Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
Recruiting · NCT05799222 · Observational (researchers observe without assigning treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Bariatrix Meal Replacement Products
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States