Clinical Research Directory

Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial

Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is a multi-center, randomized, controlled, lifestyle intervention trial among 300 older adults (≥50 years) with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) at risk of dementia. Participants are randomized in a 1:1 ratio to Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.

Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients

The goal of this clinical trial is to learn if knowing and understanding a patient's daily habits and then giving clear advice on what changes to make can help control blood pressure better than the routine way of advising people with high blood pressure. The main questions it aims to answer are: * To learn if using the Lifestyle Medicine Assessment tool (A 21-item questionnaire) to understand the current lifestyle of people with hypertension and guide them accordingly, helps in lowering blood pressure more, as compared to routine advice? * To see if this way of guiding patients results in more positive lifestyle changes than routine advice? Researchers will compare two groups of people with hypertension. One will be guided after assessing their current lifestyle with the Lifestyle Medicine Assessment Tool and one will be given routine guidance. The researchers will then see which group had better blood pressure control. Participants will be: • Asked a few questions about their lifestyle and then they will be advised accordingly on ways to make it better.

Nordic Sperm DNA Study

Introduction The goal of this prospective observational study with an embedded randomized controlled trial (RCT) is to investigate the prevalence and clinical significance of sperm DNA fragmentation (damage to the genetic material in sperm cells) (SDF) among men undergoing fertility treatment and to determine whether an individualized lifestyle programme can reduce SDF and improve pregnancy outcomes. The study includes approximately 800 men undergoing fertility treatment at a Danish fertility clinic. Objectives and methods The main research questions are: 1. How common is elevated SDF among Danish men undergoing fertility treatment? 2. Is elevated SDF associated with reduced live birth rates and increased early pregnancy loss? 3. Can a 3-month individualized lifestyle intervention reduce SDF in men with high SDF levels (above 20%)? The whole cohort will participate in the observational study. Participants with SDF above 20% will be invited to take part in the randomized controlled trial. In the RCT researchers will compare men randomized to an individualized lifestyle intervention with men receiving standard fertility care to determine whether the intervention reduces sperm DNA fragmentation and improves subsequent pregnancy outcomes. All participants will: * Provide semen samples for sperm DNA fragmentation testing and routine semen analysis. * Provide blood samples to measure hormones and other health markers On the basis of SDF results participants will either: * Have SDF of 20% or lower: Continue with routine fertility treatment and follow up. * Have SDF above 20%: Be randomly assigned to either a personalised 3-month lifestyle programme or standard fertility care. Participants in the lifestyle programme will receive personalised advice on diet, physical activity, smoking, alcohol, sleep, stress management and antioxidant supplements. Ethics and dissemination The study has been approved by the Regional Committee on health research ethics and complies with the General Data Protection Regulation. Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed scientific journals, conference presentations, trial registry reporting, and communication with participants and relevant stakeholders.

Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus

The goal of this clinical trial is to evaluate the effects of a couple-based collaborative lifestyle intervention among women with a history of gestational diabetes. The main questions it aims to answer are: Does the intervention improve body mass index and 2-hour plasma glucose after an oral glucose tolerance test? Does the intervention improve health behaviors, psychological well-being, self-efficacy, couple functioning, and life satisfaction? Researchers will compare a couple-based collaborative lifestyle intervention with a woman-only lifestyle intervention to determine whether adding spousal collaboration and support leads to greater improvements. Participants will: Receive healthy lifestyle education posts for 3 months. In the couple-based group, also receive instant messages on behavioral promotion and couple collaboration and support videos.

Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus

The goal of this clinical trial is to determine whether a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) is more effective than standard care in achieving diabetes remission in adults with overweight and type 2 diabetes mellitus. The study will also evaluate the effects of the intervention on metabolic and clinical outcomes associated with diabetes remission. The main questions it aims to answer are: * Does a low-calorie diet combined with intensive lifestyle intervention using iPDM increase the proportion of participants who achieve diabetes remission compared with standard care? * Does the intervention improve metabolic and patient-centered outcomes, including glycemic control, body weight, body composition, Time in Range (TIR) measured by continuous glucose monitoring (CGM), quality of life, and cost-effectiveness? Researchers will compare participants receiving a low-calorie diet combined with intensive lifestyle intervention using iPDM with participants receiving standard diabetes care to determine whether the intervention is more effective in achieving diabetes remission and improving metabolic health. Participants will: * Be randomly assigned to either the intervention group or the standard care group. * Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study. * If assigned to the intervention group, consume two low-calorie meal replacements per day and follow an individualized meal plan providing no more than 1,200 kcal per day during the first 3 months (intensive phase), together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks. During the following 3 months (maintenance phase), continue lifestyle modification with reinforcement sessions delivered via telemedicine every 4 weeks while following a meal plan providing no more than 1,500 kcal per day.

Reset: Enhancing Weight Loss in a Digital Intervention

The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback. The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months. The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.

A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM

This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM .

Using Life's Essential 8 in Midlife Black Women

This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women. A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric. Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.

The Impact of Enhanced Music & Natural Visuals on Emotional Health

The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and/or adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and/or frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities. The research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and/or subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.

Healthy Eating and Active Living (HEAL), Exploring Feasibility of a Lifestyle Intervention

Lifestyle interventions combining nutrition, physical activity, and behavioral strategies are increasingly recognized for improving metabolic and psychological health, yet their translation into real-world settings remains limited. Key implementation factors such as feasibility, adherence, intervention fidelity, and the integration of complex assessment modalities are often underreported, despite being essential for scaling and clinical application. The Healthy Eating and Active Living (HEAL) study is a prospective, single-arm feasibility trial evaluating a structured, multimodal lifestyle intervention within a university research environment. The 12-week program integrates supervised progressive resistance training and structured nutritional guidance, delivered through existing infrastructure including the Center for Brain and Health, the Public Health Research Center, on-campus fitness facilities, and digital dietary monitoring tools. The exercise component consists of twice-weekly supervised, machine-based resistance training with standardized progression, while the nutritional component includes four weeks of meal provision followed by guided self-management. Participants complete a multimodal assessment battery at baseline, post-intervention, and 12-week follow-up, including body composition, blood biomarkers, gut microbiome analysis, fitness testing, wearable-based activity and sleep monitoring, self-reported measures, and resting-state functional magnetic resonance imaging (fMRI). The primary objective is to assess feasibility, including recruitment, retention, adherence, intervention fidelity, safety, acceptability, and data completeness. Secondary analyses explore pre-post changes in physiological, behavioral, and neuroimaging outcomes to inform future study design. The study is not powered to assess clinical efficacy. Findings will inform the design of larger trials and the application of the HEAL framework in clinical populations.

Simplifying Diet Tracking in a Digital Weight Loss Intervention

The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss. The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.

The Brain Health PRO Online Risk Factor Reduction Study to Prevent Dementia

This study will recruit participants at risk for dementia to participate in an online educational program called Brain Health PRO (BHPro). The BHPro intervention is designed to address modifiable risk factors for dementia through a 6-month, fully online, educational program conveying the best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health. Achieving lifestyle changes in a diverse Canadian population through online education would be a major achievement in dementia prevention in Canada, with widespread personal and socioeconomic benefits. Eligible participants will be randomly assigned to either start Brain Health PRO immediately or in 6 months (delayed-start control group). All participants will have the opportunity to have access to BHPro for 6 months during the course of the study and will have open access to all content for 12 months following the initial 6-month intervention. Participation will last from 18-24 months depending on group assignment.

Effectiveness of an AI-Enabled Mobile Intervention on Lifestyle Behaviors and Maternal-Infant Health

The goal of this pragmatic randomized controlled trial is to evaluate the effectiveness of an AI-enabled mobile health management application ("Better Pregnancy" app), grounded in the Theory of Planned Behavior, in preventing gestational diabetes mellitus (GDM) among pregnant women at high risk of GDM, and to assess its impact on maternal and infant health outcomes. Study Population: Eligible participants are pregnant women aged 18-49 years, with a singleton pregnancy, gestational age \<12 weeks at enrollment, and at least one GDM risk factor (age ≥35 years, pre-pregnancy BMI ≥24 kg/m², family history of diabetes, previous history of GDM, prior delivery of a macrosomic infant \[birth weight ≥4000 g\], or polycystic ovary syndrome). Participants must have no heart, liver, or kidney diseases, use an Android smartphone, and provide written informed consent. The main questions it aims to answer are: Can the AI-driven mobile lifestyle intervention reduce the incidence of GDM in high-risk pregnant women? Does the intervention improve lifestyle behaviors (diet, physical activity, sleep) and glycemic control (measured by continuous glucose monitoring) in participants? What is the adherence, acceptability, and cost-effectiveness of this intervention in real-world clinical settings? Comparison: Researchers will compare two groups of pregnant women: the intervention group (receiving the AI-enabled "Better Pregnancy" app plus routine antenatal care) and the control group (receiving routine antenatal care alone). Participants will: Enroll in the first trimester (\<12 weeks of gestation) and complete a baseline lifestyle and health status questionnaire In the intervention group: watch 7 cognitive-attitudinal videos within the first week, then complete 12 weeks of AI-driven personalized intervention (daily check-ins, receiving tailored recommendations on diet, physical activity, sleep, etc.) During the intervention period, participants in the intervention group will wear a continuous glucose monitoring device for 7 days to assess the impact of the intervention on glycemic fluctuations Complete the first follow-up lifestyle and health status assessment after the intervention (approximately in the second trimester) Undergo an oral glucose tolerance test during the second trimester (24-28 weeks) Complete the second follow-up lifestyle and health status assessment in the third trimester (≥28 weeks) Complete the third follow-up lifestyle and health status assessment at 42 days postpartum, along with collection of delivery outcomes and infant health information A subset of participants may voluntarily provide blood and stool samples for mechanistic studies

Obesity-fertility Cohort Study: Protocol for the Assessment of Children Aged 6-12 Years and Their Mothers

Maternal preconception obesity and adverse gestational metabolic health increase the risk of childhood obesity in offspring. A group of investigators from Université de Sherbrooke therefore developed a lifestyle intervention starting during preconception in women with obesity and infertility, which was evaluated with the Obesity-Fertility randomized controlled trial (RCT). The present study will assess children who were born in the Obesity-Fertility RCT and are now aged 6-10 years old. The objective of this study is to evaluate the effect of a lifestyle intervention during preconception and pregnancy on adiposity and cardiometabolic parameters in offspring compared to those born to mothers who did not have access to the lifestyle intervention. The hypothesis being that, at the age of 6-10 years old, children born to mothers who were in the intervention group have more favorable measurements of body composition and certain metabolic and/or inflammatory blood markers than those born to control mothers. Participants in the Obesity-Fertility RCT were women with obesity and infertility recruited at the Centre hospitalier universitaire de Sherbrooke (CHUS) fertility clinic. They were randomly allocated to the control group, which followed standard care, or to the intervention group, which received a lifestyle intervention alone for 6 months, and then in combination with fertility treatments. Those who have given birth to a single child will be invited to participate in this follow-up study with their child. During the research visit, medical history, anthropometry, body composition, lifestyle, physical fitness level, and blood or saliva markers of cardiometabolic health will be assessed for both mothers and children. This study will provide new evidence on the impact of targeting lifestyle habits during preconception on the health of children and their mothers 6-10 years later; and the potential of such interventions to counteract the intergenerational transmission of obesity.

Gardening for Health for Cancer Survivors

This study is testing whether a gardening and nutrition program can improve well-being in people who have had cancer. Many cancer survivors continue to experience challenges after treatment, including changes in appetite, nutrition, stress, and quality of life. Programs that combine healthy eating, physical activity, and social connection may help address these issues. In this study, participants will take part in a 6-week, in-person program called Gardening for Health. The program includes weekly group sessions held at a garden at the University of Vermont Medical Center. Each session lasts about two hours and includes hands-on gardening activities, nutrition education, cooking demonstrations, and guided wellness practices such as mindfulness and light movement. Participants will also receive educational materials to support healthy eating and gardening at home. The main goal of the study is to determine whether this program is feasible and acceptable for cancer survivors, meaning whether people are willing to participate, attend sessions, and find the program helpful and satisfying. The study will also explore whether participation is associated with improvements in quality of life, stress, sense of belonging, and nutrition-related behaviours. Participants will complete questionnaires before starting the program and again after the 6-week program ends. These surveys will ask about overall health, stress levels, social connection, and lifestyle habits. The researchers hypothesize that participation in the Gardening for Health program will be feasible and well-received by cancer survivors, and that it may lead to improvements in quality of life, reduced stress, and increased feelings of connection and well-being. This is a single-group study, all participants receive the intervention and there is no comparison group. The results will help determine whether this type of program should be studied further in larger trials.

Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.

Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle

The goal of this study is to assess the effect of the WARIFA app on the adoption of healthy lifestyle behaviours related to Non-communicable diseases (NCDs), as well as in the management of Type 1 Diabetes (T1D). This is done using user-generated data analysis, artificial intelligence (AI) and risk estimation to provide personalised recommendations on lifestyle-related behaviours through a mobile app. * Primary objective: the objective of this study is to assess the impact of using the WARIFA app on a series of outcomes, related to the promotion of healthy lifestyles and prevention of NCDs, as well as on the management of T1D. * Secondary objectives: to assess the feasibility of implementation of a complex health app (WARIFA), and to explore which outcomes are more relevant in this context for users. The study will evaluate the app in two different populations: * Population 1: Citizens living in Europe of either sex aged \> 18 years diagnosed with no more than one NCD (of the following: CVD, any type of cancer, chronic respiratory disease and T2D) and current owners of a smartphone with internet access. * Population 2: European adult individuals of either sex aged \>18 years with T1D currently using multiple daily insulin injections or an insulin pump and current owners of a smartphone with internet access. The study will be carried out in three centres in three different countries: the Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) in Spain, the Norwegian Centre for E-health Research (NSE) in Norway, and in Romania. Participants in each population will be randomised to an intervention or control arm on a 1:1 ratio: * Intervention arm: the Warifa app will be used by the participants throughout the study. The app will provide personalised risk estimations and recommendations through user-generated data analysis and artificial intelligence. * Control arm: The control group will use a Warifa app with the same functionalities than the intervention arm, but without artificial intelligence. At baseline, information will be collected by questionnaires and a physical examination, including anthropometry and a lipid profile. These measurements will be repeated in 12 weeks and will be compared between the treatment arms. The study will last 3 months in total, start of recruitment on 10 February 2025, end of study after the last visit of the last participant, on 12 May 2025. Each user will participate in the study for 12 weeks.

A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters

The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. The main questions it aims to answer are: * Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care? * Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters? Researchers will compare firefighters receiving the smartphone-based HLS intervention to those receiving usual care to determine whether the intervention leads to improved health and fitness outcomes over 3 to 6 months. Participants will: * Use the Traditional Chinese version of the HLS mobile App, originally developed at Cambridge Health Alliance, Harvard Medical School, and adapted for firefighters in Taiwan. * Be randomly assigned to either the intervention group (HLS App) or the control group (usual care). * Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention. Anticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group.

Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）

This study aims to control risk factors of non communicable diseases by life style and care intervention based on internet technology, looking forward to improve cardiovascular and cerebrovascular complications, diabetes and all-cause death.