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OpenTrials
Completed

NCT Number: NCT05926193

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Nutrition Workshops

Primary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 6 weeks, 12 weeks

    Systolic and diastolic BP will be documented at end of visit

Secondary outcomes

  1. Patient satisfaction with culturally relevant foods

    Time frame: 12 weeks

    Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments

Other outcomes

  1. satisfaction with nutrition education sessions

    Time frame: 12 weeks

    Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments

  2. satisfaction with the DASH diet,

    Time frame: 12 weeks

    Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Arraigados Juntos - Rooted Together, Food as Medicine Project

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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