An interventional study of Produce Prescription Only and Community Health Worker navigated Produce Prescription in Hypertension (HTN) and Food Insecurity, sponsored by University of Hawaii. Not yet recruiting at 3 sites in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Hawaii · Not applicable, Interventional, and Treatment
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:
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Hawaii is the lead sponsor of 97 studies on the registry; 21 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Produce Prescription program and 1-on-1 Community Health Worker navigation sessions.
Behavioral: Community Health Worker navigated Produce Prescription
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
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.
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.
Time frame: Baseline, 3, 6, 9 and 12 months
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.
Time frame: 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.
Time frame: Baseline and 12 months
Anthropometry- Body Mass Index
: Height and weight will be used to compute BMI
Time frame: Baseline, 6 months, 12 months
Anthropometry- Waist Circumference
Waist circumference will be measured in inches
Time frame: Baseline, 6 months, 12 months
Anthropometry- Waist to Height Ratio
Waist circumference and height will be used to calculate waist to height ratios
Time frame: Baseline, 6 months, 12 months
Plan to share: Undecided
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University of Hawaii