Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06770049
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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 Dates

Start date
Jan 22, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Lifestyle Intervention (SLI) program
  • Experimental: Phenotype-tailored Lifestyle Intervention (PLI) program

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Megan Schaefer
[email protected]
507-266-6004
Andres Acosta (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic· Rochester, MN

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