Navigating Hypertension and Food Insecurity

NCT07544836 | Not Yet Recruiting

• 1 other identifier: 1R01MD020655-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fruit and vegetable consumption

  Baseline, 6 months, and 12 months

• Prevalence of Household Food Insecurity

  Baseline and 12 months

• Anthropometry- Body Mass Index

  Baseline, 6 months, 12 months

• Anthropometry- Waist Circumference

  Baseline, 6 months, 12 months

• Anthropometry- Waist to Height Ratio

  Baseline, 6 months, 12 months

Study Arms (2)

Community Health Worker Navigated Produce Prescription (Intervention Arm)

EXPERIMENTAL

Produce Prescription program and 1-on-1 Community Health Worker navigation sessions.

Behavioral: Community Health Worker navigated Produce Prescription

Produce Prescription Only (Control Arm)

ACTIVE COMPARATOR

Produce Prescription program only

Behavioral: Produce Prescription Only

Interventions

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

Produce Prescription Only (Control Arm)

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.

Community Health Worker Navigated Produce Prescription (Intervention Arm)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Hāmākua-Kohala Health Center

Honokaa, Hawaii, 96727, United States

Location

Waianae Coast Comprehensive Health Center

Waianae, Hawaii, 96792, United States

Location

Waimānalo Health Center

Waimanalo, Hawaii, 96795, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Monica K Esquivel

CONTACT

(808) 956-8691; monicake@hawaii.edu

Cherese M Kwan

CONTACT

chereses@hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2025-11

Locations

US (3)