Clinical Research Directory

Organizational Strategies and Psychosocial Skills for Maintaining Physical Activity After a Depressive Episode: a 3-month Post-rehabilitation Study.

With nearly 280 million people affected worldwide (2022), the management of depression represents a major public health issue. The study titled "Organizational Strategies and Psychosocial Skills to Maintain Physical Activity after a Depressive Episode: A 3-Month Post-Rehabilitation Study" (AP\&Depression) fits within this context. Physical activity (PA) is now recognized as an effective complementary therapy to pharmacological and psychotherapeutic treatments, helping to regulate mood and reduce depressive symptoms. However, despite these proven benefits, individuals who have experienced a depressive episode often struggle to maintain regular physical activity once they leave the hospital setting. This study aims to identify the mechanisms that influence the continuation of PA after hospitalization by exploring organizational strategies, psychosocial skills, and individual determinants involved in this process. Depression is a debilitating illness characterized by persistent sadness, loss of interest, chronic fatigue, and impaired cognitive and physical abilities (DSM-5, 2013). Among the aggravating factors, sedentary behavior plays a key role, whereas PA is associated with a significant reduction in the risk of relapse. Yet, 67.8% of individuals with depression do not meet the recommended 150 minutes of weekly PA, and this figure rises to 85.7% when activity is measured objectively. This situation is explained by several barriers: lack of motivation, low self-efficacy, fluctuating mood disorders, social isolation, and limited access to exercise facilities. Conversely, certain factors facilitate the resumption of PA after a depressive episode, including structured support, the establishment of routines, social support, and therapeutic education. The study relies on a qualitative methodology using semi-structured interviews conducted with 15 patients who stayed at the Rehabilitation Center of the Clinique des Portes de l'Eure. Participants are selected according to the following criteria: aged over 18, medically diagnosed with a depressive episode, underwent rehabilitation, and completed an initial assessment at the Maison Sport Santé. They will be interviewed three months after discharge to explore their PA practices. Data will be analyzed using NVivo software, following the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. The analysis of transcripts will help identify the organizational strategies implemented, the psychosocial skills involved, and the individual determinants influencing the maintenance of regular PA. The expected results should highlight that patients adopt various strategies to maintain PA after hospitalization. Session planning, the gradual integration of PA into daily life, and the anticipation of obstacles are major levers for establishing a sustainable routine. In addition, psychosocial skills, such as stress management and interaction with a support network, emerge as essential elements for maintaining regular physical activity. However, several obstacles may be identified, including persistent fatigue, mood fluctuations, lack of organization, and social isolation. These findings underscore the importance of personalized support after rehabilitation, particularly through mechanisms such as Patient Therapeutic Education (PTE) or individualized follow-up in Maisons Sport Santé. The aim of this study is to shed light on the mechanisms that enable individuals who have experienced a depressive episode to autonomously maintain physical activity after hospitalization. This research seeks to provide concrete recommendations for improving support during and after hospitalization to enhance adherence to PA. The study's conclusions could contribute to the development of new therapeutic approaches aimed at improving patients' quality of life.

eMOTION: Examining Implicit Attitudes in Physical Activity Engagement

This early-phase trial will test intervention strategies to influence implicit attitudes towards physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

The Effect of Screen to Move Program in Preschool Children

The aim of this study is to determine the effect of the developed program on screen usage time and physical activity for pre-school children.

On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial

This study will evaluate a program called On Track for Wellness (OTW) which is being adopted by the Illinois Department of Human Services' Division of Behavioral Health \& Recovery (DBHR) for use in all state-funded early psychosis programs in Illinois. OTW combines use of Fitbit activity trackers with health education, goal setting to promote health activation, and ongoing support for maintaining healthy lifestyles. Successful completion of this research will gauge the effectiveness of this program in improving sleep hygiene and increasing physical activity among people recently diagnosed with schizophrenia or other psychotic disorders.

Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN

The goal of this interventional study is to prevent childhood obesity in children aged 6-12 years in Chiba City, Japan. The main questions it aims to answer are: * Does the multi-component intervention for environments around children reduce the BMI z-score of children aged 6-12 years after one and two years? * Does the multi-component intervention for environments around children improve the health-related quality of life (assessed by KIDSCREEN-10) of children aged 6-12 years after one and two years? Researchers will compare school clusters receiving the intervention to control clusters to see if the intervention package promotes healthy eating, increases physical activity, improves health-related quality of life, and reduces obesity prevalence. Participants will: * Attend elementary schools within participating clusters (either the intervention or control group). * Have baseline data collected, with follow-up assessments after one year and two years. * Potentially participate in school-based programs (nutrition education, physical activity promotion) and community-based initiatives (park activation, supermarkets) if in an intervention cluster. * Have their physical activity and dietary behavior assessed through self-report questionnaires.

The Sleep2BWell Trial

Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health, in conjunction with other lifestyle behaviors, can improve CMH through complementary or synergistic pathways, most existing lifestyle change programs focus solely on diet and physical activity. Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program, an ongoing 4-week program for promoting CMH through healthy diet and physical activity, delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods. The enhanced 6-week intervention, Sleep2BWell, will include the following additional components: 1) two sleep health education and group coaching sessions, 2) self-monitoring and motivational enhancement using a Fitbit, and 3) addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution. A total of 10 community sites will receive the intervention enrolling an average of 15 participants per site for an expected sample of 150. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline and 10 weeks (primary endpoint). The investigators hypothesize that Sleep2BWell will improve CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes). To ensure the successful completion and future expansion of this work, this study will use mixed methods to understand implementation determinants and outcomes, guided by implementation science frameworks. This first-of-its-kind effectiveness-implementation study, addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies, will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings. This innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions.

Physical Activity Recommendation Behaviour in German Psychiatrists

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors

This clinical trial aims to evaluate an interactive, culturally relevant digital health promotion comic designed to support healthy dietary and physical activity behaviors among Black/African American and Latino children ages 8 to 12 years. The comic allows children's choices to affect the storyline and health content, with the goal of increasing engagement, empowering children, and improving attitudes, beliefs, and self-efficacy related to healthy behaviors. Caregivers will also receive newsletters reinforcing healthy dietary and physical activity behaviors at home. The main questions it aims to answer are: 1. Does an interactive, customizable "choose-your-own-adventure" style comic lead to greater engagement and acceptability compared to standard digital comic formats? 2. Is greater engagement with the comic associated with improved self-efficacy related to dietary and physical activity behaviors? Researchers will compare three study groups to evaluate differences in engagement, acceptability, and self-efficacy outcomes related to dietary and physical activity behaviors. Participants will: * Use a 6-week digital comic and health promotion website remotely * Complete surveys about engagement, attitudes, beliefs, and self-efficacy related to healthy behaviors * Receive periodic reminders and support messages during the intervention period * For caregivers in the enhanced and non-enhanced comic groups: receive newsletters promoting healthy dietary and physical activity behaviors at home

Effectiveness and Implementation Evaluation of NeoMayor for Improving Cardiovascular Health in Chilean Older Adults

This study aims to evaluate the effectiveness and implementation of NeoMayor, a mobile health (mHealth) intervention designed to improve cardiovascular health among older adults at elevated cardiovascular risk in Chile. NeoMayor is a smartphone-based application that provides personalized guidance on physical activity, diet, sleep, and mental well-being through a multidomain lifestyle approach. This multicenter randomized controlled trial will enroll community-dwelling older adults aged 55 to 75 years recruited from primary healthcare centers in urban and rural settings. Participants will be randomized in a 2:1 ratio to either the NeoMayor intervention or a control group receiving standard health information and usual care. The intervention duration will be four months. The primary objective is to determine whether NeoMayor improves cardiovascularhealth, measured with the Life's Essential 8 Cardiovascular Health Index (CVHI).Secondary objectives include changes in cognitive performance, depressivesymptoms, anxiety symptoms, quality of life, physical performance, and urinaryalbumin-to-creatinine ratio (UACR). This is a Hybrid Type 1 effectiveness-implementation trial. As an exploratory aim, participants in the NeoMayor arm are further randomized (2x2 factorial) to receivethe app with or without human health coach support, and with or without a wearable device, both used as implementation support strategies. The study will describe engagement, adherence, retention, and maintenance of app use over four months.This aim is hypothesis-generating; the trial is not powered to compare implementation strategies.

Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education

The goal of this cluster-randomized, controlled trial is to learn if a professional development program for childcare educators, called the Boston Healthy Child Care Initiative, can help improve the nutritional quality of meals/snacks served and the availability of physical activity opportunities in childcare programs, and also to learn if this results in improved diet quality and physical activity for young children who attend childcare, especially in under-resourced settings. The main questions it aims to answer are: Do childcare programs that receive professional development through the Boston Healthy Child Care Initiative improve the nutritional quality of the meals they serve, as measured by the Healthy Eating Index (HEI-2020), and do they also provide more physical activity opportunities to young children throughout the day? Do young children (ages 2-5 years) attending childcare programs that receive the Boston Healthy Child Care Initiative eat more nutritious foods/beverages (as measured by the HEI-2020) and engage in less sedentary time at childcare? Researchers will compare a group of childcare programs who participate in the Boston Healthy Child Care Initiative, and a sample of children who attend those programs, to a similar group of childcare programs who do not participate to see if the quality of meals served, the amounts of physical activity opportunities scheduled, young children's dietary quality, and the minutes/day spent in physical activity increase from before to after the Boston Healthy Child Care Initiative. Childcare educator participants will: * Complete the Boston Healthy Child Care Initiative professional development program (for the intervention group only) * Share copies of menus, schedules, and written policies about nutrition and physical activity in the childcare program Child participants will: * Wear ActiGraph wGT3X-BT accelerometers for two days while at childcare to measure physical activity levels. They will do this for two days each at baseline, midline, and follow-up after the initiative concludes. * Be observed during mealtimes by trained researchers to visually estimate how much they consume at meals and snacks in childcare.

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both

Physical Recovery During Bracing After Ankle Fracture (Re-BAF)

Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels. Standard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications. However, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity. The Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture \[BAF\], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire (\[MOXFQ\], primary BAF outcome) after ankle fracture. The aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.

Evaluating an Implementation Strategy to Improve Physical Activity and Reduce Cardiovascular Risk Factors in Children

The purpose of this study is to evaluate the impact of enhanced Movement for Academic Growth In Classrooms (MAGIC) for improving implementation and effectiveness of physically active breaks, lessons, and motor labs

Newenkantun: a Play-based Program to Promote Socioemotional Learning in Early Childhood Education in Chile.

What is this study about? This study will test a program called "Newenkantun" (which refers to a hand-strength game in Mapuche culture) designed to help young children develop important social and emotional skills through play and physical activity. The program focuses on helping children learn how to understand and manage their emotions, get along with others, and make good decisions - skills that are important for success in school and life. Why is this study being done? The early years of childhood are a critical time for developing social, emotional, and physical skills. Many children, especially those from low-income families, face challenges that make it harder to develop these skills. This study will test whether a program that combines active play, social-emotional learning, and family involvement can help young children in the Araucanía region of Chile develop these important abilities. The program also aims to help children be more physically active, spend less time on screens, and get better sleep - all of which are important for healthy development. Who can participate? Children ages 4-6 years old (attending transition levels 1 and 2 in early childhood education) in the cities of Temuco and Padre Las Casas in the Araucanía region of Chile. Both their teachers and parents/guardians will also participate in the program. What will participants do? Children will participate in play-based activities at their schools over 16 weeks. These activities use storytelling and imaginative play (like pretending to be different characters) to help them practice social and emotional skills. The activities respect and incorporate the cultural background of the Araucanía region, including Mapuche cultural elements. Teachers will receive training and support (both in-person and online) to learn how to teach social-emotional skills and promote healthy movement behaviors in their classrooms. They will receive materials and kits to help them run play activities. Parents and guardians will receive support through an online platform, app, social media, and printed materials. They will learn about the importance of social-emotional development and healthy movement habits, and get practical tips for supporting these at home. The program includes 8 topics delivered over 4 months, with each topic taking about 30 minutes to complete. What will be measured? Researchers will measure: Children's social and emotional skills (like managing emotions, getting along with others, and making responsible decisions) Physical activity levels, screen time, and sleep patterns Motor skills and thinking abilities Teachers' confidence and practices in teaching social-emotional skills Parents' support practices at home The school environment and how well it supports these skills These measurements will happen at the beginning of the program, at the end, and at follow-up visits 3, 6, and 12 months after the program ends. How is the study designed? The study uses a "stepped-wedge" design, which means that 10 schools will start the program at different times, chosen randomly. This design allows all schools to eventually receive the program while still allowing researchers to compare results. Each school will participate for 16 weeks, and researchers will follow what happens afterwards to see if the benefits last over time. What are the potential benefits? If successful, this program could provide a practical, culturally appropriate way to help young children develop important social, emotional, and physical skills during a critical time in their development. The program is designed to be sustainable and could potentially be used in other schools and communities in the future.

StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time

Our goal in this study is to further refine StandUPTV, an application designed to reduce SST in adults in our first study (ASU IRB # STUDY00012109), for the StandUPTV Habits program. This program aims to establish a non-sedentary habit triggered by an alert from the StandUPTV application after participants engage in approximately 30 minutes of SST in the evening.

Guided Physical Activity Counseling: A Pilot Study

This 1-arm pilot study will test the feasibility of recruitment and use of the Physical Activity Counseling Tool (PACT) in 40 UC San Diego Health patients.

PeerScreen Trial - Reducing Screen Media Use in Peer-groups of Young People

The purpose of the PeerScreen trial is to investigate whether reducing screen media use affects mental health, social interaction, sleep, physical activity, heart rate variability, and behavioral patterns in young people aged 13 to 24 years. The primary question the trial aims to answer is: Does reducing screen media use over a 4-week period improve mental health among young people? Researchers will compare a screen media reduction intervention with a control condition in which participants continue their usual screen media use to determine whether reducing screen media use leads to improvements in mental health. Participants will: * be allocated to either a 4-week screen media reduction intervention or a control condition * complete a study protocol including questionnaire-based assessments, daily self-reports, and objective monitoring of screen media use, sleep, physical activity, heart rate variability, social interactions, and geolocation

Optimizing Cardiometabolic Health, Cognition and Academic Performance in Children (HAPHC)

Children and young people are moving less and less. In combination with an unhealthy diet, this has led to a sharp increase in overweight and obesity among children worldwide. Very often, physical illnesses occur in adolescence that can be directly attributed to the overweight and obesity. In order to protect children from these consequences in time, a daily exercise unit of 45 minutes is built into their learning. This exercise will take place in addition to physical education classes as part of your child's school day and will be conducted by a teacher. We will examine the children of the participating schools with regard to health-related characteristics.

Multiple Sclerosis Severity and Caregiver Health Outcomes

This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.

Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet

The study consisted of a non-randomized controlled clinical trial with measurements at baseline and at the end of a 16 week intervention. Participants will be assigned to the intervention or control group according to their own choice and convenience. A 4 arm split was performed where the Veg-Int group was composed of people on a vegan diet who participated in the intervention, the Veg-Con group was composed of people on a vegan diet who were part of the control group, the Omn-Int group was composed of people on an omnivorous diet who participated in the intervention, and the Omn-Con group was composed of people on an omnivorous diet who were part of the control group. The Veg-Int and Omn-Int intervention groups, participated in a physical exercise program in remote modality through a digital mHealth platform. During the 16 weeks of intervention, a total of 50 training sessions were carried out, distributed in three sessions per week, with a duration per session ranging from 40 to 50 minutes. The exercise program was designed and supervised by a physical education teacher and focused on strength training using body weight exercises targeting the major muscle groups, including upper body, lower body and abdominals. The platform recorded participants attendance and the time they spent on each exercise session. At the end of the sessions, participants had the option to evaluate and share their perception of effort during the workout through a Modified Borg scale (0-10). In addition, they were given the opportunity to communicate with the teacher via phone call, text message or e-mail, to receive feedback or raise doubts.

Prediction of Chronic Disease Using Explainable Hybrid Machine Learning

In this study, a 28-item questionnaire developed by the researchers (Aysun Atacan and Gülşen Taşkın) will be used as the data collection tool. Since the intellectual property rights and developer identity belong to the researchers, there are no copyright or usage restrictions. Containing both qualitative and quantitative evaluation questions, the questionnaire consists of 5 main sections: personal information, daily life assessment, walking level assessment, household chores assessment, and work/workplace assessment. Eight of the questions cover sociodemographic information, while 20 focus on determining and evaluating physical activity levels in daily life, walking, home, work, and transportation. Participants are asked to answer the questions by considering their lifestyle over the past month. Based on these data-recorded according to how many days per week and how many minutes per day the activities are performed-calculations will be made by multiplying the MET value, frequency (days/week), and duration (minutes/day) to obtain the "MET-min/week" score. Participants will be categorized into three groups based on their total weekly MET expenditures: \<600 MET-min/week as inactive, 600-3000 MET-min/week as minimally active, and \>3000 MET-min/week as health-enhancing physically active (sufficiently active); and into groups based on their average daily step counts: \<5000 as sedentary/inactive, 5001-7499 as low active, 7500-9999 as somewhat active, 10000-12499 as active, and \>12500 as highly active. Chronic disease risk predictions will then be evaluated via machine learning based on these physical activity levels and step counts. The primary aim of this research is to quantitatively demonstrate the impact of physical activity levels and lifestyle habits on chronic disease risk factors using machine learning (ML) methods. The models to be developed aim not only for high predictive performance but also for the clinical interpretation of which physical activity parameters are more decisive on disease risk, utilizing explainable artificial intelligence methods such as SHapley Additive exPlanations (SHAP). Consequently, the goal is to establish a decision support mechanism for the early detection of individuals at risk and to place personalized exercise prescriptions on a scientific foundation.

Fathers and Children Exercising Together

Children engage in low amounts of activity, which predisposes them to develop health disparities as they age. Fathers may be instrumental in helping to promote physical activity in their children. The current proposal is designed to use community-engaged research methods to develop a physical activity intervention for children in which their fathers are the agents of change, and to determine the feasibility of implementing this intervention.

Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments

Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.