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临床试验/NCT04034511
NCT04034511已完成不适用

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Change in hemoglobin A1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor and data-analyst will be masked to treatment assignment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and over
  • Diabetes with a hemoglobin A1c>8%
  • Medicaid beneficiary
  • Enrolled in Medicaid Insurance

排除标准

  • 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

结局指标

主要结局

Change in hemoglobin A1c

时间窗: Baseline, 6 months

Change in hemoglobin A1c (percent)

次要结局

  • Change in Hemoglobin A1c(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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