Food as Medicine Project

NCT05926193 | Completed

• 1 other identifier: Pro00111072
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  Systolic and diastolic BP will be documented at end of visit

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (1)

• Patient satisfaction with culturally relevant foods

  12 weeks

Other Outcomes (2)

• satisfaction with nutrition education sessions

  12 weeks

• satisfaction with the DASH diet,

  12 weeks

Study Arms (2)

Nutrition Workshops

EXPERIMENTAL

Dietary Supplement: Tailor Food Bags

No Workshops

NO INTERVENTION

Interventions

Tailor Food Bags DIETARY_SUPPLEMENT

The treatment group will participate in 6 nutrition workshops over the course of 6 months as well as receive weekly food bags that have been tailored for a DASH diet.

Also known as: Nutrition Workshops

Nutrition Workshops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: March 30, 2023
• Primary Completion: July 29, 2023
• Study Completion: August 30, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)