Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population

Conditions
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Overweight, PreDiabetes, Diabetes Type 2, Obesity

Intervention / Treatment
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* Dietary Supplement: Bariatrix Meal Replacement Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Body mass index (BMI) greater than or equal to 27 kg/m^2 HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022 Exclusion Criteria: Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment HbA1c greater than or equal to 10 percent Plans to pursue bariatric surgery over the 6 months post-study enrollment Weight loss of greater than 5 kg within the previous 3 months Current active eating disorder, with the exception of binge eating disorder Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention Active illicit substance abuse Pregnant, breastfeeding, or considering pregnancy within the next 6 months Current participation in another clinical research trial deemed by investigator to conflict with current study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with overweight/obesity and pre-diabetes/diabetes and low income<br>Adults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income. | Dietary Supplement: Bariatrix Meal Replacement Products<br>* Meal replacement products offered through the Massachusetts General Hospital Weight Center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program adherence | Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires | 3 months |