跳至主要内容
临床试验/NCT06058338
NCT06058338Enrolling By Invitation不适用

Multi-level Evaluation of Produce Prescription Projects on Type 2 Diabetes-related Outcomes: A Pathway to Policy Change by Addressing Social Determinants of Health

Gretchen Swanson Center for Nutrition10 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
600
试验地点
10
主要终点
Hemoglobin A1c

研究概览

简要总结

Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Produce Prescription (PPR) projects are an intervention aligned with the social determinants of health that help individuals with a low-income purchase FV by providing an incentive. The impacts of PPR projects on populations with T2D and a low-income is less understood. The Multi-level evaluation of Produce Prescription Projects on type 2 diabetes- related outcomes: A pathway to policy change by addressing social determinants of health study will determine the impact of PPR projects on hemo-globin A1c (HbA1c; primary outcome), fruit and vegetable intake (FVI), food security, and related behaviors among a diverse sample of PPR participants diagnosed with T2D and low-income (Aim 1), and will conduct a cost and cost-effective analysis of PPR projects (Aim 2), and a mixed methods process evaluation to understand feasibility and best practices for PPR projects for people with/at risk for T2D (Aim 3). We hypothesize that PPR participants will see greater declines in HbA1c and improvements in other health and food-related behaviors, compared to the Standard of Care. We will recruit five GusNIP PPR projects, whose healthcare partners serve patients with T2D, and who have participating and matched non-participating control populations. We will collect data at baseline and post-intervention using validated, survey modules, clinical measures, and cost data. Five types of data will be used for this project: 1.Health and healthcare utilization data from the EHR or point-of-care, 2.Participant survey data, 3.Qualitative data, 4.Program cost data (NOT human subjects), and 5.Process data (NOT human subjects). Information extracted from medical records includes HbA1c, weight, and blood pressure and will be collected at 2 time points (months 0,6), following their standard of care protocols. Staff will also extract healthcare utilization data (e.g., #primary care and #ER visits) from the EHR at each of site. Primary analyses will use an intention to treat strategy. Analysis will include a linear mixed-effect model to the HbA1c with an interaction between group and time to examine whether there is a difference in HbA1c trajectories between intervention and control groups. Similar models will be used to determine impact on each of the secondary outcomes (e.g., healthcare utilization, BMI).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • diagnosed with Type 2 diabetes
  • have clinically screened positive for food insecurity and/or be income-eligible to receive Medicaid and/or SNAP-benefits
  • ≥ 18 years of age, and
  • be a patient at a participating healthcare site.

排除标准

  • people who pregnant or nursing and
  • plans to move away during the study period.

结局指标

主要结局

Hemoglobin A1c

时间窗: Months 0,6

Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.

次要结局

  • Self-efficacy(Months 0,6)
  • Body Mass Index(Months 0,6)
  • Food security(Months 0,6)
  • Diabetes distress(Months 0,6)
  • Blood pressure(Months 0,6)
  • Health-related Quality of Life(Months 0,6)
  • Self-reported health(Months 0,6)
  • Fruit and vegetable intake(Months 0,6)
  • Program satisfaction(Month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen Byker Shanks

Principal Research Scientist

Gretchen Swanson Center for Nutrition

研究点 (10)

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