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临床试验/NCT07544836
NCT07544836尚未招募不适用

Navigating Hypertension and Food Insecurity: A Produce Prescription Program to Improve Health Outcomes for Native Hawaiian and Pacific Islander Communities

University of Hawaii3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
3
主要终点
Change in Systolic Blood Pressure and Diastolic Blood Pressure

研究概览

简要总结

This multi-site randomized controlled trial uses a community-based approach to evaluate a Food as Medicine program for Native Hawaiian and Pacific Islander (NHPI) adults in Hawaii who have high blood pressure and difficulty affording healthy food. The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers (CHW) improves blood pressure among other health outcomes, and (2) to determine the program's cost-effectiveness.

The study will take place across three Federally Qualified Health Centers in Hawaii. Produce prescription program participants at each site will receive $100 per month, either in the form of produce boxes or monthly vouchers to purchase fruits and vegetables, for 12 months (totaling $1200). In past studies, personal challenges (e.g., lack of transportation, lack of cooking skills) have made it difficult for participants to use the vouchers and/or the purchased produce. In other food as medicine interventions, participants have similarly faced various personal, social, and environmental barriers that limit the program's efficacy. To help participants navigate through these challenges, the investigators want to test adding 1-on-1 support from a CHW throughout the program. Other studies have found that health interventions delivered by CHWs have been effective in reducing blood pressure, blood glucose and weight, especially among vulnerable populations, such as NHPIs and those with food insecurity. The CHWs in this study will receive a training using a curriculum tailored specifically to their community and that is in alignment with the Pilinahā: The Four Connections Framework, which focuses on key connections that Indigenous people seek to attain health and can be employed to overcome health disparities.

To test the effectiveness of the added CHW support, there will be two groups of participants:

Group 1 (Intervention) will receive the monthly produce prescription ($100 vouchers or produce box) plus meet with a CHW every two months for support with program challenges.

Group 2 (Control) will receive the same monthly produce prescription, but will not have meetings with a CHW.

The investigators want to see if the added support from CHWs leads to better blood pressure results, among other health outcomes.

Upon providing informed consent and enrolling into the program, produce prescription program participants will:

  • Attend 5 study visits over the one year program. These happen at the start, and then at 3, 6, 9, and 12 months.
  • Complete health checks at the first visit. This includes getting a home blood pressure monitor and learning about heart health and nutrition. Staff will measure height, weight, waist size, and blood pressure.
  • Answer surveys about their demographic background, health habits, diet, and culture.
  • Receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables at a local retailer.
  • Group 1 will additionally meet with a CHW every two months for 1-on-1 support with any challenges related to the program.
  • Group 2 will receive monthly reminders to use their vouchers but no CHW meetings.

After the program ends, researchers will analyze the financial value of the intervention. This involves calculating the total cost to run the program (including vouchers, CHW training and salaries, and administrative costs) and comparing it to potential savings in healthcare costs. By looking at improvements in blood pressure, researchers can estimate how many heart-related health problems were prevented and how much money was saved on medical care.

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
None

入排标准

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

入选标准

  • patient of the participating health center clinic
  • age 20 years and older
  • positive screen for food insecurity using a validated two-question tool
  • physician diagnosed HTN and continued indications of SBP >130 mmHG

排除标准

  • prior history of cardiovascular disease
  • unable to provide informed consent and complete study procedures in English

研究组 & 干预措施

Produce Prescription Only (Control Arm)

Active Comparator

Produce Prescription program only

干预措施: Produce Prescription Only (Behavioral)

Community Health Worker Navigated Produce Prescription (Intervention Arm)

Experimental

Produce Prescription program and 1-on-1 Community Health Worker navigation sessions.

干预措施: Community Health Worker navigated Produce Prescription (Behavioral)

结局指标

主要结局

Change in Systolic Blood Pressure and Diastolic Blood Pressure

时间窗: Baseline, 3, 6, 9 and 12 months

Systolic blood pressure and diastolic blood pressure in mmHg at all 5 time points will be measured with an automatic blood pressure machine (Omron©HEM-907XL, Omron Healthcare) following standardized protocols, including taking the average of the last 2 of 3 blood pressure measures at each time point.

次要结局

  • Fruit and vegetable consumption(Baseline, 6 months, and 12 months)
  • Prevalence of Household Food Insecurity(Baseline and 12 months)
  • Anthropometry- Body Mass Index(Baseline, 6 months, 12 months)
  • Anthropometry- Waist Circumference(Baseline, 6 months, 12 months)
  • Anthropometry- Waist to Height Ratio(Baseline, 6 months, 12 months)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Sponsor

研究点 (3)

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