Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Modified Lifestyle Intervention

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

Group Type EXPERIMENTAL

Modified Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes