Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT05799222

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

Led by Massachusetts General Hospital · Updated on 2025-12-24

20

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Body mass index (BMI) of 27 kg/m2 or higher
  • Hemoglobin A1c of 5.7% or higher or fasting glucose of 100 mg/dL or higher within the last 6 months
  • Low income defined as family income at or below 400% of the federal poverty level guidelines for 2022
Not Eligible

You will not qualify if you...

  • Using diabetes medications other than metformin or approved anti-obesity drugs or planning to start them within 3 months after enrollment
  • Hemoglobin A1c of 10% or higher
  • Planning bariatric surgery within 6 months after enrollment
  • Weight loss over 5 kg within the last 3 months
  • Active eating disorder except for binge eating disorder
  • Severe psychiatric illness or significant cognitive problems that may affect study participation
  • Active use of illicit drugs
  • Pregnant, breastfeeding, or planning pregnancy within 6 months
  • Participating in another conflicting clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

C

Chika V Anekwe, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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