Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

NCT06770049 | Recruiting Phase 4

• 2 other identifiers: 24-002375R01DK139028
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total Body Weight Loss (TBWL)

  Change in Total Body Weight Loss (TBWL) in kg

  Baseline, 52 weeks

Study Arms (2)

Standard Lifestyle Intervention (SLI) program

ACTIVE COMPARATOR

Behavioral: Standard Lifestyle Intervention (SLI) program

Phenotype-tailored Lifestyle Intervention (PLI) program

EXPERIMENTAL

Behavioral: Phenotype-tailored Lifestyle Intervention (PLI) program

Interventions

Standard Lifestyle Intervention (SLI) program BEHAVIORAL

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.

Standard Lifestyle Intervention (SLI) program

Phenotype-tailored Lifestyle Intervention (PLI) program BEHAVIORAL

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

Phenotype-tailored Lifestyle Intervention (PLI) program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or women between 18 to 65 years with obesity (BMI\>30kg/m2).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andres Acosta, MD,PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Schaefer

CONTACT

507-266-6004; RSTWEIGHTLOSS@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this 12-month, randomized, active-controlled trial, we aim to compare the effect of guiding lifestyle intervention tailored to a sub-classification of obesity based on physiological and behavioral alterations, called phenotypes.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)