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Food and Education Effects on Diabetes Study (FEED)

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ClinicalTrials.gov Identifier: NCT04034511
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : September 9, 2021
Sponsor:
Collaborators:
Moveable Feast
Priority Partners MCO
Leonard & Helen R. Stulman Charitable Foundation
France-Merrick Foundation
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Medically-tailored meal delivery and medical nutrition therapy Not Applicable

Detailed Description:
The investigators will recruit 100 individuals age 18 and over with uncontrolled diabetes (defined as a hemoglobin A1c (HbA1c) >8%) and enrolled in Priority Partners Medicaid insurance. Participants will be randomized to one of two groups: 1) 3 months of home-delivered, medically-tailored meals combined with monthly individual Medical Nutrition Therapy sessions for 6 months or 2) usual care. The investigators will follow participants for up to 12 months to assess for changes in hemoglobin A1c.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor and data-analyst will be masked to treatment assignment
Primary Purpose: Treatment
Official Title: Impact of Medically-tailored Meals on Health Care Outcomes and Costs Among Low-income Adults With Diabetes
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medically-tailored meal delivery and medical nutrition therapy
Participants 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.
Other: Medically-tailored meal delivery and medical nutrition therapy
Home-delivered, medically-tailored meals for 3 months combined with monthly individual medical nutrition therapy sessions for 6 months

No Intervention: Usual care
Participants assigned to this arm of the study will receive usual care and case management services from participants' Medicaid insurance program.



Primary Outcome Measures :
  1. Change in hemoglobin A1c [ Time Frame: Baseline, 6 months ]
    Change in hemoglobin A1c (percent)


Secondary Outcome Measures :
  1. Change in Hemoglobin A1c [ Time Frame: Baseline, 12 months ]
    Change in Hemoglobin A1c (percent)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and over
  • Diabetes with a hemoglobin A1c>8%
  • Medicaid beneficiary
  • Enrolled in Medicaid Insurance

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034511


Contacts
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Contact: Afroza Gillani, BDS, MPH 410-614-2266 agillan1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Afroza Gillani    410-614-2266      
Sponsors and Collaborators
Johns Hopkins University
Moveable Feast
Priority Partners MCO
Leonard & Helen R. Stulman Charitable Foundation
France-Merrick Foundation
Investigators
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Principal Investigator: Jeanne M Clark, MD, MPH Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04034511    
Other Study ID Numbers: IRB00200526
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
nutrition
medically-tailored meals
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases