Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT

• Published in: Contemporary clinical trials 2021-09, Vol.108, p.106511-106511, Article 106511
• Main Authors: Rising, Kristin L., Kemp, Mackenzie, Davidson, Patricia, Hollander, Judd E., Jabbour, Serge, Jutkowitz, Eric, Leiby, Benjamin E., Marco, Cheryl, McElwee, Ian, Mills, Geoffrey, Pizzi, Laura, Powell, Rhea E., Chang, Anna Marie
• Format: Article
• Language: English
• Subjects: Diabetes mellitus; Diabetes Mellitus, Type 2 - therapy; Glycated Hemoglobin A - analysis; Hemoglobin A1c; Humans; Meals; Medical nutrition therapy; Medically tailored meals; Mentha; Nutrition Therapy; Telehealth
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2021.106511

Research has shown that among people with type 2 diabetes mellitus, reduction in hemoglobin A1c (HbA1c) prevents long term complications. Medically tailored meals (MTM) and telehealth-delivered medical nutrition therapy (tele-MNT) are promising strategies for patient-centered diabetes care. Project MiNT will determine whether provision of MTM with and without the addition of telehealth-delivered medical nutrition therapy improves HbA1c and is cost effective for patients with type 2 diabetes mellitus. Patients with poorly controlled type 2 diabetes mellitus (HbA1c >8%) will be recruited from Jefferson Health. Eligible patients will be randomized to one of three arms: 1) usual care, 2) 12 weeks of home-delivered MTM, or 3) MTM + 12 months of tele-MNT. All participants (n = 600) will complete three follow-up assessments at 3, 6, and 12 months. The primary outcome is change in HbA1c at 6 months. Secondary outcomes include change in HbA1c at 3 and 12 months and cost-effectiveness of the intervention at 6 and 12 months. Conclusion Findings from Project MiNT will inform MTM coverage and financing decisions, how to structure services for scalability and system-wide integration, and the role of these services in reducing health disparities. •Glycemic control is paramount to preventing long term complications of diabetes.•Diet and nutrition education can contribute to long term glycemic control.•Medically tailored meals may improve outcomes and lower cost of care.•Tele-medical nutrition therapy may overcome barriers to patient engagement.•Opportunities exist to expand insurance coverage of meals and nutrition therapy.