Recruiting

PhytoRx Families

Sponsor:

North Carolina State University

Code:

NCT07221045

Conditions

Diet, Healthy

Health Behavior

Blood Pressure

Diabetes Mellitus Risk

Utilization, Health Care

Eligibility Criteria

Sex: All

Age: 8 - 64

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT07221045

Start date

Apr 18, 2025

Status verified date

Oct, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 64

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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).

Primary outcome measure

  • Fruit and vegetable intake [ Time Frame: Baseline and end of study at 16 weeks ]

Central Contacts and Locations

Central contacts

Basheerah Enahora, PhD

9195159125benahor@ncsu.edu

Locations

North Carolina State University

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

Basheerah Enahora, PhD

9195159125benahor@ncsu.edu

Principal Investigator:

Basheerah Enahora, PhD

More Information

Sponsor

North Carolina State University

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2025-10-27.