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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07221045
Enrollment
30
Registered
2025-10-27
Start date
2025-04-18
Completion date
2026-05-31
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

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.

Interventions

OTHERPhytoRx 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).

Sponsors

East Carolina University
CollaboratorOTHER
North Carolina State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 64 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Fruit and vegetable intakeBaseline and end of study at 16 weeksMeasured by ASA24 dietary recall

Secondary

MeasureTime frameDescription
Diet qualityBaseline and end of study at 16 weeksMeasured by ASA24 dietary recall
Food security statusBaseline and end of study at 16 weeksUSDA 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
Nutrition security statusBaseline and end of study at 16 weeks4-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
Blood pressureBaseline and end of study at 16 weeksMeasured by automated monitor; Omron HEM-907XL, Vernon Hills
Hemoglobin A1CBaseline and end of study at 16 weeksMeasured by point-of-care (PoC) testing via A1C+ Now Analyzer, PTS Diagnostics
Skin carotenoidsBaseline and end of study at 16 weeksObjective measure of fruit and vegetable intake measured by skin carotenoids, derived from a validated reflection spectroscopy device, Veggie Meter®
Self-efficacy for Healthy EatingBaseline and end of study at 16 weeksSelf-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
Food-related Parenting PracticesBaseline and end of study at 16 weeksComprehensive 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).
Barriers and Facilitators to Fruit and Vegetable ConsumptionBaseline to end of study at 16 weeksAdapted 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.
Body Mass Index-For-Age PercentileBaseline and end of study at 16 weeksWeight 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.
Body Mass IndexBaseline and end of study at 16 weeksWeight 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

Countries

United States

Contacts

Primary ContactBasheerah Enahora, PhD
benahor@ncsu.edu9195159125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026