Clinical Research Directory

Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women

Time-restricted Eating (TRE) is a dietary approach that limits food intake to 4 - 12-hour windows without intentionally altering diet quality. TRE has several benefits including modest reductions in body weight and fat mass, improved glucose control, and reduced inflammatory markers. While research supports the metabolic and weight related benefits of TRE, there is limited evidence of its effects on physical activity (PA), sedentary behavior (SB) and sleep - the core components of 24-hour Activity Cycle (24-HAC), which is a holistic framework that integrates the three health-related activities. TRE research has largely focused on clinical populations, leaving its feasibility and adherence in healthy younger adults understudied. Within this group, college students' misaligned circadian rhythms and unpredictable schedules may make adherence to TRE challenging, highlighting the need for research on its practicality in this group. These outcomes are also particularly important to investigate in women, considering that SB is more prevalent among college-aged women (69%) compared to men (46%). To address these issues, we will conduct a three-week intervention to study the effects of TRE on the 24-HAC outcomes. College aged women will be screened and enrolled, then assigned to either a control or TRE group. Participants in the TRE group will self-select the timing of their 8-hour eating window which they will maintain throughout the study (with compliance on at least six days per week needed to be considered adherent). The control group will receive a basic nutrition education at the start of the study and will have no restriction on eating times. 24 HAC behaviors will be measured continuously for one-week of baseline measurement and throughout the intervention by wrist-worn ActiGraph GT9X monitors. Participants will also record the timing of their first and last meal each day and receive periodic reminders to report their hunger and satiety ratings using visual analog scales.

Feasibility of Choose to Move Replacement Ready

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goal of this observational study is to learn if the adapted program, Choose to Move Replacement Ready (CTM-RR), is feasible to deliver to people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

Active Pauses for Musculoskeletal Disorder Prevention in Workers

The goal of this clinical trial is to learn if short exercise breaks at work can prevent muscle and joint pain in workers. The main questions it aims to answer are: Do strength exercises help workers move better and feel less pain? Are strength exercises better than stretching exercises for worker health? Researchers will compare a strength exercise program to a mobility (stretching) program to see which one works better to improve physical health and work ability. Participants will: Perform short exercise breaks (5 minutes) at their workplace every day for 8 weeks. Attend one supervised session per week to learn the exercises. Complete simple physical tests (like standing up from a chair) and answer surveys about their health at the start and end of the study.

School-based Active Play Intervention to Facilitate Movement Behaviours and Fundamental Movement Skills in Primary School Children of Bangladesh

Background In Bangladesh, many children do not get enough opportunities for active play because safe play spaces are limited, school culture often prioritises academic success over physical activity, and many families have safety concerns about outdoor play. These factors reduce the time children spend being active, despite the fact that active play is known to be crucial for children's healthy growth and development. Active play helps children move more, stay physically fit, and develop important social and emotional skills such as teamwork, confidence, and enjoyment. It also supports motor skill development, which includes basic skills like running, jumping, throwing, and catching. The lack of active play in everyday life suggests a strong need for school based programs that can safely introduce regular, structured, and enjoyable physical activity opportunities for children. Objective The main objective of this study is to find out whether a school based active play program can help children increase their daily physical activity, reduce the amount of time they spend sitting, and improve their sleep patterns. The study also aims to examine whether the program improves children's fundamental movement skills, such as running, jumping, throwing, and catching. Methods This study will use a randomised controlled trial design. Randomisation will be at the school level to ensure fairness and reduce bias. This study will test a 12-week school-based AP programme designed to help primary school children in Bangladesh be more active, sit less, sleep better, and improve their basic movement skills. The study will involve eight primary schools, with each school acting as one cluster. Four schools will receive the AP programme and the remaining four will continue their usual routine. About 43 children from each school will join, giving a total sample of around 343 students. Eligibility Criteria Children can take part if they are students at a primary school, healthy, staying in their school for at least six months, able to understand basic Bengali or English, and are Bangladeshi citizens. Children will not be included if they are outside the age range, not attending school, or regularly involved in organised sports, dance, or athletic training. These rules help ensure that the programme is safe and that the comparison between the AP group and the control group is fair. Intervention Description The AP programme will run twice a week for 60 minutes. Each session will include 30 minutes of free play where children choose their own games and 30 minutes of researcher-led guided play. Activities will help children practise running, jumping, throwing, catching, and other fundamental skills. Weekly themes will keep the sessions enjoyable. Students will earn activity points for being active during sessions, reducing screen time at home, and following healthy sleep routines. Each week, the top three "Active Champions'' from every school will receive a small reward. Orientation Sessions Before the programme begins, orientation sessions will be held for parents, teachers, and children. Parents will learn how to support safe play at home, especially when outdoor play is limited due to dengue or safety concerns. They will also receive tips on reducing screen time and encouraging good sleep habits. Teachers will be trained to integrate active breaks, organise movement-friendly classrooms, use outdoor areas safely, and give feedback to students. Children will learn why active play is important and how it can help their health, learning, confidence, and friendships. Data Collection Plan Data will be collected at three time points: before the programme (T1), immediately after 12 weeks (T2), and eight weeks later (T3). Researchers will collect questionnaire responses, measure height, weight and use wrist-worn accelerometers to measure physical activity, sitting time, and sleep. Teachers and parents will help children wear the devices correctly and keep usage records. Fundamental motor skills will be assessed using the (Test of Gross Motor Development) TGMD 3 tool. Data Analysis Researchers will check all data for accuracy and compare results between the AP and control groups. The study will examine changes in PA, sedentary behaviour, sleep patterns, and FMS. It will also explore whether age, gender, or family background affects how children respond to the programme. The results will help determine whether the AP programme is practical for Bangladeshi schools and effective in improving children's movement behaviours and FMS. Expected Results It is expected that children who participate in the AP program will show clear improvements in PA levels, movement skills, sitting time, and sleep patterns compared with children in the control group. Schools may also learn simple and low-cost ways to support children's activity within limited time and space, making the program valuable beyond the study itself.

Combining Physical Activity and Sedentary Interventions to Improve Cardiometabolic Health

Many adults spend a large part of their day sitting, especially at work. Long periods of sitting and not moving enough can increase the risk of health problems such as heart disease and type 2 diabetes. This risk is even higher in people who have early warning signs like being overweight, having high blood pressure, or problems with blood sugar. Together, these problems are called metabolic syndrome. The goal of this study is to find out whether combining regular exercise with reducing sitting time during the day can improve heart and metabolic health more than exercise alone. About 40 adults between 18 and 65 years old who work mainly at a desk and sit for more than 9 hours a day will take part. All participants will first continue their normal daily routine for two weeks. After that, they will be randomly placed into one of two groups for eight weeks: Exercise group: Participants will follow the World Health Organization guidelines for physical activity. This includes two sessions of moderate exercise each week (such as brisk walking or cycling) and one session of more intense exercise each week. Exercise plus less sitting group: Participants will do the same exercise program, but they will also be encouraged to sit less during the workday. They will be asked to stand more, use sit-stand desks if possible, and avoid sitting for longer than one hour at a time. Participants will visit the research center three times for health tests. These tests include blood samples to look at blood sugar, insulin, and fats in the blood, measurements of blood pressure and heart function, body composition scans, fitness tests, and questionnaires about sleep, diet, and quality of life. They will also wear activity monitors to measure how much they sit, stand, and move. The main outcome is how the body handles sugar (insulin sensitivity). The researchers hope to learn whether sitting less, in addition to exercising, leads to better improvements in heart and metabolic health. The results may help develop better lifestyle advice to prevent heart disease and diabetes in people with desk jobs.

Frequency of Interrupting Sitting and Cognitive Function

Rationale: Sedentary behavior (SB) has been associated with impaired cognitive function in elderly, and negatively impacts glucose metabolism. Interrupting sitting with physical activity (PA) bouts may exert beneficial effects on cognitive function via an improved glucose metabolism. Nevertheless, the impact of breaking up prolonged sitting with various frequencies of PA bouts remains unexplored in young sedentary adults. Moreover, we hypothesize that the pattern of the breaks modifies the effects. Thus, randomized controlled trials (RCTs) are highly needed to investigate the effects of interrupting sitting with different frequencies of PA on cognitive function and glucose metabolism. We now hypothesize that interrupting sitting with different frequencies of walking breaks differentially affects cognitive function and glucose metabolism. Objective: The aim is to investigate the effects of breaking up sitting with different frequencies of PA bouts on cognitive function and glucose metabolism in young sedentary adults. Study design: A randomised, controlled cross-over study will be performed, consisting of four interventions in a counterbalanced order: uninterrupted prolonged sitting, short breaks, moderate breaks, and long breaks. Intervention: Participants will complete four conditions in a randomized, counterbalanced order: sitting (uninterrupted prolonged sitting without any interruptions), short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes during the intervention). Each condition lasts 4.5 hours.

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.

Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study

The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.

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.

E-Bike Commuting and Health in Overweight College Students

This study will evaluate the effects of using a pedal-assist electric bicycle (e-bike) for commuting on physical activity, fitness, and health in overweight or obese college students. Participants will be randomly assigned to either a 12-week e-bike commuting intervention or a control group. The study will measure changes in cardiorespiratory fitness, body composition, blood biomarkers, physical activity, and psychological well-being over a 24-week period.

Education and Literacy for an Active Life (Educação e Literacia Para Uma Vida Ativa)

Health literacy is essential for children to develop healthy behaviors that persist into adulthood. It enables the access, understanding, evaluation, and application of health-related information, being a key component of health education. This study was designed as a randomized controlled study, aiming to analyze the effectiveness and feasibility of a school intervention to improve health literacy of 5th and 6th grade students on nutrition, physical activity, sleep, and mental health. Intervention will be delivered in two phases. Phase 1 will involve a pilot intervention comprising four sessions conducted over a three-month period in two schools representing distinct socioeconomic contexts. Phase 2 will scale the intervention nationally, expanding to include additional schools across Portugal. This phase will include eight sessions conducted over one entire school-year (September-June), and will integrate adjustments based on the limitations and insights identified during the pilot study. Phase 2 will additionally include 20-month follow-up assessments to be performed at the end of the following school-year (20-month).

Sedentary Activities and Passive-to-Intense Effects on Neuro-Cognitive States

Prolonged sedentary behavior is linked to poorer metabolic health, yet its effect on cognitive load and brain function remains unclear. Evidence indicates that "mentally active" sedentary tasks (e.g., reading) may support cognition, whereas "mentally passive" tasks (e.g., scrolling social media) may impair it. The cognitive demands associated with these behaviors across the general population are still poorly defined. This project will compare the acute neurophysiological and perceptual responses elicited by mentally active versus passive sedentary tasks across various age groups and in individuals with specific health conditions (i.e., obesity), clarifying how these behaviors differ in the cognitive load they impose. Neuro-cognitive, physiological, and perceptual responses will be assessed with a multimodal battery that includes portable electroencephalography combined with functional near-infrared spectroscopy (EEG + fNIRS; MUSE), eye-tracking (Pupil Core), alertness and visual fatigue via critical flicker fusion testing (CFFT; Lafayette Instrument), autonomic balance through heart-rate variability (HRV) recorded with a Polar H10 monitor, and the self-reported cognitive load assessed using the NASA Task Load Index (NASA-TLX). We hypothesise that mentally passive sedentary activities will elicit a lower cognitive load than mentally active tasks. By comparing different age groups and health conditions within a single protocol, the study will generate an initial set of group-specific data; subsequent independent studies can build on these findings to explore moderation effects in greater depth. Collectively, the results will provide both the theoretical rationale and the empirical evidence needed to sustain the "mentally active" versus "mentally passive" terminology in sedentary-behaviour research, with the ultimate aim of improving mental and cognitive health.

Protocol for a Quasi-experimental Controlled Study to Reduce Sedentary Lifestyle in Patients With Type 2 Diabetes

The prevalence of diabetes has increased worldwide, making it the most prevalent metabolic disorder. Physical inactivity contributes to the progression of this disease and aggravates other comorbidities, such as obesity and cardiovascular disease. Beneficial strategies aimed at promotion and healthy aging, oriented to decrease sedentary behavior, are necessary to obtain desirable metabolic effects and improve the quality of life of people with diabetes. The objective is to examine, through a clinical trial, the effect of decreasing sedentary time and increasing motivation to adopt an active lifestyle on different clinical, anthropometric and biochemical parameters in patients diagnosed with type 2 diabetes mellitus.

Impact of a Physical Activity Program on the Mental Health of Medical Students.

University students frequently adopt a sedentary lifestyle with low levels of physical activity, leading to a deterioration in their health. A significant number of them also suffer from social isolation. Moreover, numerous studies have highlighted the vulnerability of university students (particularly those in medical programs) to mental health issues. Medical students, with their demanding academic curriculum, are no exception to this trend. A student association at the Lyon Est Faculty of Medicine reported that students' mental health is very low (2022): at least 1 in 2 students has experienced a depressive episode, and 1 in 3 has had suicidal thoughts during their studies. Other recent studies indicate that medical students at Lyon Est exhibit high levels of stress, low self-confidence, and excessive sedentary behavior (ECOSTRESS and ECOSPERF studies, 2021, 2022, and 2023). Unfortunately, in 2024, new mental health surveys among medical students from the second year through the end of their internship continue to confirm these findings. The SANTE project aims to offer solution to student to a highly effective means of improving both their mental health and their level of physical activity throught an intervention program. More precisely, the goal of this interventional study is to evaluate the impact of a physical activity program on the mental health in second-cycle medical students at the University of Lyon 1. The development of the SANTÉ program was based on (i) data from the literature, (ii) results from a previous local study (IRB No. 2024-07-02-03) that identified student needs through individual interviews and focus groups, and (iii) local findings from a co-construction workshop with students.

Team-based Learning Intervention to Prevent Risk Factors for Chronic Diseases - a Cluster Randomized Trial

Background: Chronic diseases, such as cardiovascular diseases, diabetes, and cancer, are a major global health issue. Their modifiable risk factors, including poor diet, physical inactivity, irregular sleep, tobacco use, and excessive alcohol consumption, often emerge during adolescence and persist into adulthood. Early educational interventions can promote healthy habits and reduce their prevalence. Team-Based Learning (TBL), an active teaching method, has demonstrated effectiveness in improving knowledge and behaviors essential for a healthy lifestyle. Objective: evaluate whether a TBL-based educational intervention can improve adolescents' knowledge and habits related to chronic disease risk factors. Methods: A cluster randomized controlled trial (cRCT) will be conducted in public schools in Palmares, Brazil, targeting high school students aged 15-19 years. Fourteen schools will be randomly assigned to intervention and control groups. The intervention, consisting of four TBL modules, will cover healthy eating, physical activity, screen time, sleep, tobacco, and alcohol use, delivered by graduate nursing students under faculty supervision. Data collection will take place at three time points: pre-intervention, post-intervention, and three months later. The control group will continue receiving standard health education. Primary outcomes will assess behavioral changes, while secondary outcomes will analyze body mass index (BMI) and blood pressure. Analysis: Data will be analyzed using SPSS, with descriptive statistics, paired and unpaired t-tests, ANOVA, and chi-square tests. The analysis will account for clustering and be conducted using intention-to-treat analysis. Statistical significance will be set at p\<0.05. Conclusion: The study will provide evidence on TBL as a scalable tool for preventing risk factors in adolescents, contributing to long-term public health benefits.

Robot-based Intervention to Improve Physical Activity in Older Adults

Physical inactivity is considered a global pandemic negatively impacting the health of over 60% of older adults in America. Interventions aimed at improving physical activity in older adults focus on training reflective processes such as providing information on health benefits of physical activity. These interventions generally find that participants improved their intentions to be physically active rather than supporting actual change in behaviours to become physically active. There is growing support for the idea that human behaviour is the result of a combination of quick automatic processes and slower reflective processes. Interventional studies have used cognitive bias modification tasks that target the quick automatic processes to retrain participant's bias. Such studies find that participant's bias towards diet, alcohol, and phobias can be altered using these cognitive bias modification tasks. In this study, the investigators developed a new training task using a robotic device that aims to retrain automatic bias towards physical activity and sedentary behaviours. The robotic device allows greater immersive environments for participants to interact with and be more engaged with the cognitive bias modification task. This interventional study is testing whether this new robot-based training and the protocol for assessing physical activity is feasible for retraining older adults' bias towards physical activity and sedentary behaviour. Participants will be examined on their daily physical activity using an accelerometer, their physical ability using functional tests, and their perceptions on physical activity using questionnaires. To determine whether this protocol is feasible, the investigators will examine participant recruitment and retention rates.

HIIT Vs Snack Exercises on the Academic Stress of University Students

Mental health among Chilean university students has steadily deteriorated since 2020. One of the factors associated with mental health is the academic workload that comes with transitioning from high school to higher education, which may lead to an increase in stress levels due to university life referred to as academic stress. Academic stress has been linked to multiple negative outcomes in university students, such as a lower quality of life, as well as cardiovascular risk markers, including body composition (e.g., higher fat percentage), muscle function, aerobic capacity, and physical activity levels. Academic stress affecting more than 50% of university students represents a health issue that needs to be addressed, not only because it can lead to chronic stress, but also because it increases cardiovascular risk in a Chilean population where more than 10,000,000 people are overweight, obese, or have insufficient physical activity levels. Academic stress and its associated complications represent a prevalent health issue among university students. It is essential to implement interventions that help reduce academic stress while also counteracting its negative effects on quality of life, body composition, muscle function, aerobic capacity, and physical activity levels. Cost-effective tools, both in terms of financial resources and time, are needed. From this perspective, physical exercise meets both requirements, as it is inexpensive to implement and there are various protocols such as high-intensity interval training and "exercise snacks" that can require less than 40 minutes per week while providing beneficial effects on academic stress, body composition muscle function, aerobic capacity, and physical activity levels in university students. Expanding the body of evidence on these different training protocols would allow us to address multiple issues simultaneously. The primary one is academic stress and its related consequences, but also to generate new evidence on aspects not yet covered in the current literature, such as the impact on university students' quality of life, and to provide an accessible treatment tool for the future. Importantly, implementing these short-duration programs would also enable students to maintain their academic responsibilities, as the proposed protocols require no more than 40 minutes per week (\<10 minutes per day). Finally, these programs could be implemented within university facilities, which, in the long term, could become a permanent tool for improving students' university experience.

Impact of MBI on Biopsychosocial Factors and QOL in Children With Primary Headaches

* The Randomized Controlled Trial aims to evaluate the effectiveness of a Mindfulness-Based Intervention (MBI) in improving the quality of life and reducing psychological distress in children with primary headaches. This study focuses on children aged 8 to 12 years who experience primary headaches and aims to investigate the biopsychosocial factors influencing their well-being. * The primary objectives of this study are: * To assess the levels of mindfulness, emotional regulation, childhood traumatic experiences, psychological distress, and quality of life in children with and without primary headaches. * To identify the key biopsychosocial factors that impact the quality of life in children experiencing primary headaches. * To evaluate the effectiveness of mindfulness-based interventions in reducing psychological distress and enhancing the quality of life post-intervention. * To compare the differences between the intervention and control groups regarding their biopsychosocial well-being before and after the intervention. * To determine the long-term impact of the mindfulness-based intervention on psychological distress, quality of life, and headache frequency at a three-month follow-up. * Participants in the study will be screened from an initial survey, based on those experiencing headaches and randomly assigned to intervention and control groups. The intervention group will undergo a structured mindfulness-based program, while the control group will receive standard care. Data will be collected at baseline, post-intervention, and during follow-up assessments to measure the intervention's impact. * This study is significant as it aims to address the gaps in current research regarding pediatric primary headaches and their effect on psychological and social well-being. The findings may provide valuable insights for healthcare professionals to develop effective, non-pharmacological interventions to improve the quality of life of children suffering from primary headaches in Pakistan.

Floor Sitting Study

The goal of this clinical trial is to evaluate the impact of different sitting environments on general well-being and movement patterns in healthy young adults aged 18-35. The main questions it aims to answer are: Does floor sitting lead to increased movement and postural changes compared to chair sitting? Over a month-long period, how does sustained floor sitting influence overall well-being, posture, and movement habits? Researchers will compare the effects of chair sitting and floor sitting in a controlled lab environment (Aim 1) and observe the longer-term effects of habitual floor sitting in participants natural environments (Aim 2) to see if consistent floor sitting promotes more dynamic movement and comfort. Participants will: Undergo two 30-minute experimental sitting sessions, one in a chair and the other on the floor, while engaging in typical desk activities (Aim 1). Participate in a month-long study where they integrate an hour of floor sitting into their daily routines, recording their experiences and any changes in sitting habits through daily diaries and in-depth interview (Aim 2).