Clinical trial
Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
Recruiting now · Not applicable · 1 countries · Registry ID NCT05799222
Recruiting nowNot applicableObservational
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, PreDiabetes, Diabetes Type 2, Obesity
Full registry 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
Treatments and study arms
Bariatrix Meal Replacement Products
Dietary Supplement
Meal replacement products offered through the Massachusetts General Hospital Weight Center.
Primary outcomes
Body weight reduction3 months
Reduction in body weight by greater than or equal to 5 percent
Hemoglobin A1c reduction3 months
Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States
Chika V Anekwe, MDContact