Hypertension (HTN)NCT07544836
Navigating Hypertension and Food Insecurity
A study testing Produce Prescription Only and Community Health Worker navigated Produce Prescription in people with Hypertension (HTN) and Food Insecurity, run by University of Hawaii at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension (HTN), Food Insecurity
- What is being tested?
- Produce Prescription Only and Community Health Worker navigated Produce Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2026to 31 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- prior history of cardiovascular disease
- unable to provide informed consent and complete study procedures in English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cherese M Kwan contact
United States3 sites
Hāmākua-Kohala Health Center
Honokaa, Hawaii, 96727
Cathy Marquette, 808-930-2737, cmarquette@hamakua-health.org
Waianae Coast Comprehensive Health Center
Waianae, Hawaii, 96792
May Okihiro, (808) 697-3433, okihirom@hawaii.edu
Waimānalo Health Center
Waimanalo, Hawaii, 96795
Mary Oneha, 808-259-7948, moneha@waimanalohealth.org
About this study
Official title: 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.
Read more
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
- Being tested
- Produce Prescription Only, Community Health Worker navigated Produce Prescription
- Keywords
- hypertension, high blood pressure, produce prescription, food insecurity, cardiovascular disease prevention, community health worker, fruit and vegetable vouchers, Randomized Controlled Trial, Community-Based Participatory Research, Social Determinants of Health, cost-effectiveness analysis, Native Hawaiian health, Pacific Islander health, Federally Qualified Health Center, Food as Medicine, Hypertension self-management support, cost-effectiveness, healthcare cost reduction analysis, quality-adjusted life year
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Prescription OnlyBehavioural
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 PrescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Navigated Produce Prescription (Intervention Arm) | Experimental | Produce Prescription program and 1-on-1 Community Health Worker navigation sessions. Receives: Behavioral: Community Health Worker navigated Produce Prescription |
| Produce Prescription Only (Control Arm) | Active comparator | Produce Prescription program only Receives: Behavioral: Produce Prescription Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: Baseline and 12 months
Anthropometry- Body Mass Index
: Height and weight will be used to compute BMI
Measured: Baseline, 6 months, 12 months
Anthropometry- Waist Circumference
Waist circumference will be measured in inches
Measured: Baseline, 6 months, 12 months
Anthropometry- Waist to Height Ratio
Waist circumference and height will be used to calculate waist to height ratios
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start26 Oct 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544836
- Sponsor's protocol ID
- 1R01MD020655-01
- Other IDs
- 1R01MD020655-01
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided