Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

PHASE4RecruitingINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

January 22, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Obesity
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

Trial Locations (1)

55905

RECRUITING

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Mayo Clinic

OTHER

NCT06770049 - Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial | Biotech Hunter | Biotech Hunter