RecruitingNCT05799222
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
Sponsor
Massachusetts General Hospital
Enrollment
20 participants
Start Date
Mar 28, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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 Criteria9
- 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
Interventions
DIETARY_SUPPLEMENTBariatrix Meal Replacement Products
Meal replacement products offered through the Massachusetts General Hospital Weight Center.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05799222
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