Status:

COMPLETED

Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

Lead Sponsor:

Mayo Clinic

Conditions:

Obesity

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, a...

Eligibility Criteria

Inclusion

  • Adults with obesity (BMI \>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
  • Age: 18-65 years.
  • Gender: Men or women.

Exclusion

  • Weight change greater than 3% in the previous 3 months (weight stable).
  • History of bariatric surgery including lap band and bariatric endoscopy.
  • Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
  • Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
  • A positive score on the AUDIT-C questionnaire as judged by an investigator.
  • Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence

Key Trial Info

Start Date :

July 6 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2022

Estimated Enrollment :

215 Patients enrolled

Trial Details

Trial ID

NCT04073394

Start Date

July 6 2020

End Date

January 31 2022

Last Update

February 3 2023

Active Locations (1)

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Mayo Clinic

Rochester, Minnesota, United States, 55905