Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatrix Meal Replacement Products.
- Who it may be relevant to
- Registry conditions: Overweight, PreDiabetes, Diabetes Type 2, Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
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.
Interventions
- Dietary supplement Bariatrix Meal Replacement Products
Meal replacement products offered through the Massachusetts General Hospital Weight Center.
Primary outcome measures
- Body weight reduction [Time frame: 3 months]
- Hemoglobin A1c reduction [Time frame: 3 months]
Secondary outcome measures (1)
- Program adherence [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT05799222 · 2022P001451