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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Lifestyle Intervention | Active Comparator | 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 | Experimental | Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Lifestyle Intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-week total body weight loss | Change in body weight during the 12 week study | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | Proportion of patients losing > 3% of total body weight | 12 weeks |
| Waist Circumference | Change in waist circumference (cm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Acosta, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42382664 | Derived | Anazco D, Koball A, Cifuentes L, Villamarin J, Friend J, Fansa S, Espinosa MA, Rieck TM, Grothe K, Camilleri M, Hurtado MD, Acosta A, Clark MM, Hensrud DD. Phenotype tailored lifestyle intervention for weight management in individuals with emotional eating: A secondary analysis of the PHENO-Diet trial. Obes Pillars. 2026 Jun 17;19:100284. doi: 10.1016/j.obpill.2026.100284. eCollection 2026 Sep. | |
| 37007741 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Modified Lifestyle Intervention | 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. |
|
| 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 |
| Derived |
| Cifuentes L, Ghusn W, Feris F, Campos A, Sacoto D, De la Rosa A, McRae A, Rieck T, Mansfield S, Ewoldt J, Friend J, Grothe K, Lennon RJ, Hurtado MD, Clark MM, Camilleri M, Hensrud DD, Acosta A. Phenotype tailored lifestyle intervention on weight loss and cardiometabolic risk factors in adults with obesity: a single-centre, non-randomised, proof-of-concept study. EClinicalMedicine. 2023 Mar 24;58:101923. doi: 10.1016/j.eclinm.2023.101923. eCollection 2023 Apr. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |