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37 Weight Loss Trials near Miami, FL
Power is an online platform that helps thousands of Weight Loss 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 PowerBI 456906 for Diabetes and Obesity
Coral Gables, Florida
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight.
Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Gastric Issues, Pancreatitis, Thyroid Cancer, Others
Must Be Taking:Diet, Exercise
756 Participants Needed
Retatrutide for Obesity
Coral Gables, Florida
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Thyroid Cancer, Heart Failure, Others
Must Not Be Taking:Weight Loss Drugs
643 Participants Needed
Weight Loss Intervention for Breast Cancer Recurrence Prevention
Miami Beach, Florida
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Severe Cardiovascular, Psychiatric Disorders, Others
Must Be Taking:Hormonal Therapy
3177 Participants Needed
Orforglipron for Obesity
Miami, Florida
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Obesity Surgery, Hepatitis, Pancreatitis, Others
300 Participants Needed
Tirzepatide for Weight Loss Maintenance in Obesity
Miami, Florida
This trial is testing tirzepatide, a medication that helps people lose weight, to see if it can also help them keep the weight off. The study involves people who have already lost weight and need help maintaining it. Tirzepatide works by making people feel full and reducing their appetite. Tirzepatide has been effective in helping people lose weight and manage blood sugar levels.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Cardiovascular, Depression, Others
400 Participants Needed
GZR18 vs Tirzepatide for Obesity
Miami, Florida
This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Renal Impairment, Depression, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Mood Stabilizers, Others
285 Participants Needed
Signos mHealth Platform for Weight Loss
North Miami, Florida
This trial uses a device that continuously tracks blood sugar levels and a mobile app to help people with obesity manage their weight. The app provides personalized advice on diet and exercise based on the blood sugar data. The goal is to see if this approach helps people stick to their health goals better.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Key Eligibility Criteria
Disqualifiers:Diabetes, Eating Disorders, Severe Kidney Disease, Others
Must Not Be Taking:Diabetes Medications, Weight Loss Drugs
380 Participants Needed
NA-931 and Tirzepatide for Obesity
Hialeah, Florida
A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:19 - 80
Key Eligibility Criteria
Disqualifiers:Diabetes, Chronic Infections, Others
Must Not Be Taking:Antidiabetics, Obesity Medications
224 Participants Needed
MET097 for Diabesity
Hollywood, Florida
This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hypertension, Stroke, Cardiovascular, Others
Must Be Taking:Metformin, SGLT-2
125 Participants Needed
Trevogrumab + Garetosmab + Semaglutide for Obesity
Sunrise, Florida
This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested.
Part A of the study is focused on healthy participants. Part B and C of the study is focused on participants with obesity.
The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy.
Parts A, B, and C of the study are looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Bariatric Surgery, Hypertension, Others
999 Participants Needed
Revita DMR for Obesity
West Palm Beach, Florida
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1.
Midpoint Analysis of Randomized Cohort:
The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis.
Pivotal Analysis of Randomized Cohort:
The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 70
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Substance Abuse, Others
Must Be Taking:Tirzepatide
315 Participants Needed
VK2735 for Obesity
Ocoee, Florida
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
VK2735 or matched placebo will be administered once daily.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Chronic Pancreatitis, Others
Must Not Be Taking:GLP-1 Agonists, Weight Loss Meds
280 Participants Needed
LY3841136 for Obesity
Orlando, Florida
This trial is testing a new medication called LY3841136 to help adults who are overweight or obese manage their weight. The study aims to see if this medication is safe and effective over several months.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Conditions, Hypertension, Others
263 Participants Needed
LY3305677 for Obesity
Orlando, Florida
This trial is testing a new medication called LY3305677 to help adults who are obese or overweight manage their weight. The study will last over a year. Researchers want to see if this medication helps people lose weight and if it is safe to use.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Not Listed
179 Participants Needed
LY4086940 for Obesity
Daytona Beach, Florida
The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.
Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 9 visits.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Acute Cardiovascular, Liver Disease, Pancreatitis, Others
Must Not Be Taking:Weight Loss Drugs
165 Participants Needed
Nerve Stimulation for Weight Loss and Diabetes
Gainesville, Florida
The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:20 - 75
Key Eligibility Criteria
Disqualifiers:Neurological, Psychiatric, Cancer, Others
120 Participants Needed
Self-Monitoring Feedback for Obesity
Gainesville, Florida
Self-monitoring (of weight, intake, and activity) is a core component in evidence-based lifestyle interventions for obesity. Research has shown that interventionist feedback increases adherence to self-monitoring and improves weight loss outcomes; however, little empirical evidence exists on how this feedback should be provided. This research study aims to optimize the provision of self-monitoring feedback.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
28 Participants Needed
Online Tools for Obesity
Gainesville, Florida
The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Fifteen to twenty PCPs will be recruited, followed by 453 patients. Patients will complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:BMI≥45, Cancer, Cardiovascular, Others
Must Not Be Taking:Weight Loss Medications
473 Participants Needed
Phone-Based Weight-Loss Support for Obesity
Gainesville, Florida
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
255 Participants Needed
ResArgin for Weight Loss
Jacksonville, Florida
The goal of this clinical trial is to learn if the supplement ResArgin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. Other related health outcomes such as sleep, mood, and activity will be assessed. The main questions it aims to answer are:
Does ResArgin improve muscle loss? Does ResArgin improve sleep quality, activity, mood, and body satisfaction.
Researchers will compare ResArgin to a placebo (a look-alike substance that contains no active ingredients) to see if ResArgin works to improve muscle loss and related health outcomes.
Participants will:
Take ResArgin or the Placebo every day for 3 months
Assessment will occur at Baseline, Day 30, Day 60, and Day 90.
Participants will complete a daily diary of their mood and health.
Trial Details
Trial Status:Active Not Recruiting
Age:25 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
60 Participants Needed
Why Other Patients Applied
"I have tried to lose weight, but as I get older, it becomes harder and harder. I have lost weight in the past through diet and exercise, but it has been more difficult to accomplish as I age."
JP
Obesity PatientAge: 44
"I need to lose weight because it's affecting my knees. I've already had a knee replacement and the second one is happening on the left knee in a few months. I've participated in a study in the past for a skin-related issue, and had a good experience. That's why I'm interested in joining a study for wieght loss."
KI
Obesity PatientAge: 69
"I have a heart condition, and my fat is all in my chest, surrounding my heart. It's hard for me to exercise because my legs are thin and the upper body weight is too much — putting strain on my leg joints. It’s a vicious cycle. I am also post-menopausal, which adds additional weight loss difficulty. I also have stress with being a full time caregiver for my mom. I'm interested in trying a clinical trial."
DK
Obesity PatientAge: 56
"I am applying for my daughter. She turns 12 this year and is overweight. She's 5'4" and 176 pounds. Would be great to enroll her in a clinical trial to see if this form of care could work for her. Realize that there's no guarantee, but I support her and we'd like to give it a try."
MW
Parent of PatientAge: 46
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Virtual Coach for Weight Loss in Ventral Hernia Patients
Jacksonville, Florida
The purpose for this research is to create a MyChart-enabled virtual coach that assists obese patients lose weight prior to ventral hernia surgery. Researchers intend to show how the use of a virtual coach is more effective in preoperative weight reduction prior to ventral hernia repair over usual care. Correspondingly, this may lower unplanned hospital readmissions. For this clinical trial, where randomization is not possible, the study team will implement the use of propensity score matching that sorts individuals into different study arms as if randomly assigned. The primary outcome is the average net amount of time-dependent weight change per group over six months. Secondary outcomes are for the intervention group, patient satisfaction with the virtual coach and for both groups, quality of life. In addition, areas of social and economic disadvantage will be identified that may contribute to higher obesity rates. Machine learning (ML) modeling will be used to determine the important features for weight lost over the course of the study. The impact of this work will be to demonstrate efficacy and realized workflow efficiencies within a hospital-based surgery clinic.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Mental Disorders, Substance Use Disorder, Others
Must Not Be Taking:Psychiatric Medications, Steroids
60 Participants Needed
Ponsegromab for Cachexia
Tallahassee, Florida
This trial tests Ponsegromab, a new drug, on cancer patients who are losing weight and have high GDF 15 levels. The drug aims to lower GDF 15 to improve appetite and reduce weight loss.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Not Listed
187 Participants Needed
Lifestyle Program + Exercise for Stroke
Charleston, South Carolina
Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Dementia, Uncontrolled Diabetes, Severe Hypertension, Others
99 Participants Needed
Weight Loss and Exercise for Stroke Survivors
Charleston, South Carolina
The prevalence of obesity among U.S. adults is \~40% and is projected to climb. It is well documented that obesity is associated with increased levels of disability as well as risk for numerous adverse health-related outcomes; including occurrence of stroke and all-cause mortality. Obesity is highly prevalent in stroke survivors (\~30-45% of stroke survivors have BMI\>30) and is associated with reductions in physical function and increased disability. Furthermore, neurological sequelae following stroke result in a myriad of residual impairments that contribute to significant reductions in physical activity, which further increase the risk for obesity. The alarmingly high (and increasing) rates of obesity amongst stroke survivors represents an area of critical clinical need and, despite an abundance of information regarding weight loss approaches in neurologically healthy individuals, there is a lack of information regarding the impact of intentional weight loss on overweight and obese survivors of stroke. Thus, the purpose of this study it investigate the effect of varying weight loss approaches on physical function and psychosocial outcomes in chronic stroke survivors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:35 - 85
Key Eligibility Criteria
Disqualifiers:Congestive Heart Failure, COPD, Others
Must Not Be Taking:Anti-seizure Medications
130 Participants Needed
Digital Weight Loss Interventions for Obesity
Columbia, South Carolina
Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited in rural areas. Digital interventions offer an attractive alternative for delivering lifestyle programs to rural populations. However, in-person behavioral obesity treatment programs achieve better weight losses than digital programs, likely because in-person programs typically include personnel-intensive "high touch" treatment components. Some studies indicate that having a human "behind the curtain" of a digital program through emailed feedback or with the addition of online group sessions can significantly increase weight loss. Therefore, the aims of this study are to increase the public health impact of digital obesity treatment for rural populations by simultaneously investigating 3 "high touch" intervention components. The investigators will conduct a highly efficient experiment with participants residing in non-urban areas recruited online from across the United States. Participants (N=616; 22% racial/ethnic minority; 40% male) will be randomized to: (1) weekly facilitated synchronous group video sessions (yes vs. no); (2) type of self-monitoring feedback received (counselor-crafted vs. pre-scripted); and (3) individual coaching calls (yes vs. no). These components will be layered onto our 24-week evidence-based, interactive digital weight loss program delivered to groups of eligible individuals. Based on the results of the experiment, The investigators will identify an optimized program in which each component (or combination of components) contributes meaningfully (at least 1.5 kg greater weight loss at 6-months) to enhanced weight loss. The investigators will also exploratory analyses of weight trajectories 6-months post-treatment (i.e., at 12-months) to elucidate extended impact of the specific components on weight control. Ultimately, this research will set the stage for confirming the most promising digital behavioral weight loss intervention that can be used without geographic borders to reduce obesity rates among rural residents and provide the evidence needed to establish best practice policies for broadly effective digital approaches to weight control.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Bariatric Surgery, Heart Condition, Others
Must Not Be Taking:Weight Loss Medications
616 Participants Needed
High Fiber Diet for Obesity and Colon Cancer
Atlanta, Georgia
This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:40 - 75
Key Eligibility Criteria
Disqualifiers:Colorectal Cancer, Bowel Resection, Others
Must Not Be Taking:Anti-inflammatories, Gut-altering Drugs
60 Participants Needed
Basketball for Prediabetes
Atlanta, Georgia
The purpose of this study is to assess the efficacy of adapting the National Diabetes Prevention Program (NDPP) to include recreational sports in effort to increase physical activity (PA) and promote lifestyle changes that can help reduce the risk of developing Type 2 Diabetes Mellitus. The hypothesis is that both the traditional NDPP and the NDPP+ Basketball will be considered feasible. The primary outcome is to assess whether the intervention (NDPP+BB) compared to the standard of care (NDPP only) will result in greater weight loss, lower A1c, and increased engagement in physical activity.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 44
Key Eligibility Criteria
Disqualifiers:Diabetes, ESRD, Cancer, Others
60 Participants Needed
Weight Loss for Kidney Stones
Birmingham, Alabama
This protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis and dietary oxalate absorption to the urinary oxalate pool in obese calcium oxalate stone formers.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:19 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Hypertension, Gout, Others
Must Not Be Taking:Diuretics, SGLT2-inhibitors
14 Participants Needed
Extended Care Interventions for Weight Loss Maintenance
Birmingham, Alabama
The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people.
* The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance.
* The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people.
Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off.
The four components participants could be assigned to in Phase 2 are:
1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly
2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home
3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant
4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way
Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hypertension, Diabetes, Others
Must Not Be Taking:Weight Loss Medications
544 Participants Needed
Dietary Strategies for Prediabetes
Birmingham, Alabama
This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Eating Disorders, Others
Must Not Be Taking:Weight Loss Medications
30 Participants Needed
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Frequently Asked Questions
How much do Weight Loss clinical trials in Miami, FL 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 Weight Loss clinical trials in Miami, FL 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 Weight Loss trials in Miami, FL 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 in Miami, FL for Weight Loss 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 in Miami, FL 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 Weight Loss medical study in Miami, FL?
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 Weight Loss clinical trials in Miami, FL?
Most recently, we added Nerve Stimulation for Weight Loss and Diabetes, Dietary Strategies for Prediabetes and Ketogenic Diet for Obesity to the Power online platform.
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