Diabetes Mellitus, Type 2
Conditions
Keywords
nutrition, medically-tailored meals
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.
Interventions
OTHERMedically-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
Sponsors
Moveable Feast
Priority Partners MCO
Leonard & Helen R. Stulman Charitable Foundation
France-Merrick Foundation
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor and data-analyst will be masked to treatment assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1c | Baseline, 6 months | Change in hemoglobin A1c (percent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | Baseline, 12 months | Change in Hemoglobin A1c (percent) |
Countries
United States
Outcome results
None listed