A Food As Medicine Approach to Address Food Insecurity in Rural North Carolina
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-64
SponsorNorth Carolina State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina
Other interventionThis 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).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pilot test participantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fruit and vegetable intake
Measured by ASA24 dietary recall
Time frame
Baseline and end of study at 16 weeksSecondary outcomes
1
Skin carotenoids
Objective measure of fruit and vegetable intake measured by skin carotenoids, derived from a validated reflection spectroscopy device, Veggie Meter®
Time frame
Baseline and end of study at 16 weeks2
Diet quality
Measured by ASA24 dietary recall
Time frame
Baseline and end of study at 16 weeks3
Food security status
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
Time frame
Baseline and end of study at 16 weeks4
Nutrition security status
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
Time frame
Baseline and end of study at 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
North Carolina State University
Lead sponsor
East Carolina University
Collaborator
Source ClinicalTrials.gov