Assessment of a Fruit and Vegetable Prescription Program for Children

Innovative Nutrition Practices in Pediatric Health Care: Assessment of a Fruit and Vegetable Prescription Program for Children in Need

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Exposure to Fruit and Vegetable Prescription Program
• Intervention / Treatment: Other: Fruit and Vegetable Prescription

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.

• Study Type: Interventional
• Enrollment (Actual): 1362
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48502
      • Hurley Children's Clinic
    • Flint, Michigan, United States, 48503
      • Mott Children's Health Center
    • Flint, Michigan, United States, 48532
      • Akpinar Children's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fruit and Vegetable Prescription; Each program participant will receive a fruit and vegetable prescription that is written by pediatricians to exchange for $15 of fresh produce. Prescriptions will be distributed during pediatric office visits and are redeemable at a local farmers' market and mobile market.	Other: Fruit and Vegetable Prescription; $15 voucher for fruit and vegetables

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline child-reported mean daily intake of fruits and vegetables at 12 months	Dietary data from children will be collected via two non-consecutive dietary recalls and one validated food frequency questionnaire. Two non-consecutive 24-hour dietary recalls will be collected using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. We will also administer Block Kids Food Screener, a food frequency questionnaire, to allow for the assessment of usual and long-term eating behaviors. The Block Kids Food Screener will provide nutrient estimates and number of servings by food groups. We will use this data to determine change in child-reported mean daily intake of total fruits and vegetables, total vegetables, total fruits, and whole fruits.	12 months
Change from baseline household food security at 12 months	Caregivers will complete the US Household Food Security Survey Module: 6 Item Short Form (National Center for Health Statistics) to measure household food insecurity and hunger.	12 months
Change from baseline child-reported food security at 12 months	The Self-Administered Food Security Survey Module for Youth will be used to estimate perceived food security among youth 12 years of age and older.	12 months
Change from baseline child-reported food security at 24 months	The Self-Administered Food Security Survey Module for Youth will be used to estimate perceived food security among youth 12 years of age and older.	24 months
Change from baseline child-reported mean daily intake of fruits and vegetables at 24 months	Dietary data from children will be collected via two non-consecutive dietary recalls and one validated food frequency questionnaire. Two non-consecutive 24-hour dietary recalls will be collected using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. We will also administer Block Kids Food Screener, a food frequency questionnaire, to allow for the assessment of usual and long-term eating behaviors. The Block Kids Food Screener will provide nutrient estimates and number of servings by food groups. We will use this data to determine change in child-reported mean daily intake of total fruits and vegetables, total vegetables, total fruits, and whole fruits.	24 months
Change from baseline household food security at 24 months	Caregivers will complete the US Household Food Security Survey Module: 6 Item Short Form (National Center for Health Statistics) to measure household food insecurity and hunger.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline child BMI at 12 months	Youth weight and height will be measured without shoes or heavy outer garments. On each occasion two measures will be made, and the averages will be recorded. Height will be measured to the closest 0.1 cm using a portable stadiometer. Weight will be measured to the closest 0.2 kg on a digital platform scale accurate to 200 kg. Weight and height will be combined to report BMI in kg/m^2.	12 months
Change from baseline child BMI at 24 months	Youth weight and height will be measured without shoes or heavy outer garments. On each occasion two measures will be made, and the averages will be recorded. Height will be measured to the closest 0.1 cm using a portable stadiometer. Weight will be measured to the closest 0.2 kg on a digital platform scale accurate to 200 kg. Weight and height will be combined to report BMI in kg/m^2.	24 months
Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 12 months	Dietary information will be collected from caregivers using the National Cancer Institute Fruit & Vegetable Intake "All Day" Screener which asks frequency and portion size questions about nine food items.	12 months
Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 24 months	Dietary information will be collected from caregivers using the National Cancer Institute Fruit & Vegetable Intake "All Day" Screener which asks frequency and portion size questions about nine food items.	24 months

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Hurley Medical Center; Akpinar Children's Clinic; Mott Children's Health Center; Hurley Children's Center
• Investigators: Principal Investigator: Amy Saxe-Custack, PhD, MPH, RD, Michigan State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003370; R01HD102527 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Although the final dataset will be removed of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of participants. Therefore, we will make all individual participant data that underlie results in publications available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
• IPD Sharing Time Frame: Beginning 6 months after publication of final study results for a period of one year.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No