Food As MedicinE for Diabetes (NCT04828785) | Clinical Trial Compass
CompletedNot Applicable
Food As MedicinE for Diabetes
United States215 participantsStarted 2021-07-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Participant in diabetes, nutrition, or weight research intervention in last 12 months
* Another family member or household member is a study participant. Only one member of each household may take part in this study.
* Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
* Lack of safe, stable residence and ability to store meals
* Lack of telephone
* Pregnancy/breastfeeding or intended pregnancy in the next year
* 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.
* Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
* Known drug or alcohol misuse in the past 2 years
* Known psychosis or major psychiatric illness that prevents participation with study activities
* Intermittent use of medications (e.g., oral or in…