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The purpose of study is to evaluate the efficacy of the Mayo Clinic Diet in clinically significant weight loss (>5%) versus usual care. We also wish to evaluate the feasibility, barriers to completion, and sustainability of this intervention at the 24, and 52-week marks. Lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mayo Clinic Diet | Experimental | Subjects in the Mayo Clinic Diet (MCD) arm will be provided with options including the Mayo Clinic Diet book 3rd edition or application from digital wellness or both with full subscription paid for by the Mayo Clinic Diet for the 12 week period. The Mayo Clinic Diet arm will switch to usual care after 12 weeks. |
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| Usual Care | Active Comparator | Subjects in the usual care arm will be provided with two Mayo Clinic resources for lifestyle modifications: Eat Well Use the Plate hand out, and the Food, Physical Activity and Weight Tracking Apps with a list of self-monitoring tools to support a healthy lifestyle. The usual care arm will switch to the Mayo Clinic Diet after 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mayo Clinic Diet | Behavioral | Subjects will utilize their choice of the following resources for 12 weeks:
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| Measure | Description | Time Frame |
|---|---|---|
| Mayo Clinic Diet- Was It Worth It survey | The Mayo Clinic Diet - Was It Worth It survey consists of 6 questions to get feedback on the subjects perception of the program. | 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mayo Clinic Diet 12-item Short Form health (SF-12) survey | The 12-item short form health survey is a self-reported assessment of a subjects health, consisting of physical health and emotional health domains. Emotional health questions are rated on a 5-point Likert scale with 0 = "All of the time" and 5 = "None of the time". Physical health questions are rated on a 3-point Likert scale with 0 = "Yes, Limited A Lot" and 3 = "No, Not Limited At All". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Family Medicine Research Study Coordinators | Contact | 507-422-6823 | RSTFMSC@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tamim Rajjo | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| 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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| Usual Care | Behavioral | Subjects will be given the 'Eat Well Use the Plate' informational hand-out, as well as a list of food, physical activity and weight tracking apps to be utilized as resources for self-monitoring . |
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| Baseline, 12 weeks, 24 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |