Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
Mayo Clinic
Summary
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion: • men or women between 18 to 65 years with obesity (BMI\>30kg/m2). Exclusion: * 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 limit…
Interventions
- BehavioralStandard 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.
- BehavioralPhenotype-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
Location
- Mayo ClinicRochester, Minnesota