Navigating Hypertension and Food Insecurity

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

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 Overview

• Status: Not yet recruiting
• Conditions: Food Insecurity; Hypertension (HTN)
• Intervention / Treatment: Behavioral: Community Health Worker navigated Produce Prescription; Behavioral: Produce Prescription Only

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica K Esquivel; Phone Number: (808) 956-8691; Email: monicake@hawaii.edu
• Study Contact Backup: Name: Cherese M Kwan; Email: chereses@hawaii.edu

Study Locations

• United States
  • Hawaii
    • Honokaa, Hawaii, United States, 96727
      • Hāmākua-Kohala Health Center
      • Contact: Cathy Marquette; Phone Number: 808-930-2737; Email: cmarquette@hamakua-health.org
    • Waianae, Hawaii, United States, 96792
      • Waianae Coast Comprehensive Health Center
      • Contact: May Okihiro; Phone Number: (808) 697-3433; Email: okihirom@hawaii.edu
    • Waimanalo, Hawaii, United States, 96795
      • Waimānalo Health Center
      • Contact: Mary Oneha; Phone Number: 808-259-7948; Email: moneha@waimanalohealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Health Worker Navigated Produce Prescription (Intervention Arm); Produce Prescription program and 1-on-1 Community Health Worker navigation sessions.	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.
Active Comparator: Produce Prescription Only (Control Arm); Produce Prescription program only	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure and Diastolic Blood Pressure	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.	Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit and vegetable consumption	Fruit and vegetable (FV) consumption will be assessed using a 26-item Dietary Screener Questionnaire, which was developed by the National Institute of Health's National Cancer Institute and validated for low-income populations, that is sensitive enough to detect relatively small changes in diet intake. The scoring algorithm converts frequency responses to cup equivalent estimates of average daily diet intake for FV.	Baseline, 6 months, and 12 months
Prevalence of Household Food Insecurity	Household Food insecurity status will be measured using the United States Department of Agriculture short form 6-item food security survey module. Four levels of household food insecurity (Food Secure, Marginal Food Security, Low Food Security and Very Low Food Security)- Very low and low food security will be combined to determine prevalence of household food insecurity.	Baseline and 12 months
Anthropometry- Body Mass Index	: Height and weight will be used to compute BMI	Baseline, 6 months, 12 months
Anthropometry- Waist Circumference	Waist circumference will be measured in inches	Baseline, 6 months, 12 months
Anthropometry- Waist to Height Ratio	Waist circumference and height will be used to calculate waist to height ratios	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; Randomized Controlled Trial; cost-effectiveness; Social Determinants of Health; community health worker; cost-effectiveness analysis; Community-Based Participatory Research; high blood pressure; food insecurity; cardiovascular disease prevention; Food as Medicine; Federally Qualified Health Center; produce prescription; fruit and vegetable vouchers; Native Hawaiian health; Pacific Islander health; Hypertension self-management support; healthcare cost reduction analysis; quality-adjusted life year
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 1R01MD020655-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No