Recruiting

Produce Prescription Program for Rural North Carolina Families

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Study AimThis study aims to prevent health issues by providing rural North Carolina families with access to fresh produce through a prescription program.
What is being tested

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

Other
Who is being recruted

Behavior
+1

+ Patient Acceptance of Health Care
+ Health Behavior
From 8 to 64 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorNorth Carolina State University
Study ContactBasheerah Enahora, PhD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: April 18, 2025Actual date on which the first participant was enrolled.

The study focuses on improving the diet and health of rural families in North Carolina by increasing their intake of fruits and vegetables while reducing unhealthy components like saturated fats, salt, and added sugars. This is important because rural families often face difficulties accessing affordable healthy food, which contributes to health disparities. The goal of this program, called PhytoRx Families, is to see how providing a "produce prescription" can positively impact nutrition and related health outcomes. The study involves adults and school-aged children, aiming to help them eat more fruits and vegetables, which is a key recommendation to prevent chronic diseases. Participants in the study will take part in a program that supports them in accessing and eating more fruits and vegetables through a unique prescription model. Researchers will measure the amount of fruits and vegetables the participants consume using dietary recalls. They will also assess changes in participants' cardiovascular health by looking at factors like blood pressure, blood sugar levels, and body measurements. Additionally, the study will explore how participation in the program affects healthcare usage. This approach not only aims to improve diet but also to examine broader health benefits and potential changes in medical care needs.

Official TitlePhytoRx Families: A Pilot Test Study to Address Food Security and Fruit and Vegetable Intake in Rural North Carolina 
NCT07221045
Principal SponsorNorth Carolina State University
Study ContactBasheerah Enahora, PhD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 8 to 64 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Behavior
Patient Acceptance of Health Care
Health Behavior
Treatment Adherence and Compliance
Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.

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).
Study Objectives
Primary Objectives

Measured by ASA24 dietary recall
Secondary Objectives

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

Measured by ASA24 dietary recall

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-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

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

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

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

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

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).

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.

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
North Carolina State UniversityRaleigh, United StatesSee the location
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One Study Center