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

NCT07221045 | Recruiting DMC

• 1 other identifier: 27407
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fruit and vegetable intake

  Measured by ASA24 dietary recall

  Baseline and end of study at 16 weeks

Secondary Outcomes (11)

• Skin carotenoids

  Baseline and end of study at 16 weeks

• Diet quality

  Baseline and end of study at 16 weeks

• Food security status

  Baseline and end of study at 16 weeks

• Nutrition security status

  Baseline and end of study at 16 weeks

• Blood pressure

  Baseline and end of study at 16 weeks

Study Arms (1)

Pilot test participants

EXPERIMENTAL

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.

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

Interventions

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

Also known as: PhytoRx Families Pilot Test

Pilot test participants

Eligibility Criteria

• Age: 8 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• North Carolina State University: lead
• East Carolina University: collaborator

Study Sites (1)

North Carolina State University

Raleigh, North Carolina, 27695, United States

RECRUITING

Related Publications (21)

• Norris K, Jilcott Pitts S, Reis H, Haynes-Maslow L. A Systematic Literature Review of Nutrition Interventions Implemented to Address Food Insecurity as a Social Determinant of Health. Nutrients. 2023 Aug 5;15(15):3464. doi: 10.3390/nu15153464.

  PMID: 37571400 BACKGROUND

• Kerr D, Barua S, Glantz N, Conneely C, Kujan M, Bevier W, Larez A, Sabharwal A. Farming for life: impact of medical prescriptions for fresh vegetables on cardiometabolic health for adults with or at risk of type 2 diabetes in a predominantly Mexican-American population. BMJ Nutr Prev Health. 2020 Oct 5;3(2):239-246. doi: 10.1136/bmjnph-2020-000133. eCollection 2020 Dec.

  PMID: 33521534 BACKGROUND

• 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.

  PMID: 34301335 BACKGROUND

• 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.

  PMID: 35631144 BACKGROUND

• 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.

  PMID: 31105493 BACKGROUND

• 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.

  PMID: 31496507 BACKGROUND

• 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.

  PMID: 30792944 BACKGROUND

• 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.

  PMID: 28958671 BACKGROUND

• 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.

  PMID: 35287656 BACKGROUND

• 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.

  PMID: 22490063 BACKGROUND

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

  PMID: 23493536 BACKGROUND

• 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.

  PMID: 35318149 BACKGROUND

• 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.

  PMID: 36558409 BACKGROUND

• Schipper HS, de Ferranti S. Cardiovascular Risk Assessment and Management for Pediatricians. Pediatrics. 2022 Dec 1;150(6):e2022057957. doi: 10.1542/peds.2022-057957.

  PMID: 36321395 BACKGROUND

• 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.

  PMID: 32078375 BACKGROUND

• 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.

  PMID: 36622491 BACKGROUND

• Ducharme-Smith K, Caulfield LE, Brady TM, Rosenstock S, Mueller NT, Garcia-Larsen V. Higher Diet Quality in African-American Adolescents Is Associated with Lower Odds of Metabolic Syndrome: Evidence from the NHANES. J Nutr. 2021 Jun 1;151(6):1609-1617. doi: 10.1093/jn/nxab027.

  PMID: 33768240 BACKGROUND

• Esquivel Zuniga R, DeBoer MD. Prediabetes in Adolescents: Prevalence, Management and Diabetes Prevention Strategies. Diabetes Metab Syndr Obes. 2021 Nov 25;14:4609-4619. doi: 10.2147/DMSO.S284401. eCollection 2021.

  PMID: 34858039 BACKGROUND

• Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.

  PMID: 16182882 BACKGROUND

• Yang L, Magnussen CG, Yang L, Bovet P, Xi B. Elevated Blood Pressure in Childhood or Adolescence and Cardiovascular Outcomes in Adulthood: A Systematic Review. Hypertension. 2020 Apr;75(4):948-955. doi: 10.1161/HYPERTENSIONAHA.119.14168. Epub 2020 Mar 2.

  PMID: 32114851 BACKGROUND

• Falkner B. The enigma of primary hypertension in childhood. Front Cardiovasc Med. 2022 Nov 4;9:1033628. doi: 10.3389/fcvm.2022.1033628. eCollection 2022.

  PMID: 36407424 BACKGROUND

MeSH Terms

Conditions

Health Behavior; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance

Study Officials

• Basheerah Enahora, PhD

  North Carolina State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basheerah Enahora, PhD

CONTACT

9195159125; benahor@ncsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 27, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)