TrialGlobe

Clinical trial

Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

Recruiting now · Not applicable · 1 countries · Registry ID NCT06770049

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

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

Primary outcomes

Total Body Weight Loss (TBWL)Baseline, 52 weeks

Change in Total Body Weight Loss (TBWL) in kg

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mayo Clinic🇺🇸 Rochester, Minnesota, United States
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Megan SchaeferContact
Email · Call 507-266-6004
Andres AcostaPrincipal Investigator