PhytoRx Families for Healthy Eating

Overseen By Basheerah Enahora, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina State University

Disqualifiers: Not at risk food insecurity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program called PhytoRx Families, designed to help rural families in North Carolina improve their diets by increasing fruit and vegetable intake and reducing unhealthy foods high in saturated fat, salt, and added sugar. The program addresses the challenges faced by families with limited resources in accessing healthy food. It provides a "produce prescription" and nutrition education to determine if these changes can lead to better health outcomes. This trial suits families visiting certain clinics in specific North Carolina counties, particularly those struggling with food insecurity and having children aged 8 to 14. As an unphased trial, it offers families a unique opportunity to contribute to innovative solutions for healthier living.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on dietary changes rather than medication use.

What prior data suggests that the PhytoRx Families program is safe?

Research has shown that the PhytoRx Families program is undergoing testing to ensure safety and ease of use for participants. So far, no serious side effects have been reported. As this is an early trial, researchers are carefully monitoring any negative effects. Prospective participants can feel confident that the program's goal is to improve nutrition and health without causing harm. The program aims to help rural families access healthier food, which is expected to enhance overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PhytoRx Families for Healthy Eating because it takes a novel approach to addressing food insecurity. Unlike traditional methods that might focus solely on providing food aid or nutritional supplements, this program involves healthcare providers in local clinics to directly refer families in need, particularly those with school-aged children. This direct referral system, utilizing a secure communication platform, aims to create a more personalized and community-centered solution, potentially leading to more sustainable and impactful changes in eating habits. By targeting families with children and involving caregivers, the program hopes to foster healthier eating patterns that can last a lifetime.

What evidence suggests that the PhytoRx Families program is effective for improving dietary habits?

Research has shown that the PhytoRx Families program, which participants in this trial will engage with, might help improve nutrition by addressing food insecurity. This program uses a "food as medicine" approach, aiming to increase the intake of fruits and vegetables while reducing unhealthy elements like saturated fat, salt, and added sugar. Early results suggest that this method may effectively encourage healthier eating habits, especially in rural areas where affordable healthy food is scarce. The program seeks to positively impact health by focusing on these dietary changes. ^{1 2 6 7 8}

Who Is on the Research Team?

Basheerah Enahora, PhD

Principal Investigator

North Carolina State University

Are You a Good Fit for This Trial?

This trial is for individuals in rural North Carolina facing food insecurity and barriers to healthy eating, which may affect conditions like Type 2 Diabetes and High Blood Pressure. Participants should be interested in improving their diet through increased fruit and vegetable intake.

Inclusion Criteria

I am an adult and a parent or caregiver of a child aged 8-14, or I am a child aged 8-14.

I can receive and use fresh produce and attend nutrition classes.

Willing and able to provide written consent and participate in all study activities.

Exclusion Criteria

I am an adult without caregiving responsibilities for children aged 8-14.

Adults not at risk of food insecurity

I am unable or unwilling to fully participate due to severe dietary restrictions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PhytoRx Families produce prescription program to address food insecurity and improve dietary habits

16 weeks

Baseline and end of study visits

Follow-up

Participants are monitored for changes in fruit and vegetable intake, cardiovascular health, and healthcare utilization

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PhytoRx Families

Trial Overview The PhytoRx Families program is being tested to see if it can help lower-resourced families eat healthier by providing them with produce prescriptions (Prx). The study will measure the impact on nutrition, health outcomes, and healthcare usage.

How Is the Trial Designed?

Group I: Pilot test participants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

East Carolina University

Collaborator

Trials

111

Recruited

42,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07221045

NCT07221045 | A Food As Medicine Approach to Address ... This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related outcomes. ... Self-efficacy for Healthy Eating, Self ...

2. trial.medpath.com trial.medpath.com/clinical-trial/baa6b54169efb271/nct07221045-phytorx-families-food-security-fruit-vegetable-intake

A Food As Medicine Approach to Address Food Insecurity in ... This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related outcomes. This study will define ...

3. withpower.com withpower.com/trial/phase-patient-acceptance-of-health-care-3-2025-ab236

PhytoRx Families for Healthy Eating This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare ...

4. medicaldevicenavigator.com medicaldevicenavigator.com/food-as-medicine-north-carolina/

Innovative Food-As-Medicine Program Targets Rural North ... The PhytoRx Families program aims to identify scalable and reproducible solutions for food insecurity while making a marked impact on related health outcomes.

5. cals.ncsu.edu cals.ncsu.edu/agricultural-and-human-sciences/people/basheerah-enahora/

Basheerah Enahora, PhD, MBA, RDN, LDN In collaboration with researchers at UNC-CH and Equiti Foods, this randomized trial evaluates the impact of subsidized healthy frozen meals delivered through ...

6. issuu.com issuu.com/ncstate_cals/docs/the_phytomedicine_phytorx_guidebook

The PhytoMedicine PhytoRx Guidebook PhytoRx is a collaborative community health program that improves nutrition education for healthcare providers and empowers community members to ...

7. patlynk.com patlynk.com/trial/NCT07221045

Produce Prescription Program for Rural North Carolina ... PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina ... We uphold the highest standards of security and compliance for health data ...

8. portal.nifa.usda.gov portal.nifa.usda.gov/web/areera/Reports/2022/2022_North_Carolina_Agricultural_and_Technical_State_University_and_North_Carolina_State_University_Combined_Research_and_Extension_Annual_Report_ofnts.pdf

2022 North Carolina Agricultural and Technical State ... A& T researchers are working to find the solution from food production, food safety to post harvest, alternative energy, obesity, Ag economics and needs of ...