Clinical trial NCT04767282: Assessment of a Fruit and Vegetable Prescription Program for Children
Official title: Innovative Nutrition Practices in Pediatric Health Care: Assessment of a Fruit and Vegetable Prescription Program for Children in Need
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Fruit and Vegetable Prescription Program
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Hurley Medical Center
name: Akpinar Children's Clinic
name: Mott Children's Health Center
name: Hurley Children's Center
First posted: 2021-02-23
Enrollment: 1362
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A fruit and vegetable prescription is written by pediatricians to exchange for $15 of fresh produce. Prescriptions are redeemable at a local farmers' market and mobile market.
Primary purpose: PREVENTION

Brief summary: The objective of this study is to address gaps in knowledge related to the influence of pediatric fruit and vegetable prescription programs on food security, child dietary patterns, and weight status. To do this, we will compare demographically similar pediatric patient groups from three large clinics in a low-income urban city based on their exposure to a fruit and vegetable prescription program (FVPP) that provides one $15 prescription for fresh fruits and vegetable to every child at every office visit. Three clusters will be identified based on child exposure to the pediatric FVPP at baseline: high exposure (\>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. We will test the hypothesis that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of obesity among children. The first aim will compare baseline dietary intake, food security, and weight status between high exposure, moderate exposure, no exposure groups. The second aim will measure changes in diet, food security, and weight status at 6-, 12-, 18-, and 24-months among children newly exposed to the FVPP. The third aim will compare follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.

Detailed description: This study will evaluate a Fruit and Vegetable Prescription Program (FVPP). The program provides one $15 prescription for fresh produce to every child at every office visit. Prescriptions are redeemable at a local farmers' market and mobile market. To determine whether exposure to the FVPP is associated with improvements in dietary intake, food security, and health status, we will compare demographically similar pediatric patient groups with varying levels of exposure to the FVPP at baseline: high exposure (\>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. The central hypothesis is that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of childhood obesity over time.

We propose the following three specific aims to test our hypothesis:

Aim 1 - Compare baseline dietary intake, food security, and weight status between pediatric patients with varying levels of exposure to the FVPP.

Aim 2 - Measure changes in diet, food security, and weight status when never exposed children are introduced to the FVPP.

Aim 3 - Compare mean follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.

Eligibility criteria: Inclusion Criteria:

* Child between age 8 and 16 years and their caregiver;
* Child active patient at clinic;
* Child received at least one fruit and vegetable prescription;
* Child and caregiver English-speaking

Exclusion Criteria:

* Caregiver or child not English speaking;
* Legal guardian not present at enrollment;
* Child assent refused;
* Sibling previously enrolled (one caregiver and one child per household);
* Movement between participating clinics

Primary outcomes:
measure: Change from baseline child-reported mean daily intake of fruits and vegetables at 12 months
timeFrame: 12 months
measure: Change from baseline household food security at 12 months
timeFrame: 12 months
measure: Change from baseline child-reported food security at 12 months
timeFrame: 12 months
measure: Change from baseline child-reported food security at 24 months
timeFrame: 24 months
measure: Change from baseline child-reported mean daily intake of fruits and vegetables at 24 months
timeFrame: 24 months
measure: Change from baseline household food security at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Change from baseline child BMI at 12 months
timeFrame: 12 months
measure: Change from baseline child BMI at 24 months
timeFrame: 24 months
measure: Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 12 months
timeFrame: 12 months
measure: Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Children's Clinic
state: Michigan
city: Flint
country: United States
facility: Mott Children's Health Center
state: Michigan
city: Flint
country: United States
facility: Akpinar Children's Clinic
state: Michigan
Study officials:
affiliation: Michigan State University
name: Amy Saxe-Custack, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saxe-Custack A, Lofton HC, Hanna-Attisha M, Victor C, Reyes G, Ceja T, LaChance J. Caregiver perceptions of a fruit and vegetable prescription programme for low-income paediatric patients. Public Health Nutr. 2018 Sep;21(13):2497-2506. doi: 10.1017/S1368980018000964. Epub 2018 Apr 18.
citation: Saxe-Custack A, LaChance J, Hanna-Attisha M, Ceja T. Fruit and Vegetable Prescriptions for Pediatric Patients Living in Flint, Michigan: A Cross-Sectional Study of Food Security and Dietary Patterns at Baseline. Nutrients. 2019 Jun 25;11(6):1423. doi: 10.3390/nu11061423.
citation: Saxe-Custack A, LaChance J, Hanna-Attisha M. Child Consumption of Whole Fruit and Fruit Juice Following Six Months of Exposure to a Pediatric Fruit and Vegetable Prescription Program. Nutrients. 2019 Dec 20;12(1):25. doi: 10.3390/nu12010025.
citation: Saxe-Custack A, Sadler R, LaChance J, Hanna-Attisha M, Ceja T. Participation in a Fruit and Vegetable Prescription Program for Pediatric Patients is Positively Associated with Farmers' Market Shopping. Int J Environ Res Public Health. 2020 Jun 12;17(12):4202. doi: 10.3390/ijerph17124202.
citation: Saxe-Custack A, Todem D, Anthony JC, Kerver JM, LaChance J, Hanna-Attisha M. Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. BMC Public Health. 2022 Jan 21;22(1):150. doi: 10.1186/s12889-022-12544-y.
citation: Saxe-Custack A, Egan S, Farmer B, Pulka K, Sampson A. Caregiver-reported barriers to engagement in a paediatric fresh fruit and vegetable prescription programme. J Nutr Sci. 2024 Sep 18;13:e33. doi: 10.1017/jns.2024.33. eCollection 2024.
citation: Saxe-Custack A, Todem D, LaChance J, Kerver J, Anthony J. Association between youth blood pressure and exposure to pediatric fruit and vegetable prescriptions. Pediatr Res. 2024 Dec 10. doi: 10.1038/s41390-024-03671-w. Online ahead of print.
citation: Sadler RC, Saxe-Custack A. 'Nobody Shops at the Neighborhood Store': Leveraging a Community's Pediatric Fresh Produce Prescription Program to Inform Future Participating Store Redemption Locations. Cities Health. 2024;8(1):70-81. doi: 10.1080/23748834.2023.2281764. Epub 2023 Nov 23.