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NCT Number: NCT06770049

Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Andres Acosta

PRINCIPAL_INVESTIGATOR

Megan Schaefer

CONTACT

[email protected]

507-266-6004

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Total Body Weight Loss (TBWL)

    Time frame: Baseline, 52 weeks

    Change in Total Body Weight Loss (TBWL) in kg

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Schaefer

CONTACT

[email protected]

507-266-6004

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jan 13, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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