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This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.
The Medically Intensive Nutritional Therapy (MINT) program at Massachusetts General Hospital (MGH) Weight Center is a low-calorie nutrition plan that may offer a solution for those who have difficulty implementing a low-calorie dietary plan on their own. This study examines the effects of MINT on weight loss and blood sugar control specifically in a low-income population and explores potential reasons for discontinuing the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with overweight/obesity and pre-diabetes/diabetes and low income | Adults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatrix Meal Replacement Products | Dietary Supplement | Meal replacement products offered through the Massachusetts General Hospital Weight Center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight reduction | Reduction in body weight by greater than or equal to 5 percent | 3 months |
| Hemoglobin A1c reduction | Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Program adherence | Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with overweight or obesity and pre-diabetes or diabetes and low income
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chika V Anekwe, MD | Contact | 617-726-4400 | canekwe@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chika V Anekwe, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
There is no IPD plan.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Participants may choose to take part in an optional collection of stored blood.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |