Interventions to improve early retention of patients in antiretroviral therapy programmes in sub-Saharan Africa: A systematic review.

BACKGROUND: Several interventions to improve long term retention (12 months and above) on treatment have been rigorously evaluated in Sub-Saharan Africa (SSA). However, research on interventions to improve retention of patients in the early stages of treatment (6 months) during this era of Universal Test and Treat has only recently emerged. The aim of this study is to systematically map evidence of interventions used to improve early retention of patients in antiretroviral therapy (ART) programmes in SSA. METHODS: We searched PubMed, EMBASE and Cochrane electronic databases to identify studies describing interventions aimed at improving early retention in ART treatment. We applied the methodological frameworks by Arksey and O'Malley (2005) and Levac et al. (2010). We also followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Interventions were categorized according to key broad areas in the existing literature. RESULTS: A total of 2,241 articles were identified of which 19 met the inclusion criteria and were eligible for this review, with the majority either being randomized control trials 32% (n = 6) or cohort studies 32% (n = 6). The studies reviewed were conducted in 11 SSA countries. The most common interventions described under key broad areas included: Health system interventions such as Universal Test-and-Treat, integration of ART initiation, HIV Testing and Counselling and Antenatal Care services and reduction of ART drug costs; Patient centered approaches such as fast track ART initiation, Differentiated Drug Delivery models and point of care HIV birth testing; Behavioral interventions and support through lay counselors, mentor mothers, nurse counselors and application of quality improvement interventions and financial incentives. Majority of the studies targeted the HIV positive adults and pregnant women. CONCLUSION: With the introduction of Universal Test-and-Treat and same-day initiation of ART, findings suggest that adoption of policies that expand ART uptake with the goal of reducing HIV transmission at the population level, promoting patient centered approaches such as fast track ART initiation, Differentiated Service Delivery models and providing adequate support through Mentor Mothers, lay and nurse counselors may improve early retention in HIV care in SSA. However, these interventions have only been tested in few countries in the region which points to how hard evidence based HIV programming is. Further research investigating the impact of individual and a combination of interventions to improve early retention in HIV care, including for various groups at high risk of attrition, is warranted across SSA countries to fast track the achievement of 95-95-95 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets by 2030.

Trends in the Number of Behavioural Theory-Based Healthy Eating Interventions Inclusive of Dietitians/Nutritionists in 2000-2020.

Nutrition interventions developed using behaviour theory may be more effective than those without theoretical underpinnings. This study aimed to document the number of theory-based healthy eating interventions, the involvement of dietitians/nutritionists and the behaviour theories employed from 2000 to 2020. We conducted a review of publications related to healthy eating interventions that used behaviour change theories. Interventional studies published in English between 2000 and 2020 were retrieved from searching Medline, Cinahl, Embase, Psycinfo and Cochrane Central. Citation, country of origin, presence or absence of dietitian/nutritionist authors, participants, dietary behaviours, outcomes, theories and any behaviour change techniques (BCTs) stated were extracted. The publication trends on a yearly basis were recorded. A total of 266 articles were included. The number of theory-based interventions increased over the two decades. The number of studies conducted by dietitians/nutritionists increased, but since 2012, increases have been driven by other researchers. Social cognitive theory was the most used behaviour theory. Dietitians/nutritionists contributed to growth in publication of theory-based healthy eating interventions, but the proportion of researchers from other professions engaged in this field increased markedly. The reasons for this growth in publications from other professions is unknown but conjectured to result from greater prominence of dietary behaviours within the context of an obesity epidemic.

A staged approach to address youth unresponsive to initial obesity intervention: a randomized clinical trial.

BACKGROUND/OBJECTIVE: Maintenance interventions inherently require BMI improvement to maintain. This overlooks individuals initially unresponsive to obesity interventions. Staged pediatric clinical treatment guidelines were adapted to the school setting to develop an escalated treatment option for individuals initially unresponsive. This staged randomized controlled trial examined differences between escalated treatment (Take CHARGE!) and a maintenance program (PE Planners). Take CHARGE was hypothesized to have greater improvements in BMI as a percentage of the 95th BMI Percentile (%BMIp95) than PE Planners. SUBJECTS/METHODS: From 2018 to 2020, 171 middle and high schoolers (BMI Percentile ≥ 85) were recruited from a Houston school district to participate in a staged obesity intervention in their physical education (PE) class. After receiving a semester-long intensive lifestyle intervention (ILI) with established efficacy, all participants were randomized to Take CHARGE (n = 85) or PE Planners (n = 86). Take CHARGE escalated the behavioral treatment of obesity received in ILI with more frequent individual sessions, additional opportunities for parental and school staff involvement, and increased mentorship from trained college students. PE Planners allowed participants to decide how they wanted to be active in PE class. Mixed linear modeling examined %BMIp95 overtime between groups. This trial was registered at ClinicalTrials.gov (#NCT04362280). RESULTS: Participants were 13.63 ± 1.32 years old; 59% were female, and 85% were Hispanic. Among those initially unresponsive to ILI, Take CHARGE had significantly greater decreases in %BMIp95 than PE Planners (ß = -0.01, p < 0.01). Conversely, among those initially responsive, Take CHARGE had significantly smaller decreases in %BMIp95 than PE Planners (ß = 0.02, p < 0.05). Intention-to-treat analysis had similar results. CONCLUSIONS: Participant outcomes in semester two differed based on initial response. Individuals responsive to initial intervention were most likely to benefit from a maintenance intervention and those initially unresponsive benefited more from escalated treatment. This indicates the need for staged intervention protocols to better address obesity in the school setting.

Applying methods for personalized medicine to the treatment of alcohol use disorder.

OBJECTIVE: Numerous behavioral treatments for alcohol use disorder (AUD) are effective, but there are substantial individual differences in treatment response. This study examines the potential use of new methods for personalized medicine to test for individual differences in the effects of cognitive behavioral therapy (CBT) versus motivational enhancement therapy (MET) and to provide predictions of which will work best for individuals with AUD. We highlight both the potential contribution and the limitations of these methods. METHOD: We performed secondary analyses of abstinence among 1,144 participants with AUD participating in either outpatient or aftercare treatment who were randomized to receive either CBT or MET in Project MATCH. We first obtained predicted individual treatment effects (PITEs), as a function of 19 baseline client characteristics identified a priori by MATCH investigators. Then, we tested for the significance of individual differences and examined the predicted individual differences in abstinence 1 year following treatment. Predictive intervals were estimated for each individual to determine if they were 80% more likely to achieve abstinence in one treatment versus the other. RESULTS: Results indicated that individual differences in the likelihood of abstinence at 1 year following treatment were significant for those in the outpatient sample, but not for those in the aftercare sample. Individual predictive intervals showed that 37% had a better chance of abstinence with CBT than MET, and 16% had a better chance of abstinence with MET. Obtaining predictions for a new individual is demonstrated. CONCLUSIONS: Personalized medicine methods, and PITE in particular, have the potential to identify individuals most likely to benefit from one versus another intervention. New personalized medicine methods play an important role in putting together differential effects due to previously identified variables into one prediction designed to be useful to clinicians and clients choosing between treatment options. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Causal models accounted for research participation effects when estimating effects in a behavioral intervention trial.

OBJECTIVE: Participants in intervention studies are asked to take part in activities linked to the conduct of research, including signing consent forms and being assessed. If participants are affected by such activities through mechanisms by which the intervention is intended to work, then there is confounding. We examine how to account for research participation effects analytically. STUDY DESIGN AND SETTING: Data from a trial of a brief alcohol intervention among Swedish university students is used to show how a proposed causal model can account for assessment effects. RESULTS: The proposed model can account for research participation effects as long as researchers are willing to use existing data to make assumptions about causal influences, for instance on the magnitude of assessment effects. The model can incorporate several research processes which may introduce bias. CONCLUSIONS: As our knowledge grows about research participation effects, we may move away from asking if participants are affected by study design, toward rather asking by how much they are affected, by which activities and in which circumstances. The analytic perspective adopted here avoids assuming there are no research participation effects.

Hormonal and Metabolic Changes of Aging and the Influence of Lifestyle Modifications.

Increased life expectancy combined with the aging baby boomer generation has resulted in an unprecedented global expansion of the elderly population. The growing population of older adults and increased rate of age-related chronic illness has caused a substantial socioeconomic burden. The gradual and progressive age-related decline in hormone production and action has a detrimental impact on human health by increasing risk for chronic disease and reducing life span. This article reviews the age-related decline in hormone production, as well as age-related biochemical and body composition changes that reduce the bioavailability and actions of some hormones. The impact of hormonal changes on various chronic conditions including frailty, diabetes, cardiovascular disease, and dementia are also discussed. Hormone replacement therapy has been attempted in many clinical trials to reverse and/or prevent the hormonal decline in aging to combat the progression of age-related diseases. Unfortunately, hormone replacement therapy is not a panacea, as it often results in various adverse events that outweigh its potential health benefits. Therefore, except in some specific individual cases, hormone replacement is not recommended. Rather, positive lifestyle modifications such as regular aerobic and resistance exercise programs and/or healthy calorically restricted diet can favorably affect endocrine and metabolic functions and act as countermeasures to various age-related diseases. We provide a critical review of the available data and offer recommendations that hopefully will form the groundwork for physicians/scientists to develop and optimize new endocrine-targeted therapies and lifestyle modifications that can better address age-related decline in heath.

How effective are physical activity interventions when they are scaled-up: a systematic review.

BACKGROUND: The 'scale-up' of effective physical activity interventions is required if they are to yield improvements in population health. The purpose of this study was to systematically review the effectiveness of community-based physical activity interventions that have been scaled-up. We also sought to explore differences in the effect size of these interventions compared with prior evaluations of their efficacy in more controlled contexts, and describe adaptations that were made to interventions as part of the scale-up process. METHODS: We performed a search of empirical research using six electronic databases, hand searched reference lists and contacted field experts. An intervention was considered 'scaled-up' if it had been intentionally delivered on a larger scale (to a greater number of participants, new populations, and/or by means of different delivery systems) than a preceding randomised control trial ('pre-scale') in which a significant intervention effect (p < 0.05) was reported on any measure of physical activity. Effect size differences between pre-scale and scaled up interventions were quantified ([the effect size reported in the scaled-up study / the effect size reported in the pre-scale-up efficacy trial] × 100) to explore any scale-up 'penalties' in intervention effects. RESULTS: We identified 10 eligible studies. Six scaled-up interventions appeared to achieve significant improvement on at least one measure of physical activity. Six studies included measures of physical activity that were common between pre-scale and scaled-up trials enabling the calculation of an effect size difference (and potential scale-up penalty). Differences in effect size ranged from 132 to 25% (median = 58.8%), suggesting that most scaled-up interventions typically achieve less than 60% of their pre-scale effect size. A variety of adaptations were made for scale-up - the most common being mode of delivery. CONCLUSION: The majority of interventions remained effective when delivered at-scale however their effects were markedly lower than reported in pre-scale trials. Adaptations of interventions were common and may have impacted on the effectiveness of interventions delivered at scale. These outcomes provide valuable insight for researchers and public health practitioners interested in the design and scale-up of physical activity interventions, and contribute to the growing evidence base for delivering health promotion interventions at-scale. TRIAL REGISTRATION: PROSPERO CRD42020144842 .

Many Young Children with Autism Who Use Psychotropic Medication Do Not Receive Behavior Therapy: A Multisite Case-Control Study.

OBJECTIVES: To explore how many pre-school aged children with autism spectrum disorder (ASD) used psychotropic medication, child and geographic factors associated with psychotropic medication use, and how many children who used psychotropic medication did or did not ever receive behavior therapy. STUDY DESIGN: Children 2-5 years of age were enrolled from 2012 to 2016 in a multisite case-control study designed to investigate the development and risk factors of ASD. Children with a positive ASD screen or ASD diagnosis upon enrollment were asked to complete a comprehensive evaluation to determine ASD status and developmental level. Caregivers completed a Services and Treatments Questionnaire and multiple self-administered questionnaires to determine child use of psychotropic medication, ever receipt of behavior therapy, and presence of co-occurring symptoms. RESULTS: There were 763 children who were classified as ASD and had data collected on the Services and Treatments Questionnaire. Of those, 62 (8.1%) used psychotropic medication to treat behavioral symptoms and 28 (3.7%) were ≤3 years of age when medication was first started. Attention problems (aOR, 7.65; 95% CI, 3.41-16.1; P < .001) and study site (aOR, 2.62; 95% CI, 1.04-6.56; P = .04) were significantly associated with psychotropic medication use after controlling for maternal race/ethnicity. More than one-half (59.7%) of those who used psychotropic medication did not ever receive behavior therapy. CONCLUSIONS: Many preschool-aged children with ASD who use psychotropic medication do not receive behavior therapy. Pediatricians are an important resource for children and families and can help facilitate behavioral treatment for children with ASD and other disorders.

Reduction of hypoglycaemia, lifestyle modifications and psychological distress during lockdown following SARS-CoV-2 outbreak in type 1 diabetes.

AIMS: To assess changes in glucose metrics and their association with psychological distress and lifestyle changes in patients with type 1 diabetes (T1D) using flash glucose monitoring (FGM) during lockdown following severe acute respiratory syndrome coronavirus 2 outbreak. MATERIALS AND METHODS: Single-centre, observational, retrospective study enrolling T1D patients who attended a remote visit on April 2020 at the Endocrinology division of the University Hospital Policlinico Consorziale, Bari, Italy. Lockdown-related changes in physical activity level and dietary habits were assessed on a semi-quantitative basis. Changes in general well-being were assessed by the General Health Questionnaire-12 items with a binary scoring system. Glucose metrics were obtained from the Libreview platform for the first 2 weeks of February 2020 (T0) and the last 2 weeks before the phone visit (T1). RESULTS: Out of 84 patients assessed for eligibility, 48 had sufficient FGM data to be included in the analysis. FGM data analysis revealed significant reductions in coefficient of variation, number of hypoglycaemic events, and time below range, while no changes were found in time in range, time above range, mean sensor glucose, and glucose management indicator. Moreover, the frequency of sweets consumption was inversely related to the occurrence of hypoglycaemic events during lockdown. CONCLUSIONS: Lockdown-related lifestyle changes, albeit unhealthy, may lead to reduction in FGM-derived measures of hypoglycaemia and glycaemic variability in patients with T1D.

Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists.

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

Motivational Interviewing Adapted to Group Setting for the Treatment of Relapse in the Behavioral Therapy of Obesity. A Clinical Audit.

Motivational interviewing (MI) is devised to change unhealthy behaviors by increasing motivation. We adapted MI to a group format for the treatment of relapse during the behavioral treatment of obesity and performed a clinical audit to evaluate its effectiveness in stopping weight regain. The program was structured in seven weekly sessions, plus a 6-month follow-up. Patients (n = 86) completed a questionnaire on motivation to change in both healthy diet and physical activity, and a self-reported measurement of calorie intake and physical activity at baseline, at program end and at 6-month follow-up. The attendance to the program was high, with only 13 patients (15%) not completing the program and 24% not attending the 6-month follow-up. By the end of follow up, the prevalence of patients in either precontemplation or contemplation was reduced from over 60% at enrollment to approximately 20%, whereas the sum of patients in action or maintenance stages was increased from 9.5% in healthy diet and 14% in physical activity to 39.7% and 41.3%, respectively. These changes translated into significant behavioral changes (mean calorie intake, -13%; total physical activity, +125%; sedentary time, -8%) and finally into reduced body weight ( -3%). We conclude that MI programs adapted for groups may be used to stop relapse in individuals following a behavioral intervention for obesity.

Effect of an Integrated Package of Nutrition Behavior Change Interventions on Infant and Young Child Feeding Practices and Child Growth from Birth to 18 Months: Cohort Evaluation of the Baduta Cluster Randomized Controlled Trial in East Java, Indonesia.

The need for a multisectoral approach to tackle stunting has gained attention in recent years. Baduta project aims to address undernutrition among children during their first 1000 days of life using integrated nutrition-specific and nutrition-sensitive interventions. We undertook this cohort study to evaluate the Baduta project's effectiveness on growth among children under 2 years of age in two districts (Sidoarjo and Malang Districts) in East Java. Six subdistricts were randomly selected, in which three were from the intervention areas, and three were from the control areas. We recruited 340 pregnant women per treatment group during the third trimester of pregnancy and followed up until 18 months postpartum. The assessment of breastfeeding and complementary feeding practices used standard infant and young child feeding (IYCF) indicators in a tablet-based application. We measured weight and length at birth and every three-months after that. The enumerators met precision and accuracy criteria following an anthropometry standardization procedure. Among the breastfed children, the percentage of children who achieved the minimum dietary diversity score (DDS) and minimum acceptable diet (MAD) was higher for the intervention group than the comparison group across all age groups. The odd ratios were 3.49 (95% CI: 2.2-5.5) and 2.79 (95% CI: 1.7-4.4) for DDS and 3.49 (95% CI: 2.2-5.5) and 2.74 (95% CI: 1.8-5.2) for MAD in the 9-11 month and 16-18-month age groups, respectively. However, there was no significant improvement in growth or reduction in the prevalence of anemia. The intervention was effective in improving the feeding practices of children although it failed to show significant improvement in linear growth of children at 18 months of age.

Evaluation of a Cognitive-Behavioral Game Design-Based Mobile Game on Alcohol Use for Adolescents.

Objective: Determine the effectiveness of a cognitive behavioral game design (CBGD) based mobile game as an alcohol use intervention. Materials and Methods: Experimental design with 140 participants randomly assigned to either play a mobile game (n = 69) or watch a video documentary (n = 71). Results: Both groups displayed a decrease in intent to use and an increase in knowledge. The video intervention was superior in affecting actual use. Conclusion: Mobile game affects intent to use and is superior to the video in affecting knowledge.

Diferencias entre latinoamericanos y españoles participando en un programa de intervención en violencia de género: Resultados proximales y finales / Differences between Latin American and Spanish men in a batterer intervention programme: proximal and final outcomes

The aim of this study was to test whether there are differences in the effectiveness of a Batterer Intervention Programme (BIP) for Intimate Partner Violence (IPV) perpetrators depending on the participants' countries of origin (i.e., Spanish or Latin American immigrants). The sample included 425 male offenders who participated in a court-mandated standard BIP in Spain. Official recidivism and risk of recidivism were considered the final outcomes. Intention to change, responsibility attribution, adherence to treatment and treatment compliance were taken as the proximal outcomes. No differences were found in risk of recidivism, intention to change, responsibility attribution to the legal system and to the victim between the Spanish and Latin American participants. Significant differences between both groups were found for the variable treatment compliance. The results suggest that, at least for the Latin American immigrants participating in BIPs in Spain, it is apparently not necessary to adjust BIPs to cultural differences as adopting motivational strategies to promote change suffices

El objetivo de este estudio es comprobar si existen diferencias en la efectividad de un programa de intervención para hombres condenados por violencia de género, en función del lugar de procedencia de los participantes (i.e., españoles e inmigrantes latinoamericanos). Se utilizó una muestra de 425 hombres penados por violencia de género que participaban en un programa estándar de intervención en España. Se consideraron como variables finales la reincidencia oficial y el riesgo de reincidencia y como variables proximales la intención de cambio, la asunción de responsabilidad, la adherencia al tratamiento y el compromiso con la intervención. No se encontraron diferencias entre participantes españoles y latinoamericanos en las variables riesgo de reincidencia, intención de cambio, asunción de responsabilidad al sistema legal y a la víctima. Únicamente se encontraron diferencias significativas entre estos dos grupos en la variable compromiso con la intervención. Los resultados sugieren que, al menos para los inmigrantes latinoamericanos que se encuentran participando en programas de intervención con hombres condenados por violencia de género en España, no parece necesario ajustar la intervención en función de las diferencias culturales, siendo suficiente el uso de estrategias motivacionales para promover el cambio

Identification of Modifiable Social and Behavioral Factors Associated With Childhood Cognitive Performance.

Importance: Inequities in social environments are likely associated with a large portion of racial disparities in childhood cognitive performance. Identification of the specific exposures associated with cognitive development is needed to inform prevention efforts. Objective: To identify modifiable factors associated with childhood cognitive performance. Design, Setting, and Participants: This longitudinal pregnancy cohort study included 1503 mother-child dyads who were enrolled in the University of Tennessee Health Science Center-Conditions Affecting Neurodevelopment and Learning in Early Life study between December 1, 2006, and July 31, 2011, and assessed annually until the children were aged 4 to 6 years. The analytic sample comprised 1055 mother-child dyads. A total of 155 prenatal, perinatal, and postnatal exposures were included to evaluate environment-wide associations. Participants comprised a community-based sample of pregnant women who were recruited between 16 weeks and 28 weeks of gestation from 4 hospitals in Shelby County, Tennessee. Women with high-risk pregnancies were excluded. Data were analyzed from June 1, 2018, to April 15, 2019. Exposures: Individual and neighborhood socioeconomic position, family structure, maternal mental health, nutrition, delivery complications, birth outcomes, and parenting behaviors. Main Outcomes and Measures: Child's full-scale IQ measured by the Stanford-Binet Intelligence Scales, Fifth Edition, at age 4 to 6 years. Results: Of 1055 children included in the analytic sample, 532 (50.4%) were female. Among mothers, the mean (SD) age was 26.0 (5.6) years; 676 mothers (64.1%) were Black, and 623 mothers (59.0%) had an educational level of high school or less. Twenty-four factors were retained in the least absolute shrinkage and selection operator regression analysis and full models adjusted for potential confounding. Associations were noted between child cognitive performance and parental education and breastfeeding; for each increase of 1.0 SD in exposure, positive associations were found with cognitive growth fostering from observed parent-child interactions (ß = 1.12; 95% CI, 0.24-2.00) and maternal reading ability (ß = 1.42; 95% CI, 0.16-2.68), and negative associations were found with parenting stress (ß = -1.04; 95% CI, -1.86 to -0.21). A moderate increase in these beneficial exposures was associated with a notable improvement in estimated cognitive test scores using marginal means (0.5% of an SD). Black children experienced fewer beneficial cognitive performance exposures; in a model including all 24 exposures and covariates, no racial disparity was observed in cognitive performance (95% CIs for race included the null). Conclusions and Relevance: The prospective analysis identified multiple beneficial and modifiable cognitive performance exposures that were associated with mean differences in cognitive performance by race. The findings from this observational study may help guide experimental studies focused on reducing racial disparities in childhood cognitive performance.

Community-Based Caregiver and Family Interventions to Support the Mental Health of Orphans and Vulnerable Children: Review and Future Directions.

The goal of this paper was to conduct a review of studies from 2008 to 2019 that evaluated community-based caregiver or family interventions to support the mental health of orphans and vulnerable children (OVC) in sub-Saharan Africa, across four domains: (a) study methodology, (b) cultural adaptation and community participation, (c) intervention strategies, and (d) effects on child mental health. Ten interventions were identified. Findings revealed that the majority of studies used a randomized controlled trial or quasi-experimental design, but few conducted long-term follow-up; that all programs undertook cultural adaptation of the intervention using community participatory methods, or were locally developed; that the majority of interventions targeted caregiving behavior and/or caregiver-child relationships using behavioral and cognitive-behavioral strategies, or were home visiting interventions; and that interventions had mixed effects on OVC mental health. Progress and gaps revealed by these findings are discussed, as are suggestions for possible new directions in this area of intervention science.

Using targeting to recruit men and women of color into a behavioral weight loss trial.

BACKGROUND: The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach. METHODS: Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit. RESULTS: Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study. CONCLUSIONS: Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02368002. Registered on 20 February 2015.

Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).

BACKGROUND: Children's health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls. METHODS: The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention (n = 52) and control (n = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (ηp2) was used to calculate effect sizes. RESULTS: A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, ηp2 = 0.22). Overall there were 36.4% improvement for knowledge (ηp2 = 0.21), 53.2% for the skills (ηp2 = 0.25), 19.5% for the self-efficacy (ηp2 = 0.11), and 25.6% for the beliefs (ηp2 = 0.14) scores from baseline to 6 months' follow-up assessments among the intervention group (p < 0.001). The results also showed a significant interaction effect between group and time. CONCLUSION: The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies. TRIAL REGISTRATION: Current Controlled Trials IRCT20180528039885N1, 30th Oct 2018, 'Prospectively registered'. https://www.irct.ir/trial/31534.