Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-65
Body mass index (BMI) greater than or equal to 27 kg/m²
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bariatrix Meal Replacement Products
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov