Clinical Research Directory

Intervention to Increase Physical Activity and Wellbeing Among Staff and Residents in Assisted Living Facilities

The purpose of the study is to test a program that aims to help staff increase wellness behaviors and test the impact of this program on staff and work outcomes. We will also assess the impact of the program on residents' physical activity and function.

Evaluation of Choose to Move Replacement Ready (CTM-RR)

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 goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. 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.

Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors

The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for adolescent and young adult cancer survivors compared to a self-guided arm. Participants, diagnosed with cancer between ages 15-39, currently age 18-39, post-treatment at least 6 months, and who have overweight or obesity will be randomized to receive either: 1) a comprehensive mHealth weight management program (intervention) or 2) digital tools + health education + peer support (self-guided) over 12 months. Outcomes will be assessed at 3, 6, and 12 months.

Self-directed Use of Resources for Physical Activity

This is a pilot RCT examining physical activity outcomes at 3 months across 3 conditions: use of large language model (LLM) fully self-directed; use of LLM with guidance; and use of online tools to help with sleep.

AI-Based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study

The purpose of this research is to investigate the feasibility, acceptability, appropriateness, and preliminary efficacy of a wearable and artificial intelligence-driven mobile application-based exercise prescription grounded in self-determination theory (SDT) and behavioral change techniques (BCTs) among older adults. As no data exists on the feasibility of AI-driven exercise programs grounded in SDT and multiple BCTs specifically for older adults, this will be a pioneering study to explore the feasibility of wearable and AI-driven exercise program protocols and the rates of acceptance and appropriateness of the exercise prescription intervention among older adults. In addition, this study will test the preliminary efficacy of the intervention on physical activity (PA), mental health, and quality of life. This study follows the National Institute of Health (NIH) stage model, and it represents stage 1b of the NIH stage model, which emphasizes the feasibility and actionable processes for delivering a new health intervention. Specifically, this study will: 1.Evaluate the research protocol feasibility of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs (of goal setting, self-monitoring, graded task, and demonstration) on older adults over 8 weeks 2. Evaluate the acceptability and appropriateness of a wearable, AI-driven, mobile application-based exercise prescription grounded in SDT and BCTs among older adults over 8 weeks. 3. Evaluate the preliminary impact of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs on older adult PA (steps per day and daily duration of light PA and Moderate-vigorous PA), sedentary time, sleep, mental health (depression and anxiety), and quality of life.

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.

Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan

Heart diseases and other non-communicable diseases are serious health issues in countries like Pakistan. Many people who work in offices, like bank employees, sit for more than 8 hours a day. This is called a sedentary lifestyle, and it increases the risk of heart diseases. This research project aims to find out if a newly developed context specific mobile phone application can help these sedentary employees to improve their lifestyle. The app, called m-LIfE (mHealth-based Lifestyle Intervention for Employees), will be designed to help employees to move more during the day and eat healthier food like fruits and vegetables. The study will involve bank employees in urban Karachi, Pakistan. They will be divided into two arms: Intervention arm: Participants in this arm will use the m-LIfE app for 12 weeks. They will get reminders and tips to take breaks, exercise, and eat healthy. Routine care arm: Participants in this arm will receive printed basic educational material about prevention of risk factors of heart diseases and improving lifestyle. After the 12 weeks of intervention, there will be a follow-up period at 4th week to check if participants are maintaining healthy habits. This study could help find simple and affordable ways to improve the health of office workers and reduce pressure on the healthcare system.

Classroom Exercise Frequency and Mental Health in Medical Students

This 16-week, three-group, nonrandomized interventional study evaluated whether the weekly frequency of a brief classroom-based physical exercise program was associated with changes in mental health and physical activity among 105 undergraduate medical students at Universidad Tecnologica de Pereira, Colombia. EG2 (n=35) received two exercise sessions per week, EG1 (n=37) received one session per week, and CG (n=33) received no exercise intervention. Anxiety, depression, stress, and physical activity were assessed at baseline and after 16 weeks.

Effectiveness of NeoMayor in Improving Cardiovascular Health in Chilean Older Adults

This study aims to evaluate the effectiveness 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 the NeoMayor intervention improves cardiovascular health as measured by the Life's Essential 8 Cardiovascular Health Index. Secondary objectives include evaluating changes in cognitive performance, depressive symptoms, anxiety symptoms, quality of life and physical performance outcomes. The study will also assess feasibility and adherence to digital intervention.

The eHealth Integrated Maternal Physical Activity Programme in Prenatal Care Trial (E-IMPACT)

This will be a proof-of-concept randomised control trial (RCT) study, where 100 pregnant women will be recruited in the first trimester of pregnancy and followed-up until delivery. It aims to test these following hypotheses: 1. pregnancy is a window of opportunity to implement good lifestyle habits of physical activity and exercise as pregnant women are in regular contact with health professionals and are likely motivated and be more confident to carry out these activities according to the guidelines 2. this integrated programme will effective in a healthcare setting, and will bring Singapore's "Guidelines on Physical Activity and Exercise in Pregnancy" guidelines to implementation 3. with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.

POSH-Ex: Physiotherapist-Led Telerehabilitation Exercise Programme for Postpartum Sexual Health

Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Although pelvic floor muscle training is recommended as part of postpartum rehabilitation, evidence regarding comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remains limited. Furthermore, no standardized telerehabilitation programme has yet been evaluated using a randomized controlled trial design. The aim of this randomized controlled trial is to evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized 12-week physiotherapist-led telerehabilitation intervention designed to improve female sexual function and overall postpartum health after childbirth. Secondary objectives are to evaluate its effects on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. A total of 84 postpartum women will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will complete supervised online exercise sessions twice weekly for 12 weeks, while participants in the control group will receive usual postpartum care. Outcome assessments will be performed at baseline and immediately after completion of the intervention. The primary outcome is female sexual function assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. The findings are expected to provide high-quality evidence regarding the effectiveness of a standardized telerehabilitation programme for postpartum rehabilitation and may contribute to the development of evidence-based postpartum rehabilitation programmes and future clinical practice guidelines.

Going Places: A Multi-level Intervention to Improve Youth Transportation Efficacy and Physical Activity

Going Places is a community driven intervention to increase transportation self-efficacy among low-income youth, enabling access to community-based programs that promote physical activity and improve long term cardiometabolic health. Going Places was co-developed under the joint leadership of Duke and Durham Parks and Recreation (DPR). Going Places is pilot tested and fully functional. The intervention incorporates a multi-level approach that includes 1) workshops on navigating local transportation systems; 2) field trips and participatory assets mapping activities; and 3) youth transportation advocacy.

Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy

The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.

Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in SAI Women

This study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women.

Active Schools in Chile: Impact on Fitness, Physical Activity, and Sports Participation

Study Rationale: Currently, a significant proportion of children in Chile do not meet recommended physical activity levels, which may adversely affect their health and development. The school environment provides an ideal setting to promote healthy habits. This study was designed to evaluate whether a school-based program incorporating physical activity, sports, and health education can improve physical fitness and increase the time children dedicate to physical activity practice. Objective: The primary objective of this study is to evaluate the impact of a two-year school-based intervention on physical activity levels, muscular fitness (measured by upper body, lower body, and abdominal muscular strength), and sports participation among Chilean schoolchildren. How the study works: This is a single-arm cluster intervention study incorporating a pre-post design. Participating schools were allocated in a specialized program focused on physical activity and the promotion of sports practice throughout two school years. What was measured: At baseline and after the two-year intervention, the following outcomes were assessed: Physical Activity Levels: Measured via accelerometry; Muscular Fitness: Assessed through muscular strength tests, including upper limb strength (handgrip strength using a dynamometer), lower limb strength (standing long jump test), and abdominal strength (60-second curl-up test). Sports Participation: Evaluated through self-reports of involvement in organized sports. Researchers compared pre- and post-intervention data between the intervention to determine if children in the special program showed significantly greater improvements compared to those in the standard routine.

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.

Pain Neuroscience Education for Middle School Students

This project was designed as a single-blind, randomised controlled, prospective intervention study. The research question of the project is 'Is pain neuroscience education an effective method to improve various aspects of child health, conceptualise pain and change pain-related behaviours in middle school children?'. In other words, the aim of this project is to investigate whether pain neuroscience education (PNE4Kids) is an effective method for improving various aspects of child health, conceptualising pain and changing pain-related behaviours in middle school children. For this purpose, it is planned to implement PNE4Kids based power point presentation and interactive game training. It is aimed to evaluate children in terms of physical activity level, sleep quality/habits, pain conceptualisation level and participation in leisure time activities. Physical activity levels will be assessed with Actigraph GT3X+ accelerometer device and 'Physical Activity Scale for Older Children'. Sleep quality/ habits will be assessed with Actigraph GT3X+ accelerometer and 'Children's Sleep Habits Scale-short form'. Knowledge of pain conceptualisation will be assessed with the 'Conceptualisation of Pain' scale. Children's level of participation in leisure time activities will be assessed through the participation section/domain of the Participation Environment Measure for Children and Youth (PEM-CY). After the baseline measurements of the individuals included in the study and who volunteered will be completed, they will be randomly assigned to the control or intervention group. Participants in the intervention group will receive 'Turkish PNE4Kids Programme'. Individuals in the control group will not receive any intervention. All evaluations will be repeated before the training, immediately after the training and at the end of the 3rd month after the training.

A Multicomponent Physical Activity Intervention for Older Adults

ActiveKIT is a three-arm, parallel-group, individually randomized controlled trial. Community-dwelling adults aged 65 years or older (n=201) from Madrid and surrounding municipalities who were inactive were randomized into tree arms: a low-cost home-based exercise toolkit, the same toolkit plus remote specialist support, or usual-care. The intervention lasted 12 weeks, with assessments at baseline, 3 months, and 12 months.

Advancing Precision Medicine for Cardiovascular Disease and Diabetes in Asian Populations: Digital Intervention Cohort

The overarching aim is to improve cardiometabolic health and promote healthy ageing by supporting adults to adopt favourable lifestyle patterns identified through our observational research. The trial will recruit n=600 to be involved in Phase I (referred to as the "Optimisation Phase") of a two-phase project (Phase II trial registration will be submitted separately). All participants will complete a baseline study visit where, after consent taking, will complete a baseline questionnaire, receive a smartwatch each and additional wearables if applicable, and download the study app for the receiving and testing of interventions and completion of short form surveys. Participants will be involved in the continual evaluation and optimisation of ecological momentary interventions (EMIs) in adaptive, factorial, micro-randomised trials over 12 months. Consenting participants may also be contacted to participate in interviews to be involved in the co-design of interventions, or to provide insights to the feasibility and process evaluation of the trial.

Gamified Program in Primary School Physical Education

This study evaluates the effects of an 8-week gamified cooperative exergaming program implemented during regular physical education lessons in primary school children. Participants were assigned by classroom to either an experimental group, which completed "The Movement League" program integrating dance-based exergames, cooperative learning, and gamification, or a control group, which received conventional physical education. The study aims to determine whether this multicomponent intervention improves motivation toward physical education, increases habitual physical activity, and reduces sedentary behavior compared with standard physical education.

Gamified Exergaming Program in Primary School

This study evaluates the effects of an 8-week gamified cooperative exergaming program implemented during regular physical education lessons in primary school children. Participants were assigned by classroom to either an experimental group, which completed "The Movement League" program integrating dance-based exergames, cooperative learning, and gamification, or a control group, which received conventional physical education. The study aims to determine whether this multicomponent intervention improves motivation toward physical education, increases habitual physical activity, and reduces sedentary behavior compared with standard physical education.

Cognitive Behavioral Treatment With Activity Trackers for Smoking Cessation

Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority Worldwide. It is also known that practicing physical activity (PA) may help with smoking cessation. Physical activity trackers (PATs) have been demonstrated to increase PA levels among various populations, as a sole intervention or in combination with behavioral interventions targeting PA. This study aims to examine the feasibility and effect of a cognitive-behavioral therapy (CBT) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation. In this study, an estimated sample of 120 adult smokers of at least 10 cigarettes per day will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + PAT; 2) CBT for smoking cessation. Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + PAT and CBT for smoking cessation in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity), physiological outcomes (i.e. sleep quality, quality of life) and mental health outcomes (anxiety and depression symptoms, difficulties in emotional regulation); 3) to examine the association between PA levels and study outcomes

Reducing Health Disparity of Physical Functioning Among Young Adult Cancer Patients of Color

The purpose of the study is to pilot test of PAfitME™ among (1) young adults (YA) cancer patients of color (POC) (Analytic Sample \[N=36\] after attrition of 30%) and (2) YA cancer patients of White (POW) (Analytic Sample \[N=36\] after attrition of 30%). Aim 1: Evaluate Exergame Grading Scheme (EGS) validity when EGS is tested in relationship to standard lab tests (Bruce Treadmill Protocol and isometric/isokinetic dynamometry) and field fitness tests (6-minute walk test, handgrip, and Chair Stand Test). Aim 2a: Evaluate the feasibility (enrollment rate \[% of eligible patients\], attrition rate \[% in either intervention or control group\], adherence rate \[% of completed prescribed exergame minutes\]), safety (numbers of adverse events), and acceptability (satisfaction score \& exit qualitative interviews) of PAfitME™. Aim 2b: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip \[upper body\] and Chair Stand Test \[lower body\]) when compared with a usual care condition among YA cancer POC. Aim 2c: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip \[upper body\] and Chair Stand Test \[lower body\]) when compared with a usual care condition among YA cancer POW.

Enhance Physical Activity in Low-income Black and Hispanic Adults

The present study aims to test the efficacy of a multi-level telehealth intervention to Enhance Physical Activity (EPA) in 300 low-income Black and Hispanic/Latino adults. EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins. A control group will receive health education. The specific aims are to: 1) test if physical activity increases significantly more among participants assigned to EPA vs. wait-list controls and 2) test if physical function improves significantly more among participants in EPA vs. controls. An exploratory third aim will test mechanisms of change associated with EPA.