Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Change in Hemoglobin A1C (HbA1c)
研究概览
简要总结
This is a three-arm, parallel randomized trial study that will assess the impact of home delivery of medically-tailored meals (MTM) to community-dwelling older adults living with diabetes mellitus type 2 on measurements of diabetes control, mental health, and other exploratory outcomes such as healthcare use.
详细描述
This study aims to:
- Assess the impact of medically-tailored meals program on diabetes management and mental health in comparison to usual care without such program.
- Assess the differential impact of two delivery models being considered for payment by the health system on diabetes management and mental health: once-a-week frozen drop shipment model versus daily warm meal delivery model that is more complex to implement but allows for human connection and easier meal preparation.
Implementation of program:
Meals on Wheels (MoW) of Central Texas (MOWCTX) in Austin, Texas, will provide the meals and delivery service in this study. Meals are all medically tailored (diabetes friendly) and design by MOWCT's team of Registered Dietitians.
Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research staff responsible for data collection at the sites are blinded to the arm allocation of the participant. At follow-up time points, however, a set of questions is asked that are different for each of the three arms on food intake and preferences, and for arm 2, for the experience of delivery. To minimize influence of unblinding, we will actively cross-assign research staff to different locations for follow-up visits.
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 55-90
- •Hemoglobin A1c ≥7.5%
- •Living in Austin city limits and within a MOWCTX daily delivery route
- •Interested and available to receive meals during delivery window time
- •Has access to a freezer and a microwave
- •Pass a MOWCTX background check
排除标准
- •Participated in MOW program in previous 3 months.
- •Has any of the following: dementia or cognitive impairment, diagnosis of heart failure, cirrhosis, or active cancer
- •Is receiving hospice care
- •Does not pass a MOWCTX background check
结局指标
主要结局
Change in Hemoglobin A1C (HbA1c)
时间窗: Baseline to 6 months
Finger stick point-of-care portable device.
次要结局
- Healthcare delay due to cost(6 months, 12 months)
- Diet quality as assessed by NHANES DSQ(6 months, 12 months)
- Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)(6 months, 12 months)
- Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)(6 months)
- Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item(6 months, 12 months)
- Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form(6 months, 12 months)
- Change in Hemoglobin A1C(Baseline to 9 &12 months, 6 months to 12 months.)
- Program meal consumption(6 months, 12 months)
- Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale(6 months, 12 months)
- Emergency room visits(6 months, 12 months)
- Medication underuse due to cost (2 items)(6 months, 12 months)
- Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)(6 months, 12 months)
- Food-basic needs trade-offs (3 items)(6 months, 12 months)
研究者
Maninder Kahlon
Associate Professor
University of Texas at Austin