Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

Mayo Clinic

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Modified Lifestyle Intervention; Behavioral: Standard Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04073394

19-007485

Details and patient eligibility

About

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, and weight loss maintenance.

Enrollment: 215 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Standard Lifestyle Intervention

Active Comparator group

Description:

Participants in this group will be instructed to follow a standard low calorie diet, recommended to have 30 minutes of physical activity 3-5 days per week, and will be followed by a wellness couch weekly.

Treatment:

Behavioral: Standard Lifestyle Intervention

Modified Lifestyle Intervention

Experimental group

Description:

Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.

Treatment:

Behavioral: Modified Lifestyle Intervention