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NCT05926193 · ClinicalTrials.gov registry record · NA

Food as Medicine Project

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
53
Enrollment target

NCT05926193: Completed NA study, sponsored by Duke University.

NCT05926193 is a NA study that has completed, run by Duke University. The registered enrollment target is 53 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05926193, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
53 participants
Enrollment target

Study Summary

Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in Durham County. The goal of this research study is to determine the efficacy of the modified Dietary Approach to Stop Hypertension (DASH) diet in Black/African American and Hispanic/Latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. This research will leverage FPP's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. The study population group intends to include members of the Durham community and surrounding areas that identify as members of either the Black/African American or Hispanic/Latinx populations. Success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. Recognizing the risk of using Protected Health Information of Durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. Ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. The success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger FPP population and beyond.

Primary Outcome

Systolic and diastolic BP will be documented at end of visit

Interventions

  • DIETARY_SUPPLEMENT Tailor Food Bags

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2023-03-30
Est. Completion 2023-08-30
Phase NA
Duke University

1,725 total trials

What the finished NCT05926193 record still lists

NCT05926193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Tailor Food Bags is the first listed.

NCT05926193 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05926193 about?

NCT05926193 is a clinical study titled "Food as Medicine Project". Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded...

What is the current status of trial NCT05926193?

This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2023-03-30. Estimated completion is 2023-08-30.

What interventions are being tested in trial NCT05926193?

The interventions under investigation include: Tailor Food Bags (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05926193?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05926193's enrollment target sits among peer trials

53 1271st of 2000 higher than 729 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 NCT05926193, the US trial registry maintained by the National Library of Medicine. NCT05926193 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.