NCT05926193

Food as Medicine Project

Completed NA Last updated 22 September 2023

What this trial tests

NA trial testing Tailor Food Bags in Hypertension in 53 participants. Completed in 30 August 2023.

Timeline

30 March 2023

Primary endpoint
29 July 2023

30 August 2023

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	53
Start date	30 March 2023
Primary completion	29 July 2023
Estimated completion	30 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Tailor Food Bags

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Duke University

Who can join

18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Medically Tailored Grocery Deliveries to Improve Food Security and Hypertension in Underserved Groups: A Student-Run Pilot Randomized Controlled Trial.
   Lapay ER, Sytsma TM, Hutchinson HM, Yoon EJ, et al · · 2025 · cited 4× · PMID 39942442 · DOI 10.3390/healthcare13030253