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Background: Despite widespread use of long-lasting insecticidal nets (LLINs) and other tools, malaria caused 409,000 deaths worldwide in 2019. While indoor residual spraying (IRS) is an effective supplement, IRS is moderately expensive and logistically challenging. In endemic areas, IRS requires yearly application just before the main rainy season and potential interim reapplications. A new technology, insecticide-treated wall liner (ITWL), might overcome these challenges.Methods: We conducted a 44-cluster two-arm randomized controlled trial in Muheza, Tanzania from 2015 to 2016 to evaluate the cost and efficacy of a non-pyrethroid ITWL to supplement LLINs, analyzing operational changes over three installation phases. The estimated efficacy (with 95% confidence intervals) of IRS as a supplement to LLINs came mainly from a published randomized trial in Muleba, Tanzania. We obtained financial costs of IRS from published reports and conducted a household survey of a similar IRS program near Muleba to determine household costs. The costs of ITWL were amortized over its 4-year expected lifetime and converted to 2019 US dollars using Tanzania's GDP deflator and market exchange rates.Results: Operational improvements from phases 1 to 3 raised ITWL coverage from 35.1 to 67.1% of initially targeted households while reducing economic cost from $34.18 to $30.56 per person covered. However, 90 days after installing ITWL in 5666 households, the randomized trial was terminated prematurely because cone bioassay tests showed that ITWL no longer killed mosquitoes and therefore could not prevent malaria. The ITWL cost $10.11 per person per year compared to $5.69 for IRS. With an efficacy of 57% (3-81%), IRS averted 1162 (61-1651) disability-adjusted life years (DALYs) per 100,000 population yearly. Its incremental cost-effectiveness ratio (ICER) per DALY averted was $490 (45% of Tanzania's per capita gross national income).Conclusions: These findings provide design specifications for future ITWL development and implementation. It would need to be efficacious and more effective and/or less costly than IRS, so more persons could be protected with a given budget. The durability of a previous ITWL, progress in non-pyrethroid tools, economies of scale and competition (as occurred with LLINs), strengthened community engagement, and more efficient installation and management procedures all offer promise of achieving these goals. Therefore, ITWLs merit ongoing study.First Posted: 2015 ( NCT02533336 ). [ABSTRACT FROM AUTHOR]

Background: Multicomponent workplace-based interventions aimed at reducing sitting time among office workers are becoming increasingly popular. 'Take a Stand!' was such an intervention, reducing sitting time by 71 min after 1 month and 48 min after 3 months. However, it is unclear how the implementation process of 'Take a Stand!' affected these results. The present study explored how individual factors and organizational context influenced implementation and effect in 'Take a Stand!'Methods: This was a mixed-methods study, combining data from interviews, questionnaires and accelerometers. Directed content analysis was used for analysing interviews with participants, ambassadors and managers from the 10 intervention offices in the 'Take a Stand!'Study: Categories for analysis were taken from Framework for Evaluating Organizational-level Interventions. Interview data were combined with questionnaire and activity data, and multilevel analysis was undertaken to assess how changes in sitting time varied depending on the assessed factors. In addition, interview data were used to underpin results from the multilevel analysis.Results: Concurrent institutional changes were found to be a barrier for the intervention by ambassadors, while participants and managers did not find it to be an issue. Management support was consistently highlighted as very important. Participants evaluated ambassadors as being generally adequately active but also, that the role had a greater potential. The motivational and social aspects of the intervention were considered important for the effect. This was supported by regression analyses, which showed that a strong desire to change sitting time habits, strong motivation towards the project, and a high sense of collective engagement were associated to less sitting time at 3 months of about 30 min/8 h working day compared to participants with low scores. Influence from other participants (e.g. seeing others raise their tables) and the use of humour were continuously highlighted by participants as positive for implementation. Finally, the intervention was found to influence the social climate at the workplace positively.Conclusion: Individual motivation was related to the sitting time effect of 'Take a Stand!', but the organizational culture was relevant both to the implementation and effect within the office community. The organizational culture included among others to ensure general participation, to uphold management and peer-support, and maintain a positive environment during the intervention period.Trial Registration: ClinicalTrials.gov, NCT01996176 . Prospectively registered 21 November 2013. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial resistance (AMR) has reached alarming levels and is considered to be a worldwide public health problem. One of the most significant factors contributing to the spread of AMR is the lack of proper knowledge about the use of antibiotics, which are being used more frequently in dentistry. Recent studies have found that gamification shows promising results for helping the average person improve their knowledge about health and may also be used to boost knowledge about AMR among the public. This study aimed to assess the effects of gamification on AMR awareness, using a board game to promote knowledge about AMR among the public in Saudi Arabia.Methods: Using a single-blinded parallel group randomized controlled trial design, 94 volunteers were recruited and randomized into two groups. The study group received information about AMR by playing a board game, while the control group received the same information given in a conventional lecture. The participants were evaluated three times: (T1) before the intervention, (T2) immediately after the intervention, and (T3) one month after the intervention for follow-up to evaluate their retention of the information.Results: Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups. However, the knowledge scores also relapsed significantly from T2 to T3 in both groups. Nevertheless, the difference in knowledge score T1 to T3 was significantly higher in the study group in comparison to the control group, and the participants had higher mean scores to use the game as health promotion method.Conclusions: Gamification using a board game can significantly improve AMR knowledge, with better retention than conventional lecture. It is a promising method for boosting public knowledge about AMR and its relationship to dentistry.Trial Registration: ISRCTN registry: ISRCTN15884410 (retrospectively registered 26-October-2019). [ABSTRACT FROM AUTHOR]

Background: Second-hand smoke (SHS) in households remains a serious public health problem in Sri Lanka, partly due to a lack of voluntary prohibitions of tobacco smoking inside houses. Women are especially at risk of being exposed. Effective community based interventions to reduce the SHS in households targeting women is scarce. The objective of this study was to examine the impact of a multi-component intervention on household SHS exposure among Sri Lankan women.Methods: Thirty clusters of 25 women (aged 18-65) from 750 households were randomized into the intervention and control groups. Women in the intervention group were exposed to activities which focused on improving knowledge on the health effects of SHS, attitudes towards SHS exposure, right to a smoke-free living and women empowerment against smoking. The duration of the intervention was six months. The comparison group received no intervention. The primary outcome of interest was self-reported SHS exposure in the household within 7 days prior to data collection. The secondary outcomes were exposure in the past 30 days, knowledge of the health risks of exposure, attitudes towards exposure, right to smoke-free living, women empowerment against smoking, and smoking inside the homes.Results: Final assessment was in 329 (89.6%) in the intervention group and 309 (85.8%) in the comparison group. Following the intervention, significantly lower proportion of women in the intervention group as compared to the control group reported SHS exposure in their households within 7-days (9.2% vs. 15.3%, p = 0.02) and 30-days (13.6% vs. 21.6%, p = 0.008) prior to the post survey. As compared to the control group, significantly higher median scores were observed in the intervention group on the knowledge of the health risks of exposure to SHS (p < 0.001), attitudes on exposure to SHS (p = 0.004), right to smoke free living (p = 0.001) and women empowerment (p < 0.001).Conclusion: Multi-component intervention activities were effective in reducing household exposure to SHS among women.Trial Registration: Sri Lanka Clinical Trials Registry SLCTR/2014/033. [ABSTRACT FROM AUTHOR]

Background: It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP) is too close, as this may hinder the GP's objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient.Methods/design: The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians' and social insurance agencies' current management of long-term sick-listed patients. Individuals aged 18-65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the "common trend" assumption.Discussion: The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence.Trial Registration: ClinicalTrials.gov NCT02524392 . Registered June 23, 2015. [ABSTRACT FROM AUTHOR]

Background: As a major risk factor for cardiovascular and cerebrovascular disease (CVD), hypertension affects 33% of U.S. adults. Relative to other US races and ethnicities, Native Hawaiians have a high prevalence of hypertension and are 3 to 4 times more likely to have CVD. Effective, culturally-relevant interventions are needed to address CVD risk in this population. Investigators of the Kā-HOLO Project developed a study design to test the efficacy of an intervention that uses hula, a traditional Hawaiian dance, to increase physical activity and reduce CVD risk.Methods: A 2-arm randomized controlled trial with a wait-list control design will be implemented to test a 6-month intervention based on hula to manage blood pressure and reduce CVD risk in 250 adult Native Hawaiians with diagnosed hypertension. Half of the sample will be randomized to each arm, stratified across multiple study sites. Primary outcomes are reduction in systolic blood pressure and improvement in CVD risk as measured by the Framingham Risk Score. Other psychosocial and sociocultural measures will be included to determine mediators of intervention effects on primary outcomes. Assessments will be conducted at baseline, 3 months, and 6 months for all participants, and at 12 months for intervention participants only.Discussion: This trial will elucidate the efficacy of a novel hypertension management program designed to reduce CVD risk in an indigenous population by using a cultural dance form as its physical activity component. The results of this culturally-based intervention will have implications for other indigenous populations globally and will offer a sustainable, culturally-relevant means of addressing CVD disparities.Trial Registration: ClinicalTrials.gov: NCT02620709 , registration date November 23, 2015. [ABSTRACT FROM AUTHOR]

Background: Intimate partner violence (IPV) threatens the safety and health of women worldwide. Safety planning is a widely recommended, evidence-based intervention for women experiencing IPV, yet fewer than 1 in 5 Canadian women access safety planning through domestic violence services. Rural, Indigenous, racialized, and immigrant women, those who prioritize their privacy, and/or women who have partners other than men, face unique safety risks and access barriers. Online IPV interventions tailored to the unique features of women's lives, and to maximize choice and control, have potential to reduce access barriers, and improve fit and inclusiveness, maximizing effectiveness of these interventions for diverse groups.Methods/design: In this double blind randomized controlled trial, 450 Canadian women who have experienced IPV in the previous 6 months will be randomized to either a tailored, interactive online safety and health intervention (iCAN Plan 4 Safety) or general online safety information (usual care). iCAN engages women in activities designed to increase their awareness of safety risks, reflect on their plans for their relationships and priorities, and create a personalize action plan of strategies and resources for addressing their safety and health concerns. Self-reported outcome measures will be collected at baseline and 3, 6, and 12 months post-baseline. Primary outcomes are depressive symptoms (Center for Epidemiological Studies Depression Scale, Revised) and PTSD Symptoms (PTSD Checklist, Civilian Version). Secondary outcomes include helpful safety actions, safety planning self-efficacy, mastery, and decisional conflict. In-depth qualitative interviews with approximately 60 women who have completed the trial and website utilization data will be used to explore women's engagement with the intervention and processes of change.Discussion: This trial will contribute timely evidence about the effectiveness of online safety and health interventions appropriate for diverse life contexts. If effective, iCAN could be readily adopted by health and social services and/or accessed by women to work through options independently. This study will produce contextualized knowledge about how women engage with the intervention; its strengths and weaknesses; whether specific groups benefit more than others; and the processes explaining any positive outcomes. Such information is critical for effective scale up of any complex intervention.Trial Registration: Clinicaltrials.gov ID NCT02258841 (Registered on Oct 2, 2014). [ABSTRACT FROM AUTHOR]

Background: Addressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations.Methods/design: This trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the "Ask, Advise, Refer (AAR)" best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1) The multimodal behavioral intervention (MBI) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling, mobile app, and multimedia text messages about improving nutrition. The control condition also receives a referral to the state smoking cessation quitline.Discussion: This study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines.Trial Registration: Clinicaltrials.gov NCT02602288 . Registered 9 November 2015. [ABSTRACT FROM AUTHOR]

Background: Cigarette smoking is one of the major preventable causes of death and diseases in Qatar. The study objective was to test the effect of a structured smoking cessation program delivered by trained pharmacists on smoking cessation rates in Qatar.Methods: A prospective randomized controlled trial was conducted in eight ambulatory pharmacies in Qatar. Eligible participants were smokers 18 years and older who smoked one or more cigarettes daily for 7 days, were motivated to quit, able to communicate in Arabic or English, and attend the program sessions. Intervention group participants met with the pharmacists four times at 2 to 4 week intervals. Participants in the control group received unstructured brief smoking cessation counseling. The primary study outcome was self-reported continuous abstinence at 12 months. Analysis was made utilizing data from only those who responded and also using intent-to-treat principle. A multinomial logistic regression model was fitted to assess the predictors of smoking at 12 months. Analysis was conducted using IBM-SPSS® version 23 and STATA® version 12.Results: A total of 314 smokers were randomized into two groups: intervention (n = 167) and control (n = 147). Smoking cessation rates were higher in the intervention group at 12 months; however this difference was not statistically significant (23.9% vs. 16.9% p = 0.257). Similar results were observed but with smaller differences in the intent to treat analysis (12.6% vs. 9.5%, p = 0.391). Nevertheless, the daily number of cigarettes smoked for those who relapsed was significantly lower (by 4.7 and 5.6 cigarettes at 3 and 6 months respectively) in the intervention group as compared to the control group (p = 0.041 and p = 0.018 respectively). At 12 months, the difference was 3.2 cigarettes in favor of the intervention group but was not statistically significant (p = 0.246). Years of smoking and daily number of cigarettes were the only predictors of smoking as opposed to quitting at 12 months (p = 0.005; p = 0.027 respectively).Conclusions: There was no statistically significant difference in the smoking cessation rate at 12 months between the groups. However, the smoking cessation program led to higher (albeit non-significant) smoking cessation rates compared with usual care. More research should be conducted to identify factors that might improve abstinence.Trial Registration: Clinical Trials NCT02123329 . Registration date 20 April 2014. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are associated with high costs for productivity loss, sickness absence and unemployment. A participatory supportive return to work (RTW) program was developed in order to improve RTW among workers without an employment contract, sick-listed due to a common mental disorder. The program contained a participatory approach, integrated care and direct placement in a competitive job. The aim of this study was to evaluate the cost-effectiveness and cost-utility of this new program, compared to usual care. In addition, its return on investment was evaluated.Methods: An economic evaluation was conducted alongside a 12-month randomized controlled trial. A total of 186 participants was randomly allocated to the new program (n = 94) or to usual care (n = 92). Effect measures were the duration until sustainable RTW in competitive employment and quality-adjusted life years (QALYs) gained. Costs included intervention costs, medical costs and absenteeism costs. Registered data of the Dutch Social Security Agency were used to assess the duration until sustainable RTW, intervention costs and absenteeism costs. QALYs and medical costs were assessed using three- or six-monthly questionnaires. Missing data were imputed using multiple imputations. Cost-effectiveness analysis and cost-utility analysis were conducted from the societal perspective. A return on investment analysis was conducted from the social insurer's perspective. Various sensitivity analyses were performed to assess the robustness of the results.Results: The new program had no significant effect on the duration until sustainable RTW and QALYs gained. Intervention costs and medical costs were significantly higher in the intervention group. From the societal perspective, the maximum probability of cost-effectiveness for duration until sustainable RTW was 0.64 at a willingness to pay of about €10 000/day, and 0.27 for QALYs gained, regardless of the willingness to pay. From the social insurer's perspective, the probability of financial return was 0.18.Conclusions: From the societal perspective, the new program was neither cost-effective in improving sustainable RTW nor in gaining QALYs. From the social insurer's perspective, the program did not result in a positive financial return. Therefore, the present study provided no evidence to support its implementation.Trial Registration: The trial was listed at the Dutch Trial Register (NTR) under NTR3563 on August 7, 2012. [ABSTRACT FROM AUTHOR]

Background: The worksite cafeteria is a suitable setting for interventions focusing on changing eating behavior, because a lot of employees visit the worksite cafeteria regularly and a variety of interventions could be implemented there. The aim of this paper is to describe the intervention development and design of the evaluation of an intervention to make the purchase behavior of employees in the worksite cafeteria healthier. The developed intervention called "the worksite cafeteria 2.0" consists of a set of 19 strategies based on theory of nudging and social marketing (marketing mix). The intervention will be evaluated in a real-life setting, that is Dutch worksite cafeterias of different companies and with a number of contract catering organizations.Methods/design: The study is a randomized controlled trial (RCT), with 34 Dutch worksite cafeterias randomly allocated to the 12-week intervention or to the control group. Primary outcomes are sales data of selected products groups like sandwiches, salads, snacks and bread topping. Secondary outcomes are satisfaction of employees with the cafeteria and vitality.Discussion: When executed, the described RCT will provide better knowledge in the effect of the intervention "the worksite cafeteria 2.0" on the purchasing behavior of Dutch employees in worksite cafeterias.Trial Registration: Dutch Trial register: NTR5372 . [ABSTRACT FROM AUTHOR]

Background: The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition.Methods: In this cluster randomized trial, participants aged 30-80 diagnosed with type 2 diabetes were recruited from ten Brazilian public health units in 2014 and 2015. Five units were randomly assigned to receive the empowerment program based on a behavior change protocol, and five continued to receive only conventional treatment. The primary outcome was the biochemical and anthropometric parameters, and the secondary outcomes were self-care, attitude, knowledge and empowerment related to diabetes. The effect of the experiment was defined as the percentage variation between the values at the initial and final periods. To evaluate this effect and to compare it in the two groups, tests were used for paired and independent samples, respectively.Results: There were 238 participants: 127 and 111 in the intervention and control group, respectively. For glycated hemoglobin, the mean effect in the control and intervention groups was 3.93 and -5.13, respectively (p < 0.001). Levels of glycated hemoglobin and other metabolic indicators, as well as the most part of the secondary outcomes showed a significant difference in the experimental group compared to the control group.Conclusions: The empowerment program improved metabolic control of type 2 diabetes in Brazilian users.Trial Registration: NCT02132338 - April 22, 2014. [ABSTRACT FROM AUTHOR]

Background: Unintentional injuries to children are a major public health problem. The online social media is a potential way to implement health education for caregivers in online communities. Using WeChat, a free and popular social media service in China, this study evaluated the effectiveness of social online community-based parental health education in preventing unintentional injuries in children aged 0-3.Methods: We recruited 365 parents from two community health centers in Shanghai and allocated them into intervention and control groups randomly. Follow-up lasted for one year. The intervention group received and followed their WeChat group and a WeChat official account for dissemination of reliable medical information. The control group received only the WeChat group.Results: Between the intervention and control groups, changes in unintentional injuries (OR = 1.71, 95% CI: 1.02-2.87, P = .04), preventability (β = 0.344, 95% CI: 0.152-0.537, P < .001), daily supervision behavior (β = 0.503, 95% CI: 0.036-0.970, P = .04), and behaviors for preventing specific injuries (β = 2.198, 95% CI: 1.530-2.865, P < .001) were significantly different, and change in first-aid skills for treating a tracheal foreign body were nearly significant (P = .06).Conclusions: The WeChat-group-based parental health education can reduce the occurrence of unintentional child injuries by improving parents' skills, beliefs, and behaviors. Online social communities promote health education and reduce unintentional injuries among children.Trial Registration: ChiCTR1900020753. Registered on January 17, 2019. [ABSTRACT FROM AUTHOR]

Background: Coordinated, multi-component school-based interventions can improve health behaviors in children, as well as parents, and impact the weight status of students. By leveraging a unique collaboration between Texas AgriLife Extension (a federal, state and county funded educational outreach organization) and the University of Texas School of Public Health, the Texas Grow! Eat! Go! Study (TGEG) modeled the effectiveness of utilizing existing programs and volunteer infrastructure to disseminate an enhanced Coordinated School Health program. The five-year TGEG study was developed to assess the independent and combined impact of gardening, nutrition and physical activity intervention(s) on the prevalence of healthy eating, physical activity and weight status among low-income elementary students. The purpose of this paper is to report on study design, baseline characteristics, intervention approaches, data collection and baseline data.Methods: The study design for the TGEG study consisted of a factorial group randomized controlled trial (RCT) in which 28 schools were randomly assigned to one of 4 treatment groups: (1) Coordinated Approach to Child Health (CATCH) only (Comparison), (2) CATCH plus school garden intervention [Learn, Grow, Eat & Go! (LGEG)], (3) CATCH plus physical activity intervention [Walk Across Texas (WAT)], and (4) CATCH plus LGEG plus WAT (Combined). The outcome variables include student's weight status, vegetable and sugar sweetened beverage consumption, physical activity, and sedentary behavior. Parents were assessed for home environmental variables including availability of certain foods, social support of student health behaviors, parent engagement and behavior modeling.Results: Descriptive data are presented for students (n = 1369) and parents (n = 1206) at baseline. The sample consisted primarily of Hispanic and African American (53 % and 18 %, respectively) and low-income (i.e., 78 % eligible for Free and Reduced Price School Meals program and 43 % food insecure) students. On average, students did not meet national guidelines for vegetable consumption or physical activity. At baseline, no statistical differences for demographic or key outcome variables among the 4 treatment groups were observed.Conclusions: The TGEG study targets a population of students and parents at high risk of obesity and related chronic conditions, utilizing a novel and collaborative approach to program formulation and delivery, and a rigorous, randomized study design. [ABSTRACT FROM AUTHOR]

Background: The aims of this report were 1) to describe the duration of moderate to vigorous physical activity (MVPA) and the proportion of participants meeting the recommended criterion of at least 150 min of MVPA per week as measured by the 7 Day Physical Activity Recall Questionnaire (7D-PAR) and accelerometer among women who were enrolled in the mPED trial; 2) to assess the level of agreement of the two measures using a Bland-Altman plot; and 3) to describe the positive and negative predictive values (PPV and NPV, respectively) of meeting the guidelines by calculating the percentage of women meeting the physical activity recommendation by the 7D-PAR who also met this recommendation based on data from the accelerometer.Methods: Baseline data on duration of MVPA from the mPED trial were analyzed for 215 women. Among the women who met the recommended criterion by the 7D-PAR (self-report), we calculated the proportion of individuals who also met it by the accelerometer (objective measure). A Bland Altman Plot was used to assess concordance between the two measures.Results: The mean age was 52.4 (±11.2) years; 54.4 % were white; and 48.8 % were single or divorced. While median MVPA was 160 min/week by the 7D-PAR, it was only 24 min/week in the accelerometer. A total of 117 women met the 150-min criterion by the 7D-PAR. Of these, only 18 also met the criterion by the objective measure (PPV 15.4 %, 95 % CI 9.4-23.2 %). Among the 98 women who did not meet the criterion by the 7D-PAR, none met it by the accelerometer (NPV 100 %). A Bland Altman plot showed the mean difference of +145 min between the two measures with a 95 % limit of agreement at + 471 to -181 min.Conclusions: The large discrepancy between the self-reported and objective measures of MVPA meeting the 150-min criterion suggests that self-reported physical activity measures should be used with caution in intervention studies. While our data suggest that self-report could be used to identify a physically inactive sample, it would be likely to over-estimate the proportions of women who become active in one or both arms of trials of interventions promoting MVPA.Trial Registration: ClinicalTrials.gov NCT01280812. [ABSTRACT FROM AUTHOR]

Background: After-school programs represent a promising opportunity to assist adolescent girls' in attaining adequate physical activity. Although evaluating the process of intervention implementation is important for determining if an intervention was delivered and received as intended, comprehensive information about process evaluation methods and results are rarely reported. The purpose of this article was to evaluate the reach, dose, and fidelity of a 90-minute after-school physical activity club offered 3 days a week. The club is 1 of 3 components included in a 17-week intervention designed for 5th-8th grade girls, the majority of whom were of minority and/or low socioeconomic status.Methods: A total of 24 schools (12 intervention; 12 control) and 56-67 girls per school (total N = 1519 girls) were included in the Girls on the Move group randomized controlled trial. At the beginning of each of 3 academic years (2012-2015), 8 schools per year were randomized to receive either the intervention (n = 4) or control condition (n = 4). To evaluate the club, data collected via surveys from girls, club coaches and managers, and process evaluators were analyzed. To evaluate the opportunity for physical activity provided by the coaches and managers, process evaluators used an observation tool based on the System for Observing Fitness Instruction Time and Academic Learning Time - Physical Education. Girls wore accelerometers every other week during the club time.Results: Mean attendance was 41 % with the average attendance in year 3 being higher than rates for years 1 or 2. Mean moderate-to-vigorous physical activity time was 21.85 minutes measured via accelerometry and 21.81 minutes observed by process evaluators. Satisfaction with the intervention was high. For the most part, process evaluators perceived the club was delivered as planned and reflected constructs of the Health Promotion Model and Self-Determination Theory. Areas contributing to success included using incentives and offering a variety of activities. Issues negatively impacting implementation included managing behavioral problems, having limited space for moderate-to-vigorous physical activity, dealing with inclement weather, and getting coaches to actively participate in all physical activities with the girls.Conclusions: This process evaluation provides important information to guide future school-based physical activity intervention delivery. Barriers to implementation have been identified. Ways to overcome them warrant consideration when designing physical activity interventions. Research is needed to test innovative approaches for enhancing attendance and increasing girls' moderate-to-vigorous physical activity in after-school programs.Trial Registration: ClinicalTrials.gov Identifier NCT01503333 . Registered 23 December, 2011. [ABSTRACT FROM AUTHOR]

Background: Comorbidity between problem gambling and depression or anxiety is common. Further, the treatment needs of people with co-occurring gambling and mental health symptoms may be different from those of problem gamblers who do not have a co-occurring mental health concern. The current randomized controlled trial (RCT) will evaluate whether there is a benefit to providing access to mental health Internet interventions (G + MH intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring mental health symptoms.Methods: Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing (N = 280) to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (G-only) versus a website that contains interventions for depression and anxiety in addition to an intervention for gamblers (G + MH). It is predicted that problem gamblers who do not have co-occurring mental health symptoms will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health symptoms, it is predicted that participants receiving access to the G + MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website.Discussion: The trial will produce information on the best means of providing online help to gamblers with and without co-occurring mental health symptoms.Trial Registration: ClinicalTrials.gov NCT02800096 ; Registration date: June 14, 2016. [ABSTRACT FROM AUTHOR]

Background: Families with children under age six participating in the Temporary Assistance for Needy Families Program (TANF) must participate in work-related activities for 20 h per week. However, due to financial hardship, poor health, and exposure to violence and adversity, families may experience great difficulty in reaching self-sufficiency. The purpose of this report is to describe study design and baseline findings of a trauma-informed financial empowerment and peer support intervention meant to mitigate these hardships.Methods: We conducted a randomized controlled trial of a 28-week intervention called Building Wealth and Health Network to improve financial security and maternal and child health among caregivers participating in TANF. Participants, recruited from County Assistance offices in Philadelphia, PA, were randomized into two intervention groups (partial and full) and one control group. Participants completed questionnaires at baseline to assess career readiness, economic hardship, health and wellbeing, exposure to adversity and violence, and interaction with criminal justice systems.Results: Baseline characteristics demonstrate that among 103 participants, there were no significant differences by group. Mean age of participants was 25 years, and youngest child was 30 months. The majority of participants were women (94.2 %), never married (83.5 %), unemployed (94.2 %), and without a bank account (66.0 %). Many reported economic hardship (32.0 % very low household food secure, 65.0 % housing insecure, and 31.1 % severe energy insecure), and depression (57.3 %). Exposure to adversity was prevalent, where 38.8 % reported four or more Adverse Childhood Experiences including abuse, neglect and household dysfunction. In terms of community violence, 64.7 % saw a seriously wounded person after an incident of violence, and 27.2 % had seen someone killed. Finally, 14.6 % spent time in an adult correctional institution, and 48.5 % of the fathers of the youngest child spent time in prison.Conclusions: Baseline findings demonstrate that caregivers participating in TANF have suffered significant childhood adversity, adult violence exposure, and poverty-related stressors that can limit workforce success. High prevalence of housing and food insecurity, exposure to adversity, violence and criminal justice systems demands comprehensive programming to support families. Trauma-informed approaches to career readiness such as the Building Wealth and Health Network offer opportunities for potential success in the workforce.Trial Registration: This study is retrospectively registered with ClinicalTrials.gov. The Identifier is: NCT02577705 The Registration date is October 13, 2015. [ABSTRACT FROM AUTHOR]

Background: Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE) in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits.Methods/design: The SEED-trial is a randomized controlled trial (RCT) comparing traditional vocational rehabilitation (TVR) to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted.Discussion: The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age.Trial Registration: Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014. [ABSTRACT FROM AUTHOR]

Background: Most smokers do not use smoking cessation (SC) services although it increases successful quits. Passive referral providing SC information to smokers is commonly used in SC studies. Little was known about active referral in the community setting. This study aims to motivate community smokers to quit by brief SC advice using a validated AWARD model (Ask, Warn, Advise, Refer and Do-it-again) that adjunct with active referral of smokers to various SC services in Hong Kong.Methods/design: This is a single-blinded, parallel three-armed cluster randomized controlled trial (RCT) with two treatment groups of (1) brief SC advice using the AWARD model, active referral to SC services plus a referral card and a health warning leaflet (active referral group) and (2) brief SC advice using AWARD model and health warning leaflet (brief advice group) and a control group receives general very brief advice with a self-help booklet. A total of 1291 smokers will be recruited from 66 clusters (recruitment sessions) with 22 will be allocated to each of the two intervention and one control groups. SC ambassadors will be trained for delivering the interventions and conducting telephone follow-up. The primary outcomes are self-reported 7-days point prevalence (PP) abstinence at 3 and 6 months follow-up. Intention-to-treat principle and multi-level regressions will be used for data analysis.Discussion: This is the first RCT on assessing a model combining brief advice and active referral to SC services among community smokers. The results will inform the practices of SC services and intervention studies.Trial Registration: NCT02539875 (ClinicalTrials.gov registry; registered retrospectively on 22 July 2015). [ABSTRACT FROM AUTHOR]

Background: Violence against adolescent girls in humanitarian settings is of urgent concern given their additional vulnerabilities to violence and unique health and well-being needs that have largely been overlooked by the humanitarian community. In order to understand what works to prevent violence against adolescent girls, a multi-component curriculum-based safe spaces program (Creating Opportunities through Mentorship, Parental involvement and Safe Spaces - COMPASS) will be implemented and evaluated. The objectives of this multi-country study are to understand the feasibility, acceptability and effectiveness of COMPASS programming to prevent violence against adolescent girls in diverse humanitarian settings.Methods/design: Two wait-listed cluster-randomized controlled trials are being implemented in conflict-affected communities in eastern Democratic Republic of Congo (N = 886 girls aged 10-14 years) and in refugee camps in western Ethiopia (N = 919 girls aged 13-19 years). The intervention consists of structured facilitated sessions delivered in safe spaces by young female mentors, caregiver discussion groups, capacity-building activities with service providers, and community engagement. In Ethiopia, the research centers on the overall impact of COMPASS compared to a wait-list group. In DRC, the research objective is to understand the incremental effectiveness of the caregiver component in addition to the other COMPASS activities as compared to a wait-list group. The primary outcome is change in sexual violence. Secondary outcomes include decreased physical and emotional abuse, reduced early marriage, improved gender norms, and positive interpersonal relationships, among others. Qualitative methodologies seek to understand girls' perceptions of safety within their communities, key challenges they face, and to identify potential pathways of change.Discussion: These trials will add much needed evidence for the humanitarian community to meet the unique needs of adolescent girls and to promote their safety and well-being, as well as contributing to how multi-component empowerment programming for adolescent girls could be adapted across humanitarian settings.Trial Registration: Clinical Trials NCT02384642 (Registered: 2/24/15) & NCT02506543 (Registered: 7/19/15). [ABSTRACT FROM AUTHOR]

Background: Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored.Methods/design: The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group.Discussion: This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course.Trial Registration: ACTRN12611000386932. Registered 13 April 2011. [ABSTRACT FROM AUTHOR]

Background: The aim of the current study is to evaluate the efficacy of an exercise intervention to reduce work-related fatigue. Exercise is a potentially effective intervention strategy to reduce work-related fatigue, since it may enhance employees' ability to cope with work stress and it helps to detach from work. However, based on available research, no clear causal inferences regarding its efficacy can be made. This RCT therefore investigates whether exercise is effective in reducing work-related fatigue, and in improving other indicators of employees' mental and physical well-being and performance.Methods/design: A two-arm parallel trial will be conducted. Participants (N = 108) who experience high levels of work-related fatigue will be randomized at a 1:1 ratio to a 6-week exercise intervention or wait list (control). The exercise intervention consists of three one-hour low-intensity outdoor running sessions a week. Each week, two sessions take place in a group under supervision of a trainer, and one session is completed individually. The running sessions will be carried out during leisure time. The primary outcome is work-related fatigue. Secondary outcomes include work ability, self-efficacy, sleep quality, cognitive functioning, and aerobic fitness. These data will be collected at pre-intervention, post-intervention, and at 6 weeks and 12 weeks after the intervention. In addition, weekly measures of employees' well-being, and exercise activities (i.e. type, frequency, and duration) and experiences (i.e. pleasure, effort, and detachment) will be collected during the intervention period.Discussion: This study will compare an exercise intervention to a wait list. This enables us to examine the effect of exercise on work-related fatigue compared to the natural course of these symptoms. As such, this study contributes to a better understanding of the causal link between exercise and work-related fatigue. If the intervention is proven effective, the results could provide a basis for future 'effectiveness' trials in which the (implementation of the) intervention can be investigated among a broader defined population in a less standardized way, eventually leading to better evidence-based policies and practices to employees, employers, health practitioners, and policy makers concerning the effect of exercise on work-related fatigue.Trial Registration: NTR5034. Registered 10 March 2015. [ABSTRACT FROM AUTHOR]

Background: Farm and rural youth have frequent exposure to hazardous noise on the farm and recreationally, and have an increased prevalence of noise-induced hearing loss. There is a lack of programs to prepare this high-risk population to use hearing conservation strategies.Methods: The purpose of this project is to test innovative hearing health education programs delivered to a large target group and to determine the effectiveness and sustainability of these programs in promoting hearing health among farm and rural youth. Specifically, this project includes: a) an interactive face-to-face informational program alone, b) an interactive face-to-face informational program followed by an Internet-based booster, and c) a no-intervention control. Sites will include selected affiliates of a major farm youth safety education organization. Data will be collected at baseline, 3, and 12 months. A linear mixed model will be used to compare the effectiveness of the three interventions over time. Descriptive statistics will be used to compare program costs and sustainability ratings.Discussion: Outcomes of this project will provide knowledge necessary to implement quality and cost-effective services to farm and rural youth, a high-risk and underserved population, that can be implemented and sustained after the study is completed.Trial Registration: Clinicaltrials.gov NCT02472821 Registered 09 Jun, 2015. [ABSTRACT FROM AUTHOR]

Background: Problematic alcohol consumption is associated with a high disease burden for affected individuals and has a detrimental impact on companies and society due to direct and indirect health costs. This protocol describes a study design to evaluate the (cost)-effectiveness of a guided and unguided Internet-based self-help intervention for employees called "GET.ON Clever weniger trinken" (be smart - drink less) compared to a waiting list control group.Methods: In a three-arm randomized controlled trial, 528 German adults who are currently members of the workforce will be recruited by occupational health departments of major health insurance companies. Employees aged 18 and older displaying problematic drinking patterns (>21/14 drinks per week and an AUDIT score > 8/6 for men/women) will be randomly assigned to one of three following study conditions: 1. unguided web-based self-help for problematic drinking, 2. adherence-focused guided self-help, and 3. waiting list control. Self-report data will be collected at baseline (T1), 6 weeks (T2), and 6 months (T3) after randomization. The primary outcome will be the reduction of alcohol standard units during the 7 days prior to T2, using the Timeline Followback method. Cost-effectiveness analyses to determine direct and indirect costs will be conducted from the perspectives of employers and the society. Data will be analyzed on an intention-to-treat basis and per protocol.Discussion: There is a need to identify effective low-threshold solutions to improve ill-health and reduce the negative economic consequences due to problematic alcohol drinking in workforces. If the proposed web-based intervention proves both to be efficacious and cost-effective, it may be a useful tool to increase utilization rates of interventions for problematic drinking in occupational settings.Trial Registration: German Register of Clinical Studies (DRKS): DRKS00006105 , date of registration: 2014-07-07. [ABSTRACT FROM AUTHOR]

Background: After the first six months of exclusive breastfeeding, children are introduced to liquids and semi-solid food, known as the complementary feeding phase. This phase is critical because it is often accompanied by improper feeding in children, which may lead to wasting and other nutrition problems. Fortified biscuits have been provided for wasting children as a nationwide programme. However, the ability of children to accept food supplementation remains questionable. This paper describes the protocol of a study investigating the efficacy of food supplementation (PMT biscuit) and nutrition education to improve the nutritional status of wasting children in Indonesia.Method: The efficacy of a government food supplementation programme will be examined using a randomized control trial design. Parents with wasting children aged 6-17 months will be recruited to participate in the study. After obtaining informed consent and pre-intervention measures, participants will be assigned into three arms of intervention with PMT biscuits and/or nutrition education only. The two primary outcomes for this study are the nutritional status of wasting children and PMT biscuit compliance. Characteristics of all subjects in each arm will be analysed and compared with each other to assess their comparability at the beginning. The data will be collected at pre-intervention, at 3 months of intervention, post-intervention, and at the 6- to 9-month follow up.Discussion: This paper aims to describe the study protocol of a randomized controlled trial investigating the effects of different PMT biscuit portion and nutrition education in two arms and nutrition education only in another arm. This study is important because it will provide evidence for the Indonesian government regarding the efficacy of food supplementation and/or food-based recommendations to improve the nutritional status of wasting children aged 6-23 months in Indonesia.Trial Registration: The study has been registered at clinicaltrials.gov, maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), on April 26, 2018, and was last updated on April 30, 2018 (registration number: NCT03509155 ). [ABSTRACT FROM AUTHOR]