Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073394
• Other study ID #: 19-007485
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials