Navigating Hypertension and Food Insecurity

Summary

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.

Conditions

• Hypertension (HTN)
• Food Insecurity

Interventions

BEHAVIORAL

Produce Prescription Only

Participants in the Control Arm receive a 12-month Produce Prescription program only. This includes the same $100 monthly vouchers to buy fresh fruits and vegetables at a local retailer (or produce box of the same value) as the intervention arm, but no bi-monthly 1-on-1 sessions with the Community Health Worker (CHW). Participants will receive 1 monthly reminder from the CHW to use vouchers each month

BEHAVIORAL

Community Health Worker navigated Produce Prescription

Participants in the Intervention Arm receive a 12-month Community Health Worker (CHW) navigated Produce Prescription program, including $100 monthly vouchers to buy fresh fruits and vegetables at a local retailer (or produce box of the same value). In addition to the vouchers, this group receives at minimum, bi-monthly, 1-on-1 sessions with a trained CHW (at least 6 sessions total). CHWs will use motivational interviewing and goal setting to drive behavior change, connect participants to community resources, and provide access to reputable nutrition information to help debunk misinformation. They will use their understanding of the local community to provide relevant support. This guidance is designed to overcome barriers to voucher redemption and encourage positive health behaviors as a result of being in the program.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of Hawaii

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• United States

Study Locations