Clinical Research Directory

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.

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined. The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

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.

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).

Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention

This prospective, single-arm interventional study will investigate why adults receiving the same prescribed dose and relative intensity of exercise show divergent changes in energy balance, body weight, and body composition. A total of 150 sedentary Chinese adults aged 18-40 years with overweight or obesity will complete a 12-week, supervised treadmill exercise programme. Exercise will be performed five times per week at an intensity corresponding to 60% of each participant's measured maximal oxygen uptake. Prescribed exercise energy expenditure will increase progressively from 150 kcal per session in Weeks 1-4 to 250 kcal per session in Weeks 5-8 and 350 kcal per session in Weeks 9-12. The primary objective is to quantify inter-individual variability in energy compensation after the standardized intervention. Detailed measurements will characterize total and resting energy expenditure, energy intake, appetite, physical activity, body composition, glucose dynamics, cardiorespiratory fitness, brain responses to food-related stimuli, and molecular phenotypes. Multi-omics analyses will include gut microbiome, metabolomic, proteomic, extracellular-vesicle, peripheral blood mononuclear cell, and transcriptomic assessments. The study will explore physiological, behavioral, and molecular factors associated with divergent compensatory responses. No randomized comparator group is included; therefore, causal comparisons between exercise and non-exercise conditions are outside the study scope.

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 8-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 16-week period.

Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol

This protocol describes a quasi-experimental controlled study evaluating the effects of the Super Quinas in Preschool programme on 24-hour movement behaviours and motor development in preschool children aged 3-6 years. The intervention consists of one additional structured 60-minute physical activity session per week for 12 weeks, delivered by a qualified exercise professional in a public preschool in Maia, Portugal. Four classes (\~80 children) are allocated at the class level: two to the intervention condition and two to the control condition (usual curricular Physical Education). Baseline data collection (T0) was conducted between 4 and 18 March 2026; the intervention commenced on 25 March 2026. Subsequent assessments are planned for early May (T1, mid-intervention), end of June (T2, post-intervention), and mid-September 2026 (T3, follow-up). Primary outcomes are 24-hour movement behaviours (ActiGraph GT3X accelerometry) and motor competence and physical fitness (Motor Competence Assessment + PREFIT subtests). Secondary outcomes include executive function (HTKS; Day-Night Stroop) and socioemotional regulation (SDQ). Statistical analyses will use longitudinal linear mixed-effects models under an intention-to-treat framework.

Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 2)

This study develops and tests a dynamic workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity.

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.

Interactive Roles of Cardiorespiratory Fitness and Adiposity on Glucose and Vascular Control After Physical Inactivity

The far-reaching negative health effects of the reduced physical activity (RPA) epidemic are often overlooked by the general population and health professionals. Short-term RPA induces cardiometabolic dysfunction, including impaired glucose control and vascular function, that may precede disease development. The impact of existing health status on RPA-induced cardiometabolic dysfunction and recovery of impaired glucose control following RPA is unexplored. Thus, the investigators' objectives are 1) to investigate the effect of existing health status (cardiorespiratory fitness and adiposity) on the recovery of impaired glucose control following a period of RPA and 2) to determine the role of vascular function as a mechanism of impaired glucose control. The investigators' final objective is to 3) expose undergraduate students to meritorious biomedical clinical research methods. The investigators have piloted the clinical research methods and analysis with undergraduate researcher associates and are well-prepared to complete this proposal. Preliminary data show that low cardiorespiratory fitness and/or high adiposity impair the recovery of glucose control following short-term RPA. Thus, the investigators aim to examine the interactive role of health status (cardiorespiratory fitness and adiposity) on the ability to recover impaired glucose control following short-term RPA. The investigators also seek to examine changes in vascular function as a mechanism of recovery of impaired glucose control following a return to normal PA. The investigators will recruit men and women with divergent health status (cardiorespiratory fitness and adiposity) to examine glucose control and vascular function during 7-d of normal PA, 7-d of RPA, and 7-d of resumption of normal RA. Continuous glucose monitoring and oral glucose tolerance tests will be performed to assess glucose control. Increases in vascular shear stress induced by passive leg movement and central arterial stiffness will be measured to assess vascular function.

Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers. The main question it aims to answer is : Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment? The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests.

Sex Differences in Heart Rate Variability Responses to Eight Weeks of Circuit Training

The main goal of this study is to find out how an 8-week circuit training exercise program affects heart health and how the body recovers in young adults who do not regularly exercise. The researchers also want to see if these responses are different between men and women. The body's nervous system controls automatic functions like heart rate. Measuring changes in heart rate patterns-known as heart rate variability (HRV)-helps show how well the body switches between "fight-or-flight" (stress/exercise mode) and "rest-and-digest" (recovery mode). While men and women naturally have different heart rate patterns at rest, less is known about whether they recover differently after a structured exercise program. The main questions this study aims to answer are: 1. Does 8 weeks of circuit training improve heart rate recovery and nervous system balance in inactive young adults? 2. Do men and women show different heart rate responses or recovery patterns after taking part in circuit training? To answer these questions, inactive university students took part in an 8-week supervised circuit training program. Participants were considered inactive if they did less than 150 minutes of moderate exercise or less than 75 minutes of vigorous exercise per week. Participants completed 20 exercise sessions (2 times per week) led by the study team: * Exercise Sessions: Each session started with a 5-minute warm-up, followed by 10 exercise stations using light weights, resistance bands, and bodyweight movements. Exercises targeted both upper and lower body muscles. * Workouts and Rest: Participants did each exercise for 30 seconds, rested for 1 minute between stations, and rested for 5 minutes between full sets. * Progression: During Weeks 1 to 4, participants did 2 sets per session. During Weeks 5 to 8, they increased to 3 sets per session. To measure heart rate recovery, participants wore a heart rate chest monitor while resting quietly lying down: 1. Before starting the 8-week program (Baseline) 2. At 10 minutes after a workout at Week 8 (Short-term recovery) 3. At 24 hours after a workout at Week 8 (Full recovery) The researchers compared the heart rate data between men and women across these time points to see how quickly their nervous systems returned to a resting state after exercise.

Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are: * Does using the app help with short-term glycemic control? * Does using the app help with longer-term glycemic control? * Does using the app help increase physical activity? Participants will: * Wear a continuous glucose monitoring device for 6 months * Wear a physical activity tracker for 6 months * Use the study smartphone app for 6 months * Complete 3 in-person study visits with fasting blood draws * Report dietary intake intermittently throughout the study

Women in Action: A Multicomponent Intervention for Older Women

"Women in Action" is a quasi-experimental, mixed-methods study evaluating a 16-week multicomponent intervention (supervised strength/aerobic/balance training plus psychoeducational and nutrition-focused behavioral workshops) for women aged 55-75 in perimenopause, menopause, and early ageing. The study will assess the feasibility, implementation fidelity, and acceptability of the program, together with its preliminary effects on a single primary outcome (handgrip strength) and secondary physical function, dietary, and psychosocial outcomes, compared with a passive control group receiving no intervention.

Physical Activity for PLWH and Unhealthy Drinking

Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months.

Roybal Via Habit Formation

This pilot study will develop and evaluate ViaHabit, a personalized walking intervention designed to promote physical activity habit formation among sedentary midlife adults (ages 45-65). During an initial 2-week observation period, participants' daily routines will be characterized using data collected from wearable devices, smartphones, and digital calendars. Personalized models will identify routine transitions, defined as periods between everyday activities, that may serve as receptive opportunities for initiating physical activity. Participants will then complete a 4-week intervention in which they create individualized "if-then" action plans linking routine transitions to a 15-minute brisk walk and receive automated smartwatch prompts at selected cue times. The study will assess the feasibility and acceptability of identifying routine transitions and delivering timely physical activity prompts, while exploring changes in walking behavior, habit strength, and physical activity engagement.

Heat Therapy During Reduced Physical Activity

The purpose of this randomized controlled trial is to determine whether daily Finnish dry sauna therapy attenuates the adverse cardiovascular, muscular, and metabolic effects of seven days of experimentally reduced physical activity in healthy adults. Participants will be randomized to one of three groups: (1) maintained habitual physical activity with daily sauna therapy, (2) reduced physical activity with daily room-temperature sauna visits (control), or (3) reduced physical activity with daily sauna therapy. Reduced physical activity will be achieved by decreasing daily step count to approximately 1,000 steps per day with the assistance of a power wheelchair. Outcome measures include vascular endothelial function, exercise tolerance, muscle protein synthesis, body composition, blood pressure, glucose regulation, and physiological responses to heat exposure. The study will determine whether passive heat therapy can serve as a practical intervention to preserve cardiometabolic health during short periods of reduced mobility.

Exercise Engagement in People Over 60 at Risk of Falls

It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise. Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls. To explore: 1. Patients' preferences to exercise format and type eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual personalized rehabilitation programme handouts 2. The ability to discuss falls risk with health professionals. 3. If health inequalities exist with people at risk of falls and exercising. 4. Sustainability of exercise, in order to reduce the risk of falls in this population. 5. The need to develop MSK internal and external facing falls management pathways. Suitability: Patients over the age of 60, who have been identified at risk of falls, having been referred to MSK Physiotherapy in Rossendale. 'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination. Semi structured interviews on up to ten participants. It is anticipated that this sample size will give adequate data saturation. Approximately 12 months from participant recruitment to analysis of findings.

High-Intensity Interval Training and Monocyte Epigenetic Adaptation After Detraining

This randomized, work-matched training-detraining-rechallenge study evaluated whether repeated high-intensity interval training produces persistent functional and epigenetic adaptations in human monocytes. Eighty healthy physically inactive adults aged 18-30 years were randomly assigned in a 2:2:1 ratio to high-intensity interval training (HIIT), moderate-intensity continuous training (MCT), or a non-training control group. HIIT and MCT completed 6 weeks of supervised cycling training matched for external mechanical work, followed by 4 weeks without prescribed structured training. All groups subsequently completed a standardized 30-minute cycling rechallenge. The primary outcome was the between-group difference in change in ex-vivo LPS-stimulated TNF-alpha release from baseline to the post-detraining assessment. Secondary outcomes included IL-6 release, H3K18 lactylation, monocyte subset distribution, blood lactate exposure, chromatin accessibility, H3K18la CUT\&Tag occupancy, and RNA-seq transcriptional profiling.

Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy \[i.e., nicotine replacement therapies (NRT)\], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.

Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight \[25 \< BMI \< 30\]) or obese (30 \< BMI \<40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration

Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.

Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms

The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.

Exercise Incentives for YMCA Based Exercise

The investigators will conduct a randomized controlled trial to test financial incentive programs (versus control) to promote physical activity among 330 adults who have a YMCA membership. Participants will have the opportunity to earn up to $100 or $200 (depending on the condition they are assigned to) for attending at least 50 sessions at the YMCA over 6 months. Participants will have two 6-month windows during which they will have the opportunity to earn the incentive. In addition to the incentives, participants will complete research assessments every 3 months.