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NCT Number: NCT07544836

Navigating Hypertension and Food Insecurity

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hāmākua-Kohala Health Center, Honokaa, Hawaii, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Produce Prescription Only

Behavioral

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

Community Health Worker navigated Produce Prescription

Behavioral

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.

Primary outcomes

  1. Change in Systolic Blood Pressure and Diastolic Blood Pressure

    Time frame: 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.

Secondary outcomes

  1. Fruit and vegetable consumption

    Time frame: Baseline, 6 months, and 12 months

    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.

  2. Prevalence of Household Food Insecurity

    Time frame: Baseline and 12 months

    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.

  3. Anthropometry- Body Mass Index

    Time frame: Baseline, 6 months, 12 months

    : Height and weight will be used to compute BMI

  4. Anthropometry- Waist Circumference

    Time frame: Baseline, 6 months, 12 months

    Waist circumference will be measured in inches

  5. Anthropometry- Waist to Height Ratio

    Time frame: Baseline, 6 months, 12 months

    Waist circumference and height will be used to calculate waist to height ratios

Study contacts

Contact information is provided by the study sponsor or research team.

Cherese M Kwan

CONTACT

[email protected]

Monica K Esquivel

CONTACT

[email protected]

(808) 956-8691

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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