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