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Background: Liver cancer (LC) screening, such as AFP test and abdominal ultrasound, is an effective way to prevent LC, one of the most common cancers worldwide. Despite the proven screening benefits, screening participation among high-risk populations for LC remains low. This suggests that targeted, systematic, and effective interventions should be provided to improve knowledge and awareness related to LC screening, enhance screening intentions, and thereby promote screening behaviors. Telephone is people's main medium of daily communication and mHealth-based programs offer a potential and effective solution for promoting health behaviors. The purpose of this study is to develop and implement a mHealth (WeChat app) based intervention guided by Fogg's Behavior Model (FBM) to augment the knowledge of LC prevention among people at risk of LC and enhance their motivation for screening, and to validate its effectiveness in improving LC screening. Methods: We propose a two-arm, single-blind randomized controlled trial with 82 at-risk individuals of LC, delivering a 6-month mHealth-based intervention program with optional health counseling. Recruitment will be through tertiary hospitals and community organizations in 4 districts in Heng Yang. In total, 82 individuals at high risk for HCC will be randomized 1:1 to intervention or control (usual care) groups. The intervention group will receive intervention, whose contents are based on the FBM model, via multiple forms of media including PowerPoint presentation, multimedia video, health information booklet and screening message, which is delivered in the WeChat Applet. Control dyads will be provided with usual health education. Outcomes will be assessed at baseline and post-intervention. Discussion: The findings of this study will provide evidence of the benefits of utilizing mHealth-based approaches in intervention development to enhance the effectiveness of screening adherence for high-risk people of LC. Further, the findings would provide reference to the potential incorporation of the targeted intervention in local community organizations. Trial registration: Chinese Clinical Trial Registry (ChiCTR2400080530) Date registered: 31/1/2024. [ABSTRACT FROM AUTHOR]

Background: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. Methods: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. Results: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). Conclusions: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. Trial registration: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35]. [ABSTRACT FROM AUTHOR]

Background: Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in a person attempting weight loss (index participant). Purpose: To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on 24-month weight loss. Methods: This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 18–74 years, lived with a partner, and had no medical contraindications to weight loss; partners were aged 18–74 years and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. Results: Among couples assigned to partner-assisted (n = 115) or participant-only intervention (n = 116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg], p=0.80). There were no differences in 24-month average daily caloric intake (estimated mean difference 50 cal [95% CI: -233, 132 cal], p=0.59) or steps (estimated mean difference 806 steps [95% CI: -1675, 64 steps], p=0.07). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p = 0.11). Conclusions: Partner-assisted and individual weight management interventions led to similar outcomes in index participants. Trial registration: Clinicaltrials.gov NCT03801174, January 11, 2019. [ABSTRACT FROM AUTHOR]

Abstract Background Liver cancer (LC) screening, such as AFP test and abdominal ultrasound, is an effective way to prevent LC, one of the most common cancers worldwide. Despite the proven screening benefits, screening participation among high-risk populations for LC remains low. This suggests that targeted, systematic, and effective interventions should be provided to improve knowledge and awareness related to LC screening, enhance screening intentions, and thereby promote screening behaviors. Telephone is people’s main medium of daily communication and mHealth-based programs offer a potential and effective solution for promoting health behaviors. The purpose of this study is to develop and implement a mHealth (WeChat app) based intervention guided by Fogg’s Behavior Model (FBM) to augment the knowledge of LC prevention among people at risk of LC and enhance their motivation for screening, and to validate its effectiveness in improving LC screening. Methods We propose a two-arm, single-blind randomized controlled trial with 82 at-risk individuals of LC, delivering a 6-month mHealth-based intervention program with optional health counseling. Recruitment will be through tertiary hospitals and community organizations in 4 districts in Heng Yang. In total, 82 individuals at high risk for HCC will be randomized 1:1 to intervention or control (usual care) groups. The intervention group will receive intervention, whose contents are based on the FBM model, via multiple forms of media including PowerPoint presentation, multimedia video, health information booklet and screening message, which is delivered in the WeChat Applet. Control dyads will be provided with usual health education. Outcomes will be assessed at baseline and post-intervention. Discussion The findings of this study will provide evidence of the benefits of utilizing mHealth-based approaches in intervention development to enhance the effectiveness of screening adherence for high-risk people of LC. Further, the findings would provide reference to the potential incorporation of the targeted intervention in local community organizations. Trial registration Chinese Clinical Trial Registry (ChiCTR2400080530) Date registered: 31/1/2024.

Abstract Background Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. Methods We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. Results We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). Conclusions This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. Trial registration The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35].

Abstract Background Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in a person attempting weight loss (index participant). Purpose To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on 24-month weight loss. Methods This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 18–74 years, lived with a partner, and had no medical contraindications to weight loss; partners were aged 18–74 years and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. Results Among couples assigned to partner-assisted (n = 115) or participant-only intervention (n = 116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg], p=0.80). There were no differences in 24-month average daily caloric intake (estimated mean difference 50 cal [95% CI: -233, 132 cal], p=0.59) or steps (estimated mean difference 806 steps [95% CI: -1675, 64 steps], p=0.07). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p = 0.11). Conclusions Partner-assisted and individual weight management interventions led to similar outcomes in index participants. Trial registration Clinicaltrials.gov NCT03801174, January 11, 2019.

Abstract 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 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

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]

Abstract 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 Background Intimate partner violence (IPV) threatens the safety, health and quality of life of women worldwide. Comprehensive IPV interventions that are tailored, take a long-term view of women’s needs, including health concerns, and maximize choice and control, have the potential to effectively address heath and safety concerns. Few such interventions have been tested, including in the Canadian context. Methods A parallel randomized controlled trial of adult (age 19 + years), English-speaking, Canadian women with histories of IPV randomized either to iHEAL, a tailored health promotion intervention delivered by Registered Nurses over 6–7 months, or to community service information (usual care control). Primary (Quality of Life, PTSD symptoms) and secondary outcomes (Depression, Confidence in Managing Daily Life, Chronic Pain, IPV Severity) were measured at baseline and 6, 12 and 18 months post-intervention via an online survey. Generalized estimating equations were used to test for differences by study arm in intention-to-treat (full sample) and per protocol (1 + iHEAL visit) analyses focussing on short-term (immediately post-intervention) and longer-term (1 year post-intervention) effects. Selected process evaluation data were summarized using descriptive statistics. Results Of 331 women enrolled, 175 were randomized to iHEAL (135 who engaged in 1 + visits) and 156 to control. Women who received iHEAL showed significantly greater short-term improvement in Quality of Life compared to the control group, with these effects maintained 1 year later. Changes in PTSD Symptoms also differed significantly by group, with weaker initial effects that were stronger 1 year post-intervention. Significant moderate, short- and longer-term group effects were also observed for Depression and Confidence in Managing Daily Life. IPV Severity decreased for both groups, with significant immediate effects in favour of the intervention group that grew stronger 1 year post-intervention. There were no changes in Chronic Pain. Conclusion iHEAL is an effective, acceptable and safe intervention for diverse groups of women with histories of IPV. Trial results provide a foundation for implementation and ongoing evaluation in health care settings and systems. Delayed effects noted for PTSD Symptoms and IPV Severity suggest that longer-term assessment of these outcomes may be needed in trials of IPV interventions. Trial registration Clinicaltrials.gov ID NCT03573778 (Registered on June 29, 2018).

Abstract 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.

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]

Abstract Background Food pantry clients have high rates of food insecurity and greater risk for and prevalence of diet-related diseases. Many clients face time, resource, and physical constraints that limit their ability to prepare healthy meals using foods typically provided by pantries. We compared two novel approaches to alleviate those barriers and encourage healthier eating: meal kits, which bundle ingredients with a recipe on how to prepare a healthy meal, and nutritious no-prep meals, which can be eaten after thawing or microwaving. Methods Participants were adult pantry clients from a large food pantry in the Southern sector of Dallas, Texas. We conducted a repeated measures between-subjects study with 70 clients randomized to receive 14-days of meal kits (n = 35) or no-prep meals (n = 35). Participants completed questionnaires at baseline and two-week follow-up on demographics, hedonic liking of study meals, perceived dietary quality, and food security. Two-way repeated measures analysis of variance was used to examine group and time effects, and group by time interactions. We also describe feasibility and satisfaction outcomes to inform future implementation. Results Sixty-six participants completed the study (94%). Participants were predominantly Hispanic or Latino(a) (63%) and African American or Black (31%) women (90%). There was a significant interaction on hedonic liking of study meals (ηp²=0.16, F(1,64) = 11.78, p

Abstract Background The COVID-19 pandemic has had an impact on population-wide mental health and well-being. Although people experiencing socioeconomic disadvantage may be especially vulnerable, they experience barriers in accessing mental health care. To overcome these barriers, the World Health Organization (WHO) designed two scalable psychosocial interventions, namely the web-based Doing What Matters in Times of Stress (DWM) and the face-to-face Problem Management Plus (PM+), to help people manage stressful situations. Our study aims to test the effectiveness of a stepped-care program using DWM and PM + among individuals experiencing unstable housing in France – a majority of whom are migrant or have sought asylum. Methods This is a randomised controlled trial to evaluate the effectiveness and cost effectiveness of a stepped-care program using DWM and PM + among persons with psychological distress and experiencing unstable housing, in comparison to enhanced care as usual (eCAU). Participants (N = 210) will be randomised to two parallel groups: eCAU or eCAU plus the stepped-care program. The main study outcomes are symptoms of depression and anxiety measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Discussion This randomised controlled trial will contribute to a better understanding of effective community-based scalable strategies that can help address the mental health needs of persons experiencing socioeconomic disadvantage, whose needs are high yet who frequently have limited access to mental health care services. Trial registration this randomised trial has been registered at ClinicalTrials.gov under the number NCT05033210.

Abstract Background Upon arrival, the prevalence of overweight and obesity is lower in new immigrants than their native counterparts in the U.S. With longer residency in the U.S., these differences converge over time, followed by higher prevalence among immigrants than native U.S. residents. Results from the Live Well project in the Greater Boston area demonstrate the viability of utilizing a culturally adapted, community-based participatory research (CBPR) approach to reduce weight gain among newly immigrated mother–child dyads. Methods Haitian, Latina, and Brazilian mother–child dyads (n = 390), new to the U.S. (fewer than 10 years) were enrolled in a one- to two-year long CBPR lifestyle intervention that targeted dietary and physical activity behaviors. Attendance was recorded to establish dose. Demographics, anthropometrics, and relevant covariates were collected from participants at baseline, 6, 12, 18, and 24 months. Body Mass Index (BMI) was calculated using objectively measured height and weight. Linear mixed regression models were used to assess change in BMI and BMI z-score of mothers and children respectively. Results At baseline, nearly 75% of mothers and 50% of children were either overweight or obese (BMI ≥ 25.0 and BMI z-score ≥ 85th percentile, respectively). Only 20% of mothers attended all 12 intervention sessions in year 1. Using intent-to-treat analyses, no significant time, intervention, or time × intervention effects were observed for weight change of mothers or children at follow-up. Mothers in the highest quantile (those who attended all 12 intervention sessions) had significant reductions in BMI at 18 months (1.76 units lower, 95%CI: -3.14, -0.37) and 24 months (2.61 units, 95%CI -3.92, -1.29) compared to mothers in the lower quantiles, including those with no exposure. Such dose effects on BMI z-scores were not noted for children. Conclusions Findings from Live Well demonstrate the viability of utilizing a CBPR approach to address overweight and obesity among immigrant mothers. Given the higher-than-expected prevalence of overweight and obesity among mother–child dyads by ~ 6 years of U.S. residency, and lower maternal participation rates in the intervention, additional research is necessary to identify the optimal intervention length, retention strategies, and approach to jointly support healthy maternal and child weight.

Background: Food pantry clients have high rates of food insecurity and greater risk for and prevalence of diet-related diseases. Many clients face time, resource, and physical constraints that limit their ability to prepare healthy meals using foods typically provided by pantries. We compared two novel approaches to alleviate those barriers and encourage healthier eating: meal kits, which bundle ingredients with a recipe on how to prepare a healthy meal, and nutritious no-prep meals, which can be eaten after thawing or microwaving. Methods: Participants were adult pantry clients from a large food pantry in the Southern sector of Dallas, Texas. We conducted a repeated measures between-subjects study with 70 clients randomized to receive 14-days of meal kits (n = 35) or no-prep meals (n = 35). Participants completed questionnaires at baseline and two-week follow-up on demographics, hedonic liking of study meals, perceived dietary quality, and food security. Two-way repeated measures analysis of variance was used to examine group and time effects, and group by time interactions. We also describe feasibility and satisfaction outcomes to inform future implementation. Results: Sixty-six participants completed the study (94%). Participants were predominantly Hispanic or Latino(a) (63%) and African American or Black (31%) women (90%). There was a significant interaction on hedonic liking of study meals (ηp²=0.16, F(1,64) = 11.78, p <.001), such that participants that received meal kits had greater improvements in hedonic liking over time than participants in the no-prep group. We observed significant improvements in perceived dietary quality (ηp²=0.36, F(1,64) = 36.38, p <.001) and food security (ηp²=0.36, F(1,64) = 36.38, p <.001) across both groups over time, but no between group differences or significant interactions indicating one intervention was more effective than the other. Program satisfaction was high across both groups, but higher among the meal kit group (ηp²=0.09, F(1,64) = 6.28, p =.015). Conclusions: Results suggest nutritious meal kits and no-prep meals may be desirable nutrition intervention strategies for pantry clients and have potential to increase food security and perceived dietary quality in the short-term. Our findings are limited by a small sample and short follow-up. Future studies should continue to test both interventions, and include longer follow-up, objective measures of dietary quality, and relevant clinical outcomes. Trial registration: This trial was registered on 25/10/2022 on ClinicalTrials.gov, identifier: NCT05593510. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has had an impact on population-wide mental health and well-being. Although people experiencing socioeconomic disadvantage may be especially vulnerable, they experience barriers in accessing mental health care. To overcome these barriers, the World Health Organization (WHO) designed two scalable psychosocial interventions, namely the web-based Doing What Matters in Times of Stress (DWM) and the face-to-face Problem Management Plus (PM+), to help people manage stressful situations. Our study aims to test the effectiveness of a stepped-care program using DWM and PM + among individuals experiencing unstable housing in France – a majority of whom are migrant or have sought asylum. Methods: This is a randomised controlled trial to evaluate the effectiveness and cost effectiveness of a stepped-care program using DWM and PM + among persons with psychological distress and experiencing unstable housing, in comparison to enhanced care as usual (eCAU). Participants (N = 210) will be randomised to two parallel groups: eCAU or eCAU plus the stepped-care program. The main study outcomes are symptoms of depression and anxiety measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Discussion: This randomised controlled trial will contribute to a better understanding of effective community-based scalable strategies that can help address the mental health needs of persons experiencing socioeconomic disadvantage, whose needs are high yet who frequently have limited access to mental health care services. Trial registration: this randomised trial has been registered at ClinicalTrials.gov under the number NCT05033210. [ABSTRACT FROM AUTHOR]

Background: Upon arrival, the prevalence of overweight and obesity is lower in new immigrants than their native counterparts in the U.S. With longer residency in the U.S., these differences converge over time, followed by higher prevalence among immigrants than native U.S. residents. Results from the Live Well project in the Greater Boston area demonstrate the viability of utilizing a culturally adapted, community-based participatory research (CBPR) approach to reduce weight gain among newly immigrated mother–child dyads. Methods: Haitian, Latina, and Brazilian mother–child dyads (n = 390), new to the U.S. (fewer than 10 years) were enrolled in a one- to two-year long CBPR lifestyle intervention that targeted dietary and physical activity behaviors. Attendance was recorded to establish dose. Demographics, anthropometrics, and relevant covariates were collected from participants at baseline, 6, 12, 18, and 24 months. Body Mass Index (BMI) was calculated using objectively measured height and weight. Linear mixed regression models were used to assess change in BMI and BMI z-score of mothers and children respectively. Results: At baseline, nearly 75% of mothers and 50% of children were either overweight or obese (BMI ≥ 25.0 and BMI z-score ≥ 85th percentile, respectively). Only 20% of mothers attended all 12 intervention sessions in year 1. Using intent-to-treat analyses, no significant time, intervention, or time × intervention effects were observed for weight change of mothers or children at follow-up. Mothers in the highest quantile (those who attended all 12 intervention sessions) had significant reductions in BMI at 18 months (1.76 units lower, 95%CI: -3.14, -0.37) and 24 months (2.61 units, 95%CI -3.92, -1.29) compared to mothers in the lower quantiles, including those with no exposure. Such dose effects on BMI z-scores were not noted for children. Conclusions: Findings from Live Well demonstrate the viability of utilizing a CBPR approach to address overweight and obesity among immigrant mothers. Given the higher-than-expected prevalence of overweight and obesity among mother–child dyads by ~ 6 years of U.S. residency, and lower maternal participation rates in the intervention, additional research is necessary to identify the optimal intervention length, retention strategies, and approach to jointly support healthy maternal and child weight. [ABSTRACT FROM AUTHOR]

BackgroundAdolescent 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.MethodsAdolescents 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.DiscussionThis 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 registrationClinicalTrials.gov: NCT04707911, registered on January 13, 2021.

BackgroundObesity 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.MethodsAdult 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.DiscussionThis 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 registrationThis study was registered on ClinicalTrials.gov , identifier NCT04335799t , on April 6, 2020.

Abstract 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 Background Little is known about the potential impacts of visible and up-to-date health warning labels on alcoholic beverage containers on a range of outcomes in low- and middle-income countries. We conducted an experimental study to test the potential impacts of visible health warning labels (on the principal panel of the package) on thinking about health risks, product attractiveness, visual avoidance, and intention to change alcohol use among students in Mexico aged 18–30 years. Methods A double-blind, parallel-group, online randomized trial was conducted from November 2021 to January 2022 in 11 states in Mexico. In the control group, participants were presented with the image of a conventional beer can with a fictional design and brand. In the intervention groups, the participants observed pictograms with a red font and white backgrounds (health warning label in red—HWL red) or with a black font and yellow backgrounds (health warning label in yellow—HWL yellow), located at the top, covering around one-third of the beer can. We used Poisson regression models -unadjusted and adjusted for covariates- to assess differences in the outcomes across study groups. Results Using intention-to-treat analysis (n = 610), we found more participants in groups HWL red and HWL yellow thought about the health risks from drinking beer compared to the control group [Prevalence Ratio (PR) = 1.43, CI95%:1.05,1.93 for HWL red; PR = 1.25, CI95%: 0.91, 1.71 for HWL yellow]. A lower percentage of young adults in the interventions vs control group considered the product attractive (PR 0.74, 95%CI 0.51, 1.06 for HWL red; PR 0.56, 95%CI 0.38, 0.83 for HWL yellow). Although not statistically significant, a lower percentage of participants in the intervention groups considered buying or consuming the product than the control group. Results were similar when models were adjusted for covariates. Conclusions Visible health warning labels could lead individuals to think about the health risks of alcohol, reducing the attractiveness of the product and decreasing the intention to purchase and consume alcohol. Further studies will be required to determine which pictograms or images and legends are most contextually relevant for the country. Trial registration The protocol of this study was retrospectively registered on 03/01/2023: ISRCTN10494244.

Abstract 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

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]

Abstract 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 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 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. Graphical Abstract

Background: Little is known about the potential impacts of visible and up-to-date health warning labels on alcoholic beverage containers on a range of outcomes in low- and middle-income countries. We conducted an experimental study to test the potential impacts of visible health warning labels (on the principal panel of the package) on thinking about health risks, product attractiveness, visual avoidance, and intention to change alcohol use among students in Mexico aged 18–30 years. Methods: A double-blind, parallel-group, online randomized trial was conducted from November 2021 to January 2022 in 11 states in Mexico. In the control group, participants were presented with the image of a conventional beer can with a fictional design and brand. In the intervention groups, the participants observed pictograms with a red font and white backgrounds (health warning label in red—HWL red) or with a black font and yellow backgrounds (health warning label in yellow—HWL yellow), located at the top, covering around one-third of the beer can. We used Poisson regression models -unadjusted and adjusted for covariates- to assess differences in the outcomes across study groups. Results: Using intention-to-treat analysis (n = 610), we found more participants in groups HWL red and HWL yellow thought about the health risks from drinking beer compared to the control group [Prevalence Ratio (PR) = 1.43, CI95%:1.05,1.93 for HWL red; PR = 1.25, CI95%: 0.91, 1.71 for HWL yellow]. A lower percentage of young adults in the interventions vs control group considered the product attractive (PR 0.74, 95%CI 0.51, 1.06 for HWL red; PR 0.56, 95%CI 0.38, 0.83 for HWL yellow). Although not statistically significant, a lower percentage of participants in the intervention groups considered buying or consuming the product than the control group. Results were similar when models were adjusted for covariates. Conclusions: Visible health warning labels could lead individuals to think about the health risks of alcohol, reducing the attractiveness of the product and decreasing the intention to purchase and consume alcohol. Further studies will be required to determine which pictograms or images and legends are most contextually relevant for the country. Trial registration: The protocol of this study was retrospectively registered on 03/01/2023: ISRCTN10494244. [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]

Abstract 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 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

Abstract Background Physical activity is recommended for all pregnant individuals and can prevent excessive gestational weight gain. However, physical activity has not been assessed among military personnel and other TRICARE beneficiaries, who experience unique military lifestyles. The current study assessed physical activity among pregnant TRICARE beneficiaries, both active duty and non-active duty, as measured by accelerometry and self-report data to examine potential predictors of physical activity engagement in the third trimester, and if self-report data was consistent with accelerometry data. We expected having a lower BMI, being active-duty, and having higher baseline physical activity engagement to be associated with higher physical activity at 32-weeks. We also hypothesized that accelerometry data would show lower physical activity levels than the self-reported measure. Methods Participants were 430 TRICARE adult beneficiaries (204 Active Duty; 226 non-Active Duty) in San Antonio, TX who were part of a randomized controlled parent study that implemented a stepped-care behavioral intervention. Participants were recruited if they were less than 12-weeks gestation and did not have health conditions precluding dietary or physical activity changes (e.g., uncontrolled cardiovascular conditions) or would contribute to weight changes. Participants completed self-report measures and wore an Actical Activity Monitor accelerometer on their wrist to collect physical activity data at baseline and 32-weeks gestation. Results Based on the accelerometer data, 99% of participants were meeting moderate physical activity guidelines recommending 150 min of moderate activity per week at baseline, and 96% were meeting this recommendation at 32-weeks. Based on self-report data, 88% of participants at baseline and 92% at 32-weeks met moderate physical activity recommendations. Linear regression and zero-inflated negative binomial models indicated that baseline physical activity engagement predicted moderate physical activity later in pregnancy above and beyond BMI and military status. Surprisingly, self-reported data, but not accelerometer data, showed that higher baseline activity was associated with decreased vigorous activity at 32-weeks gestation. Additionally, self-report and accelerometry data had small correlations at baseline, but not at 32-weeks. Conclusions Future intervention efforts may benefit from intervening with individuals with lower pre-pregnancy activity levels, as those who are active seem to continue this habit. Trial Registration The trial is registered on clinicaltrials.gov (NCT 03057808).

Abstract Background The first three years of life are the critical and sensitive periods for the formation of individual abilities. However, existing data indicates that early childhood development (ECD) in economically vulnerable areas of China is lagging, which is closely related to the lack of parenting knowledge and poor parenting practices. Methods We conducted a non-masked cluster-randomized controlled trial in a former nationally designated poverty county of China. All 6–36-month-old children and their caregivers living in 18 communities/clusters (10 towns and 8 districts of the county seat) were enrolled in a 9-month parenting training program. In the treatment-group communities, ECD centers were installed where community workers provided parenting training sessions. If caregivers were unable to visit the center, home-based parenting training was offered. No intervention was provided to the control group. Furthermore, we assigned half of the treatment group to receive monthly developmental feedback in addition to the parenting training. Based on the baseline and follow-up data, we investigated the treatment effects on parenting knowledge, attitudes, and practices through Intention-to-Treat (ITT) and Treatment-on-the-Treated (TOT) analyses. Results We found no effects on the parenting knowledge and attitudes of the caregivers but significant effects on the parenting practices. The effects were heterogeneous among families with different characteristics. Specifically, on average, the program had the largest effect on internally oriented caregivers, mothers with higher education, and mothers who are primary caregivers. We want to emphasize that, although the ITT effect on parenting practices (the average treatment effect) were stronger for mothers with higher education, the TOT effect on parenting practices (the local average treatment effect, LATE) were stronger for mothers with less education. That is, even though on average the program helped mothers with higher education, but among complier families, the program benefited mothers with less education. Conclusion The findings indicate that, at least in the short run, the program can directly change caregivers’ parenting practices without changing their knowledge and attitudes. Future studies are needed to investigate whether parenting knowledge and attitudes can change in the long run.

Abstract Background Despite the decline in cigarette smoking prevalence during nearly the past two decades, tobacco use is still widespread in the German adult population, accounting for 125,000 deaths each year and causing tremendous social costs. To accelerate the reduction in tobacco smoking prevalence, evidence-based smoking cessation methods are pivotal to a national tobacco control strategy. The present study aims to evaluate the effectiveness of the national German Smokers Quitline offering cessation support to smokers. Methods A total sample of 910 daily smokers, who are motivated to quit, will be recruited via an online access panel and randomly assigned to either the intervention (telephone counselling) or control condition. In the intervention group, participants will receive up to six proactive phone calls during an intervention period of approximately six weeks. The provided treatment will combine the principles of motivational interviewing and those of the cognitive behavioural approach to treating substance use. Participants in the control condition will receive a self-help brochure to support smoking cessation. Data collection will take place at baseline as well as three (post assessment) and twelve months (follow-up assessment) after baseline assessment. Primary outcome measures will include the seven-day point prevalence abstinence at 3-month and 12-month assessments as well as prolonged abstinence (abstinence over the 12 month period). Secondary outcome measures will include a change in smoking-related cognitions and coping strategies among all participants. Among non-abstainers, treatment success indicators such as a reduction in number of cigarettes smoked per day and changes in the number and duration of quit attempts after intervention start will be assessed. It is expected that after both three and twelve months, smoking cessation rates will be higher in the telephone counselling condition compared to the control condition. Discussion The results will provide insights into the effectiveness of proactive telephone counselling by the national German Smokers Quitline. Trial registration The protocol for this study is registered with the German Clinical Trials Register: DRKS00025343, Date of registration: 2021/06/07, https://www.drks.de/drks_web/setLocale_EN.do

Abstract Background Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings. Methods/design This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes. Discussion This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery. Trial registration ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

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]

Abstract Background Maternal knowledge that motivates improvements in critical perinatal health behaviors has the potential to significantly reduce maternal and neonatal mortality. However, evidence-based health information often fails to reach mothers and their partners. mHealth video micro-messages, which disseminate evidence-based perinatal health messages, have the potential to address this gap. Methods The study will make use of a mixed method design, using both qualitative and quantitative methods. The study consists of two phases. During Phase 1, qualitative in-depth interviews will be used as part of a human-centered design approach to co-create 10 videos on priority perinatal behaviors. During Phase 2, quantitative methods (a randomized control trial) will be used to test the effectiveness of the videos in improving maternal knowledge and intended behavioral change. Discussion We hypothesize that by engaging mothers and their partners through emotive, resonant narratives and visuals, we can facilitate the delivery of evidence-based health messages at the foundation of perinatal health, thereby motivating life-saving improvements in health behaviors during the perinatal period. Trial registration This trial has been prospectively registered on the Pan African Clinical Trials Registry (PACTR), with the registration number PACTR202203673222680 . Registration date: 14 March 2022. Trial registration WHO data set Registry – Pan African Clinical Trials Registry (PACTR). Date: 14 March 2022. Secondary identification number - grant number: GCCSOAFMNH1. Source of support: Science for Africa Foundation. Primary sponsor – Clinton Health Access Initiative South Africa. Secondary sponsor - Stanford University School of Medicine and Heidelberg University. Contact for public & scientific queries: amandlamamasa@clintonhealthaccess.org ; +27 123,426,911; 1166 Francis Baard St, Hatfield, Pretoria, 0028. Public title – Amandla Mama. Scientific title - Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa. Countries of recruitment – South Africa. Health conditions – antenatal care. Intervention – Amandla Mama mHealth videos, short 2D animated health promotional videos that promote healthy behavior in expectant mothers. Inclusion and exclusion criteria - Expectant mothers and their partners must be 18 years and older. Study type – randomized control trial. Date of first enrollment – 14 March 2021. Sample size – plan to enrol 450 participants, participants enrolled 29 participants. Recruitment Status – suspended. Primary outcome – improving knowledge. Secondary outcome – intended behavioral change. Ethics review – Approved on 24 January 2022 by Pharma-Ethics, contact Mrs. Marzelle Haskins, marzelle@pharma-ethics.co.za . Completion date – N/A. Summary results – N/A. IPD sharing statement – yes, through the publication of results in a journal article.

Abstract Background Influenza vaccination coverage rate among the elderly is low in China. We aimed to evaluate the impact of video-led educational intervention on influenza vaccine uptake among the Chinese elderly. Methods A randomized controlled trial was conducted in 8 communities of Xi’an, a representative city in western China. Elderly aged over 60 years were randomized to the control group and intervention group (12-minute video education on influenza and its vaccination). Participants’ knowledge, attitudes, and practices (KAP) of influenza was assessed by using a questionnaire survey before and after the intervention. The primary outcomes were participants’ willingness to get influenza vaccinated and their actual uptake rates in the 2020-21 flu season. Secondary outcomes were the variations of pre- and post-intervention KAP scores. Intention-to-treat analysis was performed to analyze the data, and sensitivity analyses were conducted to examine the robustness of the results. Results A total of 350 people were enrolled, with 175 individuals for each group. Participants in the intervention group were more willing to receive influenza vaccination than those in the control group (64.6% vs. 51.4%, p

Abstract Background Prostate cancer survivors (PCS) experience long-term side effects beyond treatment such as fatigue, depression and anxiety. Quality and engaging supportive care programs are needed to reduce these chronic and debilitating effects. Independent of physical activity (PA), high volumes of sedentary behavior (SB) are associated with chronic disease-related risk factors and poorer cancer-specific quality of life (QoL). Simultaneously increasing PA and decreasing SB may be an effective health promotion strategy. Given that PCS may face several barriers to engaging in supervised programs, there is a need to develop and assess the efficacy of interventions that employ distance-based approaches for behavior change. The primary aim of this study is to determine the effects of a 12-week intervention (Fitbit + behavioral counselling) vs. Fitbit-only control group in reducing SB among PCS. Secondary outcomes include light-intensity PA, QoL, motivational outcomes, and patient satisfaction. Methods This two-armed, randomized controlled trial will recruit inactive PCS (stage I-IV) across Canada who self-report engaging in >8 hours/day of SB. Participants will be randomized to the intervention (n=60; Fitbit and behavioral support) or active control group (n=60; Fitbit-only). The intervention consists of the use of a Fitbit and a series of six behavioral support sessions (two group, four individual) to aid PCS in gradually replacing SB with light-intensity PA by increasing their daily step counts to 3,000 steps above their baseline values. The Fitbit-only control condition will receive a Fitbit and public health PA resources. The primary outcome is change in SB measured objectively using activPAL inclinometers. All secondary outcomes will be measured via self-report, except for PA which will be measuring using Fitbits. Data will be collected at baseline, post-intervention, and at 6-month post-intervention. Discussion Reducing SB and increasing light-intensity PA plays an important, yet often undervalued role in the health and well-being of PCS. This study will create a unique distance-based platform that can be used by clinical and community-based organizations as a low-cost, supportive care tool to improve health outcomes for PCS. Trial Registration ClinicalTrials.gov Identifier NCT05214937 . Registered January 28, 2022 Protocol version: v.1

Abstract Introduction The COVID-19 pandemic placed an unprecedented overload on healthcare system globally. With all medical resources being dedicated to contain the spread of the disease, the pandemic may have impacted the burden of other infectious diseases such as dengue, particularly in countries endemic for dengue fever. Indeed, the co‐occurrence of COVID‐19 made dengue diagnosis challenging because of some shared clinical manifestations between the two pathogens. Furthermore, the sudden emergence and novelty of this global public health crisis has forced the suspension or slow-down of several research trials due to the lack of sufficient knowledge on how to handle the continuity of research trials during the pandemic. We report on challenges we have faced during the COVID-19 pandemic and measures that were implemented to continue the iDEM project (intervention for Dengue Epidemiology in Malaysia). Methods This randomized controlled trial aims to assess the effectiveness of Integrated Vector Management (IVM) on the incidence of dengue in urban Malaysia by combining: targeted outdoor residual spraying (TORS), deployment of auto-dissemination devices (ADDs), and active community engagement (CE). Our operational activities started on February 10, 2020, a few weeks before the implementation of non-pharmaceutical interventions to contain the spread of COVID-19 in Malaysia. Results The three main issues affecting the continuity of the trial were: ensuring the safety of field workers during the interventions; ensuring the planned turnover of TORS application and ADD deployment and services; and maintaining the CE activities as far as possible. Conclusions Even though the pandemic has created monumental challenges, we ensured the safety of field workers by providing complete personal protective equipment and regular COVID-19 testing. Albeit with delay, we maintained the planned interval time between TORS application and ADDs services by overlapping the intervention cycles instead of having them in a sequential scheme. CE activities continued remotely through several channels (e.g., phone calls and text messages). Sustained efforts of the management team, significant involvement of the Malaysian Ministry of Health and a quick and smart adaptation of the trial organisation according to the pandemic situation were the main factors that allowed the successful continuation of our research. Trial registration Trial registration number: ISRCTN-81915073 . Date of registration: 17/04/2020, 'Retrospectively registered'.

BackgroundMen who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India.MethodsFunded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months.DiscussionHIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group.Trial registrationClinicalTrials.gov Identifier: NCT02556294 , registered 22 September 2015.

Background: Physical activity is recommended for all pregnant individuals and can prevent excessive gestational weight gain. However, physical activity has not been assessed among military personnel and other TRICARE beneficiaries, who experience unique military lifestyles. The current study assessed physical activity among pregnant TRICARE beneficiaries, both active duty and non-active duty, as measured by accelerometry and self-report data to examine potential predictors of physical activity engagement in the third trimester, and if self-report data was consistent with accelerometry data. We expected having a lower BMI, being active-duty, and having higher baseline physical activity engagement to be associated with higher physical activity at 32-weeks. We also hypothesized that accelerometry data would show lower physical activity levels than the self-reported measure. Methods: Participants were 430 TRICARE adult beneficiaries (204 Active Duty; 226 non-Active Duty) in San Antonio, TX who were part of a randomized controlled parent study that implemented a stepped-care behavioral intervention. Participants were recruited if they were less than 12-weeks gestation and did not have health conditions precluding dietary or physical activity changes (e.g., uncontrolled cardiovascular conditions) or would contribute to weight changes. Participants completed self-report measures and wore an Actical Activity Monitor accelerometer on their wrist to collect physical activity data at baseline and 32-weeks gestation. Results: Based on the accelerometer data, 99% of participants were meeting moderate physical activity guidelines recommending 150 min of moderate activity per week at baseline, and 96% were meeting this recommendation at 32-weeks. Based on self-report data, 88% of participants at baseline and 92% at 32-weeks met moderate physical activity recommendations. Linear regression and zero-inflated negative binomial models indicated that baseline physical activity engagement predicted moderate physical activity later in pregnancy above and beyond BMI and military status. Surprisingly, self-reported data, but not accelerometer data, showed that higher baseline activity was associated with decreased vigorous activity at 32-weeks gestation. Additionally, self-report and accelerometry data had small correlations at baseline, but not at 32-weeks. Conclusions: Future intervention efforts may benefit from intervening with individuals with lower pre-pregnancy activity levels, as those who are active seem to continue this habit. Trial Registration: The trial is registered on clinicaltrials.gov (NCT 03057808). [ABSTRACT FROM AUTHOR]

Background: The first three years of life are the critical and sensitive periods for the formation of individual abilities. However, existing data indicates that early childhood development (ECD) in economically vulnerable areas of China is lagging, which is closely related to the lack of parenting knowledge and poor parenting practices.Methods: We conducted a non-masked cluster-randomized controlled trial in a former nationally designated poverty county of China. All 6-36-month-old children and their caregivers living in 18 communities/clusters (10 towns and 8 districts of the county seat) were enrolled in a 9-month parenting training program. In the treatment-group communities, ECD centers were installed where community workers provided parenting training sessions. If caregivers were unable to visit the center, home-based parenting training was offered. No intervention was provided to the control group. Furthermore, we assigned half of the treatment group to receive monthly developmental feedback in addition to the parenting training. Based on the baseline and follow-up data, we investigated the treatment effects on parenting knowledge, attitudes, and practices through Intention-to-Treat (ITT) and Treatment-on-the-Treated (TOT) analyses.Results: We found no effects on the parenting knowledge and attitudes of the caregivers but significant effects on the parenting practices. The effects were heterogeneous among families with different characteristics. Specifically, on average, the program had the largest effect on internally oriented caregivers, mothers with higher education, and mothers who are primary caregivers. We want to emphasize that, although the ITT effect on parenting practices (the average treatment effect) were stronger for mothers with higher education, the TOT effect on parenting practices (the local average treatment effect, LATE) were stronger for mothers with less education. That is, even though on average the program helped mothers with higher education, but among complier families, the program benefited mothers with less education.Conclusion: The findings indicate that, at least in the short run, the program can directly change caregivers' parenting practices without changing their knowledge and attitudes. Future studies are needed to investigate whether parenting knowledge and attitudes can change in the long run. [ABSTRACT FROM AUTHOR]

Abstract 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.