Food and Education Effects on Diabetes Study
FEED
Impact of Medically-tailored Meals on Health Care Outcomes and Costs Among Low-income Adults With Diabetes
1 other identifier
interventional
74
1 country
1
Brief Summary
Low-income adults are disproportionately affected by diabetes, experiencing greater rates of diabetes, diabetes-related complications, and mortality. Dietary habits play an important role in achieving and maintaining glycemic control to improve health outcomes. However, low-income adults are less likely to adopt the necessary dietary changes to improve glycemic control largely due to poor access to care, limited knowledge and skills to facilitate lifestyle change, and financial and environmental constraints that limit access to healthy foods. Nutrition interventions that target key barriers to healthy dietary habits among low-income adults with diabetes may have a profound impact on improving glycemic control. The provision of home-delivered, medically-tailored meals in addition to individualized medical nutrition therapy is a promising approach to improve dietary habits in socially disadvantaged populations with diabetes. Evidence suggests the provision of medically tailored meals may be beneficial in improving health outcomes and health care costs among socially disadvantaged adults with chronic illnesses, however rigorous studies specifically exploring the benefits of meal provision and medical nutrition therapy among adults with type 2 diabetes are lacking. The investigators aim to conduct a randomized-controlled clinical trial examining the impact of medically-tailored meals and medical nutrition therapy on health-related outcomes and health care costs among low-income adults with type 2 diabetes.
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-mellitus-type-2
Started Jan 2020
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedOctober 10, 2023
October 1, 2023
2.7 years
July 24, 2019
October 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in hemoglobin A1c
Change in hemoglobin A1c (percent)
Baseline, 6 months
Secondary Outcomes (1)
Change in Hemoglobin A1c
Baseline, 12 months
Study Arms (2)
Medically-tailored meal delivery and medical nutrition therapy
EXPERIMENTALParticipants assigned to this arm will receive home-delivered, medically-tailored meals for 3 months combined with monthly individual Medical Nutrition Therapy sessions for 6 months. Participants will also receive participants' usual case management services from participants' Medicaid insurance program.
Usual care
NO INTERVENTIONParticipants assigned to this arm of the study will receive usual care and case management services from participants' Medicaid insurance program.
Interventions
Home-delivered, medically-tailored meals for 3 months combined with monthly individual medical nutrition therapy sessions for 6 months
Eligibility Criteria
You may qualify if:
- Age 18 and over
- Diabetes with a hemoglobin A1c\>8%
- Medicaid beneficiary
- Enrolled in Medicaid Insurance
You may not qualify if:
- Medical conditions that are indications for additional dietary requirements (e.g., advanced chronic kidney disease, end-stage renal disease, chronic wounds, or severe alcohol use disorder)
- Swallowing difficulties
- Food allergies
- Non-English speaking
- Language or hearing impairment
- Currently pregnant or breast feeding
- Does not have a refrigerator/freezer in the home to store meals
- Has plans to move out of the meal delivery service area in the next 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Moveable Feastcollaborator
- Priority Partners MCOcollaborator
- Leonard & Helen R. Stulman Charitable Foundationcollaborator
- France-Merrick Foundationcollaborator
Study Sites (1)
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Related Publications (1)
Clark JM, Maw MTT, Pettway K, Chander G, Elias S, Zisow-McClean S, Maruthur NM, Greer RC. Impact of Medically Tailored Meals on Clinical Outcomes Among Low-Income Adults with Type 2 Diabetes: A Pilot Randomized Trial. J Gen Intern Med. 2025 Jun;40(8):1711-1719. doi: 10.1007/s11606-024-09248-x. Epub 2024 Dec 13.
PMID: 39672984DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeanne M Clark, MD, MPH
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor and data-analyst will be masked to treatment assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 26, 2019
Study Start
January 21, 2020
Primary Completion
October 4, 2022
Study Completion
September 30, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share