MedTrace Logo

Food As MedicinE for Diabetes

NCT04828785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

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.

OTHER

Food Subsidy

$40/month food subsidy

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Community Servings

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Seth Berkowitz, MD · UNC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2025-09-11
Completion
2026-02-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828785 on ClinicalTrials.gov