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

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

Recruiting
18-65 years
All
Phase N/A

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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.

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.

Eligibility

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 antiobesity 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 details
    Overweight
    PreDiabetes
    Diabetes Type 2
    Obesity

NCT05799222

Massachusetts General Hospital

27 January 2024

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