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Food As MedicinE for Diabetes
Sponsor: University of North Carolina, Chapel Hill
Summary
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
Official title: Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-07-02
Completion Date
2026-03
Last Updated
2025-09-24
Healthy Volunteers
No
Conditions
Interventions
MTM
weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
Food Subsidy
$40/month food subsidy
Locations (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States