NCT05799222Recruiting
Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 3 Mar 2023
- Start date
- 28 Mar 2023
- Primary completion date
- 8 Nov 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05799222
What you commit to
- Study type: Observational
- Planned participants: 20
- From 28 Mar 2023 to the primary completion date, 8 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Plans to pursue bariatric surgery over the 6 months post-study enrollment
- Weight loss of greater than 5 kg within the previous 3 months
Other illness
- 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
Lab values
- HbA1c greater than or equal to 10 percent
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.