@article{e596a34adfa849c4b7429d56b3b45dfd,
title = "Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT",
abstract = "Background: 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. Objectives: 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. Methods: 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.",
keywords = "Diabetes mellitus, Hemoglobin A1c, Medical nutrition therapy, Medically tailored meals, Telehealth",
author = "Rising, {Kristin L.} and Mackenzie Kemp and Patricia Davidson and Hollander, {Judd E.} and Serge Jabbour and Eric Jutkowitz and Leiby, {Benjamin E.} and Cheryl Marco and Ian McElwee and Geoffrey Mills and Laura Pizzi and Powell, {Rhea E.} and Chang, {Anna Marie}",
note = "Funding Information: We developed Project Meals and Nutrition Therapy (Project MiNT) to study the long term impact of MTM and MNT on outcomes for patients with T2DM. This is a pragmatic RCT funded by the National Institute of Diabetes and Digestive and Kidney Diseases (1R18DK118590). The primary outcome is change in Hemoglobin A1c (HbA1c) after 6 months of treatment with MTM and tele-MNT in patients with T2DM. Secondary outcomes include change in HbA1c at 3 and 12 months and cost effectiveness of the interventions at 6 and 12 months. We hypothesize that there will be a greater reduction in HbA1c in both treatment arms (MTM only or MTM + tele-MNT) as compared to usual care at both 3 and 6 months; however, at 12 months the effect will only be sustained in the MTM + tele-MNT arm. If successful, this study will provide robust evidence needed regarding the efficacy and cost-effectiveness of MTM and tele-MNT. Funding Information: This study was supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant 1R18DK118590. The content is solely the responsibility of the authors and does not necessarily reflect the official views of the National Institutes of Health. Publisher Copyright: {\textcopyright} 2021 Elsevier Inc.",
year = "2021",
month = sep,
doi = "10.1016/j.cct.2021.106511",
language = "English (US)",
volume = "108",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
}