Trial Outcomes & Findings for Assessment of a Fruit and Vegetable Prescription Program for Children (NCT NCT04767282)

NCT ID: NCT04767282

Last Updated: 2025-10-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1400 participants

Primary outcome timeframe

Baseline, 6 months,12 months

Results posted on

2025-10-16

Participant Flow

Caregiver-child dyads were recruited from February 2021 through June 2022 at pediatric clinics in Flint, Michigan. The high exposure clinic is a large pediatric clinic that introduced Michigan's first pediatric fruit and vegetable prescription program in February 2016. The moderate exposure clinic is one of the largest private-practice pediatric clinics in Flint serving over 3,000 patients. The no/low exposure clinic is the largest pediatric clinic in Flint.

Exposure to the pediatric fruit and vegetable prescription program was based on length of time a child was a patient at one of three partnering clinics that offered the fruit and vegetable prescription program. Number of participants started represents the number of individual participants (caregivers and children).

Participant milestones

Participant milestones
Measure
Moderate Exposure to the FVPP
Patients with Moderate Exposure to the FVPP
High Exposure to the FVPP
Patients with High Exposure to the FVPP
No/Low Exposure to the FVPP
Patients with No/Low Exposure to the FVPP
Overall Study
STARTED
362
406
632
Overall Study
Children
181
203
316
Overall Study
Caregivers
181
203
316
Overall Study
COMPLETED
350
402
608
Overall Study
NOT COMPLETED
12
4
24

Reasons for withdrawal

Reasons for withdrawal
Measure
Moderate Exposure to the FVPP
Patients with Moderate Exposure to the FVPP
High Exposure to the FVPP
Patients with High Exposure to the FVPP
No/Low Exposure to the FVPP
Patients with No/Low Exposure to the FVPP
Overall Study
Refused or did not begin surveys
6
2
2
Overall Study
Duplicate household previously enrolled
2
0
8
Overall Study
Unable to confirm legal guardian
0
2
8
Overall Study
Withdrawal by Subject
0
0
6
Overall Study
Survey comprehension challenges
4
0
0

Baseline Characteristics

For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Moderate Exposure to the FVPP
n=350 Participants
Participants with Moderate Exposure to the FVPP
High Exposure to the FVPP
n=402 Participants
Participants with High Exposure to the FVPP
No/Low Expsoure to the FVPP
n=608 Participants
Participants with No/Low Exposure to the FVPP
Total
n=1360 Participants
Total of all reporting groups
Age, Categorical
<=18 years
175 Participants
n=348 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
201 Participants
n=402 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
300 Participants
n=599 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
676 Participants
n=1349 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
Age, Categorical
Between 18 and 65 years
167 Participants
n=348 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
198 Participants
n=402 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
291 Participants
n=599 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
656 Participants
n=1349 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
Age, Categorical
>=65 years
6 Participants
n=348 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
3 Participants
n=402 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
8 Participants
n=599 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
17 Participants
n=1349 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
Age, Continuous
Age
26.99 years
STANDARD_DEVIATION 15.61 • n=348 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
25.92 years
STANDARD_DEVIATION 14.87 • n=402 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
25.72 years
STANDARD_DEVIATION 15.54 • n=599 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
26.11 years
STANDARD_DEVIATION 15.36 • n=1349 Participants • For the age distribution, 11 participants did not provide their age. So, 1349 participants did provide data to generate the age at enrollment.
Sex: Female, Male
Total · Female
250 Participants
n=350 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
282 Participants
n=402 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
428 Participants
n=604 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
960 Participants
n=1356 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Sex: Female, Male
Total · Male
100 Participants
n=350 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
120 Participants
n=402 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
176 Participants
n=604 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
396 Participants
n=1356 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Sex: Female, Male
Children · Female
91 Participants
n=175 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
103 Participants
n=201 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
159 Participants
n=304 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
353 Participants
n=680 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Sex: Female, Male
Children · Male
84 Participants
n=175 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
98 Participants
n=201 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
145 Participants
n=304 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
327 Participants
n=680 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Sex: Female, Male
Caregivers · Female
159 Participants
n=175 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
179 Participants
n=201 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
269 Participants
n=300 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
607 Participants
n=676 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Sex: Female, Male
Caregivers · Male
16 Participants
n=175 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
22 Participants
n=201 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
31 Participants
n=300 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
69 Participants
n=676 Participants • For the sex distribution, 4 participants did not provide their sex. So, 1356 participants did provide data on their sex modality. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Total · Hispanic or Latino
5 Participants
n=350 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=402 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
12 Participants
n=608 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
18 Participants
n=1360 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Total · Not Hispanic or Latino
341 Participants
n=350 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
401 Participants
n=402 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
579 Participants
n=608 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1321 Participants
n=1360 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Total · Unknown or Not Reported
4 Participants
n=350 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=402 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
17 Participants
n=608 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
21 Participants
n=1360 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Children · Hispanic or Latino
2 Participants
n=175 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=201 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
5 Participants
n=304 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
7 Participants
n=680 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Children · Not Hispanic or Latino
172 Participants
n=175 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
201 Participants
n=201 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
289 Participants
n=304 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
662 Participants
n=680 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Children · Unknown or Not Reported
1 Participants
n=175 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=201 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
10 Participants
n=304 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
11 Participants
n=680 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
3 Participants
n=175 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=201 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
7 Participants
n=304 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
11 Participants
n=680 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
169 Participants
n=175 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
200 Participants
n=201 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
290 Participants
n=304 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
659 Participants
n=680 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
3 Participants
n=175 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=201 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
7 Participants
n=304 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
10 Participants
n=680 Participants • The number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · American Indian or Alaska Native
3 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
5 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
3 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
11 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · Asian
1 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
2 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
4 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
7 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · Native Hawaiian or Other Pacific Islander
1 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
2 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
3 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · Black or African American
253 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
330 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
414 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
997 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · White
68 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
47 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
129 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
244 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · More than one race
15 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
17 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
27 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
59 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Total · Unknown or Not Reported
4 Participants
n=345 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=401 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
17 Participants
n=596 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
21 Participants
n=1342 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · American Indian or Alaska Native
1 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
3 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
2 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
6 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · Asian
1 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
3 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · Native Hawaiian or Other Pacific Islander
1 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
2 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · Black or African American
128 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
165 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
212 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
505 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · White
30 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
19 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
57 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
106 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · More than one race
11 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
13 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
16 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
40 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Children · Unknown or Not Reported
1 Participants
n=173 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=201 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
10 Participants
n=299 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
11 Participants
n=673 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
2 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
2 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
5 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · Asian
0 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
3 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
4 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
0 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
1 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · Black or African American
125 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
165 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
202 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
492 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · White
38 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
28 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
72 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
138 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · More than one race
4 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
4 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
11 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
19 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
3 Participants
n=172 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
0 Participants
n=200 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
7 Participants
n=297 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
10 Participants
n=669 Participants • Total in subgroups does not include Hispanics. There are 5, 1 and 12 Hispanics in high, moderate and no/low exposure group respectively. Additionally, the number analyzed in row differs from overall because the first row (titled Total) represents the overall study sample (children and caregivers).
Region of Enrollment
United States
350 participants
n=350 Participants
402 participants
n=402 Participants
608 participants
n=608 Participants
1360 participants
n=1360 Participants
Age of Study Participants
Age of youth participants
12.93 Years
STANDARD_DEVIATION 2.34 • n=175 Participants • There were missing data either with the youth or adult data.
12.47 Years
STANDARD_DEVIATION 2.63 • n=201 Participants • There were missing data either with the youth or adult data.
11.98 Years
STANDARD_DEVIATION 2.39 • n=300 Participants • There were missing data either with the youth or adult data.
12.37 Years
STANDARD_DEVIATION 2.48 • n=676 Participants • There were missing data either with the youth or adult data.
Age of Study Participants
Age of adult participants
41.22 Years
STANDARD_DEVIATION 9.02 • n=173 Participants • There were missing data either with the youth or adult data.
39.74 Years
STANDARD_DEVIATION 8.53 • n=201 Participants • There were missing data either with the youth or adult data.
39.51 Years
STANDARD_DEVIATION 9.89 • n=299 Participants • There were missing data either with the youth or adult data.
39.91 Years
STANDARD_DEVIATION 9.30 • n=673 Participants • There were missing data either with the youth or adult data.

PRIMARY outcome

Timeframe: Baseline, 6 months,12 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from youth participants with no/low exposure to the FVPP at baseline who completed the Block Kids Food Screener.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=300 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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
Change in mean daily intake of total fruits (6 months versus baseline)
0.21 cup equivalents per day
Interval 0.0 to 0.41
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
Change in mean daily intake of total fruits (12 months versus baseline)
0.17 cup equivalents per day
Interval -0.01 to 0.34
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
Change in mean daily intake of whole fruits (6 months versus baseline)
0.14 cup equivalents per day
Interval 0.01 to 0.26
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
Change in mean daily intake of whole fruits (12 months versus baseline)
0.05 cup equivalents per day
Interval -0.06 to 0.16
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
Change in mean daily intake of total vegetables (6 months versus baseline)
0.11 cup equivalents per day
Interval -0.06 to 0.28
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
Change in mean daily intake of total vegetables (12 months versus baseline)
-0.01 cup equivalents per day
Interval -0.14 to 0.12

PRIMARY outcome

Timeframe: Baseline, 6 months,12 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from caregivers with no/low exposure to th FVPP at baseline who completed the entire US Household Food Security Module.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=300 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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
Odds ratios for higher food security (6 months versus baseline)
0.87 High Food Security Odds Ratio
Interval 0.59 to 1.29
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
Odds ratios for higher food security (12 months versus baseline)
0.92 High Food Security Odds Ratio
Interval 0.61 to 1.37

PRIMARY outcome

Timeframe: Baseline, 6 months,12 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from youth 12 years of age and older who were newly introduced to the FVPP and completed the Self-Administered Food Security Survey Module for Youth.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=142 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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.
Odds ratios for higher food security (6 months versus baseline)
0.86 High Food Security Odds Ratio
Interval 0.39 to 1.9
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.
Odds ratios for higher food security (12 months versus baseline)
0.64 High Food Security Odds Ratio
Interval 0.32 to 1.28

PRIMARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from youth 12 years of age and older who were newly introduced to the FVPP and completed the Self-Administered Food Security Survey Module for Youth.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=142 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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
Odds ratios for higher food security (6 months versus baseline)
0.86 High Food Security Odds Ratio
Interval 0.39 to 1.9
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
Odds ratios for higher food security (12 months versus baseline)
0.64 High Food Security Odds Ratio
Interval 0.32 to 1.28
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
Odds ratios for higher food security (18 months versus baseline)
0.48 High Food Security Odds Ratio
Interval 0.25 to 0.95
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
Odds ratios for higher food security (24 months versus baseline)
0.39 High Food Security Odds Ratio
Interval 0.19 to 0.78

PRIMARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" groups. Analysis includes data from youth participants who were newly introduced to the FVPP and completed the Block Kids Food Screener.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=300 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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
Change in mean daily intake of whole fruits (6 months versus baseline)
0.14 cup equivalents per day
Interval 0.01 to 0.26
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
Change in mean daily intake of whole fruits (12 months versus baseline)
0.05 cup equivalents per day
Interval -0.06 to 0.16
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
Change in mean daily intake of whole fruits (24 months versus baseline)
0.12 cup equivalents per day
Interval 0.0 to 0.25
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
Change in mean daily intake of total vegetables (24 months versus baseline)
-0.02 cup equivalents per day
Interval -0.16 to 0.12
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
Change in mean daily intake of total fruits (6 months versus baseline)
0.21 cup equivalents per day
Interval 0.0 to 0.41
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
Change in mean daily intake of total fruits (12 months versus baseline)
0.17 cup equivalents per day
Interval -0.01 to 0.34
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
Change in mean daily intake of total fruits (18 months versus baseline)
0.37 cup equivalents per day
Interval 0.19 to 0.55
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
Change in mean daily intake of total fruits (24 months versus baseline)
0.09 cup equivalents per day
Interval -0.1 to 0.29
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
Change in mean daily intake of whole fruits (18 months versus baseline)
0.20 cup equivalents per day
Interval 0.09 to 0.32
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
Change in mean daily intake of total vegetables (6 months versus baseline)
0.11 cup equivalents per day
Interval -0.06 to 0.28
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
Change in mean daily intake of total vegetables (12 months versus baseline)
-0.01 cup equivalents per day
Interval -0.14 to 0.12
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
Change in mean daily intake of total vegetables (18 months versus baseline)
0.19 cup equivalents per day
Interval 0.03 to 0.35

PRIMARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from caregivers newly introduced to the FVPP who completed the US Household Food Security Module.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=300 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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
Odds ratios for higher food security (6 months versus baseline)
0.87 High Food Security Odds Ratio
Interval 0.59 to 1.29
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
Odds ratios for higher food security (12 months versus baseline)
0.92 High Food Security Odds Ratio
Interval 0.61 to 1.37
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
Odds ratios for higher food security (18 months versus baseline)
0.71 High Food Security Odds Ratio
Interval 0.47 to 1.07
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
Odds ratios for higher food security (24 months versus baseline)
0.92 High Food Security Odds Ratio
Interval 0.59 to 1.46

SECONDARY outcome

Timeframe: Baseline, 6 months,12 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Pediatric patients with recorded height and weight measurements.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=296 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP
Change in BMI percentiles (6 months versus baseline)
-0.48 BMI percentile
Interval -2.46 to 1.5
Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP
Change in BMI percentile (12 months versus baseline)
-1.93 BMI percentile
Interval -3.36 to -0.5

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Pediatric patients with recorded height and weight measurements.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=296 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Change in BMI percentile (6 months versus baseline)
-0.48 BMI percentile
Interval -2.46 to 1.5
Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Change in BMI percentile (12 months versus baseline)
-1.93 BMI percentile
Interval -3.36 to -0.5
Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Change in BMI percentile (18 months versus baseline)
-1.98 BMI percentile
Interval -3.88 to -0.08
Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Change in BMI percentile (24 months versus baseline)
-3.43 BMI percentile
Interval -5.3 to -1.57

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from caregivers newly introduced to the FVPP who completed the NCI All Day Screener.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=299 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP
Change in mean daily intake of fruits and vegetables (12 months versus baseline)
-0.56 cup equivalents per day
Interval -1.14 to 0.01
Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP
Change in mean daily intake of fruits and vegetables (6 months versus baseline)
-0.21 cup equivalents per day
Interval -1.0 to 0.58

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months

Population: This outcome measure was pre-specified to only assess participants in the "low/no exposure to FVPP" group. Analysis includes data from caregivers newly introduced to the FVPP who completed the NCI All Day Screener.

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.

Outcome measures

Outcome measures
Measure
No/Low Exposure
n=299 Participants
Patients with the lowest exposure to the pediatric fruit and vegetable prescription program at baseline who were followed for 24 months to assess changes in outcome measures.
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
Change in mean daily intake of fruits and vegetables (6 months versus baseline)
-0.21 cup equivalents per day
Interval -1.0 to 0.58
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
Change in mean daily intake of fruits and vegetables (12 months versus baseline)
-0.56 cup equivalents per day
Interval -1.14 to 0.01
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
Change in mean daily intake of fruits and vegetables (18 months versus baseline)
-0.90 cup equivalents per day
Interval -1.73 to -0.07
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
Change in mean daily intake of fruits and vegetables (24 months versus baseline)
-0.50 cup equivalents per day
Interval -1.08 to 0.09

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Children With High Exposure to the FVPP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Caregivers With High Expsoure to the FVPP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Children With Moderate Exposure to the FVPP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Caregivers With Moderate Exposure to the FVPP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Children With No/Low Exposure to the FVPP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Caregivers With No/Low Exposure to the FVPP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Custack, Associate Professor

Michigan State University

Phone: 8106005656

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place