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NCT Number: NCT07221045

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

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.

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Key information

Conditions

Diet, Healthy Behavior Blood Pressure Diabetes Mellitus Risk Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance Utilization, Health Care

Age range

8 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina State University

Raleigh, North Carolina, 27695, United States

Location status: Recruiting

Location contact

Basheerah Enahora, PhD

CONTACT

[email protected]

9195159125

Basheerah Enahora, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

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).

Other names: PhytoRx Families Pilot Test

Primary outcomes

  1. Fruit and vegetable intake

    Time frame: Baseline and end of study at 16 weeks

    Measured by ASA24 dietary recall

Secondary outcomes

  1. Skin carotenoids

    Time frame: Baseline and end of study at 16 weeks

    Objective measure of fruit and vegetable intake measured by skin carotenoids, derived from a validated reflection spectroscopy device, Veggie Meter®

  2. Diet quality

    Time frame: Baseline and end of study at 16 weeks

    Measured by ASA24 dietary recall

  3. Food security status

    Time frame: Baseline and end of study at 16 weeks

    USDA 6-Item Food Security Survey. Score range is 0 to 6. Responses of "often" or "sometimes" on questions HH3 and HH4, and "yes" on AD1, AD2, and AD3 are coded as affirmative (yes). Responses of "almost every month" and "some months but not every month" on AD1a are coded as affirmative (yes). The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1-High or marginal food security; Raw score 2-4-Low food security; Raw score 5-6-Very low food security

  4. Nutrition security status

    Time frame: Baseline and end of study at 16 weeks

    4-Item Household Nutrition Security Screener (Gretchen Swanson/Center for Nutrition & Health Impact), Score range is 0 (if the participant selects "Always") to 4 (if the participant selects "Never"), with higher scores indicating a greater degree of Household Nutrition Security

  5. Blood pressure

    Time frame: Baseline and end of study at 16 weeks

    Measured by automated monitor; Omron HEM-907XL, Vernon Hills

  6. Hemoglobin A1C

    Time frame: Baseline and end of study at 16 weeks

    Measured by point-of-care (PoC) testing via A1C+ Now Analyzer, PTS Diagnostics

  7. Body Mass Index

    Time frame: Baseline and end of study at 16 weeks

    Weight in kilograms and height in meters (collected at baseline only) will be assessed by electronic scale with stadiometer, SECA 874dr scale. BMI will be calculated by dividing weight (kg) by height (m) squared

  8. Self-efficacy for Healthy Eating

    Time frame: Baseline and end of study at 16 weeks

    Self-efficacy for Eating Behaviors Scale. Score range from 1 (participant responds strongly disagree) to 5 (participant responds strongly agree), with higher scores indicating higher self efficacy for choosing healthy foods

  9. Food-related Parenting Practices

    Time frame: Baseline and end of study at 16 weeks

    Comprehensive Home Environment Survey (CHES). Measurement of social and physical home environment to assess food-related parenting practices. Scale from 1 (participant responds "Never") to 5 (participant responds "Always"), with higher scores indicating positive food-related parenting practices (ie eating meals together as a family, modeling healthy behaviors, cooking at home, involving children in the meal planning/cooking process).

  10. Barriers and Facilitators to Fruit and Vegetable Consumption

    Time frame: Baseline to end of study at 16 weeks

    Adapted instruments from the Family Life, Activity, Sun, Health, and Eating (FLASHE) Parent Module and the Singleton et al 2018 study to assess barriers and facilitators to fruit and vegetable consumption. Score range from 1 (participant responds "Strongly Disagree") to 5 (participant responds "Strongly Agree"), with higher scores representing more barriers to eating fruits and vegetables.

  11. Body Mass Index-For-Age Percentile

    Time frame: Baseline and end of study at 16 weeks

    Weight in kilograms and height in meters (collected at baseline only) will be assessed by electronic scale with stadiometer, SECA 874dr scale. BMI will be calculated by dividing weight (kg) by height (m) squared, then plotted on a growth chart.

Study contacts

Contact information is provided by the study sponsor or research team.

Basheerah Enahora, PhD

CONTACT

[email protected]

9195159125

Sponsors and collaborators

Lead sponsor

North Carolina State University

Other

Collaborators

  • East Carolina University

Registry information

Official study title

PhytoRx Families: A Pilot Test Study to Address Food Security and Fruit and Vegetable Intake in Rural North Carolina

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2025
Registry last updated
Oct 27, 2025

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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