Navigating Hypertension and Food Insecurity
Public ClinicalTrials.gov record NCT07544836. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Navigating Hypertension and Food Insecurity: A Produce Prescription Program to Improve Health Outcomes for Native Hawaiian and Pacific Islander Communities
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07544836
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Interventions
- Produce Prescription Only Behavioral
- Community Health Worker navigated Produce Prescription Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 20 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 25, 2026
- Primary completion
- Jul 30, 2028
- Completion
- Jul 30, 2028
- Last update posted
- Aug 4, 2026
2026 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hāmākua-Kohala Health Center | Honokaa | Hawaii | 96727 | — |
| Waianae Coast Comprehensive Health Center | Waianae | Hawaii | 96792 | — |
| Waimānalo Health Center | Waimanalo | Hawaii | 96795 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07544836, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07544836 live on ClinicalTrials.gov.