Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 22, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether meal replacements can help people who are overweight or have diabetes lose weight and manage their blood sugar levels. The study is aimed specifically at individuals with low incomes, and it hopes to find out if this approach can be an effective way to support their health and well-being.

To participate in the study, you need to be between 18 and 65 years old, have a body mass index (BMI) of 27 or higher, and show signs of pre-diabetes or diabetes, like having a specific level of blood sugar. The study is currently looking for participants, and if you join, you can expect to receive guidance on nutrition and meal planning as part of the program. It’s important to note that individuals with certain health conditions or those taking specific medications may not be eligible, so it’s a good idea to discuss your situation with your doctor if you’re considering joining.

Gender

ALL

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, breastfeeding, or considering pregnancy within the next 6 months
• • Current participation in another clinical research trial deemed by investigator to conflict with current study