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NCT Number: NCT05799222

Medically Intensive Nutrition Therapy Program for 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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Chika V Anekwe, MD

CONTACT

[email protected]

617-726-4400

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bariatrix Meal Replacement Products

Dietary Supplement

Meal replacement products offered through the Massachusetts General Hospital Weight Center.

Primary outcomes

  1. Body weight reduction

    Time frame: 3 months

    Reduction in body weight by greater than or equal to 5 percent

  2. Hemoglobin A1c reduction

    Time frame: 3 months

    Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent

Secondary outcomes

  1. Program adherence

    Time frame: 3 months

    Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Chika V Anekwe, MD

CONTACT

[email protected]

617-726-4400

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: MINT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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