NCT06770049

Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-22
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2025-01-13
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States