Nutrition therapy program for obesity and diabetes in low-income individuals
Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
This study tests a special meal replacement program to see if it helps low-income people with obesity and diabetes lose weight and manage their blood sugar better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05799222 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are low-income adults aged 18-65 with a BMI of 27 or higher and elevated blood sugar levels.
Not a fit: Patients currently using certain diabetes medications or planning bariatric surgery may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could provide an effective weight loss and diabetes management solution for low-income patients.
How similar studies have performed: Other studies have shown promise in using meal replacements for weight management and diabetes control, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.