. We reported the results narratively and, where applicable, we conducted meta-analyses. We included 21 studies representing 25 units of analysis. Overall, we found low quality evidence suggesting positive effects of drug registration (OR=0.23; 95% CI 0.08 to 0.67), and WHO-prequalification of drugs (OR=0.06; 95% CI 0.01 to 0.35) in reducing the prevalence of counterfeit and substandard drugs. Low quality evidence suggests that licensing of drug outlets is probably ineffective (OR=0.66; 95% CI 0.41 to 1.05). For multifaceted interventions (including a mix of regulations, training of inspectors, public-private collaborations and legal actions), low quality evidence suggest they may be effective. The single RCT provided moderate quality evidence of no effect of 'two extra inspections' in improving drug quality. Policymakers and stakeholders would benefit from registration and WHO-prequalification of drugs and may also consider multifaceted interventions. Future effectiveness studies should address the methodological limitations of the available evidence. PROSPERO CRD42014009269
Janssen, Kasper W; van der Zwaard, Babette C; Finch, Caroline F; van Mechelen, Willem; Verhagen, Evert A L M
To describe the association between participants' person-related potential predictor variables and cumulative compliance with interventions for preventing ankle sprains: neuromuscular training, wearing an ankle brace, and a combined training and bracing. Secondary analysis of compliance data from a randomized controlled trial (RCT) comparing measures preventing ankle ligament injuries. Ordinal regression with a backward selection method was used to obtain a descriptive statistical model linking participants' person-related potential predictor variables with the monthly cumulative compliance measurements for three interventions preventing ankle ligament injuries. Having had a previous ankle injury was significantly associated with a higher compliance with all of the preventive measures trialed. Overall compliance with bracing and the combined intervention was significantly lower than the compliance with NM training. Per group analysis found that participating in a high-risk sport, like soccer, basketball, and volleyball, was significantly associated with a higher compliance with bracing, or a combined bracing and NM training. In contrast, participating in a high-risk sport was significantly associated with a lower per group compliance with NM training. Future studies should include at least registration of previous ankle sprains, sport participation (high- or low-risk), experience in NM training, and hours of sport exposure as possible predictors of compliance with interventions preventing ankle sprains. Practitioners should take into account these variables when prescribing preventive neuromuscular training or bracing. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Lemieux, Anthony F; Fisher, Jeffrey D; Pratto, Felicia
This research examines the process of conducting and evaluating a music-based HIV prevention intervention among urban adolescents, and is informed by the information, motivation, behavioral skills (IMB) model. Musically talented opinion leaders were recruited to write, record, and distribute HIV prevention themed music to their peers to increase HIV prevention motivation, behavioral skills, and behaviors. In this 3-month field experiment, participants were 306 students enrolled in health classes at each of three large multiracial urban high schools (one treatment school; two control schools). Measures of HIV prevention information, motivation, behavioral skills, and behaviors, both pre- and postintervention. Results indicate that the intervention influenced several aspects of HIV prevention motivation, behavioral skills, and condom use and HIV testing behaviors. This research demonstrates that the incorporation of music into HIV prevention interventions for adolescents has the potential to be effective.
EMMA ELISE ROBERTS
Teachers have a central role in the management and prevention of bullying within schools and are in turn involved in the implementation of anti-bullying interventions (Kochenderfer-Ladd & Pelletier, 2008). Therefore an assessment of teachers’ attitudes towards bullying interventions is needed to determine how helpful they perceived interventions to be. This study investigated teachers’ attitudes towards anti-bullying interventions and the types of bullying they perceived the interventions wou...
The African Development of AIDS Prevention Trials (ADAPT2) capacity building initiative is an African-Canadian partnership that aims to increase the number and quality of HIV prevention trials led by African researchers. Building on experience gained during ADAPT1 - funded by the Global Health Research Initiative ...
The African Development of AIDS Prevention Trials (ADAPT2) capacity building initiative is an African-Canadian partnership that aims to increase the number and quality of HIV prevention trials led by African researchers. Building on experience gained during ADAPT1 - funded by the Global Health Research Initiative ...
Cox, Georgina R; Fisher, Caroline A; De Silva, Stefanie; Phelan, Mark; Akinwale, Olaoluwa P; Simmons, Magenta B; Hetrick, Sarah E
Depressive disorders often begin during childhood or adolescence. There is a growing body of evidence supporting effective treatments during the acute phase of a depressive disorder. However, little is known about treatments for preventing relapse or recurrence of depression once an individual has achieved remission or recovery from their symptoms. To determine the efficacy of early interventions, including psychological and pharmacological interventions, to prevent relapse or recurrence of depressive disorders in children and adolescents. We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) (to 1 June 2011). The CCDANCTR contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). In addition we handsearched the references of all included studies and review articles. Randomised controlled trials using a psychological or pharmacological intervention, with the aim of preventing relapse or recurrence from an episode of major depressive disorder (MDD) or dysthymic disorder (DD) in children and adolescents were included. Participants were required to have been diagnosed with MDD or DD according to DSM or ICD criteria, using a standardised and validated assessment tool. Two review authors independently assessed all trials for inclusion in the review, extracted trial and outcome data, and assessed trial quality. Results for dichotomous outcomes are expressed as odds ratio and continuous measures as mean difference or standardised mean difference. We combined results using random-effects meta-analyses, with 95% confidence intervals. We contacted lead authors of included trials and requested additional data where possible. Nine trials with 882 participants were included in the review. In five trials the outcome assessors were blind to the participants' intervention condition and in the remainder of trials it was
Full Text Available ABSTRACTIntroduction:Scientific evidence supports the sinergy between biomedical and behavioral interventions aimed at preventing the transmission of HIV as a strategy to eradicate AIDS.Objective:To characterize comparatively the benefits from biomedical and behavioral interventions to prevent HIV transmission.Methods:Narrative review. We performed a comparative analysis of the benefits of studied interventions by means of estimating the number needed to treat (NNT. Evaluated interventions: counseling activities for behavior change to prevent exposure to HIV; antiretroviral pre-exposure prophylaxis (PrEP and antiretroviral post-exposure prophylasis (PEP for HIV and treatment of serodiscordant couples as a strategy for prevention of HIV transmission (TasP.Results:counseling interventions and TasP have smaller NNTs, equal to, respectively, 11 (95%CI 9 - 18 at 12 months and 34 (95%CI 23 - 54 in 42 months comparatively to PrEP interventions, that resulted in 41 (95%CI 28 - 67 individuals receiving antiretrovirals in order to prevent one case of HIV infection at 36 months for men and serodiscordant couples. PEP interventions are associated with protective effects estimated at 81%. Lack of trials evaluating PEP prevents estimate of NNT.Conclusion:The estimate of the NNT can be a helpful parameter in the comparison between the effectiveness of different behavioral and biomedical HIV prevention strategies. Studies evaluating the benefit and safety of combined behavioral and biomedical interventions are needed, especially considering the attributable fraction of each component. Integration of behavioral and biomedical interventions is required to achieve complete suppression of the virus, and thus reducing viral replication, infectivity and the number of cases.
Miovský, Michal; Voňková, Hana; Gabrhelík, Roman; Šťastná, Lenka
This study aims to examine the effect of school-based preventive intervention on cannabis use in Czech adolescents with different levels of risk factors and provide evidence of its universality. A randomized controlled prevention trial with six waves was conducted over a period of 33 months. We used a two-level logistic random-intercept model for panel data; we first looked at the statistical significance of the effect of the intervention on cannabis use, controlling for the characteristics of the children and time dummies. Then we analyzed the effects of the interactions between the intervention and the characteristics of the children on cannabis use and related it to the definition of universal preventive interventions. The setting for the study was in basic schools in the Czech Republic in the years 2007-2010. A total of 1,874 sixth-graders (mean age 11.82 years) who completed the baseline testing. According to our results, the prevention intervention was effective. We found all the selected characteristics of the children to be relevant in relation to cannabis use, except their relationships with their friends. We showed empirically that the intervention is universal in two dimensions for the selected characteristics of the children. First, all adolescents who undergo the intervention are expected to benefit. Second, with respect to the effect of the intervention on cannabis use, the total level of individual risk of cannabis use is superior to the composition of the risk factors in the individual risk profile. We present indicative evidence that the drug prevention intervention may be considered a true universal preventive intervention.
Khavjou, Olga A.; Bradley, Christina; Neuwahl, Simon; Hoerger, Thomas J.; Bellard, David; Cash, Amanda J.
Introduction In 2010, the Centers for Disease Control and Prevention funded 50 communities to participate in the Communities Putting Prevention to Work (CPPW) program. CPPW supported community-based approaches to prevent or delay chronic disease and promote wellness by reducing tobacco use and obesity. We collected the direct costs of CPPW for the 44 communities funded through the American Recovery and Reinvestment Act (ARRA) and analyzed costs per person reached for all CPPW interventions and by intervention category. Methods From 2011 through 2013, we collected quarterly data on costs from the 44 CPPW ARRA-funded communities. We estimated CPPW program costs as spending on labor; consultants; materials, travel, and services; overhead activities; and partners plus the value of in-kind donations. We estimated communities’ costs per person reached for each intervention implemented and compared cost allocations across communities that focused on reducing tobacco use, or obesity, or both. Analyses were conducted in 2014; costs are reported in 2012 dollars. Results The largest share of CPPW total costs of $363 million supported interventions in communities that focused on obesity ($228 million). Average costs per person reached were less than $5 for 84% of tobacco-related interventions, 88% of nutrition interventions, and 89% of physical activity interventions. Costs per person reached were highest for social support and services interventions, almost $3 for tobacco‑use interventions and $1 for obesity prevention interventions. Conclusions CPPW cost estimates are useful for comparing intervention cost per person reached with health outcomes and for addressing how community health intervention costs vary by type of intervention and by community size. PMID:27468157
Schelke, Matthew W; Hackett, Katherine; Chen, Jaclyn L; Shih, Chiashin; Shum, Jessica; Montgomery, Mary E; Chiang, Gloria C; Berkowitz, Cara; Seifan, Alon; Krikorian, Robert; Isaacson, Richard Scott
Alzheimer's disease (AD) is a major source of morbidity and mortality, with the disease burden expected to rise as the population ages. No disease-modifying agent is currently available, but recent research suggests that nutritional and lifestyle modifications can delay or prevent the onset of AD. However, preventive nutritional interventions are not universally applicable and depend on the clinical profile of the individual patient. This article reviews existing nutritional modalities for AD prevention that act through improvement of insulin resistance, correction of dyslipidemia, and reduction of oxidative stress, and discusses how they may be modified on the basis of individual biomarkers, genetics, and behavior. In addition, we report preliminary results of clinical application of these personalized interventions at the first AD prevention clinic in the United States. The use of these personalized interventions represents an important application of precision medicine techniques for the prevention of AD that can be adopted by clinicians across disciplines. © 2016 New York Academy of Sciences.
Hanefeld, Johanna; Bond, Virginia; Seeley, Janet; Lees, Shelley; Desmond, Nicola
Increasing attention is being paid to the potential of anti-retroviral treatment (ART) for HIV prevention. The possibility of eliminating HIV from a population through a universal test and treat intervention, where all people within a population are tested for HIV and all positive people immediately initiated on ART, as part of a wider prevention intervention, was first proposed in 2009. Several clinical trials testing this idea are now in inception phase. An intervention which relies on universally testing the entire population for HIV will pose challenges to human rights, including obtaining genuine consent to testing and treatment. It also requires a context in which people can live free from fear of stigma, discrimination and violence, and can access services they require. These challenges are distinct from the field of medical ethics which has traditionally governed clinical trials and focuses primarily on patient researcher relationship. This paper sets out the potential impact of a population wide treatment as prevention intervention on human rights. It identifies five human right principles of particular relevance: participation, accountability, the right to health, non-discrimination and equality, and consent and confidentiality. The paper proposes that explicit attention to human rights can strengthen a treatment as prevention intervention, contribute to mediating likely health systems challenges and offer insights on how to reach all sections of the population. © 2013 John Wiley & Sons Ltd.
Hoogeveen, Ruben C; Dorresteijn, Johannes A N; Kriegsman, Didi M W; Valk, Gerlof D.
BACKGROUND: Ulceration of the feet, which can lead to the amputation of feet and legs, is a major problem for people with diabetes mellitus, and can cause substantial economic burden. Single preventive strategies have not been shown to reduce the incidence of foot ulceration to a significant extent.
Alcohol dependence is a chronic, debilitating disorder that is an important public health problem worldwide. Combined psychological and pharmacological treatment packages produce best outcomes in its management. In this paper we discuss the three NICE – approved relapse prevention medications used in treatment of ...
Higher Education Center for Alcohol, Drug Abuse, and Violence Prevention, 2012
Developed in 1993 at the University of Washington, Brief Alcohol Screening and Intervention for College Students (BASICS) is a preventive intervention program to reduce drinking and enhance awareness about alcohol-related issues. BASICS targets college students who are considered at risk because of heavy drinking behaviors. The brief intervention…
Meijel, Berno van
This thesis describes a study into the development and testing of a nursing intervention with a view to preventing psychotic relapses in patients suffering from schizophrenia or a related disorder. The purpose of the intervention is to recognise the early signs of an oncoming psychotic relapse. If
Coley, Rebecca Yates; Browna, Elizabeth R.
Inconsistent results in recent HIV prevention trials of pre-exposure prophylactic interventions may be due to heterogeneity in risk among study participants. Intervention effectiveness is most commonly estimated with the Cox model, which compares event times between populations. When heterogeneity is present, this population-level measure underestimates intervention effectiveness for individuals who are at risk. We propose a likelihood-based Bayesian hierarchical model that estimates the individual-level effectiveness of candidate interventions by accounting for heterogeneity in risk with a compound Poisson-distributed frailty term. This model reflects the mechanisms of HIV risk and allows that some participants are not exposed to HIV and, therefore, have no risk of seroconversion during the study. We assess model performance via simulation and apply the model to data from an HIV prevention trial. PMID:26869051
Han, Claire Jungyoun; Lee, Young Ji; Demiris, George
Regarding cancer awareness, social media effectively promotes health and supports self-management. Given the diverse study designs, methodologies, and approaches of social media interventions in oncology, it is difficult to determine the effects of social media on cancer prevention and management. We aim to systematically review intervention studies using social media for cancer care. A systematic search, using 7 electronic databases (PubMed, Web of Science, CINAHL, Cochrane Library, Scopus, EMBASE, and PsycINFO), was conducted to identify surveys and interventions using contemporary social media tools with a focus on cancer. Of the 18 selected studies, 7 were randomized controlled trials. Most studies were conducted for all types of cancer, and some were conducted for breast cancer in the United States, with mostly white female participants. Facebook was the most frequently used platform. Most studies targeted healthy participants providing cancer prevention education. With social media platforms as part of a larger intervention, or the main component of interventions, interventions were overall feasible and showed a significant improvement in cancer prevention and management. Social media tools have the potential to be effective in delivering interventions for cancer prevention and management. However, there was a dearth of studies with rigorous study methodologies to test social media effects on various cancer-related clinical outcomes. Social media use in cancer care will facilitate improved communication and support among patients, caregivers, and clinicians and, ultimately, improved patient care. Clinicians need to carefully harness social media to enhance patient care and clinical outcomes.
Oude Hengel, K.M.; Joling, C.I.; Proper, K.I.; Blatter, B.M.; Bongers, P.M.
Background. A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program
Hölmich, P; Larsen, K; Krogsgaard, Kim
programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...
Becker, Carolyn Black; Bull, Stephanie; Schaumberg, Katherine; Cauble, Adele; Franco, Amanda
The aim of this study was to replicate and extend results of a previous trial that investigated the effectiveness of 2 peer-led eating disorders prevention interventions in reducing eating disorder risk factors in undergraduate women (C. B. Becker, L. M. Smith, & A. C. Ciao, 2006). To extend findings from the previous study by allowing for…
Miller-Day, Michelle; Hecht, Michael L.
This paper describes a Narrative Engagement Framework (NEF) for guiding communication-based prevention efforts. This framework suggests that personal narratives have distinctive capabilities in prevention. The paper discusses the concept of narrative, links narrative to prevention, and discusses the central role of youth in developing narrative interventions. As illustration, the authors describe how the NEF is applied in the keepin’ it REAL adolescent drug prevention curriculum, pose theoretical directions, and offer suggestions for future work in prevention communication. PMID:23980613
Gómez-Gascón, Tomás; Martín-Fernández, Jesús; Gálvez-Herrer, Macarena; Tapias-Merino, Ester; Beamud-Lagos, Milagros; Mingote-Adán, José Carlos
Burnout syndrome is an important health problem that affects many professionals and must be addressed globally, with both organizational measures and personal interventions. Burnout of health professionals can be prevented in order to avoid personal, familial, and social consequences, as well as repercussions for patients. This work describes a protocol for a controlled, pragmatic, randomized clinical trial in 2 parallel groups: intervention and control. All health professionals from 7 health care centers will form the intervention group, and all health professionals from 7 different health care centers will form the control group. The intervention group will receive 16 hours of training at their work place. The Maslach's burnout inventory, the Cuestionario de Desgaste Profesional Médico or the Cuestionario de Desgaste Profesional de Enfermería, and the 28-item Goldberg's General Health Questionnaire, validated for our setting, will be used as measurement tools. Change in the average scores from the Maslach's burnout inventory emotional exhaustion scale will be compared between the intervention and control groups, measured as intention-to-treat, and the intervention will be considered effective if a minimum decrease of 20% is achieved. Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work, it is necessary to evaluate the effectiveness of certain interventions for its prevention. Organizational measures are important for preventing burnout syndrome, but so is providing professionals with coping strategies, as this group intervention intends to do. ClinicalTrials.gov processed this record on June 10, 2013. ClinicalTrials.gov Identifier: NCT01870154.
JUANITA HENAO ESCOBAR
Full Text Available The article presents a review of different kinds of international early violence prevention-intervention programs,which have shown effectiveness in the reduction of preschooler’s aggression, and in some cases, in the prevention ofviolent behavior during adolescence and youth. The central matter of this article is what we can learn from theexperiences on this field of knowledge around the world. First, the target intervention problem is presented andframed in the colombian context. After presenting the main research findings about aggressive behavior in childrenand the risk factors associated with it, the related intervention modalities will be analyzed and described. Finally, thearticle derives some pragmatic conclusions and recommendations.
Noar, Seth M; Black, Hulda G; Pierce, Larson B
To conduct a meta-analysis of computer technology-based HIV prevention behavioral interventions aimed at increasing condom use among a variety of at-risk populations. Systematic review and meta-analysis of existing published and unpublished studies testing computer-based interventions. Meta-analytic techniques were used to compute and aggregate effect sizes for 12 randomized controlled trials that met inclusion criteria. Variables that had the potential to moderate intervention efficacy were also tested. The overall mean weighted effect size for condom use was d = 0.259 (95% confidence interval = 0.201, 0.317; Z = 8.74, P partners, and incident sexually transmitted diseases. In addition, interventions were significantly more efficacious when they were directed at men or women (versus mixed sex groups), utilized individualized tailoring, used a Stages of Change model, and had more intervention sessions. Computer technology-based HIV prevention interventions have similar efficacy to more traditional human-delivered interventions. Given their low cost to deliver, ability to customize intervention content, and flexible dissemination channels, they hold much promise for the future of HIV prevention.
The purpose of this article was to review international (excluding the United States) school-based interventions for preventing obesity in children published between 1999 and 2005. A total of 21 such interventions were found from Australia (1), Austria (1), Canada (1), Chile (1), France (1), Germany (3), Greece (1), New Zealand (1), Norway (1), Singapore (1) and the United Kingdom (9). The grade range of these interventions was from pre-school to high school with the majority (17) from elementary schools. Nine of these interventions targeted nutrition behaviours followed by seven aiming to modify both physical activity and nutrition behaviours. Only five interventions in international settings were based on any explicit behavioural theory which is different than the interventions developed in the United States. Majority of the interventions (9) were one academic year long. It can be speculated that if the interventions are behavioural theory-based, then the intervention length can be shortened. All interventions that documented parental involvement successfully influenced obesity indices. Most interventions (16) focused on individual-level behaviour change approaches. Most published interventions (16) used experimental designs with at least 1-year follow-up. Recommendations from international settings for enhancing the effectiveness of school-based childhood obesity interventions are presented.
Pontoppidan, Maiken W.
-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome......Background: Infancy is an important period in a child’s life, with rapid growth and development. Early experiences shape the developing brain, and adverse experiences can have both an immediate and lifelong impact on health and wellbeing. Parenting interventions offered to parents of newborns can...... support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two...
A combination of quantitative and qualitative research was used to determine the effectiveness of a cardiac rehabilitation (CR) programme in a cohort of patients referred to the service at a London hospital. Quantitative data analysis provided evidence of effectiveness of participation in CR in reduced hospital readmission rates and use of recognised pharmacological management strategies. Self-reported physical activity levels and quality of life (QOL) in individuals who participated in the cardiac rehabilitation programme were qualitatively measured with questionnaires. Results provided evidence of benefit in continued participation in exercise. However, there was no evidence of benefit to QOL status post participation at 1 year. A p-value of 0.001 provided significant statistical evidence supporting the hypothesis of benefit in continued participation in exercise in participants following attendance at a cardiac rehabilitation programme. QOL status; a statistically significant p-value of 0.001 rejected the hypothesis (H1) of benefit. This would imply that participation CR programmes does not appear to provide sustained benefits in QOL. A number of moderating variables were suggested as explaining the finding such as homogeneity of respondents, age, mood bias and the timeframe of 1 year between participation in rehabilitation and self-reporting. CR appears to be an effective but time-limited intervention in relation to improvements in QOL. Collaborative working partnerships between specialist interventions, such as CR with chronic disease management strategies may provide greater sustainability of benefits gained from participation in cardiac rehabilitation programmes.
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.
Jorm, Anthony Francis; Mackinnon, Andrew James
Background Recruiting participants to randomized controlled trials of health interventions can be very difficult. Internet-based recruitment is becoming an increasingly important mode of recruitment, yet there are few detailed accounts of experiences recruiting participants to mental health interventions. Objective To report on our experience with Internet-based recruitment to an online depression prevention intervention and pass on lessons we learned. Methods Participants were recruited to the Mood Memos study, an online preventive depression intervention, purely through Internet-based sources. The study was targeted to adults with subthreshold depression symptoms from several English-speaking countries. A variety of online recruitment sources were trialed, including search engine advertising (Google, Yahoo!, Bing), Facebook advertising, posts in forums and online noticeboards, and promotion through relevant websites and email newsletters of mental health organizations. Results The study website received visits from 94,808 individuals over the 14-month recruitment period. The recruitment target was reached with 1699 individuals signing up to the randomized controlled trial and 1326 fully enrolling. Most visitors arrived via Google advertising, which promoted a depression-screening questionnaire. Google advertising accounted for nearly half of the total participants who signed up to the study, at an average cost of AUD $12 per participant. Promoting the study through trustworthy organizations and websites known to participants was also effective. Recruitment techniques that were less effective were contacting forums, email groups, and community noticeboards. Conclusions Several techniques, including Google advertising, were successful in recruiting participants to a trial evaluating an online depression intervention. Results suggest that Internet-based recruitment to mental health interventions is feasible and can be relatively affordable. Trial Registration ACTRN
Philpott, Sean; Heise, Lori; McGrory, Elizabeth; Paxton, Lynn; Hankins, Catherine; Alexander, Lorraine; Apuuli, David Kihumuro; Baeten, Jared; Birx, Deborah; de Bruyn, Guy; Bukusi, Elizabeth; Burns, David; Calazans, Gabriela; Campbell, James; Caswell, Georgina; Coutinho, Alex; Dawson, Liza; Dhai, Amaboo; Dube, Samukeliso; Ecuru, Julius; Essack, Zaynab; Farley, Timothy; Gafos, Mitzy; Irungu, Pauline; Kaleebu, Pontiano; Kamali, Anatoli; Kestelyn, Evelyne; Kublin, James; Lohse, Nicolai; Lutalo, Tom; Macklin, Ruth; Mâsse, Benôıt; Mauney, Chris; McCormack, Sheena; Miller, Lori; Mfutso-Bengo, Joseph; Misra, Rajender; Muganwa, Margaret; Ndase, Patrick; Nel, Annalene; Nielsen, Leslie; Nkala, Busisiwe; O'Reilly, Kevin; Okware, Sam; Paicheler, Geneviève; Rees, Helen; Rerks-Ngarm, Supachai; Ridzon, Renee; Rosenberg, Zeda; Singh, Jerome; Sugarman, Jeremy; Taylor, Douglas; Tusubira, Evans; Ukpong, Morenike; Umulisa, Marie-Michèle; Warren, Mitchell; Slevin, Katherine West; van de Wijgert, Janneke
As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on
Full Text Available Doctors are exposed to high levels of stress in the course of their profession and are particularly susceptible to experiencing burnout. Burnout has far-reaching implications on doctors; patients and the healthcare system. Doctors experiencing burnout are reported to be at a higher risk of making poor decisions; display hostile attitude toward patients; make more medical errors; and have difficult relationships with co-workers. Burnout among doctors also increases risk of depression; anxiety; sleep disturbances; fatigue; alcohol and drug misuse; marital dysfunction; premature retirement and perhaps most seriously suicide. Sources of stress in medical practice may range from the emotions arising in the context of patient care to the environment in which doctors practice. The extent of burnout may vary depending on the practice setting; speciality and changing work environment. Understanding dynamic risk factors associated with burnout may help us develop strategies for preventing and treating burnout. Some of these strategies will be reviewed in this paper.
Doctors are exposed to high levels of stress in the course of their profession and are particularly susceptible to experiencing burnout. Burnout has far-reaching implications on doctors; patients and the healthcare system. Doctors experiencing burnout are reported to be at a higher risk of making poor decisions; display hostile attitude toward patients; make more medical errors; and have difficult relationships with co-workers. Burnout among doctors also increases risk of depression; anxiety; sleep disturbances; fatigue; alcohol and drug misuse; marital dysfunction; premature retirement and perhaps most seriously suicide. Sources of stress in medical practice may range from the emotions arising in the context of patient care to the environment in which doctors practice. The extent of burnout may vary depending on the practice setting; speciality and changing work environment. Understanding dynamic risk factors associated with burnout may help us develop strategies for preventing and treating burnout. Some of these strategies will be reviewed in this paper.
As the largest prostate cancer prevention trial ever undertaken, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) has assembled a substantial biorepository of specimens. To help make SELECT resources available to a wider research community, NCI and the Southwest Oncology Group are developing a plan for prostate cancer biology and nutritional science and micronutrient studies. |
Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P
Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results
Worksites are increasingly being used as locations for implementing healthy diet and weight loss interventions. Hence, there is an urgent need to identify programs that are both successful and sustainable. We conducted a 6-month pilot randomized controlled trial in overweight and obese employees a...
Emery, C A; Roos, E M; Verhagen, E; Finch, C F; Bennell, K L; Story, B; Spindler, K; Kemp, J; Lohmander, L S
The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for injury prevention RCTs are critical to informing evidence-based practice and policy decisions in health care, public health and the community. Recommendations regarding the interpretation and conduct of injury prevention RCTs will inform the highest level of evidence in the field. These recommendations will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history
Tikka, Christina; Verbeek, Jos H; Kateman, Erik; Morata, Thais C; Dreschler, Wouter A; Ferrite, Silvia
This is the second update of a Cochrane Review originally published in 2009. Millions of workers worldwide are exposed to noise levels that increase their risk of hearing disorders. There is uncertainty about the effectiveness of hearing loss prevention interventions. To assess the effectiveness of non-pharmaceutical interventions for preventing occupational noise exposure or occupational hearing loss compared to no intervention or alternative interventions. We searched the CENTRAL; PubMed; Embase; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; and OSH UPDATE to 3 October 2016. We included randomised controlled trials (RCT), controlled before-after studies (CBA) and interrupted time-series (ITS) of non-clinical interventions under field conditions among workers to prevent or reduce noise exposure and hearing loss. We also collected uncontrolled case studies of engineering controls about the effect on noise exposure. Two authors independently assessed study eligibility and risk of bias and extracted data. We categorised interventions as engineering controls, administrative controls, personal hearing protection devices, and hearing surveillance. We included 29 studies. One study evaluated legislation to reduce noise exposure in a 12-year time-series analysis but there were no controlled studies on engineering controls for noise exposure. Eleven studies with 3725 participants evaluated effects of personal hearing protection devices and 17 studies with 84,028 participants evaluated effects of hearing loss prevention programmes (HLPPs). Effects on noise exposure Engineering interventions following legislationOne ITS study found that new legislation in the mining industry reduced the median personal noise exposure dose in underground coal mining by 27.7 percentage points (95% confidence interval (CI) -36.1 to -19.3 percentage points) immediately after the implementation of stricter legislation. This roughly translates to a 4.5 dB(A) decrease in
Vind, Ane B; Andersen, Hanne E; Pedersen, Kirsten D
, mean age 74, 73.7%women, who had visited the emergency department or had been hospitalized due to a fall. INTERVENTION: Identification of general medical, cardiovascular, and physical risk factors for falls and individual intervention in the intervention group. Participants in the control group....... Followup exceeded 90.0%. A total of 422 falls were registered in the intervention group, 398 in the control group. Intention-to-treat analysis revealed no effect of the intervention on fall rates (relative risk=1.06, 95%confidence interval (CI)=0.75 -1.51), proportion with falls (odds ratio (OR)=1.20, 95......OBJECTIVES: To evaluate the effect of multifactorial fall prevention in community-dwelling people aged 65 and older in Denmark. DESIGN: Randomized, controlled clinical trial. SETTING: Geriatric outpatient clinic at Glostrup University Hospital. PARTICIPANTS: Three hundred ninety-two elderly people...
Poteat, Tonia; Wirtz, Andrea L; Radix, Anita; Borquez, Annick; Silva-Santisteban, Alfonso; Deutsch, Madeline B; Khan, Sharful Islam; Winter, Sam; Operario, Don
Worldwide, transgender women who engage in sex work have a disproportionate risk for HIV compared with natal male and female sex workers. We reviewed recent epidemiological research on HIV in transgender women and show that transgender women sex workers (TSW) face unique structural, interpersonal, and individual vulnerabilities that contribute to risk for HIV. Only six studies of evidence-based prevention interventions were identified, none of which focused exclusively on TSW. We developed a deterministic model based on findings related to HIV risks and interventions. The model examines HIV prevention approaches in TSW in two settings (Lima, Peru and San Francisco, CA, USA) to identify which interventions would probably achieve the UN goal of 50% reduction in HIV incidence in 10 years. A combination of interventions that achieves small changes in behaviour and low coverage of biomedical interventions was promising in both settings, suggesting that the expansion of prevention services in TSW would be highly effective. However, this expansion needs appropriate sustainable interventions to tackle the upstream drivers of HIV risk and successfully reach this population. Case studies of six countries show context-specific issues that should inform development and implementation of key interventions across heterogeneous settings. We summarise the evidence and knowledge gaps that affect the HIV epidemic in TSW, and propose a research agenda to improve HIV services and policies for this population. PMID:25059941
Schug, Stephan A; Peyton, Philip
Identifying operations and individuals with an increased risk of chronic postsurgical pain (CPSP) has led to significant interest in interventions with the potential to achieve primary prevention of this condition. Pharmacological prevention remains controversial with a Cochrane review identifying perioperative ketamine administration as the only intervention with possible benefit although, with only small, heterogeneous studies, the authors called for a large randomised controlled trial (RCT) to confirm the validity of this result. In response to these data, a group of researchers from Australia and Hong Kong designed the ROCKet trial - Reduction Of Chronic Post-surgical Pain with Ketamine, endorsed by the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network (CTN).
Spink, Martin J; Fotoohabadi, Mohammad R; Wee, Elin; Landorf, Karl B; Hill, Keith D; Lord, Stephen R; Menz, Hylton B
Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. The intervention group (n = 153, mean age 74.2 years) of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i) foot orthoses, (ii) footwear advice and footwear cost subsidy, and (iii) a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components. Adherence to the three components of the intervention was as follows: foot orthoses (69%), footwear (54%) and home-based exercise (72%). Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified. Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling. Australian New Zealand Clinical Trials Registry ACTRN12608000065392.
Moore, Ida M; Hockenberry, Marilyn J; Anhalt, Cynthia; McCarthy, Kathy; Krull, Kevin R
Despite evidence that CNS treatment is associated with cognitive and academic impairment, interventions to prevent or mitigate these problems are limited. The purpose was to determine if early intervention can prevent declines in mathematics abilities. Fifty-seven children with ALL were enrolled and randomized to a Mathematics Intervention or Standard Care. Subjects completed neurocognitive assessments prior to the intervention, post-intervention, and 1 year later. Parents received written results and recommendations for use with their school. The Mathematics Intervention was based on Multiple Representation Theory and delivered individually over 1 year. Thirty-two of 57 subjects completed the study and were included in data analyses. These 32 subjects completed all neurocognitive assessments and, for those in the Intervention Group, 40-50 hours of the Mathematics Intervention. There were no group differences on relevant demographic variables; risk stratification; number of intrathecal methotrexate injections; or high dose systemic methotrexate. Significant improvements in calculation and applied mathematics from Baseline to Post-Intervention (P = 0.003 and 0.002, respectively) and in visual working memory from Baseline to 1 year Follow-up (P = 0.02) were observed in the Intervention but not the Standard Care Group. Results from repeated measures ANOVA demonstrated significant between group differences for applied mathematics [F(2,29) = 12.47, P Mathematics Intervention improved mathematics abilities and visual working memory compared to standard care. Future studies are needed to translate the Mathematics Intervention into a "virtual" delivery method more readily available to parents and children. Copyright © 2011 Wiley Periodicals, Inc.
Selph, Shelley S; Bougatsos, Christina; Blazina, Ian; Nelson, Heidi D
In 2004, the U.S. Preventive Services Task Force determined that evidence was insufficient to recommend behavioral interventions and counseling to prevent child abuse and neglect. To review new evidence on the effectiveness of behavioral interventions and counseling in health care settings for reducing child abuse and neglect and related health outcomes, as well as adverse effects of interventions. MEDLINE and PsycINFO (January 2002 to June 2012), Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the second quarter of 2012), Scopus, and reference lists. English-language trials of the effectiveness of behavioral interventions and counseling and studies of any design about adverse effects. Investigators extracted data about study populations, designs, and outcomes and rated study quality using established criteria. Eleven fair-quality randomized trials of interventions and no studies of adverse effects met inclusion criteria. A trial of risk assessment and interventions for abuse and neglect in pediatric clinics for families with children aged 5 years or younger indicated reduced physical assault, Child Protective Services (CPS) reports, nonadherence to medical care, and immunization delay among screened children. Ten trials of early childhood home visitation reported reduced CPS reports, emergency department visits, hospitalizations, and self-reports of abuse and improved adherence to immunizations and well-child care, although results were inconsistent. Trials were limited by heterogeneity, low adherence, high loss to follow-up, and lack of standardized measures. Risk assessment and behavioral interventions in pediatric clinics reduced abuse and neglect outcomes for young children. Early childhood home visitation also reduced abuse and neglect, but results were inconsistent. Additional research on interventions to prevent child abuse and neglect is needed. Agency for Healthcare Research and Quality.
The Canadian International Development Agency (CIDA) is funding the Africa HIV/AIDS Prevention Trials Capacity Building Program under the umbrella of the Global Health Research Initiative (GHRI). The aim of the program is to build the capacity of African researchers and institutions to conduct anticipated clinical trials ...
Morgan, Amy Joanna; Jorm, Anthony Francis; Mackinnon, Andrew James
Recruiting participants to randomized controlled trials of health interventions can be very difficult. Internet-based recruitment is becoming an increasingly important mode of recruitment, yet there are few detailed accounts of experiences recruiting participants to mental health interventions. To report on our experience with Internet-based recruitment to an online depression prevention intervention and pass on lessons we learned. Participants were recruited to the Mood Memos study, an online preventive depression intervention, purely through Internet-based sources. The study was targeted to adults with subthreshold depression symptoms from several English-speaking countries. A variety of online recruitment sources were trialed, including search engine advertising (Google, Yahoo!, Bing), Facebook advertising, posts in forums and online noticeboards, and promotion through relevant websites and email newsletters of mental health organizations. The study website received visits from 94,808 individuals over the 14-month recruitment period. The recruitment target was reached with 1699 individuals signing up to the randomized controlled trial and 1326 fully enrolling. Most visitors arrived via Google advertising, which promoted a depression-screening questionnaire. Google advertising accounted for nearly half of the total participants who signed up to the study, at an average cost of AUD $12 per participant. Promoting the study through trustworthy organizations and websites known to participants was also effective. Recruitment techniques that were less effective were contacting forums, email groups, and community noticeboards. Several techniques, including Google advertising, were successful in recruiting participants to a trial evaluating an online depression intervention. Results suggest that Internet-based recruitment to mental health interventions is feasible and can be relatively affordable. ACTRN12609000925246.
Skouteris, Helen; Hill, Briony; McCabe, Marita; Swinburn, Boyd; Sacher, Paul; Chadwick, Paul
The aim of this paper was to compare the recruitment strategies of two recent studies that focused on the parental influences on childhood obesity during the preschool years. The first study was a randomised controlled trial (RCT) of the Mind, Exercise, Nutrition?…?Do It! 2-4 obesity prevention programme and the second was a longitudinal cohort…
Gale, E A M; Bingley, P J; Emmett, C L
Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done......, and number of islet autoantibodies detected was 1.01 (0.73-1.38; p=0.97). Of 168 (30.4%) participants who withdrew from the trial, 83 were on placebo. The number of serious adverse events did not differ between treatment groups. Nicotinamide treatment did not affect growth in children or first-phase insulin...
The purpose of the present article is to provide a detailed description of the highly successful lifestyle intervention administered to 1,079 participants, which included 45% racial and ethnic minorities and resulted in a 58% reduction in the incidence rate of diabetes (2). The two major goals of the Diabetes Prevention Program (DPP) lifestyle intervention were a minimum of 7% weight loss/weight maintenance and a minimum of 150 min of physical activity similar in intensity to brisk walking. B...
van den Driessche, José J; Plat, Jogchum; Mensink, Ronald P
Functional foods can be effective in the prevention of metabolic syndrome and subsequently the onset of cardiovascular diseases and type II diabetes mellitus. More recently, however, another term was introduced to describe foods with additional health benefits: "superfoods", for which, to date, no generally accepted definition exists. Nonetheless, their consumption might contribute to the prevention of metabolic syndrome, for example due to the presence of potentially bioactive compounds. This review provides an overview of controlled human intervention studies with foods described as "superfoods" and their effects on metabolic syndrome parameters. First, an Internet search was performed to identify foods described as superfoods. For these superfoods, controlled human intervention trials were identified until April 2017 investigating the effects of superfood consumption on metabolic syndrome parameters: waist circumference or BMI, blood pressure, or concentrations of HDL cholesterol, triacylglycerol or glucose. Seventeen superfoods were identified, including a total of 113 intervention trials: blueberries (8 studies), cranberries (8), goji berries (3), strawberries (7), chili peppers (3), garlic (21), ginger (10), chia seed (5), flaxseed (22), quinoa (1), cocoa (16), maca (1), spirulina (7), wheatgrass (1), acai berries (0), hemp seed (0) and bee pollen (0). Overall, only limited evidence was found for the effects of the foods described as superfoods on metabolic syndrome parameters, since results were not consistent or the number of controlled intervention trials was limited. The inconsistencies might have been related to intervention-related factors, such as duration or dose. Furthermore, conclusions may be different if other health benefits are considered.
Halloran, M Elizabeth; Auranen, Kari; Baird, Sarah; Basta, Nicole E; Bellan, Steven E; Brookmeyer, Ron; Cooper, Ben S; DeGruttola, Victor; Hughes, James P; Lessler, Justin; Lofgren, Eric T; Longini, Ira M; Onnela, Jukka-Pekka; Özler, Berk; Seage, George R; Smith, Thomas A; Vespignani, Alessandro; Vynnycky, Emilia; Lipsitch, Marc
Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.
Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda A; Braunschweig, Carol L; Gomez, Sandra L; Van Horn, Linda; Dyer, Alan R
The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the nine schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the nine control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and postintervention. At postintervention, children in the intervention schools engaged in more moderate-to-vigorous physical activity (MVPA) than children in the control schools (difference between adjusted group means = 7.46 min/day, P = 0.02). Also, children in the intervention group had less total screen time (-27.8 min/day, P = 0.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not on diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision.
Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian
The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.
Ames, Genevieve M.; Bennett, Joel B.
The workplace offers advantages as a setting for interventions that result in primary prevention of alcohol abuse. Such programs have the potential to reach broad audiences and populations that would otherwise not receive prevention programs and, thereby, benefit both the employee and employer. Researchers have implemented and evaluated a variety of workplace alcohol problem prevention efforts in recent years, including programs focused on health promotion, social health promotion, brief interventions, and changing the work environment. Although some studies reported significant reductions in alcohol use outcomes, additional research with a stronger and integrated methodological approach is needed. The field of workplace alcohol prevention also might benefit from a guiding framework, such as the one proposed in this article. PMID:22330216
Chang, Larry W; Serwadda, David; Quinn, Thomas C; Wawer, Maria J; Gray, Ronald H; Reynolds, Steven J
The promise of combination HIV prevention-the application of multiple HIV prevention interventions to maximise population-level effects-has never been greater. However, to succeed in achieving significant reductions in HIV incidence, an additional concept needs to be considered: combination implementation. Combination implementation for HIV prevention is the pragmatic, localised application of evidence-based strategies to enable high sustained uptake and quality of interventions for prevention of HIV. In this Review, we explore diverse implementation strategies including HIV testing and counselling models, task shifting, linkage to and retention in care, antiretroviral therapy support, behaviour change, demand creation, and structural interventions, and discusses how they could be used to complement HIV prevention efforts such as medical male circumcision and treatment as prevention. HIV prevention and treatment have arrived at a pivotal moment when combination efforts might result in substantial enough population-level effects to reverse the epidemic and drive towards elimination of HIV. Only through careful consideration of how to implement and operationalise HIV prevention interventions will the HIV community be able to move from clinical trial evidence to population-level effects. Copyright © 2013 Elsevier Ltd. All rights reserved.
Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools
van Rossum Erik
Full Text Available Abstract Background There is an interest for intervention studies aiming at the prevention of disability in community-dwelling physically frail older persons, though an overview on their content, methodological quality and effectiveness is lacking. Methods A search for clinical trials involved databases PubMed, CINAHL and Cochrane Central Register of Controlled Trials and manually hand searching. Trials that included community-dwelling frail older persons based on physical frailty indicators and used disability measures for outcome evaluation were included. The selection of papers and data-extraction was performed by two independent reviewers. Out of 4602 titles, 10 papers remained that met the inclusion criteria. Of these, 9 were of sufficient methodological quality and concerned 2 nutritional interventions and 8 physical exercise interventions. Results No evidence was found for the effect of nutritional interventions on disability measures. The physical exercise interventions involved 2 single-component programs focusing on lower extremity strength and 6 multi-component programs addressing a variety of physical parameters. Out of 8 physical exercise interventions, three reported positive outcomes for disability. There was no evidence for the effect of single lower extremity strength training on disability. Differences between the multi-component interventions in e.g. individualization, duration, intensity and setting hamper the interpretation of the elements that consistently produced successful outcomes. Conclusion There is an indication that relatively long-lasting and high-intensive multicomponent exercise programs have a positive effect on ADL and IADL disability for community-living moderate physically frail older persons. Future research into disability prevention in physical frail older persons could be directed to more individualized and comprehensive programs.
Full Text Available Introduction. Depression in adolescents and young people is associated with reduced social, occupational, and interpersonal functioning, increases in suicide and self-harm behaviours, and problematic substance use. Age-appropriate, evidence-based treatments are required to provide optimal care. Methods. “Evidence mapping” methodology was used to quantify the nature and distribution of the extant high-quality research into the prevention and treatment of depression in young people across psychological, medical, and other treatment domains. Results. Prevention research is dominated by cognitive-behavioral- (CBT- based interventions. Treatment studies predominantly consist of CBT and SSRI medication trials, with few trials of other psychological interventions or complementary/alternative treatments. Quality studies on relapse prevention and treatment for persistent depression are distinctly lacking. Conclusions. This map demonstrates opportunities for future research to address the numerous evidence gaps for interventions to prevent or treat depression in young people, which are of interest to clinical researchers, policy makers, and funding bodies.
Burry, L. D.; Hutton, Brian; Guenette, M.
Background: Delirium is characterized by acute changes in mental status including inattention, disorganized thinking, and altered level of consciousness, and is highly prevalent in critically ill adults. Delirium has adverse consequences for both patients and the healthcare system; however......, at this time, no effective treatment exists. The identification of effective prevention strategies is therefore a clinical and research imperative. An important limitation of previous reviews of delirium prevention is that interventions were considered in isolation and only direct evidence was used. Our......-randomized trials of critically ill adults evaluating any pharmacological, non-pharmacological, or multi-component intervention for delirium prevention, administered in or prior to (i.e., peri-operatively) transfer to the ICU. Two authors will independently screen search results and extract data from eligible...
Zatzick, Douglas F; Koepsell, Thomas; Rivara, Frederick P
The population impact of a preventive intervention depends on two factors: what proportion of the full population at risk receives the intervention and how large a reduction in risk occurs among those who receive it. We sought to illustrate how information from a cognitive behavioral psychotherapy (CBT) trial and stepped collaborative care (CC) trial could be used to estimate the population impact of two contrasting approaches to PTSD prevention. We first specified trauma center target populations represented by participants in each trial. Patient characteristics were compared, as were effect size and reach indices and population-level reductions in PTSD incidence. The CBT trial demonstrated a larger effect size (50% PTSD prevention), but minimal reach (27/10,000), while the CC trial demonstrated a smaller effect size (7% PTSD prevention) but greater reach (1762/10,000). Modeling of the population impact suggested that a 9.5-fold greater cumulative reduction in the incidence of PTSD would result from the dissemination of the CC broad reach prevention strategy. A reciprocal relationship between effect size and reach was evident in these two trials. By specifying a target population, effect size and reach could be combined to project the overall population impact of each PTSD prevention approach.
Tone Langjordet Johnsen
Full Text Available Abstract Background Subjective health complaints, such as musculoskeletal and mental health complaints, have a high prevalence in the general population, and account for a large proportion of sick leave in Norway. It may be difficult to prevent the occurrence of subjective health complaints, but it may be possible to influence employees’ perception and management of these complaints, which in turn may have impact on sick leave and return to work after sick leave. Long term sick leave has many negative health and social consequences, and it is important to gain knowledge about effective interventions to prevent and reduce long term sick leave. Methods/Design This study is a cluster randomised controlled trial to evaluate the effect of the modified atWork intervention, targeting non-specific musculoskeletal complaints and mental health complaints. This intervention will be compared to the original atWork intervention targeting only non-specific musculoskeletal complaints. Kindergartens in Norway are invited to participate in the study and will be randomly assigned to one of the two interventions. Estimated sample size is 100 kindergartens, with a total of approximately 1100 employees. Primary outcome is sick leave at unit level, measured using register data from the Norwegian Labour and Welfare Administration. One kindergarten equals one unit, regardless of number of employees. Secondary outcomes will be measured at the individual level and include coping, health, job satisfaction, social support, and workplace inclusion, collected through questionnaires distributed at baseline and at 12 months follow up. All employees in the included kindergartens are eligible for participating in the survey. Discussion The effect evaluation of the modified atWork intervention is a large and comprehensive project, providing evidence-based information on prevention of long-term sick leave, which may be of considerable benefit both from a societal
Thomas, Roger E; Baker, Philip R A; Thomas, Bennett C
Tobacco is the main preventable cause of death and disease worldwide. Adolescent smoking is increasing in many countries with poorer countries following the earlier experiences of affluent countries. Preventing adolescents from starting smoking is crucial to decreasing tobacco-related illness. To assess effectiveness of family-based interventions alone and combined with school-based interventions to prevent children and adolescents from initiating tobacco use. Fourteen bibliographic databases and the Internet, journals hand-searched, and experts consulted. Randomized controlled trials (RCTs) with children or adolescents and families, interventions to prevent starting tobacco use, and follow-up ≥6 months. Abstracts/titles independently assessed and data independently entered by 2 authors. Risk of bias was assessed with the Cochrane Risk-of-Bias tool. Twenty-seven RCTs were included. Nine trials of never-smokers compared with a control provided data for meta-analysis. Family intervention trials had significantly fewer students who started smoking. Meta-analysis of 2 RCTs of combined family and school interventions compared with school only, showed additional significant benefit. The common feature of effective high-intensity interventions was encouraging authoritative parenting. Only 14 RCTs provided data for meta-analysis (approximately a third of participants). Of the 13 RCTs that did not provide data for meta-analysis 8 compared a family intervention with no intervention and 1 reported significant effects, and 5 compared a family combined with school intervention with a school intervention only and none reported additional significant effects. There is moderate-quality evidence that family-based interventions prevent children and adolescents from starting to smoke. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.
Dec 20, 2017 ... New research into HIV prevention among the “choice disabled” — vulnerable groups who are less able to make the right choices to protect themselves — has led to a groundbreaking national trial for HIV prevention in Botswana. Three years of research in southern Africa revealed important pointers for ...
Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R
The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best
Lager, Kate E; Mistri, Amit K; Khunti, Kamlesh; Haunton, Victoria J; Sett, Aung K; Wilson, Andrew D
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 studie