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Contemp Clin Trials ; 108: 106511, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34314856

RESUMO

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.


Assuntos
Diabetes Mellitus Tipo 2 , Terapia Nutricional , Humanos , Diabetes Mellitus Tipo 2/dietoterapia , Hemoglobinas Glicadas/análise , Refeições , Ensaios Clínicos Controlados Aleatórios como Assunto
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