Recruiting

Lifestyle Intervention

Sponsor:

Mayo Clinic

Code:

NCT06770049

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard Lifestyle Intervention (SLI) program

Phenotype-tailored Lifestyle Intervention (PLI) program

Study Details

Brief 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

Study ID

NCT06770049

Start date

Jan 22, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 limits their participation in the study
  • Principal Investigator discretion

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Lifestyle Intervention (SLI) program

experimental: Phenotype-tailored Lifestyle Intervention (PLI) program

Interventions

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.

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 measure

  • Total Body Weight Loss (TBWL) [ Time Frame: Baseline, 52 weeks ]

Central Contacts and Locations

Central contacts

Megan Schaefer

507-266-6004RSTWEIGHTLOSS@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Megan Schaefer

507-266-6004RSTWEIGHTLOSS@mayo.edu

Principal Investigator:

Andres Acosta

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-11.