Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

"Mayo Clinic Diet" Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes (PHENO-Diet Trial)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Standard Lifestyle Intervention; Behavioral: Modified Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Behavioral: Standard Lifestyle Intervention; Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the Mayo Clinic Diet program.
EXPERIMENTAL: Modified Lifestyle Intervention; Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.	Behavioral: Modified Lifestyle Intervention; Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the participants obesity phenotype.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-week total body weight loss	Change in body weight during the 12 week study	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2020
• Primary Completion (ACTUAL): January 31, 2022
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (ACTUAL): August 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 19-007485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No