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176 Lifestyle Trials Near You
Power is an online platform that helps thousands of Lifestyle patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBUILT Family Lifestyle Program for ADHD
Chicago, Illinois
This trial tests the BUILT program, an online course for families in Chicago Park District programs. It aims to improve children's health and behavior through better food, sleep, and exercise routines. Families will participate in challenges to build these healthy habits.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 12
Key Eligibility Criteria
Disqualifiers:Age, Aerobic Conditions, Enrollment, Others
316 Participants Needed
Walking Exercise for Mild Cognitive Impairment
Chicago, Illinois
The purpose of this study is to see if 6 months of home-based walking will improve memory, and brain structure and function, compared to health education in older adults that have chronic kidney disease and mild cognitive impairment.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55+
Key Eligibility Criteria
Disqualifiers:Dementia, Heart Failure, Psychiatric Disorders, Others
Must Not Be Taking:Antidepressants, Antipsychotics
144 Participants Needed
Mobile Health Exercise Program for Cancer Survivors
Knoxville, Tennessee
Participation in regular physical activity is vital to a healthy lifestyle. Research has shown that regular participation in physical activity among cancer survivors is not only able to improve health outcomes, but is also related to their quality of life.
As we live in an age of technology, health wearables and smartphone apps might be one novel manner by which to help cancer survivors increase physical activity as well as improve health outcomes. Yet, the effectiveness of wearable and app as a tool for health promotion among cancer survivors is largely unstudied.
The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) on physical activity, weight, quality of life, individual beliefs, and emotions among cancer survivors.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Stage 4 Cancer, Metastasis, Pregnancy, Others
160 Participants Needed
Online Program for Sedentary Lifestyle
Winston-Salem, North Carolina
This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Physical Limitations, Medical Conditions, Others
60 Participants Needed
Mobile Intervention for Pain and Obesity
Winston-Salem, North Carolina
Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Obesity exacerbates many of these health issues, contributing to a higher frequency of intractable pain episodes, increased pain severity, multi-site pain, and the use of stronger opioid medications compared to normal weight individuals with chronic pain. In addition, older adults who suffer from chronic pain are significantly more sedentary than those without chronic pain. Despite evidence relating increased sedentary behavior to pain, non-pharmacological treatments have largely focused on structured moderate-to-vigorous physical activity (MVPA) by way of conventional forms of exercise.
Recent evidence from an intervention designed to decreased sedentary behavior (SB) demonstrated the approach is effective in preventing weight regain following weight loss. A subsequent study-a mobile intervention to reduce pain and improve health (MORPH: Wake Forest Baptist Health institutional review board \[IRB\] 00046364)-demonstrated that a primarily home-delivered intervention (9 of 12 delivered in home; 3 of 12 delivered in a research center) supported by technology can produce significant weight loss, reductions in sedentary time, increases in daily steps, less pain intensity, and better physical function compared with a waitlist control. MORPH included a focus on dietary weight loss plus movement across the day through a combination of group telecoaching and a custom mobile health (mHealth) application, but results indicated that participants did not internalize the day-long movement intervention. Instead, they appeared to achieve a greater number of steps through conventional walking exercise, allowing for high levels of sitting, stiffness, and pain.
MORPH concluded with a two-group randomized controlled pilot trial (RCT) in obese (BMI=30-45 kg/m2), low-active, older (55-85 years) adults with chronic pain who were randomized to either 12-weeks of active intervention or a wait-list control. This study represents an extension of MORPH-hereafter MORPH II-with the intention of immediately addressing limitations in the original MORPH study. Participants will be randomize 30 older, low-active, obese adults to the active intervention or to a standard control for 12 weeks. To build upon the last phase of MORPH, the research team will deliver this intervention fully remotely, providing cellular data-equipped tablet computers to protect participant safety and reduce technical issues that may arise due to lack of face-to-face orientation appointments. Given the current COVID-19 climate, the investigators have chosen to deliver the entire intervention remotely. The investigators are implementing intensive individual coaching throughout the program and greater emphasis on frequent movement to drive better uptake of a day-long movement program and will transition participants to a 12-week no-contact follow-up to observe whether behavior change sustains following completion of the focused intervention.
This study is couched within a contemporary engineering-inspired design framework-the multiphase optimization strategy (MOST)-which emphasizes rapid identification of successful intervention components and the removal or redesign of components that are either ineffective or perceived as a nuisance. To this end, the study team will carry momentum from MORPH into MORPH II wherein the team will assess the impact of a fully remote MORPH intervention with the addition of high-contact coaching on pain ratings, physical function, levels of physical activity and sedentary behavior, and body weight. This is particularly timely given limited access to center-based resources for many during the COVID-19 pandemic, and especially those who are high-risk, including older adults with chronic pain.
Aims and Hypotheses Specific Aim 1: To conduct a pilot RCT to provide initial evidence for the effect size associated with the proposed intervention on pain, sitting time, and daily steps. Investigators will also explore the impact of this program on social connection (i.e., relatedness) and physical function.
Hypothesis 1: It is expected that the provision of the in-home application to contribute to clinically meaningful improvements in pain ratings and steps and a reduction in daily sedentary time compared to the control condition.
Specific Aim 2: To examine whether a socially mediated, home-delivered health intervention produces lasting behavior change over a 12-week no-contact period.
Hypothesis 2: It is expected that levels of physical activity at week 24 will remain meaningfully improved over baseline in the intervention condition relative to the control.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Severe Heart Disease, Uncontrolled Hypertension, Others
Must Not Be Taking:Growth Hormones, Oral Steroids
44 Participants Needed
Phentermine for Obesity
Winston-Salem, North Carolina
This trial is studying the long-term effects of the weight-loss drug phentermine on people with obesity. The drug helps by making you feel less hungry and burning more calories. Researchers want to see if it is safe and effective over an extended period. Phentermine has been used in various formulations and combinations for weight loss, showing modest efficacy but with potential cardiovascular and psychiatric side effects.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Heart Disease, Glaucoma, Substance Use, Others
Must Not Be Taking:MAO Inhibitors, Stimulants
870 Participants Needed
Mobile Intervention for Osteoarthritis
Winston Salem, North Carolina
The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance.
The overarching goal of the proposed Stage II "mobile intervention to reduce pain and improve health-III (MORPH-III)" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own.
The Specific Aims are:
Specific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6.
Specific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6.
Exploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and/or 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and/or 18 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:65+
Key Eligibility Criteria
Disqualifiers:Severe Arthritis, Cognitive Impairment, Uncontrolled Hypertension, Others
Must Not Be Taking:Weight Loss Medications
200 Participants Needed
NDPP-NextGen for Diabetes Risk Reduction
Winston-Salem, North Carolina
The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.
The main goals of the study are:
1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth
All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:
1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression
2. Body size measurements
3. Fasted blood draws
Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 39
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Long-acting Contraceptives, Others
403 Participants Needed
This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Other Cancer, Walking Issues, Falls, Others
120 Participants Needed
Exercise and Diet for Metabolic Disorders
Toronto, Ontario
This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:
* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?
* What is the effect modification of adding a diet quality intervention to exercise?
* What is the effect modification by menopausal status?
The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:30+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cardiovascular Diseases, Diabetes, Cancer, Others
Must Not Be Taking:Weight Loss Medications, Exogenous Hormones
180 Participants Needed
Modified Breath Test for Sedentary Lifestyle
Toronto, Ontario
Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. The current study aims to refine our previous breath test method to be more effective at measuring changes in how the body processes protein in different situations, such as resting, reducing physical activity, and doing resistance exercise. We hypothesize that using a lower amount of dietary amino acids in our breath test will be effective at detecting lower amounts of amino acids used after exercise, and a greater amount with step reduction compared to normal activity levels
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 35
Key Eligibility Criteria
Disqualifiers:Chronic Disease, Cancer, Smoking, Others
Must Not Be Taking:NSAIDs, Anticoagulants, Statins, Others
12 Participants Needed
Online Exercise Promotion for Sedentary Lifestyle
Toronto, Ontario
Given the importance of reducing mortality-morbidity, more effective Physical Activity (PA) interventions are important, and the recently observed stabilizations of PI levels suggest that novel methods must be explored (Ozemek et al., 2019).
This study aims to provide a select sedentary subpopulation with a customized intervention hypothesized to increase their PA adoption. Novel recruiting methods are used to identify a target subpopulation (based on multiple characteristics) that can be contacted in multiple sections of North America. We will intervene online and rigorously test the theoretical formulations that identify the subpopulation and the customized intervention.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Bipolar, Borderline, OCD, Schizophrenia, Others
90 Participants Needed
Healthy Lifestyle Interventions for Breast Cancer Survivors
Toronto, Ontario
This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:
* What is the impact of exercise on cardiometabolic health and body composition in BC survivors?
* What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition?
* Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors?
The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Cardiovascular Diseases, Diabetes, Others
Must Not Be Taking:Tamoxifen, Chemotherapy, Radiation, Hormones
45 Participants Needed
Lifestyle Interventions for Dementia Prevention
Toronto, Ontario
Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) receive a comprehensive dementia risk assessment, including nonmodifiable and modifiable risk factors, from which they receive a Personalized Dementia Risk Report and Program Strategy, indicating their health conditions increasing and their risk level in five modifiable risk domains: physical activity, brain- healthy eating, cognitive engagement, social connections, and mental wellbeing. Equipped with this information, participants enroll in programs within the Centre to address their risk factors. Changes to their dementia risk, cognition, and Personalized Program Strategy are communicated through re-assessments of risk factors every six months (risk and cognition) and every year (comprehensive assessment).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Dementia
450 Participants Needed
Fit-for-Fertility Program for Female Infertility and Obesity
Toronto, Ontario
This trial tests the Fit-For-Fertility program, which helps women with obesity and infertility adopt healthier lifestyles. The program includes sessions with dietitians and kinesiologists, and group education. It aims to improve fertility and reduce treatment costs by promoting sustainable healthy habits.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uncontrolled Conditions, IVF Only, Others
408 Participants Needed
Plant-based Lifestyle Intervention for Diabetes
Toronto, Ontario
The goal of this clinical trial is to learn if a plant-based intensive lifestyle intervention can achieve remission of diabetes. It will also learn if a plant-based intensive lifestyle intervention can achieve weight loss ≥15% of initial body weight.
The main questions it aims to answer are:
* What proportion of participants achieved diabetes remission (normal blood sugar for at least 3 months without medication)?
* What proportion of participants achieved ≥15% weight loss from their initial weight?
* What is the impact on weight, body composition, blood pressure, blood sugars, cholesterol and inflammation levels?
Researchers will compare the plant-based intensive lifestyle intervention to the current standard of care.
Participants will be randomly placed into one of two groups:
1. Standard of care, where they will continue their usual diabetes care with their health care providers
2. Plant-based intensive lifestyle intervention, where they will follow a diet and exercise program
Participants in the standard of care will:
* Continue with their usual diabetes care for 12 months
* Attend clinic visits on 5 occasions over the 12 months
* Allow study staff to take measurements (e.g. weight, blood pressure)
* Provide blood samples
* Track their food and exercise and complete questionnaires
Participants in the plant-based intensive lifestyle intervention will:
* Follow a plant-based low calorie diet for 3 months followed by a calorie-balanced plant-based diet for 9 months
* Participate in a 16-week exercise program
* Attend clinic visits every 2-4 weeks over the 12 months
* Allow study staff to take measurements (e.g. weight, blood pressure)
* Provide blood sample
* Track their food and exercise and complete questionnaires
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Recent Weight Loss, Eating Disorder, Allergies, Pregnancy, Others
Must Be Taking:Non-insulin Antihyperglycemics
160 Participants Needed
Lifestyle Changes + Metformin for Diabetes Prevention
Rockville, Maryland
The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.
DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.
The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:25+
Key Eligibility Criteria
Disqualifiers:Not Listed
2779 Participants Needed
Lifestyle Intervention vs Metformin for Gestational Diabetes
Washington, District of Columbia
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is:
Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes?
Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes.
Participants will:
* Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
* Track diet, physical activity, and weight using the Fitbit and Looseit! apps.
* Attend weekly online group sessions for the first 4 weeks, then biweekly sessions.
* If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study.
* If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication.
* Continue with biweekly group sessions or have regular check-in calls.
* If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study.
* Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm.
* At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Malignancy, Others
Must Not Be Taking:Weight Loss Medications
60 Participants Needed
Plant-based Diet for Kidney Transplant Recipients
Washington, District of Columbia
The goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows:
* To test the feasibility of transiting renal allograft recipients who are \> 3 months post-transplant to a PBD
* To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients
* To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients
Participants will be asked to:
* Complete a 2-week investigator-designed PBD transition program
* Follow a PBD for a minimum of 16 weeks
* Consent for blood draws, urine samples, and fecal samples along with physical exams
* Complete intermittent food frequency questionnaires and quality of life questionnaires
* Periodically meet with investigators and other study participants
Researchers will compare baseline measurements with future measurements for each participant.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
25 Participants Needed
Healthy Lifestyle Education for Pregnancy Outcomes
Milwaukee, Wisconsin
The goal of this randomized controlled clinical trial is to determine if healthy lifestyle education can help improve cardiovascular health and reduce pregnancy complications in women during the preconception period or early pregnancy. The main aims include:
1. Determine the feasibility and acceptability of the LEAN into pregnancy study.
2. Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular health score.
3. Determine the impact of health lifestyle education on adverse pregnancy outcomes, specifically gestational diabetes and preeclampsia.
A total of 200 participants will be randomly assigned to receive healthy lifestyle education in addition to routine care, or routine care alone. Participants will be asked to participate in the following activities:
* Blood draws to test hemoglobin A1c and lipids
* Surveys about diet, physical activity, sleep, and tobacco use
* Gaples Nutritional Education Modules (if applicable)
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:No Smartphone, Major Fetal Anomaly
200 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
Daily Goal Setting for Cognitive Health
Hershey, Pennsylvania
The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:30 - 70
Key Eligibility Criteria
Disqualifiers:Neurodegenerative Disease, Heart Failure, Others
200 Participants Needed
Decision Support Tool for Prediabetes
Lutherville, Maryland
The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Diabetes, Non-English, Severe Psychiatric, Others
100 Participants Needed
Proactive Care for Osteoarthritis
Hershey, Pennsylvania
The aim of this pragmatic randomized controlled trial is to test the effects of a brief proactive care intervention involving mailed material and two phone calls on: (1) increasing participation in SilverSneakers exercise programs among older adults with osteoarthritis; (2) improving physical, social and psychological outcomes identified as important to older adults with osteoarthritis; and (3) reducing costly osteoarthritis-related health service use. Approximately 1,454 older adults with osteoarthritis who have SilverSneakers access through their Medicare Advantage plan, but no prior SilverSneakers use, will be recruited to participate across the United States. Key outcome measures will be assessed over a two-year follow-up period.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Dual Enrollment, Hospice, Institutional Care
1454 Participants Needed
Basic Needs Navigation for Diabetic Kidney Disease
Milwaukee, Wisconsin
The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.
The study objective will be achieved with the following aims:
Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.
Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.
Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Active Psychosis, Alcohol/drug Abuse, Others
50 Participants Needed
Sit-stand Desk for Diabetes Prevention
Milwaukee, Wisconsin
More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial.
The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses.
The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Musculoskeletal Disorders, Neuropathy, Others
Must Not Be Taking:Diabetes Medications, Insulin, Steroids
198 Participants Needed
mPATH for Cognitive Impairment and Insomnia
Baltimore, Maryland
Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in low-income older adults. The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in low-income older adults.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Sleep Apnea, Severe Depression, Dementia, Others
176 Participants Needed
Sedentary Reduction Strategies for Sedentary Lifestyle
Baltimore, Maryland
The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk of becoming frail.
The main question this project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light walking over 60 days.
There are other questions this project aims to answer that include:
1. whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts
2. whether becoming less sedentary and more active leads to feeling better, have less stress, pain, and fatigue and have more confidence in becoming more regularly active
3. whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism
Participants will be randomized into one of two sedentary reduction behavior programs; one program that gradually replaces sedentary time with one 30-minute walking bout and the other program that gradually replaces sedentary time with three 10-minute walking bouts in the morning, afternoon, and evening. Researchers will compare both programs to see which one is easier to achieve and maintain over 60 days.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Diabetes, Alcohol/drug Issues, Mobility, Others
60 Participants Needed
Group Exercise for Psychiatric Hospitalization
Baltimore, Maryland
More research is needed to elucidate the impacts of physical activity interventions on short- and long-term activity and neuropsychiatric symptoms (NPS) in psychiatric inpatients and to support its advantageousness when compared to current standards of care. To investigate the impact of regular exercise on activity level, NPS, and sleep in an inpatient psychiatry unit, the investigators propose a placebo-controlled study with measures of activity, mood, anxiety, energy, and sleep as primary outcomes in 50 psychiatric inpatients at Johns Hopkins Hospital. Given the challenges of maintaining blinded assignment to treatment arm, the investigators will compare patients during two time periods (3 months each): the first is treatment as usual (TAU), the second adds exercise intervention (EXI).
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Physical Conditions, Safety Concerns, Others
60 Participants Needed
Lifestyle Intervention for Obesity
Richmond, Virginia
Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women. The primary purpose of this study is to test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity, as well as improving biomarkers of inflammation and metabolic risk over 12 months compared with a traditional behavioral weight loss intervention. This treatment program will be tested in emerging adult (EA) women ages 18-25 years old with a BMI of 25-50 kg/m\^2.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 25
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Heart Conditions, Others
Must Not Be Taking:Weight Loss, Anti-inflammatory
32 Participants Needed
Anti-Inflammatory Lifestyle Intervention for Cancer Survivors
Richmond, Virginia
To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 29
Key Eligibility Criteria
Disqualifiers:Pregnancy, Uncontrolled Hypertension, Bipolar, Others
Must Not Be Taking:Weight Loss Medications
19 Participants Needed
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Frequently Asked Questions
How much do Lifestyle clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Lifestyle clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Lifestyle trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Lifestyle is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Lifestyle medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Lifestyle clinical trials?
Most recently, we added Olives for a Healthy Lifestyle, Exercise Program for Lymphoma and Plant-based Lifestyle Intervention for Diabetes to the Power online platform.
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