Food as Medicine Project

NCT ID: NCT05926193

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2023-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nutrition Workshops

Group Type: EXPERIMENTAL

Tailor Food Bags

Intervention Type: 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.

No Workshops

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tailor Food Bags

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Nutrition Workshops

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00111072

Identifier Type: -

Identifier Source: org_study_id