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RECRUITING
NCT06770049
PHASE4

Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2025-01-22

Completion Date

2030-12

Last Updated

2025-06-05

Healthy Volunteers

No

Conditions

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States