Recruiting NCT07221045

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

No phase Interventional Diet, Healthy Health Behavior Blood Pressure Diabetes Mellitus Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina.
Who it may be relevant to: Registry conditions: Diet, Healthy, Health Behavior, Blood Pressure, Diabetes Mellitus Risk. Basic parameters: 8 years — 64 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Other PhytoRx 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).

Primary outcome measures

Fruit and vegetable intake [Time frame: Baseline and end of study at 16 weeks]

Secondary outcome measures (11)

Skin carotenoids [Time frame: Baseline and end of study at 16 weeks]
Diet quality [Time frame: Baseline and end of study at 16 weeks]
Food security status [Time frame: Baseline and end of study at 16 weeks]
Nutrition security status [Time frame: Baseline and end of study at 16 weeks]
Blood pressure [Time frame: Baseline and end of study at 16 weeks]
Hemoglobin A1C [Time frame: Baseline and end of study at 16 weeks]
Body Mass Index [Time frame: Baseline and end of study at 16 weeks]
Self-efficacy for Healthy Eating [Time frame: Baseline and end of study at 16 weeks]
Food-related Parenting Practices [Time frame: Baseline and end of study at 16 weeks]
Barriers and Facilitators to Fruit and Vegetable Consumption [Time frame: Baseline to end of study at 16 weeks]
Body Mass Index-For-Age Percentile [Time frame: Baseline and end of study at 16 weeks]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Prevention

Study locations

United States · 1 center

North Carolina State University — Raleigh

Publications

Norris K, Jilcott Pitts S, Reis H, Haynes-Maslow L. A Systematic Literature Review of Nutrition Interventions Implemented to Address Food Insecurity as a Social Determinant of Health. Nutrients. 2023 Aug 5;15(15):3464. doi: 10.3390/nu15153464. PMID 37571400
Kerr D, Barua S, Glantz N, Conneely C, Kujan M, Bevier W, Larez A, Sabharwal A. Farming for life: impact of medical prescriptions for fresh vegetables on cardiometabolic health for adults with or at risk of type 2 diabetes in a predominantly Mexican-American population. BMJ Nutr Prev Health. 2020 Oct 5;3(2):239-246. doi: 10.1136/bmjnph-2020-000133. eCollection 2020 Dec. PMID 33521534
Heasley C, Clayton B, Muileboom J, Schwanke A, Rathnayake S, Richter A, Little M. "I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Arch Public Health. 2021 Jul 23;79:135. doi: 10.1186/s13690-021-00657-6. eCollection 2021. PMID 34301335
Fischer L, Bodrick N, Mackey ER, McClenny A, Dazelle W, McCarron K, Mork T, Farmer N, Haemer M, Essel K. Feasibility of a Home-Delivery Produce Prescription Program to Address Food Insecurity and Diet Quality in Adults and Children. Nutrients. 2022 May 10;14(10):2006. doi: 10.3390/nu14102006. PMID 35631144
Harkin N, Johnston E, Mathews T, Guo Y, Schwartzbard A, Berger J, Gianos E. Physicians' Dietary Knowledge, Attitudes, and Counseling Practices: The Experience of a Single Health Care Center at Changing the Landscape for Dietary Education. Am J Lifestyle Med. 2018 Nov 23;13(3):292-300. doi: 10.1177/1559827618809934. eCollection 2019 May-Jun. PMID 31105493
Rahman V. Time to Revamp Nutrition Education for Physicians. Perm J. 2019;23:19-052. doi: 10.7812/TPP/19.052. Epub 2019 Aug 19. PMID 31496507
Wolfson JA, Ramsing R, Richardson CR, Palmer A. Barriers to healthy food access: Associations with household income and cooking behavior. Prev Med Rep. 2019 Jan 31;13:298-305. doi: 10.1016/j.pmedr.2019.01.023. eCollection 2019 Mar. PMID 30792944
Reicks M, Kocher M, Reeder J. Impact of Cooking and Home Food Preparation Interventions Among Adults: A Systematic Review (2011-2016). J Nutr Educ Behav. 2018 Feb;50(2):148-172.e1. doi: 10.1016/j.jneb.2017.08.004. Epub 2017 Sep 25. PMID 28958671

Identifiers

NCT: NCT07221045 · 27407

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗