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

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Massachusetts General Hospital

You may qualify if…

  • 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

You may not qualify if…

  • 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

Where it's recruiting

Source: ClinicalTrials.gov · NCT05799222 · last updated 2025-12-24

Medically Intensive Nutrition Therapy Program for Obesity and Diabetes · TrialPath