Clinical trial NCT04034511: Food and Education Effects on Diabetes Study
Official title: Impact of Medically-tailored Meals on Health Care Outcomes and Costs Among Low-income Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: nutrition
medically-tailored meals
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Moveable Feast
name: Priority Partners MCO
name: Leonard & Helen R. Stulman Charitable Foundation
name: France-Merrick Foundation
First posted: 2019-07-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeanne M Clark, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: