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

NCT05799222 · Massachusetts General Hospital
In plain English

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Official title
Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 20 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-03-28
Estimated completion: 2026-11-10
Last updated: 2025-12-24
Interventions
Dietary Supplement: Bariatrix Meal Replacement Products
Primary outcomes
  • Body weight reduction (3 months)
  • Hemoglobin A1c reduction (3 months)
Sponsor
Massachusetts General Hospital · other
Contacts & investigators
ContactChika V Anekwe, MD · contact · canekwe@mgh.harvard.edu · 617-726-4400
InvestigatorChika V Anekwe, MD · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States