A Food As Medicine Approach to Address Food Insecurity in Rural North Carolina

NCT ID: NCT07221045

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2026-05-31

Brief Summary

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Increasing fruit and vegetable (FV) intake, and reducing saturated fat, salt, and added sugar are central lifestyle recommendations in the Dietary Guidelines for Americans to prevent chronic disease. Yet, while diet is modifiable, numerous barriers exist for lower-resourced families to engage in healthy dietary behaviors. In particular, rural families face structural and systemic disparities, such as inadequate access to affordable healthy food. Thus, this project. Thus, this study, PhytoRx Families, an innovative produce prescription (Prx) program, addresses health disparities in rural North Carolina (NC). This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes.

Detailed Description

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Increasing fruit and vegetable (FV) intake, and reducing saturated fat, salt, and added sugar are central lifestyle recommendations in the Dietary Guidelines for Americans to prevent chronic disease. Yet, while diet is modifiable, numerous barriers exist for lower-resourced families to engage in healthy dietary behaviors. In particular, rural families face structural and systemic inequities, such as inadequate access to affordable healthy food. Thus, this project, PhytoRx Families, an innovative produce prescription (Prx) program, will address health disparities in rural North Carolina (NC). This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related outcomes. This study will define impact on FV intake using the ASA24 dietary recall (primary outcome) among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade). The study will also explore the impact of PhytoRxF on cardiovascular health-related outcomes (blood pressure, glycated hemoglobin (HbA1C), height, weight (BMI calculated)). Finally the study will examine the change in healthcare utilization among PhytoRxF participants.

Conditions

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Diet, Healthy Health Behavior Blood Pressure Diabetes Mellitus Risk Utilization, Health Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pilot test participants

Participants will be referred by healthcare providers during office visits at local clinics. Providers will refer school-aged children (8-14 year olds) or adults, who are also a caregiver for a school-aged child, who screen positive for food insecurity and will submit patient referrals to the Project Coordinator utilizing a HIPAA-compliant KiteWorks platform.

Group Type EXPERIMENTAL

PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina

Intervention Type OTHER

This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade).

Interventions

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PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina

This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade).

Intervention Type OTHER

Other Intervention Names

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PhytoRx Families Pilot Test

Eligibility Criteria

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Inclusion Criteria

* Fluent in English or Spanish (speaking, reading, writing)
* An adult (18 years of age or older) who's a parent or caregiver of a child ages 8 to 14 years old or a child ages 8 to 14 years old
* Served at participating clinic in a county where the program is being implemented (Goldsboro Pediatrics, Bertie County Rural Health Association, and Roanoke Chowan Community Health in Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
* Living in a county where the program is being implemented (Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
* Free living to the extent they are able to receive and use a box of fresh produce and participate in direct nutrition education classes
* Willing and able to provide written consent and participate in all study activities.

Exclusion Criteria

* Adults not at risk of food insecurity
* Adults, who are not parents nor caregivers of a child 8 to 14 years
* Adults who do not want to or could not fully participate (e.g., an adult family member with advanced kidney disease with severe dietary restrictions).
Minimum Eligible Age

8 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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East Carolina University

OTHER

Sponsor Role collaborator

North Carolina State University

OTHER

Sponsor Role lead

Responsible Party

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Basheerah Enahora

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basheerah Enahora, PhD

Role: PRINCIPAL_INVESTIGATOR

North Carolina State University

Locations

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North Carolina State University

Raleigh, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Basheerah Enahora, PhD

Role: CONTACT

9195159125

Facility Contacts

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Basheerah Enahora, PhD

Role: primary

9195159125

References

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Heasley C, Clayton B, Muileboom J, Schwanke A, Rathnayake S, Richter A, Little M. "I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Arch Public Health. 2021 Jul 23;79:135. doi: 10.1186/s13690-021-00657-6. eCollection 2021.

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Fischer L, Bodrick N, Mackey ER, McClenny A, Dazelle W, McCarron K, Mork T, Farmer N, Haemer M, Essel K. Feasibility of a Home-Delivery Produce Prescription Program to Address Food Insecurity and Diet Quality in Adults and Children. Nutrients. 2022 May 10;14(10):2006. doi: 10.3390/nu14102006.

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Harkin N, Johnston E, Mathews T, Guo Y, Schwartzbard A, Berger J, Gianos E. Physicians' Dietary Knowledge, Attitudes, and Counseling Practices: The Experience of a Single Health Care Center at Changing the Landscape for Dietary Education. Am J Lifestyle Med. 2018 Nov 23;13(3):292-300. doi: 10.1177/1559827618809934. eCollection 2019 May-Jun.

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Rahman V. Time to Revamp Nutrition Education for Physicians. Perm J. 2019;23:19-052. doi: 10.7812/TPP/19.052. Epub 2019 Aug 19.

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Wolfson JA, Ramsing R, Richardson CR, Palmer A. Barriers to healthy food access: Associations with household income and cooking behavior. Prev Med Rep. 2019 Jan 31;13:298-305. doi: 10.1016/j.pmedr.2019.01.023. eCollection 2019 Mar.

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Reicks M, Kocher M, Reeder J. Impact of Cooking and Home Food Preparation Interventions Among Adults: A Systematic Review (2011-2016). J Nutr Educ Behav. 2018 Feb;50(2):148-172.e1. doi: 10.1016/j.jneb.2017.08.004. Epub 2017 Sep 25.

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Levi R, Schwartz M, Campbell E, Martin K, Seligman H. Nutrition standards for the charitable food system: challenges and opportunities. BMC Public Health. 2022 Mar 14;22(1):495. doi: 10.1186/s12889-022-12906-6.

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PMID: 35287656 (View on PubMed)

Lutfiyya MN, Chang LF, Lipsky MS. A cross-sectional study of US rural adults' consumption of fruits and vegetables: do they consume at least five servings daily? BMC Public Health. 2012 Jun 1;12:280. doi: 10.1186/1471-2458-12-280.

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Laraia BA. Food insecurity and chronic disease. Adv Nutr. 2013 Mar 1;4(2):203-12. doi: 10.3945/an.112.003277.

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Backonja U, Park S, Kurre A, Yudelman H, Heindel S, Schultz M, Whitman G, Turner AM, Marchak NT, Bekemeier B. Supporting rural public health practice to address local-level social determinants of health across Northwest states: Development of an interactive visualization dashboard. J Biomed Inform. 2022 May;129:104051. doi: 10.1016/j.jbi.2022.104051. Epub 2022 Mar 19.

Reference Type BACKGROUND
PMID: 35318149 (View on PubMed)

Byker Shanks C, Andress L, Hardison-Moody A, Jilcott Pitts S, Patton-Lopez M, Prewitt TE, Dupuis V, Wong K, Kirk-Epstein M, Engelhard E, Hake M, Osborne I, Hoff C, Haynes-Maslow L. Food Insecurity in the Rural United States: An Examination of Struggles and Coping Mechanisms to Feed a Family among Households with a Low-Income. Nutrients. 2022 Dec 9;14(24):5250. doi: 10.3390/nu14245250.

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Harrington RA, Califf RM, Balamurugan A, Brown N, Benjamin RM, Braund WE, Hipp J, Konig M, Sanchez E, Joynt Maddox KE. Call to Action: Rural Health: A Presidential Advisory From the American Heart Association and American Stroke Association. Circulation. 2020 Mar 10;141(10):e615-e644. doi: 10.1161/CIR.0000000000000753. Epub 2020 Feb 10.

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Abrahamowicz AA, Ebinger J, Whelton SP, Commodore-Mensah Y, Yang E. Racial and Ethnic Disparities in Hypertension: Barriers and Opportunities to Improve Blood Pressure Control. Curr Cardiol Rep. 2023 Jan;25(1):17-27. doi: 10.1007/s11886-022-01826-x. Epub 2023 Jan 9.

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Other Identifiers

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27407

Identifier Type: -

Identifier Source: org_study_id

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