Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Obesity

Treatments: Behavioral: Phenotype-tailored Lifestyle Intervention (PLI) program; Behavioral: Standard Lifestyle Intervention (SLI) program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06770049

24-002375

R01DK139028 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 2 patient groups

Standard Lifestyle Intervention (SLI) program

Active Comparator group

Treatment:

Behavioral: Standard Lifestyle Intervention (SLI) program

Phenotype-tailored Lifestyle Intervention (PLI) program

Experimental group

Treatment:

Behavioral: Phenotype-tailored Lifestyle Intervention (PLI) program