Food as Medicine Project

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Tailor Food Bags

• Registration Number: NCT05926193
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-30
• Status Verified: 2023-06
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Primary Completion: 2023-07-29
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Adult parent/legal guardian (age 18 or older)
2. Documented essential hypertension (systolic BP >140 and/or diastolic BP >90, at least two documented clinical measurements)
3. Self-reported African American or Latino

Exclusion Criteria

1. Hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, Cushing's disease etc.)
2. Homelessness or insecure/transitional housing
3. Inability to prepare or cook food for themselves
4. Participants not living in Durham County, N.C.
5. Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Workshops	Tailor Food Bags	-

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline, 6 weeks, 12 weeks	Systolic and diastolic BP will be documented at end of visit

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with culturally relevant foods	12 weeks	Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States