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

Mass General Brigham

Status: Enrolling

Conditions: Overweight; Obesity; Diabetes Type 2; PreDiabetes

Treatments: Dietary Supplement: Bariatrix Meal Replacement Products

Study type: Observational

Funder types: Other

Identifiers

NCT05799222

2022P001451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Adults with overweight/obesity and pre-diabetes/diabetes and low income

Description:

Adults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income.

Treatment:

Dietary Supplement: Bariatrix Meal Replacement Products