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

Recruiting

• Conditions: Overweight; Diabetes Type 2; Obesity; PreDiabetes
• Interventions: Dietary Supplement: Bariatrix Meal Replacement Products

• Registration Number: NCT05799222
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-22
• Study Start: 2023-03-28
• Study First Posted: 2023-04-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-11-08
• Study Completion: 2025-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with overweight/obesity and pre-diabetes/diabetes and low income	Bariatrix Meal Replacement Products	Adults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c reduction	3 months	Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent
Body weight reduction	3 months	Reduction in body weight by greater than or equal to 5 percent

Secondary Outcome Measures

Name	Time	Method
Program adherence	3 months	Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States