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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 Being Tested

DIETARY_SUPPLEMENT

Bariatrix Meal Replacement Products

Meal replacement products offered through the Massachusetts General Hospital Weight Center.

Locations (1)

Massachusetts General Hospital
Boston, Massachusetts, United States