N/A
N=1,400
Assessment of a Fruit and Vegetable Prescription Program for Children
Exposure to Fruit and Vegetable Prescription Program
Bottom Line
View on ClinicalTrials.gov: NCT04767282 ↗Enrolled (actual)
1,400
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: 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 — 0.21; 0.17; 0.14; 0.05 cup equivalents per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fruit and Vegetable Prescription (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.21; 0.17; 0.14; 0.05; 0.11; -0.01 | — |
| PRIMARY 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 |
0.87; 0.92 | — |
| PRIMARY 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. |
0.86; 0.64 | — |
| PRIMARY 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 |
0.86; 0.64; 0.48; 0.39 | — |
| PRIMARY 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 |
0.21; 0.17; 0.37; 0.09; 0.14; 0.05 | — |
| PRIMARY 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 |
0.87; 0.92; 0.71; 0.92 | — |
| SECONDARY Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP |
-0.48; -1.93 | — |
| SECONDARY Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP |
-0.48; -1.93; -1.98; -3.43 | — |
| SECONDARY Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP |
-0.21; -0.56 | — |
| SECONDARY 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 |
-0.21; -0.56; -0.90; -0.50 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04767282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.