Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 12-week total body weight loss [12 weeks]
Change in body weight during the 12 week study
Secondary Outcome Measures
- Responder Rate [12 weeks]
Proportion of patients losing > 3% of total body weight
- Waist Circumference [12 weeks]
Change in waist circumference (cm)
- Fat Loss [12 weeks]
Change in fat mass during the 12 week study using DEXA
- Calorie Intake [12 weeks]
Change in daily calorie intake
- Calories to Fullness [12 weeks]
Change in calories consumed to fullness during the 12 week study using satiation test
- Gastric Emptying [12 weeks]
Change in half gastric emptying time during the 12 week study using scintigraphy
- Gastric Emptying 2 Hours [12 weeks]
Change in gastric emptying percentage at 2 hours during the 12 week study using scintigraphy
- 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
- Resting Metabolic Rate [12 weeks]
Change in resting energy expenditure during the 12 week study using an indirect calorimetry
- Adherence [12 weeks]
Adherence and compliance with program defined by the number of contacts with the team
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Age: 18-65 years.
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Gender: Men or women.
Exclusion Criteria:
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Weight change greater than 3% in the previous 3 months (weight stable).
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History of bariatric surgery including lap band and bariatric endoscopy.
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Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
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Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
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A positive score on the AUDIT-C questionnaire as judged by an investigator.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Andres Acosta, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-007485