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

Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; PreDiabetes; Diabetes Type 2
• Intervention / Treatment: Dietary supplement: Bariatrix Meal Replacement Products

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Chika V Anekwe, MD; Phone Number: 617-726-4400; Email: canekwe@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Chika V Anekwe, MD; Phone Number: 617-726-4400; Email: canekwe@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with overweight/obesity and pre-diabetes/diabetes and low income; Adults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income.	Dietary supplement: Bariatrix Meal Replacement Products; Meal replacement products offered through the Massachusetts General Hospital Weight Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight reduction	Reduction in body weight by greater than or equal to 5 percent	3 months
Hemoglobin A1c reduction	Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program adherence	Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires	3 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Chika V Anekwe, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): November 10, 2026

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: 2022P001451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IPD plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No