Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
This study tests whether using meal replacement products can help you lose weight and improve blood sugar levels if you have obesity or are overweight and have diabetes or pre-diabetes. The research is designed specifically for people with lower incomes to see if this nutrition approach works well for your situation.
Key Objective: The trial is testing whether meal replacements can effectively help people lose weight and control blood sugar levels in those with obesity and diabetes.
Who to Consider: People with low income who are overweight or obese and have diabetes or pre-diabetes should consider enrolling in this study.
Trial Parameters
Brief 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 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, breastfeed