NCT06770049 · Mayo Clinic
Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
What this study is about
The purpose of this study is to develop an evidence-based precision medicine approach for obesity that enhances weight loss and promotes weight loss maintenance.
View original scientific description
The purpose of this study is to develop an evidence-based precision medicine approach for obesity that enhances weight loss and promotes weight loss maintenance.
Interventions
BEHAVIORAL
Standard Lifestyle Intervention (SLI) program
Subjects will receive recommendations for calorie and macronutrient intake, physical activity, and behavioral skills to be followed for 12 months and will be delivered by a multidisciplinary team of obesity experts in a 12-month structured follow up. Participants will meet with a registered dietician as well as member of the study team to learn more about their intervention. Diets will be prescribed for each participant with a 30% calorie deficit calculated from measured REE. Macronutrient composition will be guided based on the patient preference. Participants will be prescribed 150 minutes of physical activity per week (spread across 4-5 days) and recommendations to reach 10,000 steps daily. During the first 12 weeks, participants will be scheduled a 12-week behavioral program focusing on self-monitoring and stimulus control using cognitive-behavioral approaches to promote adherence to diet and exercise prescriptions.
BEHAVIORAL
Phenotype-tailored Lifestyle Intervention (PLI) program
Subjects will receive recommendations for calorie and macronutrient intake, physical activity, and behavioral skills to be followed for 12 months and will be delivered by a multidisciplinary team of obesity experts. The recommendations will be determined a priori to tailor for each obesity phenotype
Primary outcome measures
Total Body Weight Loss (TBWL)
Time frame: Baseline, 52 weeks
Change in Total Body Weight Loss (TBWL) in kg
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- • men or women between 18 to 65 years with obesity (BMI\>30kg/m2).
Exclusion criteria
- weight change greater than 3% in the previous 3 months
- history of bariatric surgery and bariatric endoscopy
- untreated psychiatric disorders including binge eating disorders and bulimia
- current use of AOMs
- history of use of medications affecting weight or energy intake or energy expenditure in the last 6 months
- history of type 1 diabetes mellitus or uncontrolled medical conditions (e.g., uncontrolled hypertension)
- women who are pregnant or plan to become pregnant,
- any condition that limits their participation in the study
- Principal Investigator discretion
Where
- Rochester, Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations