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Clinical Trials/NCT04767282
NCT04767282
Completed
N/A

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

Michigan State University3 sites in 1 country1,400 target enrollmentFebruary 23, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Exposure to Fruit and Vegetable Prescription Program
Sponsor
Michigan State University
Enrollment
1400
Locations
3
Primary Endpoint
Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2021
End Date
June 25, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amy Saxe-Custack

Assistant Professor

Michigan State University

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

Outcomes

Primary Outcomes

Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP

Time Frame: Baseline, 6 months,12 months

Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits.

Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6 and 12 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP

Time Frame: Baseline, 6 months,12 months

Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.

Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6 and 12 Months Relative to Baseline Among Youth 12 Years of Age and Older Who Were Newly Introduced to the FVPP.

Time Frame: Baseline, 6 months,12 months

Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses ("a lot" or "sometimes") to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.

Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP

Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months

Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses ("a lot" or "sometimes") to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.

Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP

Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months

Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits.

Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP

Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months

Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.

Secondary Outcomes

  • Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP(Baseline, 6 months,12 months)
  • Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP(Baseline, 6 months, 12 months, 18 months, 24 months)
  • Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP(Baseline, 6 months, 12 months)
  • Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP(Baseline, 6 months, 12 months, 18 months, 24 months)

Study Sites (3)

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