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NCT Number: NCT04034511

Food and Education Effects on Diabetes Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medically-tailored meal delivery and medical nutrition therapy

Other

Home-delivered, medically-tailored meals for 3 months combined with monthly individual medical nutrition therapy sessions for 6 months

Primary outcomes

  1. Change in hemoglobin A1c

    Time frame: Baseline, 6 months

    Change in hemoglobin A1c (percent)

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: Baseline, 12 months

    Change in Hemoglobin A1c (percent)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • France-Merrick Foundation
  • Leonard & Helen R. Stulman Charitable Foundation
  • Moveable Feast
  • Priority Partners MCO

Registry information

Official study title

Impact of Medically-tailored Meals on Health Care Outcomes and Costs Among Low-income Adults With Diabetes

Acronym: FEED

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 26, 2019
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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