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Clinical Trial, NHPI Adults, Hawaii, Hypertension, Food Insecurity

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Summary

NIH registered clinical trial NCT07544836, a multi-site randomized controlled trial at three Federally Qualified Health Centers in Hawaii evaluating a Food as Medicine produce prescription program for Native Hawaiian and Pacific Islander adults with hypertension and food insecurity. Participants receive $100 per month in produce boxes or vouchers for 12 months ($1200 total). The two-arm study compares produce prescription only against CHW-navigated produce prescription to determine which approach yields better blood pressure outcomes and cost-effectiveness. The study has a start date of April 22, 2026.

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About this source

GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 667 changes logged to date.

What changed

This ClinicalTrials.gov registration entry documents a new NIH-sponsored randomized controlled trial (NCT07544836) evaluating a Food as Medicine intervention for a vulnerable population. The study is not a regulatory instrument and creates no compliance obligations for outside parties.

Affected parties include healthcare providers at participating FQHCs who may wish to replicate the intervention model, and public health researchers monitoring Food as Medicine evidence generation. The study's structured comparison of standard vs. CHW-navigated produce prescriptions may inform future community health programs targeting hypertension and food insecurity.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Navigating Hypertension and Food Insecurity

N/A NCT07544836 Kind: NA Apr 22, 2026

Abstract

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 wi...

Conditions: Hypertension (HTN), Food Insecurity

Interventions: Produce Prescription Only, Community Health Worker navigated Produce Prescription

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07544836
Docket
NCT07544836

Who this affects

Applies to
Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial design Community health intervention Food insecurity research
Geographic scope
US-HI US-HI

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Healthcare Food Safety

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