Nutrition therapy program for obesity and diabetes in low-income individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a medically intensive nutritional therapy program, specifically using meal replacements, for weight loss and blood sugar control in low-income individuals with obesity and diabetes. Conducted at Massachusetts General Hospital, the program provides a structured low-calorie diet to assist participants who struggle with self-directed weight management. The study will also investigate reasons for program discontinuation among participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Chika V Anekwe, MD — Massachusetts General Hospital
• Study coordinator: Chika V Anekwe, MD
• Email: canekwe@mgh.harvard.edu
• Phone: 617-726-4400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.