Community Servings: Food as Medicine for Diabetes

Completed · Not applicable

Conditions studied: Diabetes

In brief

Food insecurity, defined as difficulty accessing food owing to cost, affects 1 in 5 diabetes patients. To address this, the investigators are conducting a pilot randomized controlled trial of medically tailored meal delivery (MTM). The pilot study has two specific aims: Aim 1: To determine the effect of receiving MTM on dietary quality for food insecure diabetes patients with hyperglycemia Aim 2: To determine the feasibility and acceptability of the program as a medical intervention and refine the program as needed for testing in larger studies. This study is a crossover randomized controlled pilot trial, where approximately 50 participants, 25 in each arm, will be randomized to receipt of 12 weeks of MTM, to begin immediately, or waitlist control. After 12 weeks, the groups will crossover, with the waitlist control group now receiving 12 weeks of MTM. At baseline, 12 weeks, and 24 weeks, the participants will complete assessments of their dietary quality (HEI score), psychosocial measures such as diabetes distress and food insecurity, along with measures of body mass index, blood pressure, hemoglobin A1c, and lipids.

Key facts

Study ID

NCT02426138

Run by

Massachusetts General Hospital

People needed

44

Starts

2015-04-01

Expected to finish

2017-07-31

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Diagnosis of type 2 diabetes
• Age 18 years or older
• HbA1c level >8.0%
• Report food insecurity as indicated by the 2-item USDA Food Security Survey Module13
• Willing to commit to random assignment to either receive CS meals immediately or as a waitlist control
• Stable health, with no severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
• Be willing to keep a food diary
• Be willing to attend and complete a baseline, 12 week, and 24 week assessment at MGH
• Be able to understand and communicate effectively in English
• Have a primary care physician within the MGH practice based research network
• Live in an area where Community Servings can deliver meals
• Ability to store and prepare Community Servings meals

You may not qualify if…

• • Must not be pregnant or planning pregnancy in the next year
• Currently enrolled in another diabetes study Food allergy that would prohibit consumption of meals
• Receiving episodic treatments that may increase blood glucose levels (e.g. prednisone)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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