Clinical Research Directory

Recreational Badminton, Sleep and Melatonin

Poor sleep quality is increasingly prevalent among physically inactive young adults and is associated with adverse physical and mental health outcomes. Regular physical activity may improve sleep quality and circadian regulation, although evidence regarding recreational sports remains limited. This randomized controlled trial investigated the effects of a 4 week supervised recreational badminton program on sleep quality and salivary melatonin concentrations in physically inactive young adults. Participants were randomly assigned to either a badminton intervention group or a control group. Sleep quality and salivary melatonin levels were assessed before and after the intervention.

Future School of Comprehensive Well-Being

Good physical, mental and social health, particularly in childhood and early adolescence, are powerful predictors of positive life trajectories. Contrary to this, problems in these domains expose individuals to negative developmental trajectories. Schools are ideal settings to address these issues due to their incisiveness and long-term impact. However, school-based well-being interventions are not designed to be ingrained in basic pedagogical processes of school, this is, learning, teaching and studying. In this study the effects of a school-based pedagogically ingrained comprehensive well-being trial will be studied, involving curriculum embedded socio-pedagogical activities, designed to cultivate simultaneously learning and their mental, social and physical well-being. In the Future School of Comprehensive Well-Being (SchoolWell) Comprehensive wellbeing pedagogy intervention for primary and lower secondary school students: rationale and study protocol for the SchoolWell cluster randomized controlled trial -study the investigators use a cluster randomized hybrid type 1 effectiveness-implementation design. SchoolWell involves 10 Finnish speaking Teacher Training Schools including both primary and secondary schools. Randomization occurs at the school level. The intervention is a multicomponent implementation strategy that has been co-designed by SchoolWell research team and case schools' teachers. All 5th and 8th graders (aged 11-12 years and 14-15 years), from the control and intervention schools are eligible for the study. Total of 1440 students (560 5th and 880 8th graders) will be recruited for the study (n=717 students from intervention schools and n=723 students from control schools). Data is collected from Grade 5 and 8 students representing schools randomized to experimental (n=5) and control condition (n=5). The control group in Year 1 remains on the waitlist until the start of Year 2, when the second cohort of the experiment (low support condition) for these schools begins. The purpose of the low support condition is to examine whether intervention effects can be achieved with less support than in the high support condition, where researchers are more actively involved. Schools allocated to the intervention group deliver weekly SchoolWell activities over the full school year as part of the regular curriculum. The activities include socio-pedagogical activities, these are modes of teaching, learning and studying, promoting student mental, social and physical well-being as well as learning aligned with regular curriculum goals. Intervention schools have access to six implementation support strategies in addition to the training received as usual delivery to build knowledge and skills. Implementation and effectiveness outcomes are assessed using weekly online surveys, interviews at baseline T0 (8/2024), T1 (11/2024), T2 (4/2025) and at 19-month follow-up (T3; 4/2026) and four dialogues with teachers. Semi-structured interviews with teachers and support staff will be used to examine which implementation strategies worked for whom and under what conditions. The primary outcome is study engagement. Secondary outcomes include measures on learning, mental, social and physical well-being. Economic and process evaluations will also be conducted to determine cost-effectiveness, program acceptability, implementation, adaptability, and sustainability in schools. SchoolWell draws on the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Implementation Studies (StaRI) in evaluating the SchoolWell intervention. Also, the Consolidated Framework for Implementation Research (CFIR) is used to guide support strategies. The CFIR provides constructs that have been associated with effective implementation (intervention, outer settings, inner settings, individuals, implementation process). Subsequently, the Proctor's framework is followed to evaluate the implementation process. The framework stands for acceptability (treatment is agreeable or satisfactory), adoption (intention to employ an innovation or evidence-based practice), appropriateness (fit of the innovation to address a particular issue or problem), cost (cost impact of an implementation effort), feasibility (extent to which a new treatment can be successfully carried out in given setting), fidelity (extent how intervention is delivered as intended), penetration (number of providers who deliver treatment), and sustainability (extent to which a newly implemented treatment is maintained). Hypotheses are: H1. SchoolWell 1 intervention will have a positive effect on student-level outcomes (8- and 19-month post-tests). H2. The multidisciplinary intervention enhances both learning and mental, physical, and social well-being.

Optimizing a Technology-based Body and Mind Intervention

Older adults may feel at risk for falling, but do not have a physical risk of falling. On the other hand, some older adults may not feel at risk for falling, but do have a physical risk of falling. This study is being done to test a preventative, in-home exercise program (called PEER) which may allow older adults to improve balance, align the perceived risk for falling with the physical risk for falling, and prevent falls. Participants will be asked to participate in this study for approximately 9 months. This study has three specific aims: 1. Examine differences in balance, fall risk, and physical activity after program completion, follow-up 3 months and 6 months between older adults (OAs) in the Physio-fEedback Exercise pRogram (PEER) intervention and OAs in attention control (AC) condition. 2. Explore differences in exercise adherence and the proportion of shifting in fall risk appraisal and negative self-perception on aging after program completion, follow-up 3 months and 6 months between OAs in the PEER intervention and OAs in AC condition. 3. Explore participants' experiences with the PEER intervention and potential barriers to access and adoption of the technology-based PEER intervention to inform future research.

Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol

This study aims to compare acute thyroid hormone and cortisol responses to aerobic and anaerobic exercise in sedentary women. Thirty sedentary women aged 18-25 years will voluntarily participate in the study. Participants will complete a 20-meter shuttle run test as the aerobic exercise protocol and a 30-second Wingate test as the anaerobic exercise protocol in separate testing sessions. Blood samples will be collected immediately before and after each exercise protocol. Serum thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), and cortisol concentrations will be determined using chemiluminescence-based laboratory methods. Changes in hormone concentrations will be compared between the aerobic and anaerobic exercise conditions.

Promoting Physical Activity in Older Hispanic/Latino(a) Adults

In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington (State) to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).

Exercise From Afar: Progressing At Risk Individuals to Independent Exercise

The purpose of this study is to investigate the efficacy of a technology-driven independent exercise program on health outcomes associated with dementia risk among underactive rural adults. Underactive adults (n=50), ages 40-70 years, from federally designated rural and frontier Kansas counties will be recruited to participate in this study. Specific inclusionary and exclusionary criteria will be used to screen potential participants and determine eligibility. Following recruitment and screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. Following completion of baseline assessments, a personal training/fitness app will be employed to design and deliver exercise programming and track exercise participation, adherence and progression over the course of the study. All prescribed exercise will follow national governing body recommendations and include specific exercises found in previous work to be beneficial for physical health and brain plasticity. The study team will record exercise instruction videos that can be accessed by all participants at any time throughout the study. The particular app used will allow the research team to organize exercise videos into structured training sessions, allowing participants to exercise on their own, at the location of their choice, with ample instruction. The app will also allow participants to record themselves performing various exercises and send them to the research team for analysis of technique and safety. Communication between study personnel and participants will be delivered via the app. Phone calls and/or Zoom sessions will be offered as an alternative if necessary. Our goal is to create a safe, effective means of delivering personalized exercise programming to rural adults that reduces barriers to exercise, improves physical fitness and biomarkers associated with dementia risk and lends itself to exercise adherence in a population that is at an increased risk for cognitive decline. Middle aged adults will be included in the study as they are at an age when successful behavior change is more probable (than older, institutionalized adults); older adults will be included as they are in the high-risk category for dementia. Following the exercise intervention, all baseline assessments will be repeated. Data will be compared to determine the impact of the exercise program on each variable (i.e. dementia risk biomarkers, QOL, physical fitness, etc.).

Gamified Versus Regular Exercise Snacks on Stationary Bikes, as One 10-Minute or Two 5-Minute Sessions a Day, for Children in an Inclusive Primary School

The goal of this pilot clinical trial is to learn how short exercise breaks, often called exercise snacks, on stationary exercise bikes can best be offered during the school day to students in Primary 4 to 6 at an inclusive primary school in Macao, including autistic students. It will also learn whether the program is practical and safe in an inclusive school. The main questions it aims to answer are: When the bike screen shows a game with points and a ranking among the four riders in the group, do students ride farther per scheduled minute than when the same screen shows a regular display with a cartoon cyclist, heart rate, distance and time remaining? Is any extra riding on game days larger when the 10 minutes are ridden at once than when they are split into two 5-minute rides, and is it accompanied by better or worse feelings during and after the ride? When the same 10 minutes are split into two 5-minute rides, do students receive the same riding dose and are they as focused on their classwork afterwards? How many planned rides actually happen and are completed, and what support do autistic students need? The investigators expect students to ride more on game days. Whether that extra riding comes with better or worse feelings, and whether it depends on ride length. The comparison with the waitlist group only estimates how large the differences are, to help plan a larger study. Thirty-two riders ride in fixed groups of four on 3 fixed school days a week for 8 weeks, 10 minutes a day: one 10-minute ride a day for 4 weeks and two 5-minute rides a day for the other 4 weeks. Within each 4-week period, the display shown to a group on each riding day is randomly assigned, with equal numbers of game and regular-display days, and the same virtual tracks are used under both displays. Riders wear a heart-rate arm band and answer a few picture-supported questions before, during and after each ride. Trained observers, who do not know which display or schedule students are on, record how focused students are on their classwork in the lesson after riding. Sixteen waitlist students follow the usual school routine, complete the same assessments, and receive access to the bikes after the study. All students complete a short tablet attention task and questionnaires about exercise motivation and quality of life before and after the 8 weeks.

Community Park-Based Programs for Health Promotion: Active Older Adults Prospective Cohort Study

The Active Older Adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). Duke will perform a secondary analysis of the data collected as part of the Active Older Adults prospective cohort study run by Miami-Dade County Parks and Recreation.

The Effect of Different Exercise Models on Body Fat and Bone Mineral Density in Sedentary Women

The aim of this research is to evaluate the effects of different exercise models on body fat percentage and bone mineral density in sedentary women. Twenty-four volunteer sedentary female participants were divided into four groups using stratified randomization: core exercise group, core-walking group, walking group, and step group. Training protocols lasted for 3 days a week over an 8-week period. Fat and bone mineral density measurements were performed in the department of radiology at Selcuk University Faculty of Medicine Hospital.

Effects of Interrupting Prolonged Sitting With Different Standing Intervals on Vascular Health in Women

The goal of this clinical trial is to examine the effects of interrupting prolonged sitting with different standing intervals on vascular health in healthy women aged 18-45 years. The main questions it aims to answer are: Does interrupting prolonged sitting with short standing intervals (10 minutes every hour) improve blood pressure and pulse wave velocity more than prolonged continuous standing intervals (30 minutes every hour)? Does interrupting prolonged sitting with prolonged intermittent standing intervals (30 minutes every hour divided into three 10-minute standing bouts) improve blood pressure and pulse wave velocity more than prolonged continuous standing intervals (30 minutes every hour)? The researcher will compare three different sitting interruption conditions to evaluate their effects on vascular health outcomes: Standing for 10 minutes every hour. Continuous standing for 30 minutes every hour. Intermittent standing for 30 minutes every hour divided into three 10-minute standing bouts. Participants will: Attend three experimental sessions in random order separated by at least 7 days. Complete 3 hours of sitting with different standing interruption protocols. Undergo measurements of blood pressure, pulse wave velocity, and heart rate before sitting and after each hour of the experiment. Undergo height, weight, and body mass index measurements.

Exercise Snacks Enabled by an mHealth Intervention Delivered in General Practice to Promote a Sustainable Active Lifestyle in Adults With Obesity

Adults with obesity gain as much from regular physical activity as anyone else, but structured exercise programmes are hard to sustain once the programme ends. This trial tests a different approach, built around exercise snacks, that is short bouts of activity of a few minutes at a time, spread through an ordinary day. Physically inactive adults aged 18 to 65 with obesity are invited by their own general practitioner. Everyone who takes part receives a wrist-worn activity tracker and keeps it at the end of the study. Participants are allocated at random in two steps. At the start, two out of every three take part in a six-month programme of supervised group exercise sessions and individual counselling based on motivational interviewing. The remaining third receives the tracker together with brief standardised advice on physical activity. After six months, everyone who took part in the programme is allocated at random a second time, half and half: one half receives an automated conversational agent that supports them by message for the following twelve months, and the other half receives no further support. The trial asks two questions. First, whether the six-month programme increases physical activity compared with the tracker and brief advice alone. Second, whether the automated conversational agent helps participants sustain their activity over the following year. Physical activity is measured with a research-grade accelerometer worn on the wrist for one week at the start, at six months and at eighteen months. Aerobic fitness, cardiometabolic blood markers, physical function and wellbeing are measured at the same three visits.

Wakaya: Rising Up for Choctaw Youth Health

Investigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.

An Intervention to Reduce Sedentary Behavior and Promote Physical Activity in Colorectal Cancer Chemotherapy

This single-group feasibility study develops and evaluates an intervention designed to reduce sedentary behavior and promote physical activity in patients with colorectal cancer undergoing chemotherapy. During chemotherapy, treatment-related symptoms such as fatigue often lead to reduced physical activity and prolonged sitting time. Replacing sedentary time with light-intensity movement is associated with improved metabolic outcomes and a lower risk of several chronic conditions, including cancer. The intervention is developed using the Capability, Opportunity, Motivation-Behavior (COM-B) model and the Behavior Change Wheel (BCW), and is delivered over 3 weeks using a smartwatch. It comprises smartwatch-based prompts to interrupt prolonged sitting, symptom assessment and symptom-management education, and feedback on physical activity and sedentary behavior. Sedentary behavior and physical activity are measured objectively by smartwatch continuously before, during, and after the 3-week intervention. The primary aim is to evaluate the feasibility of the intervention across the domains of acceptability, demand, implementation, and practicality. Secondary aims explore preliminary changes in physical activity, sedentary behavior, symptoms, health-related quality of life, and self-efficacy to reduce sedentary behavior. The findings are intended to inform the development of future interventions and nursing care to support health management in patients with cancer.

Sitting Interruption and Whole-body Cardiovascular Health

There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.

Effects of a Sedentary Behaviors at Work on Health in Emergency Medical Dispatchers and CODIS Operators (SECODIS)

The purpose of the study is to study changes in sedentary behavior following a behavioral intervention (sit-and-stand desk, and cycloergometer)

The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.

The Effect of Aerobic and Resistance Training on the Immune System

Six-week exercise interventions in sedentary young women demonstrated that aerobic exercise and resistance exercise differentially optimize inflammatory and immune responses through their effects on osteocalcin and IgM, and IgA, respectively. These distinct effects of exercise modality on immune biomarkers can be utilized to design personalized exercise programs.

Brief Training Program for General Practitioners on Malnutrition and Adapted Physical Activity

This randomized, parallel-group interventional study evaluated the impact of brief targeted training on general practitioners' knowledge and professional practices regarding malnutrition and adapted physical activity (APA). Final-year GP residents and practicing GPs in the Pays de la Loire region were randomly assigned to either a malnutrition training group or an APA training group. Each group served as an active control for the topic not received. Knowledge and self-reported practices were assessed using an online questionnaire before and one month after training.

Effectiveness of Interventions to Promote Physical Activity During Pregnancy

Pregnant women are more sedentary (sit, recline, lie down more) on average than non-pregnant women (more than 12 versus less than 8 waking sedentary hours/day). Sedentary behavior has been related to psychological distress, pregnancy weight gain, impaired sleep and very large size infants, while adequate physical activity has been found to improve mental health, decrease risk of high blood pressure in pregnancy and lower risk of preterm birth infants (less than 37 weeks gestation). Decreased sedentary behavior and increased physical activity may be crucial and neglected lifestyle behavior changes that can be promoted to reduce these and other maternal health and birth outcome problems among pregnant women.

Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty

This study aims to evaluate the feasibility and effectiveness of a sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in older adults with coronary heart disease and frailty. Participants will be randomly assigned to an intervention group or a control group. The intervention is designed around the three core components of ITHBC-knowledge and beliefs, self-regulation skills and abilities, and social facilitation-to help participants reduce sedentary behavior, improve physical activity, and enhance their ability to manage health-related behaviors. The study will include a 1-month intervention period followed by a 2-month follow-up period, with a total study duration of 3 months for each participant. Changes in sedentary behavior and other health-related outcomes will be assessed throughout the study period.

Effects of a Wearable Postural Feedback Device on Scapular Muscle Endurance, Trunk Proprioception and Postural Awareness in Sedentary Office Workers

This study aims to investigate the effects of a wearable postural feedback device on scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness in sedentary office workers. A total of 70 sedentary office workers aged 25-45 years will be randomly allocated to either the wearable postural feedback device group or the control group using block randomization. Participants in the intervention group will use the wearable postural feedback device for 12 weeks (5 days per week, 60 minutes per day), while the control group will maintain their usual working routine without receiving any intervention. Outcome assessments will be performed at baseline, immediately after the 12-week intervention, and at the end of a 4-week follow-up period (Week 16). The primary outcome measures are scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness. The primary research question is whether the use of a wearable postural feedback device improves these outcomes in sedentary office workers compared with no intervention. It is hypothesized that participants using the wearable postural feedback device will demonstrate greater improvements in scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness than those in the control group.

Families Implementing Good Health Traditions for Life

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

B4B Evolution Type II Hybrid Effectiveness-Implementation Trial

Break4Brain Evolution is a school-based programme designed to help teachers incorporate brief, safe and inclusive movement activities into normal classroom routines. The study aims to examine both how the programme is adopted and delivered in real-world schools and whether it improves students' physical activity, attention, executive functions and academic achievement. This is a type II hybrid implementation-effectiveness study with two complementary components. The implementation component will examine the scale-up of Break4Brain Evolution across at least 50 preschool, primary and secondary schools in the Balearic Islands and mainland Spain. Information from school leaders, teachers and students will be used to assess programme reach, adoption, acceptability, feasibility, appropriateness, fidelity, adaptations and maintenance. The effectiveness component is an embedded cluster-randomized controlled trial conducted in six primary schools in Mallorca. Schools will be randomly allocated to either the Break4Brain Evolution programme or usual school practice, with three schools in each group. Two classrooms from each school, one grade 5 and one grade 6 classroom, will participate, resulting in an estimated sample of 300 students. Baseline assessments will be conducted in September 2026. Schools allocated to the intervention group will begin implementing Break4Brain Evolution in October 2026 and will use the programme during the academic year. Follow-up assessments will be conducted in February 2027, June 2027 and December 2027.

Exercise Snacking and Cardiometabolic Health

Regular physical activity is associated with numerous health benefits, yet many young adults do not achieve recommended levels of physical activity. Exercise snacking, which involves performing brief bouts of physical activity throughout the day, may provide a practical alternative to traditional exercise programs by making physical activity easier to incorporate into daily routines. This randomized controlled trial will evaluate whether a 12-week exercise snacking intervention improves physical activity levels, aerobic fitness, cardiometabolic health, and psychological well-being in insufficiently active young adults. Participants will be randomly assigned to either an exercise snacking intervention or a usual behavior control group. Assessments will be completed at baseline, after the 12-week intervention, and after an additional 12-week follow-up period to determine whether any changes are maintained after the intervention ends. The study will measure physical activity using wearable activity monitors and assess aerobic fitness, body composition, blood pressure, blood lipids, glucose, exercise motivation, affective responses to exercise, and mental well-being. The findings will help determine whether exercise snacking is an effective and sustainable strategy for improving health in young adults and may inform future physical activity recommendations and interventions