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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