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| Name | Class |
|---|---|
| Moveable Feast | UNKNOWN |
| Priority Partners MCO | UNKNOWN |
| Leonard & Helen R. Stulman Charitable Foundation | UNKNOWN |
| France-Merrick Foundation |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medically-tailored meal delivery and medical nutrition therapy | Experimental | 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. |
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| Usual care | No Intervention | Participants assigned to this arm of the study will receive usual care and case management services from participants' Medicaid insurance program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c | Change in hemoglobin A1c (percent) | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Change in Hemoglobin A1c (percent) | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne M Clark, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39672984 | Derived | Clark JM, Maw MTT, Pettway K, Chander G, Elias S, Zisow-McClean S, Maruthur NM, Greer RC. Impact of Medically Tailored Meals on Clinical Outcomes Among Low-Income Adults with Type 2 Diabetes: A Pilot Randomized Trial. J Gen Intern Med. 2025 Jun;40(8):1711-1719. doi: 10.1007/s11606-024-09248-x. Epub 2024 Dec 13. |
| Label | URL |
|---|---|
| France-Merrick Foundation | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| UNKNOWN |
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The outcome assessor and data-analyst will be masked to treatment assignment
| D004700 | Endocrine System Diseases |