Assessment of a Fruit and Vegetable Prescription Program for Children

Not Applicable

Completed

Conditions: Exposure to Fruit and Vegetable Prescription Program

Registration Number: NCT04767282

Lead Sponsor: Michigan State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1400

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	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	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.	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	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	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	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 Outcome Measures

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

Trial Locations

Locations (3): Hurley Children's Clinic
🇺🇸
Flint, Michigan, United States
Mott Children's Health Center
🇺🇸
Flint, Michigan, United States
Akpinar Children's Clinic
🇺🇸
Flint, Michigan, United States
Hurley Children's Clinic
🇺🇸Flint, Michigan, United States