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NCT07544836 · ClinicalTrials.gov registry record · NA

Navigating Hypertension and Food Insecurity

A NA study, sponsored by University of Hawaii.

Not yet
Registry status
NA
Development phase
250
Enrollment target

NCT07544836: Clinical Trial NA study, sponsored by University of Hawaii.

NCT07544836 is a NA study that has not yet begun recruiting, run by University of Hawaii. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07544836, a NA study, has not yet begun recruiting, sponsored by University of Hawaii.

NOT YET RECRUITING
Registry status
NA
Development phase
250 participants
Enrollment target

Study 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

Primary Outcome

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.

Interventions

  • BEHAVIORAL Produce Prescription Only
  • BEHAVIORAL Community Health Worker navigated Produce Prescription

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2026-09-01
Est. Completion 2028-03
Phase NA
University of Hawaii

77 total trials

What is known before NCT07544836 opens enrollment

NCT07544836 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Produce Prescription Only is the first listed.

NCT07544836 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07544836 about?

NCT07544836 is a clinical study titled "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 pro...

What is the current status of trial NCT07544836?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2026-09-01. Estimated completion is 2028-03.

What interventions are being tested in trial NCT07544836?

The interventions under investigation include: Produce Prescription Only (BEHAVIORAL), Community Health Worker navigated Produce Prescription (BEHAVIORAL).

Who is sponsoring clinical trial NCT07544836?

This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07544836's enrollment target sits among peer trials

250 410th of 2000 higher than 1,567 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07544836, the US trial registry maintained by the National Library of Medicine. NCT07544836 (mid enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.