NCT04828785Completed
Food As MedicinE for Diabetes
Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 215 (actual)
- First submitted
- 30 Mar 2021
- Start date
- 2 Jul 2021
- Primary completion date
- 11 Sept 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Type 2 diabetes
- NCT number
- NCT04828785
What you commit to
- Study type: Interventional
- Participants enrolled: 215
- From 2 Jul 2021 to the primary completion date, 11 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Known drug or alcohol misuse in the past 2 years
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Other illness
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Known psychosis or major psychiatric illness that prevents participation with study activities
Lab values
- Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
Age
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
Other
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
- Pregnancy/breastfeeding or intended pregnancy in the next year
Who the study is looking for
- Diagnosis of Type 2 Diabetes Mellitus
- Hemoglobin A1c ≥ 7.0% and ≤ 12.0% in last 12 months
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- BMI ≥25 kg/m\^2 (≥ 23 kg/m\^2 if self-report Asian ancestry)
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.