Recruiting
Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
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.
ClinicalTrials.gov IDNCT05799222
PhaseNot Applicable
Enrollment20
SponsorMassachusetts General Hospital
Age18 Years
SexALL
Conditions studied
Overweight, PreDiabetes, Diabetes Type 2, Obesity
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.
Interventions
- Dietary Supplement: Bariatrix Meal Replacement Products — Meal replacement products offered through the Massachusetts General Hospital Weight Center.
Primary outcomes
- Body weight reduction (3 months)
- Hemoglobin A1c reduction (3 months)
Eligibility information
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
Study locations
- Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.