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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 is a NA study that has completed, run by Duke University. The registered enrollment target is 53 participants.
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.
Interventions
- DIETARY_SUPPLEMENT Tailor Food Bags
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2023-03-30 |
| Est. Completion | 2023-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05926193
The ClinicalTrials.gov registry entry for NCT05926193 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tailor Food Bags is the first listed.
NCT05926193 reports 0 study locations.
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.
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