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Completed

NCT Number: NCT04767282

Assessment of a Fruit and Vegetable Prescription Program for Children

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.

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Key information

Conditions

Exposure to Fruit and Vegetable Prescription Program

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akpinar Children's Clinic, Flint, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit and Vegetable prescription

Other

$15 voucher for fruit and vegetables

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP

    Time frame: Baseline, 6 months,12 months

    Body mass index (BMI) was calculated from child weight and height (weight (kg)/[height (m)]2). BMI was then categorized into percentiles by sex and age to serve as an indicator of overweight and obesity. Child overweight and obesity status were categorized as follows: overweight (95th percentile for age and sex > BMI ≥ 85th percentile for age and sex), obese (BMI ≥ 95th percentile for age and sex). Because achievement of healthy weight in youth (85th percentile for age and sex ≥ BMI > 5th percentile for age and sex) was a secondary objective, a negative change in BMI percentile represents a desirable outcome.

  2. Change From Baseline BMI 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

    Body mass index (BMI) was calculated from child weight and height (weight (kg)/[height (m)]2). BMI was then categorized into percentiles by sex and age to serve as an indicator of overweight and obesity. Child overweight and obesity status were categorized as follows: overweight (95th percentile for age and sex > BMI ≥ 85th percentile for age and sex), obese (BMI ≥ 95th percentile for age and sex). Because achievement of healthy weight in youth (85th percentile for age and sex ≥ BMI > 5th percentile for age and sex) was a secondary objective, a negative change in BMI percentile represents a desirable outcome.

  3. Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP

    Time frame: Baseline, 6 months, 12 months

    To investigate whether exposure to the pediatric fruit and vegetable prescription program is associated with increased fruit and vegetable consumption among caregivers, dietary data from caregivers was collected using the National Cancer Institute Fruit & Vegetable Intake "All Day" Screener which asks frequency and portion size questions about nine food items. This will be used to calculate mean daily intake of vegetables and total fruits.

  4. 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

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

    To investigate whether exposure to the pediatric fruit and vegetable prescription program is associated with increased fruit and vegetable consumption among caregivers, dietary data from caregivers was collected using the National Cancer Institute Fruit & Vegetable Intake "All Day" Screener which asks frequency and portion size questions about nine food items. This will be used to calculate mean daily intake of vegetables and total fruits.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Akpinar Children's Clinic
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Hurley Children's Center
  • Hurley Medical Center
  • Mott Children's Health Center

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2021
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.