Community Servings: Food as Medicine for Diabetes
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Apr 2015
Typical duration for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedResults Posted
Study results publicly available
October 30, 2019
CompletedOctober 30, 2019
October 1, 2019
2.3 years
March 7, 2015
April 15, 2019
October 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Healthy Eating Index 2010 Score
Calculated using data from ASA24 24-hour dietary recall tool Healthy Eating Index 2010 Score Minimum and Maximum range = 0 to 100 Higher scores indicate better diet quality The score is an average of the three-time periods that data was collected
Average of 3 24-hour food recalls per study period (on and off meals; one in-person visit and 2 over the phone at 4 and 8 weeks into the study)
Secondary Outcomes (2)
Number of Participants With Food Insecurity
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Diabetes Distress Scale
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other Outcomes (14)
Hemoglobin A1c
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
LDL Cholesterol
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Body Mass Index
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
- +11 more other outcomes
Study Arms (2)
Med. Tailored Meal Delivery, Usual Care + Choose Myplate
EXPERIMENTALParticipants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure for 12 weeks.
Usual Care + Choose Myplate, Med. Tailored Meal Delivery
ACTIVE COMPARATORParticipants will receive usual diabetes care and a Choose MyPlate healthy eating brochure for 12 weeks.
Interventions
Patients will receive delivery of medically tailored meals for 12 weeks
Patients will receive usual diabetes care + a Choose MyPlate healthy eating brochure for 12 weeks
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Berkowitz SA, Delahanty LM, Terranova J, Steiner B, Ruazol MP, Singh R, Shahid NN, Wexler DJ. Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial. J Gen Intern Med. 2019 Mar;34(3):396-404. doi: 10.1007/s11606-018-4716-z. Epub 2018 Nov 12.
PMID: 30421335RESULTBerkowitz SA, Shahid NN, Terranova J, Steiner B, Ruazol MP, Singh R, Delahanty LM, Wexler DJ. "I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. BMC Endocr Disord. 2020 Jan 20;20(1):10. doi: 10.1186/s12902-020-0491-z.
PMID: 31959176DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Short-term study designed to test change in diet quality only. Not designed for clinical endpoints Single center study in one region of US
Results Point of Contact
- Title
- Dr. Seth A. Berkowitz
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Seth A Berkowitz, MD MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor in Medicine
Study Record Dates
First Submitted
March 7, 2015
First Posted
April 24, 2015
Study Start
April 1, 2015
Primary Completion
July 31, 2017
Study Completion
July 31, 2017
Last Updated
October 30, 2019
Results First Posted
October 30, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share