Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Standard Lifestyle Intervention; Behavioral: Modified Lifestyle Intervention

• Registration Number: NCT04073394
• Lead Sponsor: Mayo Clinic

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, and weight loss maintenance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Study Start: 2020-07-06
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Lifestyle Intervention	Standard Lifestyle Intervention	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.
Modified Lifestyle Intervention	Modified Lifestyle Intervention	Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.

Primary Outcome Measures

Name	Time	Method
12-week total body weight loss	12 weeks	Change in body weight during the 12 week study

Secondary Outcome Measures

Name	Time	Method
Gastric Emptying 2 Hours	12 weeks	Change in gastric emptying percentage at 2 hours during the 12 week study using scintigraphy
Waist Circumference	12 weeks	Change in waist circumference (cm)
Responder Rate	12 weeks	Proportion of patients losing \> 3% of total body weight
Fat Loss	12 weeks	Change in fat mass during the 12 week study using DEXA
Gastric Emptying	12 weeks	Change in half gastric emptying time during the 12 week study using scintigraphy
Adherence	12 weeks	Adherence and compliance with program defined by the number of contacts with the team
Calorie Intake	12 weeks	Change in daily calorie intake
Anxiety Level	12 weeks	Change is anxiety level during the 12 week study using the HADS-A scale
Emotional Eating	12 weeks	Change is emotional eating level during the 12 week study using the TFEQ score
Calories to Fullness	12 weeks	Change in calories consumed to fullness during the 12 week study using satiation test
Resting Metabolic Rate	12 weeks	Change in resting energy expenditure during the 12 week study using an indirect calorimetry

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States