Search

Background: Human papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently approved HPV vaccine, Gardasil-9, protects against HPV infection and can prevent HPV-associated invasive cancers. However, Gardasil-9 is one of the most underused vaccines in the US today. Young adults are at risk for HPV infection, but many are not vaccinated. This study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. In this paper, we describe the research protocol. Methods: The study uses a two by three factorial design. A total of 1200 young adults in Texas, age 18–26 years, who have not been previously fully vaccinated against HPV will be randomly assigned to one of six conditions to receive: (1) standard CDC information about HPV vaccination (control); (2) video narratives about HPV vaccination; (3) written narratives about HPV vaccination; or (4–6) enhanced access to HPV vaccine combined with (4) standard CDC information, (5) video narratives, or (6) written narratives. The two primary outcomes are the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-ups. We will determine the impact of the individual level intervention (i.e., persuasive narratives through video or written format), the systemic level intervention (i.e., enhanced access to HPV vaccines), and the combination of both levels, on HPV vaccination initiation and completion. We will also use purposive sampling to select participants to take part in semi-structured interviews/focus groups to better understand the mechanisms of the intervention. Discussion: Recruitment and data collection began in March 2022. We expect to complete data collection by March 2026. We expect that narratives, enhanced access, and the combination of both will improve HPV vaccination initiation and completion rates among young adults. If proven successful, these individual- and system-level interventions can be easily disseminated in regions with low HPV vaccination rates to improve HPV vaccination, and ultimately decrease HPV-related cancer burden. Trial Registration: NCT05057312. [ABSTRACT FROM AUTHOR]

Introduction: We assessed the impact of a personal agency-based training for refugee women and their male partners on their economic and social empowerment, rates of intimate partner violence (IPV), and non-partner violence (NPV). Methods: We conducted an individually randomized controlled trial with 1061 partnered women (aged 18–45) living in a refugee camp in Rwanda. Women received two days of training, and their partners received one day of training. The follow-up survey where all relevant outcomes were assessed was carried out at 6–9 months post-intervention. Results: At follow up, women in the intervention arm were more likely to report partaking in income generating activities (aIRR 1.27 (1.04–1.54), p < 0.05) and skill learning (aIRR 1.59 (1.39–1.82), p < 0.001) and reported a reduction in experience of physical or sexual NPV in the past six months (aIRR 0.65 (0.39–1.07), p < 0.09). While improved, no statistically significant impacts were seen on physical or sexual IPV (aIRR 0.80 (0.58–1.09), p = 0.16), food insecurity (β 0.98 (0.93 to 1.03), p = 0.396), or clean cookstove uptake (aIRR 0.95 (0.88 to 1.01), p = 0.113) in the past six months. We found statistically significant reduction in physical and sexual IPV amongst those experiencing IPV at baseline (aIRR 0.72 (0.50 to 1.02), p < 0.07). Small improvements in self-efficacy scores and our indicator of adapting to stress were seen in the intervention arm. Some challenges were also seen, such as higher prevalence of probable depression and/or anxiety (aIRR 1.79 (1.00-3.22), p = 0.05) and PTSD (aIRR 2.07 (1.10–3.91), p < 0.05) in the intervention arm compared to the control arm. Conclusion: Our findings echo previous research showing personal agency training can support economic well-being of women. We also find potentially promising impacts on gender-based violence. However, there is some evidence that integration of evidence-based mental health support is important when enhancing agency amongst conflict-affected populations. Trial registration number: The trial was registered with ClinicalTrials.gov, Identifier: NCT04081441 on 09/09/2019. Key message: What is known? • There are limited impacts of economic interventions in humanitarian settings on gender-based violence. • Outside of humanitarian settings, agency-based training interventions, both with/or without male partner engagement, have been shown to improve economic impacts, however IPV impacts are not known. • Integrated multi-component interventions that economically empower women and engage male partners hold promise in conflict-affected populations. What are the new findings? • An abbreviated two-day personal agency training for women and one-day training for their male partners led to significant increases in uptake of income generating activities and skill building for women. • Promising trends suggest reduction in non-partner violence for the full study sample and a reduction in intimate partner violence for women who reported IPV at baseline. • Increased rates of probable anxiety and/or depression and post-traumatic stress disorder (PTSD) were identified in the intervention group. What do the new findings imply? • Promising impacts on livelihoods and experience of violence are possible despite the abbreviated nature of this training. • Despite improvements in livelihoods and reduction in experience of violence, more concerted efforts are needed to prevent the increased risk of anxiety, depression, and PTSD found in conflict-affected populations. [ABSTRACT FROM AUTHOR]

Background: The objective of the present study was to examine the short-term effectiveness of the national German quitline for smoking cessation. Methods: A parallel-group, two-arm, superiority, randomized controlled trial with data collection at baseline and post-intervention (three months from baseline) was conducted. Individuals were randomized to either the intervention group, receiving up to six telephone counselling calls, or the control group, receiving an active control intervention (self-help brochure). The primary outcome was the seven-day point prevalence abstinence at post-assessment. Secondary outcomes included changes in smoking-related cognitions and coping strategies from pre- to post-assessment, the perceived effectiveness of intervention components, and the satisfaction with the intervention. Results: A total of n = 905 adult daily smokers were assigned to either the intervention group (n = 477) or the control group (n = 428). Intention-to-treat analyses demonstrated that individuals allocated to the telephone counselling condition were more likely to achieve seven-day point prevalence abstinence at post-assessment compared to those allocated to the self-help brochure condition (41.1% vs. 23.1%; OR = 2.3, 95% CI [1.7, 3.1]). Participants who received the allocated intervention in both study groups displayed significant improvements in smoking-related cognitions and coping strategies with the intervention group showing greater enhancements than the control group. This pattern was also found regarding the perceived effectiveness of intervention components and the satisfaction with the intervention. Conclusion: The present study provides first empirical evidence on the short-term effectiveness of the national German quitline for smoking cessation, highlighting its potential as an effective public health intervention to reduce the burden of disease associated with smoking. Trial registration: This study is registered in the German Clinical Trials Register (DRKS00025343). Date of registration: 2021/06/07. [ABSTRACT FROM AUTHOR]

Background: The objective of the present study was to examine the short-term effectiveness of the national German quitline for smoking cessation. Methods: A parallel-group, two-arm, superiority, randomized controlled trial with data collection at baseline and post-intervention (three months from baseline) was conducted. Individuals were randomized to either the intervention group, receiving up to six telephone counselling calls, or the control group, receiving an active control intervention (self-help brochure). The primary outcome was the seven-day point prevalence abstinence at post-assessment. Secondary outcomes included changes in smoking-related cognitions and coping strategies from pre- to post-assessment, the perceived effectiveness of intervention components, and the satisfaction with the intervention. Results: A total of n = 905 adult daily smokers were assigned to either the intervention group (n = 477) or the control group (n = 428). Intention-to-treat analyses demonstrated that individuals allocated to the telephone counselling condition were more likely to achieve seven-day point prevalence abstinence at post-assessment compared to those allocated to the self-help brochure condition (41.1% vs. 23.1%; OR = 2.3, 95% CI [1.7, 3.1]). Participants who received the allocated intervention in both study groups displayed significant improvements in smoking-related cognitions and coping strategies with the intervention group showing greater enhancements than the control group. This pattern was also found regarding the perceived effectiveness of intervention components and the satisfaction with the intervention. Conclusion: The present study provides first empirical evidence on the short-term effectiveness of the national German quitline for smoking cessation, highlighting its potential as an effective public health intervention to reduce the burden of disease associated with smoking. Trial registration: This study is registered in the German Clinical Trials Register (DRKS00025343). Date of registration: 2021/06/07. [ABSTRACT FROM AUTHOR]

Background and aims: Tobacco use has posed a tremendous public health problem for China. The Chinese government has taken great efforts to curb the tobacco epidemic. However, the existing smoking cessation services available in China are underused and have some limitations. Our research team intends to develop a smartphone smoking cessation application (SSC APP) and integrate it with the existing smoking cessation services. This study aims to assess the efficacy of the SSC APP developed by our research team through a randomized controlled trial (RCT). Methods: Current smokers who are motivated to quit within 1 month (n = 1000) will be recruited both online and offline, and all potential participants will register and complete the prescreening assessment online. Participants will be randomly assigned to either the intervention group (receiving the SSC APP and a self-help smoking cessation manual) or the control group (receiving a self-help smoking cessation manual only) using a block randomization method. This study will be a two-arm, single-blind, parallel-group RCT. Participants will be followed up after enrollment through online questionnaires or by phone call. The primary outcome is self-reported 6-month continuous abstinence. The main secondary outcomes include self-reported 7-day point-prevalence abstinence at each follow-up; self-reported 3-month continuous abstinence; reduction in the number of cigarettes smoked per day; and the number of recent quit attempts. Discussion: If this SSC APP proves to be effective, it could be integrated with the existing smoking cessation services and further facilitate smoking cessation at the population level in China. Trial registration: Chinese Clinical Trial Registry: ChiCTR2200062097, Registered July 22, 2022. [ABSTRACT FROM AUTHOR]

Background: Domestic violence (DV) prior to, and during pregnancy is associated with increased risks for morbidity and mortality. As pregnant women routinely attend antenatal care this environment can be used to offer support to women experiencing DV. We have developed a video intervention that focuses on the use of behavioral coping strategies, particularly regarding disclosure of DV experiences. The effectiveness of this intervention will be evaluated through a randomized controlled trial (RCT) and a concurrent process evaluation. Methods: All pregnant women between 12–22 weeks of gestation attending routine antenatal care at two tertiary level hospitals in Nepal are invited to participate. DV is measured using the Nepalese version of the Abuse Assessment Screen (N-AAS). Additionally, we measure participants' mental health, use of coping strategies, physical activity, and food security through a Color-coded Audio Computer Assisted Self Interview (C-ACASI). Irrespective of DV status, women are randomized into the intervention or control arm using a computer-generated randomization program. The intervention arm views a short video providing information on DV, safety improving actions women can take with an emphasis on disclosing the violence to a trusted person along with utilizing helplines available in Nepal. The control group watches a video on maintaining a healthy pregnancy and when to seek healthcare. The primary outcome is the proportion of women disclosing their DV status to someone. Secondary outcomes are symptoms of anxiety and depression, coping strategies, the use of safety measures and attitudes towards acceptance of abuse. Follow-up is conducted after 32 weeks of gestation, where both the intervention and control group participants view the intervention video after completing the follow-up questionnaire. Additionally, a mixed methods process evaluation of the intervention will be carried out to explore factors influencing the acceptability of the intervention and the disclosure of DV, including a review of project documents, individual interviews, and focus group discussions with members of the research team, healthcare providers, and participants. Discussion: This study will provide evidence on whether pregnant women attending regular antenatal visits can enhance their safety by disclosing their experiences of violence to a trusted person after receiving a video intervention. Trial registration: The study is registered in ClinicalTrial.gov with identifier NCT05199935. [ABSTRACT FROM AUTHOR]

Background: Adherence to prescribed treatment in chronic diseases, as occurs in multiple sclerosis (MS), is a critical factor for a successful therapeutic response. This study aimed to investigate the effect of educational program based on Theory of Planned Behavior (TPB) on treatment adherence in patients with multiple sclerosis (MS) receiving injectable immunomodulatory drugs. Methods: The present study is an educational randomized controlled trial research that was conducted on 100 patients with MS who had gone to MS clinic in Tehran city (Iran). The samples were randomly assigned to the intervention (N = 50) and control groups (N = 50). Data collection instrument was a researcher-made questionnaire based on TPB. Then, educational program was performed for the intervention group through four educational sessions. After three months, data collection was repeated for the two groups and data were analyzed. Results: The knowledge and performance of the intervention group on treatment adherence drugs increased from 56.25 ± 20.3 to 78.31 ± 15.57 and 56.22 ± 5.76 to 71.62 ± 12.01 after the education respectively (p < 0.001). The mean of construct of TPB in the intervention group also increased after the intervention (p < 0.05). Conclusion: Applying the TPB model proved is very effective in developing an educational program for patients with MS, to enhance treatment adherence drugs. Besides such programs, follow-up education for controlling and monitoring are highly recommended. Trial registration: This trial has been registered at Iranian Registry of Clinical Trials, IRCT20210808052109N1. Prospectively registered at 12-Aug-2021, (12/8/2021) available at: URL: https://en.irct.ir/trial/57994 [ABSTRACT FROM AUTHOR]

Background: Mobile Health ("mHealth") interventions have shown promise in improving HIV treatment outcomes for stigmatized populations. This paper presents the findings from a randomized controlled trial to assess the efficacy, participant-level feasibility and acceptability of a theory-informed mHealth intervention, Motivation Matters!, designed to improve viral suppression and ART adherence among HIV-seropositive women who engage in sex work in Mombasa, Kenya. Methods: A total of 119 women were randomized between the intervention and standard of care control. The primary outcome examined viral suppression (≤ 30 copies/mL) six months following ART initiation. ART adherence was assessed monthly using a visual analogue scale. Participant-level feasibility was measured through response rates to study text messages. Acceptability was assessed through qualitative exit interviews. Results: Six months following treatment initiation, 69% of intervention and 63% of control participants were virally suppressed (Risk Ratio [RR] = 1.09, 95% Confidence Interval [95% CI] (0.83, 1.44). Among women who were viremic at baseline and endorsed engagement in sex work, 74% of women in the intervention arm compared with 46% of women in the control arm achieved viral suppression at month six RR = 1.61, 95% CI (1.02, 2.55). Adherence was higher in intervention versus control participants every month. All participants responded to at least one message, and there was a 55% overall response rate to intervention text messages. Qualitative exit interviews suggested high acceptability and perceived impact of the intervention. Conclusion: The improvements in ART adherence and viral suppression, combined with encouraging data on feasibility and acceptability, provides preliminary evidence that Motivation Matters! could support ART adherence and viral suppression in women who engage in sex work. Trial registration: This trial was registered with ClinicalTrials.gov (NCT02627365, 10/12/2015; http://clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background and aims: Developing accessible, affordable, and effective approaches to smoking cessation is crucial for tobacco control. Mobile health (mHealth) based interventions have the potential to aid smokers in quitting, and integrating treatments from multiple sources may further enhance their accessibility and effectiveness. As part of our efforts in smoking cessation, we developed a novel behavioral intervention delivery modality for smoking cessation that integrated three interventions using the WeChat app, called the "Way to Quit" modality (WQ modality). It is presented here the protocol for a randomized controlled trial evaluating the effectiveness, feasibility, and cost-effectiveness of the WQ modality in Chinese smokers. Methods: Eligible participants (n = 460) will be recruited via online advertisement in Beijing, China. They will be randomly assigned to receive either quitline-based treatment (QT, n = 230) or WQ modality-based treatment (WQ, n = 230) using a block randomization method. Participants in the QT group will receive telephone-assisted treatment over a four-week period (multi-call quitline protocol), while those in the WQ group will receive integrated interventions based on the WQ modality for four weeks. A four-week supply of nicotine replacement therapy (gums) will be provided to all participants. Participants will be asked to complete phone or online follow-up at 1, 3, 6, and 12-months. At 1-month follow-up, individuals with self-reported smoking abstinence for more than 7 days will be invited to receive an exhaled carbon monoxide (CO) test for biochemical validation. The primary aim is to determine whether the WQ modality is effective in assisting smokers in quitting smoking. The secondary aims are to evaluate the acceptability, satisfaction, and cost-effectiveness of the WQ modality. Discussion: If the WQ modality is determined to be effective, acceptable, and affordable, it will be relatively easy to reach and provide professional cessation treatments to the communities, thus helping to reduce the disparities in smoking cessation services between different regions and socioeconomic groups. Trial registration: Chinese Clinical Trial Registry: ChiCTR2200066427, Registered December 5, 2022. [ABSTRACT FROM AUTHOR]

Background: This article outlines the protocol for a trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. Experimental studies show that contact with nature (e.g. walks in parks) improve mental health. A growing number of teachers have been applying outdoor education within the regular school curriculum and evidence suggests that such teaching methods could improve students' mental health but a randomized controlled trial has never been conducted. Methods: A two-arm clustered randomized controlled trial will be conducted in elementary schools across Québec, Canada. Following informed consent by teachers, parents and students, schools will be randomly assigned 1:1 to the intervention or the control group with a total of 2500 5-6th grade students and 100 teachers expected to participate. The intervention will take place outdoors in a green-space (2 h per week for 12 weeks) and include a toolkit of 30 activities to foster well-being (e.g. mindfulness) and academic competencies (e.g. mathematics). Questionnaires will be administered to teachers and students before, immediately after and 3 months after the intervention. The primary outcome will be reductions of mental health problems in children from pre-to-post test (Social Behavior Questionnaire: self and teacher reports). Secondary outcomes include depression, positive and negative affect, nature connectedness, and pro-environmental behaviors among children. We will explore, immediate benefits on teacher's well-being and positive and negative affect and sustained benefits among students at 3 months follow-up. For the primary outcome, we will explore moderators including child's sex, child's disability status, the green-space of neighbourhoods, the school's socio-economic position and teacher's experience. Discussion: In conducting the first randomized controlled trial of the Open Sky School, our results could provide empirical evidence on the effectiveness of nature-based interventions in reducing mental health problems among elementary school children. Trial registration: This study was registered with clinicaltrials.gov: NCT05662436 on December 22, 2022. [ABSTRACT FROM AUTHOR]

Background: Human papillomavirus (HPV) vaccination could prevent cervical and other HPV-associated cancers attributable to vaccine-associated HPV types. However, HPV vaccination coverage among women aged 9–18 years old is low in China. Common barriers include poor financial affordability, minimal public engagement, and low confidence in domestically produced HPV vaccines. Pay-it-forward offers an individual a free or subsidized service then an opportunity to voluntarily donate and/or create a postcard message to support future people. This study aims to assess the effectiveness of pay-it-forward as compared to standard-of-care self-paid vaccination to improve HPV vaccine uptake among adolescent girls aged 15–18 years, who are left out in the current pilot free HPV vaccination task force in some parts of China. Methods: This is a two-arm randomized controlled trial in Chengdu, China. Eligible adolescent girls (via caregivers) will be randomly selected and recruited through four community health centers (one in the most developed urban areas, one in higher middle-income and one in lower middle-income suburban areas, and one in the least developed rural areas) using the resident registration list. A total of 320 participants will be randomized into two study arms (user-paid versus pay-it-forward vaccination) in a 1:1 ratio. The intervention assignment will be blinded to recruiters and participants using envelop concealment until the research assistants open the envelop to determine which treatment to deliver to each individual. The primary outcome of the study will be HPV vaccine uptake by administrative data. Secondary outcomes include costs, vaccine hesitancy, and the completion rates of the 3-dose HPV vaccination series. Discussion: This study will investigate an innovative pay-it-forward strategy's effectiveness and economic costs to improve HPV vaccination among 15–18-year-old adolescent girls. Study findings will have implications for increasing HPV vaccine uptake in places where HPV vaccines are provided for a fee. Trial registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2200055542. Registered on 11 January 2022. [ABSTRACT FROM AUTHOR]

Background: Adolescent and young adult use of electronic nicotine delivery systems ("vaping") has increased rapidly since 2018. There is a dearth of evidence-based vaping cessation interventions for this vulnerable population. Social media use is common among young people, and smoking cessation groups on social media have shown efficacy in the past. The objective of this study is to describe the protocol for a randomized controlled trial (RCT) testing the efficacy of an Instagram-based vaping cessation intervention for adolescents and young adults. Methods: Adolescents and young adults aged 13–21 residing in California who have vaped at least once per week in the past 30 days will be recruited through social media ads, community partners, and youth serving organizations. Participants will be randomly assigned to intervention or control conditions: the intervention group takes place on Instagram, where participants receive up to 3 posts per weekday for 25 days over 5 weeks; the control group will be directed to kickitca.org, a website offering links to chatline and texting cessation services operated by the California Smokers' Helpline. The primary outcome is biochemically verified 7-day point prevalence abstinence for nicotine vaping; secondary outcomes are vaping reduction by 50% or more, vaping quit attempts, readiness to quit vaping, confidence in ability to quit, desire to quit, commitment to abstinence, and use of evidence-based cessation strategies. Both the primary outcome and secondary outcomes will be assessed immediately, 3 months, and 6 months after the treatment. Discussion: This is the first RCT to test a vaping cessation intervention delivered through Instagram. If effective, it will be one of the first evidence-based interventions to address vaping among adolescents and young adults and add to the evidence base for social media interventions for this population. Trial registration: ClinicalTrials.gov: NCT04707911, registered on January 13, 2021. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity is a major problem in Europe, increasing the need for prevention and rehabilitation programs. In Germany no guidelines have been developed that focus on patients with multiple chronic non-communicable diseases (NCDs). Benefits of physical activity (PA) and exercise in NCDs have been proven, but most interventions focus on single conditions. The evaluation of the effectiveness, efficiency and safety of PA programs in patients suffering from multiple NCDs and the feasibility of the implementation within the health care service remain open research questions.Methods: The multi-site randomized controlled pragmatic trial includes 320 sedentary subjects with at least two of the following NCDs, either manifested or in a pre-stage with evident risk factors: Cardio-vascular disease, Diabetes mellitus type 2, knee/ hip osteoarthritis and obesity. Participants will be recruited from general practitioners and medical specialists and randomized to standard care of a statutory health insurance or MultiPill-Exercise. Standard care includes a choice of one or a maximum of two 8- to 12-week health programs, including nutrition, exercise, relaxation or special disease management programs. MultiPill-Exercise is based on the bio-psycho-social health model, considering a person-oriented perspective in light of given individual characteristics and context factors. The 24-weeks intervention focuses on aerobic and strengthening exercises in line with the WHO PA recommendations. Psychological and pedagogical elements along with behavior change techniques are implemented to ease the initiation and maintenance of exercise participation and lifestyle change, including nutrition. Primary outcome will be short- and long-term PA measured with the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ). Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.Discussion: Results of this trial evaluate the PA intervention program in people with multiple NCDs in a real-life scenario. It will serve as a proof of concept with the opportunity of translation into routine practice. This approach, as a multi-site RCT with its rigorous methods and standardized operating procedures for the conduction of the intervention, will allow valid conclusions for the implementation of PA interventions in people with multimorbidity.Trial Registration: The trial was registered at www.drks.de (ID: DRKS00025033 ) on 30th September 2021. [ABSTRACT FROM AUTHOR]

Background: Obesity is a persistent public health concern and a risk factor for many chronic diseases including at least 13 different cancers. Adult Black females have the highest prevalence of obesity (57%) compared to other racial/gender groups in the U.S. Although behavioral weight loss (BWL) interventions have demonstrated effectiveness, Black females tend to lose less weight than White counterparts. The higher prevalence of chronic psychological stress reported by Black females may contribute to their disproportionate prevalence of obesity and observed suboptimal weight loss. This study will examine the effectiveness of a 12-month culturally-targeted, stress management-enhanced BWL intervention on weight loss and stress reduction among Black females in a fully-powered randomized, controlled trial.Methods: Adult Black females with obesity (n = 340) will be randomized to either a culturally targeted stress management-enhanced BWL intervention (BWL-Stress) or the same BWL intervention alone (BWL-alone). The primary outcome is weight change at month 6. Secondary outcomes will include changes in stress measures (e.g., perceived stress, cortisol), energy intake, and physical activity at month 6. We will also assess process measures (e.g., treatment adherence, treatment burden). Each outcome will also be evaluated at month 12 to assess longer-term effects of the intervention.Discussion: This novel approach for enhancing an evidence-based BWL program with culturally-targeted stress management strategies for Black females addresses an understudied barrier to effective weight management among a population at high risk for obesity and obesity-related chronic diseases. This study will potentially elucidate psychological or behavioral mechanisms linking our novel intervention to study outcomes. If the intervention is proven to be effective, this study will have significant clinical and public health implications for weight management among Black females.Trial Registration: This study was registered on ClinicalTrials.gov , identifier NCT04335799t , on April 6, 2020. [ABSTRACT FROM AUTHOR]

Background: Minority stress may lead to poorer mental health for sexual and gender minority adolescents, yet no interventions have been tested through an RCT to address these concerns.Methods: We report on an RCT of an intervention-Proud & Empowered-with four high schools. Measures assess the intervention's impact on mental health symptoms.Results: Compared to the control, participants in the treatment condition reported significant differences in minority stress, anxiety, and depressive symptoms. Moderation analyses showed that the intervention significantly moderated the relationship between minority stress and PTSD (b = -1.28, p = .032), depression (b = -0.79, p = .023), and suicidality (b = 0.14, p = .012) symptoms; those in the intervention condition had mitigated relationships between measures of stress and health outcomes compared to those in the control condition.Conclusions: Results suggest that Proud & Empowered help reduce mental health symptoms and exposure to minority stressors and build coping strategies.Trial Registration: The intervention was registered on clinicaltrials.gov on August 1, 2019 under Trial # NCT04041414 . [ABSTRACT FROM AUTHOR]

Background: Occupational stress is a major public health challenge that requires a variety of evidence-based preventative approaches to increase their reach within the working population. Behavioral stress management interventions are considered an established approach for occupational stress prevention. Both in-person group-based stress management training (gSMT) and individual Internet-based training (iSMT) have been shown to be effective at reducing stress in employees. However, there remains a lack of evidence on the comparative efficacy of the newer digital format compared to well-established, in-person, group-based training. This study aims (1) to directly compare an evidence-based iSMT with an established gSMT on stress in employees, (2) to analyze the two conditions from a cost perspective, and (3) to explore moderators of the comparative efficacy.Methods: In a randomized, controlled, non-inferiority trial employees from the general working population will be allocated to iSMT or gSMT. The primary outcome will be perceived stress, assessed using the Perceived Stress Scale, three months after randomization. The non-inferiority margin for the primary outcome measure will be set at 2 points (Cohen's d = 0.29). This trial will also compare the two interventions from a health economics perspective, and conduct explorative analyses to identify potential effect moderators.Discussion: To reach a larger proportion of the working population, well-established gSMT should be complemented with interventions that fit today's society's increasingly digital lifestyle. The current trial will provide evidence supporting the responsible implementation of Internet-based stress management training if the digital format proves to at least be non-inferior to established group-based training. Additional explorative moderator analyses may guide future practices to aid in matching select programs with select users.Trial Registration: German Register of Clinical Studies (DRKS): DRKS00024892, date of registration: 2021-04-09. Protocol version: 02, 16-10-2021. [ABSTRACT FROM AUTHOR]

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: Alcohol and other drug use disorders contribute substantially to the global burden of illness. The majority of people with substance use disorders do not receive any treatment for their problems, and developing treatments that are attractive and effective to patients should be a priority. However, whether treatment is best delivered in a group format or an individual format has only been studied to a very limited degree. The COMDAT (Combined Drug and Alcohol Treatment) trial evaluates the feasibility, acceptability, and cost effectiveness of MOVE group (MOVE-G) treatment versus MOVE individual (MOVE-I) treatment in four community-based outpatient treatment centres in Denmark.Methods: A two-arm non-inferiority trial comparing MOVE-I (Pedersen et al., Drug Alcohol Depend 218:108363, 2020) with MOVE-G a combined group treatment for both alcohol use disorder and drug use disorder. The primary objective is to examine whether MOVE-G is non-inferior to MOVE-I in relation to abstinence from drug and/or alcohol, number of sessions received, and completion of treatment as planned. All participants will receive treatment based on cognitive behavioral therapy and motivational interviewing, vouchers for attendance and text reminders, as well as medication as needed (MOVE). Participants (n = 300) will be recruited over a one-year period at four public treatment centers in four Danish municipalities. A short screening will determine eligibility and randomization status. Hereafter, participants will be randomized to the two treatment arms. A thorough baseline assessment will be conducted approximately 1 week after randomization. Follow-up assessments will be conducted at 9 months post-randomization. In addition, patients' use of drugs and alcohol, and patients' wellbeing will be measured in all sessions. The main outcome measures are drug and alcohol intake at 9 months follow-up, number of sessions attended, and dropout from treatment.Discussion: The present study will examine the potential and efficacy of combined groups (patients with alcohol and drug disorders in the same group) versus individually based treatment both based on the treatment method MOVE (Pedersen et al., Drug Alcohol Depend 218:108363, 2020).Trial Registration: ISRCTN88025085 , registration date 30/06/2020. [ABSTRACT FROM AUTHOR]

Background: The prevalence of poor diet quality and type 2 diabetes are exceedingly high in many rural American Indian (AI) communities. Because of limited resources and infrastructure in some communities, implementation of interventions to promote a healthy diet is challenging-which may exacerbate health disparities by region (urban/rural) and ethnicity (AIs/other populations). It is critical to adapt existing evidence-based healthy food budgeting, purchasing, and cooking programs to be relevant to underserved populations with a high burden of diabetes and related complications. The Cooking for Health Study will work in partnership with an AI community in South Dakota to develop a culturally-adapted 12-month distance-learning-based healthy food budgeting, purchasing, and cooking intervention to improve diet among AI adults with type 2 diabetes.Methods: The study will enroll 165 AIs with physician-diagnosed type 2 diabetes who reside on the reservation. Participants will be randomized to an intervention or control arm. The intervention arm will receive a 12-month distance-learning curriculum adapted from Cooking Matters® that focuses on healthy food budgeting, purchasing, and cooking skills. In-person assessments at baseline, month 6 and month 12 will include completion of the Nutrition Assessment Shared Resources Food Frequency Questionnaire and a survey to assess frequency of healthy and unhealthy food purchases. Primary outcomes of interest are: (1) change in self-reported intake of sugar-sweetened beverages (SSBs); and (2) change in the frequency of healthy and unhealthy food purchases. Secondary outcomes include: (1) change in self-reported food budgeting skills; (2) change in self-reported cooking skills; and (3) a mixed-methods process evaluation to assess intervention reach, fidelity, satisfaction, and dose delivered/received.Discussion: Targeted and sustainable interventions are needed to promote optimal health in rural AI communities. If effective, this intervention will reduce intake of SSBs and the purchase of unhealthy foods; increase the purchase of healthy foods; and improve healthy food budgeting and cooking skills among AIs with type 2 diabetes - a population at high risk of poor health outcomes. This work will help inform future health promotion efforts in resource-limited settings.Trial Registration: This study was registered on ClinicalTrials.gov on October 9, 2018 with Identifier NCT03699709 . [ABSTRACT FROM AUTHOR]

Background: Poor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City.Methods: This ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness.Discussion: The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins.Trial Registration: This trial was registered with ClinicalTrials.gov ( NCT03205982 ) on July 2, 2017. [ABSTRACT FROM AUTHOR]

Background: Client-Centered Representative Payee (CCRP) is an intervention modifying implementation of a current policy of the US Social Security Administration, which appoints organizations to serve as financial payees on behalf of vulnerable individuals receiving Social Security benefits. By ensuring beneficiaries' bills are paid while supporting their self-determination, this structural intervention may mitigate the effects of economic disadvantage to improve housing and financial stability, enabling self-efficacy for health outcomes and improved antiretroviral therapy adherence. This randomized controlled trial will test the impact of CCRP on marginalized people living with HIV (PLWH). We hypothesize that helping participants to pay their rent and other bills on time will improve housing stability and decrease financial stress.Methods: PLWH (n = 160) receiving services at community-based organizations will be randomly assigned to the CCRP intervention or the standard of care for 12 months. Fifty additional participants will be enrolled into a non-randomized ("choice") study allowing participant selection of the CCRP intervention or control. The primary outcome is HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts. Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months. Viral load, CD4, and appointment adherence data will be collected at baseline, 6, 12, 18, and 24 months from medical records. Outcomes will be compared by treatment group in the randomized trial, in the non-randomized cohort, and in the combined cohort. Qualitative data will be collected from study participants, eligible non-participants, and providers to explore underlying mechanisms of adherence, subjective responses to the intervention, and implementation barriers and facilitators.Discussion: The aim of this study is to determine if CCRP improves health outcomes for vulnerable PLWH. Study outcomes may provide information about supports needed to help economically fragile PLWH improve health outcomes and ultimately improve HIV health disparities. In addition, findings may help to refine service delivery including the provision of representative payee to this often-marginalized population. This protocol was prospectively registered on May 22, 2018 with ClinicalTrials.gov (NCT03561103) . [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]

Evidence of the impact of community-based nutrition programs is uncommon for two main reasons: the lack of untreated controls, and implementation does not account for the evaluation design. Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households. Suchana is being implemented in 157 unions, the smallest administrative unit of government, in two districts of Sylhet. Suchana will deliver a package of interventions to poor people in about 40 randomly selected new unions annually over 4 years, until all are covered. All beneficiaries will receive the normal government nutrition services. For evaluation purposes the last 40 unions will act as a control for the first 40 intervention unions. The remaining unions will receive the program but will not take part in the evaluation. A baseline survey was conducted in both intervention and control unions; it will be repeated after 3 years to estimate the impact on the prevalence of stunted children and other indicators. This stepped wedge design has several advantages for both the implementation and evaluation of services, as well as some disadvantages. The units of delivery are randomized, which controls for other influences on outcomes; the program supports government service delivery systems, so it is replicable and scalable; and the program can be improved over time as lessons are learned. The main disadvantages are the difficulty of estimating the impact of each component of the program, and the geographical distribution of unions, which increases program delivery costs. Stepped implementation allows a cluster randomized trial to be achieved within a large-scale poverty alleviation program and phased-in and scaled-up over a period of time. This paper may encourage evaluators to consider how to estimate attributable impact by using stepped implementation, which allows the counterfactual group eventually to be treated. [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: During the recent decade presence of digital media, especially handheld devices, in everyday life, has been increasing. Survey data suggests that children and adults spend much of their leisure on screen media, including use of social media and video services. Despite much public debate on possible harmful effects of such behavioral shifts, evidence from rigorously conducted randomized controlled trials in free-living settings, investigating the efficacy of reducing screen media use on physical activity, sleep, and physiological stress, is still lacking. Therefore, a family and home-based randomized controlled trial - the SCREENS trial - is being conducted. Here we describe in detail the rationale and protocol of this study.Methods: The SCREENS pilot trial was conducted during the fall of 2018 and spring of 2019. Based on experiences from the pilot study, we developed a protocol for a parallel group randomized controlled trial. The trial is being conducted from May 2019 to ultimo 2020 in 95 families with children 4-14 years recruited from a population-based survey. As part of the intervention family members must handover most portable devices for a 2-week time frame, in exchange for classic mobile phones (not smartphones). Also, entertainment-based screen media use during leisure must be limited to no more than 3 hours/week/person. At baseline and follow-up, 7-day 24-h physical activity will be assessed using two triaxial accelerometers; one at the right hip and one the middle of the right thigh. Sleep duration will be assessed using a single channel EEG-based sleep monitor system. Also, to assess physiological stress (only assessed in adults), parameters of 24-h heart rate variability, the cortisol awakening response and diurnal cortisol slope will be quantified using data sampled over three consecutive days. During the study we will objectively monitor the families' screen media use via different software and hardware monitoring systems.Discussion: Using a rigorous study design with state-of-the-art methodology to assess outcomes and intervention compliance, analyses of data from the SCREENS trial will help answer important causal questions of leisure screen media habits and its short-term influence on physical activity, sleep, and other health related outcomes among children and adults.Trial Registration: NCT04098913 at https://clinicaltrials.gov [20-09-2019, retrospectively registered]. [ABSTRACT FROM AUTHOR]

Background: Alcohol-related hospital admissions have doubled in the last ten years to > 1.2 m per year in England. High-need, high-cost (HNHC) alcohol-related frequent attenders (ARFA) are a relatively small subgroup of patients, having multiple admissions or attendances from alcohol during a short time period. This trial aims to test the effectiveness of an assertive outreach treatment (AOT) approach in improving clinical outcomes for ARFA, and reducing resource use in the acute setting.Methods: One hundred and sixty ARFA patients will be recruited and following baseline assessment, randomly assigned to AOT plus care as usual (CAU) or CAU alone in equal numbers. Baseline assessment includes alcohol consumption and related problems, physical and mental health comorbidity and health and social care service use in the previous 6 months using standard validated tools, plus a measure of resource use. Follow-up assessments at 6 and 12 months after randomization includes the same tools as baseline plus standard measure of patient satisfaction. Outcomes for CAU + AOT and CAU at 6 and 12 months will be compared, controlling for pre-specified baseline measures. Primary outcome will be percentage of days abstinent at 12 months. Secondary outcomes include emergency department (ED) attendance, number and length of hospital admissions, alcohol consumption, alcohol-related problems, other health service use, mental and physical comorbidity 6 and 12 months post intervention. Health economic analysis will estimate the economic impact of AOT from health, social care and societal perspectives and explore cost-effectiveness in terms of quality adjusted life years and alcohol consumption at 12-month follow-up.Discussion: AOT models piloted with alcohol dependent patients have demonstrated significant reductions in alcohol consumption and use of unplanned National Health Service (NHS) care, with increased engagement with alcohol treatment services, compared with patients receiving CAU. While AOT interventions are costlier per case than current standard care in the UK, the rationale for targeting HNHC ARFAs is because of their disproportionate contribution to overall alcohol burden on the NHS. No previous studies have evaluated the clinical and cost-effectiveness of AOT for HNHC ARFAs: this randomized controlled trial (RCT) targeting ARFAs across five South London NHS Trusts is the first.Trial Registration: International standard randomized controlled trial number (ISRCTN) registry: ISRCTN67000214, retrospectively registered 26/11/2016. [ABSTRACT FROM AUTHOR]

Background: Responding to intimate partner violence (IPV) and its consequences is made complex by women's diverse needs, priorities and contexts. Tailored online IPV interventions that account for differences among women have potential to reduce barriers to support and improve key outcomes.Methods: Double blind randomized controlled trial of 462 Canadian adult women who experienced recent IPV randomly were assigned to receive either a tailored, interactive online safety and health intervention (iCAN Plan 4 Safety) or a static, non-tailored version of this tool. Primary (depressive symptoms, PTSD symptoms) and secondary (helpfulness of safety actions, confidence in safety planning, mastery, social support, experiences of coercive control, and decisional conflict) outcomes were measured at baseline and 3, 6, and 12 months later via online surveys. Generalized Estimating Equations were used to test for differences in outcomes by study arm. Differential effects of the tailored intervention for 4 strata of women were examined using effect sizes. Exit survey process evaluation data were analyzed using descriptive statistics, t-tests and conventional content analysis.Results: Women in both tailored and non-tailored groups improved over time on primary outcomes of depression (p < .001) and PTSD (p < .001) and on all secondary outcomes. Changes over time did not differ by study arm. Women in both groups reported high levels of benefit, safety and accessibility of the online interventions, with low risk of harm, although those completing the tailored intervention were more positive about fit and helpfulness. Importantly, the tailored intervention had greater positive effects for 4 groups of women, those: with children under 18 living at home; reporting more severe violence; living in medium-sized and large urban centers; and not living with a partner.Conclusion: This trial extends evidence about the effectiveness of online safety and health interventions for women experiencing IPV to Canadian women and provides a contextualized understanding about intervention processes and effects useful for future refinement and scale up. The differential effects of the tailored intervention found for specific subgroups support the importance of attending to diverse contexts and needs. iCAN is a promising intervention that can complement resources available to Canadian women experiencing IPV.Trial Registration: Clinicaltrials.gov ID NCT02258841 (Prospectively Registered on Oct 2, 2014). [ABSTRACT FROM AUTHOR]

Background: Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs.Methods: A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months.Results: The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]).Conclusions: Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults.Trial Registration: (if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered. [ABSTRACT FROM AUTHOR]

Background: Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2.Methods/design: The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months.Discussion: Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2.Trial Registration: ClinicalTrials.gov Identifier: NCT03053336 ; 7 Feb, 2017. [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: The purpose of the FABO-study is to evaluate the effect of family-based behavioral social facilitation treatment (FBSFT), designed to target children's family and social support networks to enhance weight loss outcomes, compared to the standard treatment (treatment as usual, TAU) given to children and adolescents with obesity in a routine clinical practice. Methods: Randomized controlled trial (RCT), in which families (n = 120) are recruited from the children and adolescents (ages 6-18 years) referred to the Obesity Outpatient Clinic (OOC), Haukeland University Hospital, Norway. Criteria for admission to the OOC are BMI above the International Obesity Task Force (IOTF) cut-off ≥ 35, or IOTF ≥ 30 with obesity related co-morbidity. Families are randomized to receive FBSFT immediately or following one year of TAU. All participants receive a multidisciplinary assessment. For TAU this assessment results in a plan and a contract for chancing specific lifestyle behaviors. Thereafter each family participates in monthly counselling sessions with their primary health care nurse to work on implementing these goals, including measuring their weight change, and also meet every third month for sessions at the OOC. In FBSFT, following assessment, families participate in 17 weekly sessions at the OOC, in which each family works on changing lifestyle behaviors using a structured cognitive-behavioral, socio-ecological approach targeting both parents and children with strategies for behavioral maintenance and sustainable weight change. Outcome variables include body mass index (BMI; kg/m²), BMI standard deviation score (SDS) and percentage above the IOTF definition of overweight, waist-circumference, body composition (bioelectric impedance (BIA) and dual-X-rayabsorptiometry (DXA)), blood tests, blood pressure, activity/inactivity and sleep pattern (measured by accelerometer), as well as questionnaires measuring depression, general psychological symptomatology, self-esteem, disturbed eating and eating disorder symptoms. Finally, barriers to treatment and parenting styles are measured via questionnaires. Discussion: This is the first systematic application of FBSFT in the treatment of obesity among youth in Norway. The study gives an opportunity to evaluate the effect of FBSFT implemented in routine clinical practice across a range of youth with severe obesity. [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: 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: 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: Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation.Methods: This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms.Discussion: This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings.Trial Registration: NCT02692027 , registered February 21, 2016. [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]