Food and Education Effects on Diabetes Study

Diabetes Mellitus, Type 2 Clinical Trial

— FEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034511
• Other study ID #: IRB00200526
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 30, 2023
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	France-Merrick Foundation, Leonard & Helen R. Stulman Charitable Foundation, Moveable Feast, Priority Partners MCO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin A1c	Change in hemoglobin A1c (percent)	Baseline, 6 months
Secondary	Change in Hemoglobin A1c	Change in Hemoglobin A1c (percent)	Baseline, 12 months

External Links

•   France-Merrick Foundation