Exposure to Fruit and Vegetable Prescription ProgramNCT04767282

Assessment of a Fruit and Vegetable Prescription Program for Children

A study testing Fruit and Vegetable Prescription in people with Exposure to Fruit and Vegetable Prescription Program, run by Michigan State University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Exposure to Fruit and Vegetable Prescription Program
What is being tested?: Fruit and Vegetable Prescription
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,400 participants
Where: 3 sitesUnited States
Study dates: 23 Feb 2021to 25 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Hurley Children's Clinic
Flint, Michigan, 48502
Mott Children's Health Center
Flint, Michigan, 48503
Akpinar Children's Clinic
Flint, Michigan, 48532

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Exposure to Fruit and Vegetable Prescription Program
Being tested: Fruit and Vegetable Prescription

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fruit and Vegetable PrescriptionOther
$15 voucher for fruit and vegetables

Study groups in NCT04767282
Study group	Role	What they receive
Fruit and Vegetable Prescription	Other	Each program participant will receive a fruit and vegetable prescription that is written by pediatricians to exchange for $15 of fresh produce. Prescriptions will be distributed during pediatric office visits and are redeemable at a local farmers' market and mobile market. Receives: Other: Fruit and Vegetable Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: Baseline, 6 months,12 months
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
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.
Measured: Baseline, 6 months,12 months
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.
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.
Measured: Baseline, 6 months,12 months
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
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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
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
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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
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
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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202125 Jun 2024

First posted23 Feb 2021
Study start23 Feb 2021
Primary completion30 May 2024
Study completion25 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Exposure to Fruit and Vegetable Prescription ProgramStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: A fruit and vegetable prescription is written by pediatricians to exchange for $15 of fresh produce. Prescriptions are redeemable at a local farmers' market and mobile market.
Masking: None (open label)
Enrolment: 1,400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04767282
Sponsor's protocol ID: STUDY00003370
Other IDs: R01HD102527
Status last verified: Sep 2025
First submitted: 17 Feb 2021
Last updated: 16 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Although the final dataset will be removed of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of participants. Therefore, we will make all individual participant data that underlie results in publications available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Publications

Saxe-Custack A, Lofton HC, Hanna-Attisha M, Victor C, Reyes G, Ceja T, LaChance J. Caregiver perceptions of a fruit and vegetable prescription programme for low-income paediatric patients. Public Health Nutr. 2018 Sep;21(13):2497-2506. doi: 10.1017/S1368980018000964. Epub 2018 Apr 18.
PubMed 29667562
Saxe-Custack A, LaChance J, Hanna-Attisha M, Ceja T. Fruit and Vegetable Prescriptions for Pediatric Patients Living in Flint, Michigan: A Cross-Sectional Study of Food Security and Dietary Patterns at Baseline. Nutrients. 2019 Jun 25;11(6):1423. doi: 10.3390/nu11061423.
PubMed 31242555
Saxe-Custack A, LaChance J, Hanna-Attisha M. Child Consumption of Whole Fruit and Fruit Juice Following Six Months of Exposure to a Pediatric Fruit and Vegetable Prescription Program. Nutrients. 2019 Dec 20;12(1):25. doi: 10.3390/nu12010025.
PubMed 31877635
Saxe-Custack A, Sadler R, LaChance J, Hanna-Attisha M, Ceja T. Participation in a Fruit and Vegetable Prescription Program for Pediatric Patients is Positively Associated with Farmers' Market Shopping. Int J Environ Res Public Health. 2020 Jun 12;17(12):4202. doi: 10.3390/ijerph17124202.
PubMed 32545578
Saxe-Custack A, Todem D, Anthony JC, Kerver JM, LaChance J, Hanna-Attisha M. Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. BMC Public Health. 2022 Jan 21;22(1):150. doi: 10.1186/s12889-022-12544-y.
PubMed 35062926
Saxe-Custack A, Egan S, Farmer B, Pulka K, Sampson A. Caregiver-reported barriers to engagement in a paediatric fresh fruit and vegetable prescription programme. J Nutr Sci. 2024 Sep 18;13:e33. doi: 10.1017/jns.2024.33. eCollection 2024.
PubMed 39314532
Saxe-Custack A, Todem D, LaChance J, Kerver J, Anthony J. Association between youth blood pressure and exposure to pediatric fruit and vegetable prescriptions. Pediatr Res. 2025 Aug;98(2):654-662. doi: 10.1038/s41390-024-03671-w. Epub 2024 Dec 10.
PubMed 39653792
Sadler RC, Saxe-Custack A. 'Nobody Shops at the Neighborhood Store': Leveraging a Community's Pediatric Fresh Produce Prescription Program to Inform Future Participating Store Redemption Locations. Cities Health. 2024;8(1):70-81. doi: 10.1080/23748834.2023.2281764. Epub 2023 Nov 23.
PubMed 38585045

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Innovative Nutrition Practices in Pediatric Health Care: Assessment of a Fruit and Vegetable Prescription Program for Children in Need
ClinicalTrials.gov ID: NCT04767282
Acronym / sponsor ID: STUDY00003370
Conditions: Exposure to Fruit and Vegetable Prescription Program
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,400 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Hurley Medical Center, Akpinar Children's Clinic, Mott Children's Health Center, Hurley Children's Center
Study start: 23 Feb 2021 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 25 Jun 2024 (actual)
First posted: 23 Feb 2021 (actual)
Results: Posted 16 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A fruit and vegetable prescription is written by pediatricians to exchange for $15 of fresh produce. Prescriptions are redeemable at a local farmers' market and mobile market.

Arm	Type	Receives
Fruit and Vegetable Prescription	Other	Other: Fruit and Vegetable PrescriptionEach program participant will receive a fruit and vegetable prescription that is written by pediatricians to exchange for $15 of fresh produce. Prescriptions will be distributed during pediatric office visits and are redeemable at a local farmers' market and mobile market.

Who may qualify

Ages: 8 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fruit and Vegetable Prescription$15 voucher for fruit and vegetables	Other	Fruit and Vegetable Prescription

Primary outcome

Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP
Time frame: Baseline, 6 months,12 months
Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits.
Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6 and 12 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP
Time frame: Baseline, 6 months,12 months
Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6 and 12 Months Relative to Baseline Among Youth 12 Years of Age and Older Who Were Newly Introduced to the FVPP.
Time frame: Baseline, 6 months,12 months
Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses ("a lot" or "sometimes") to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses ("a lot" or "sometimes") to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits.
Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.

4 secondary outcomes

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
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
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
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

Results and safety

Results posted to the registry on 16 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate Exposure to the FVPP	362	350
High Exposure to the FVPP	406	402
No/Low Exposure to the FVPP	632	608

Primary outcome: 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. Mean (95% Confidence Interval). Unit: cup equivalents per day

Measure	No/Low Exposure n = 300
Change in mean daily intake of total fruits (6 months versus baseline)	0.21 (0.00 to 0.41)
Change in mean daily intake of total fruits (12 months versus baseline)	0.17 (-0.01 to 0.34)
Change in mean daily intake of whole fruits (6 months versus baseline)	0.14 (0.01 to 0.26)
Change in mean daily intake of whole fruits (12 months versus baseline)	0.05 (-0.06 to 0.16)
Change in mean daily intake of total vegetables (6 months versus baseline)	0.11 (-0.06 to 0.28)
Change in mean daily intake of total vegetables (12 months versus baseline)	-0.01 (-0.14 to 0.12)

Population analysed: 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.

Primary outcome: 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. Number (95% Confidence Interval). Unit: High Food Security Odds Ratio

Measure	No/Low Exposure n = 300
Odds ratios for higher food security (6 months versus baseline)	0.87 (0.59 to 1.29)
Odds ratios for higher food security (12 months versus baseline)	0.92 (0.61 to 1.37)

Population analysed: 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.

Primary outcome: 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. Number (95% Confidence Interval). Unit: High Food Security Odds Ratio

Measure	No/Low Exposure n = 142
Odds ratios for higher food security (6 months versus baseline)	0.86 (0.39 to 1.90)
Odds ratios for higher food security (12 months versus baseline)	0.64 (0.32 to 1.28)

Population analysed: 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.

Primary outcome: 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. Number (95% Confidence Interval). Unit: High Food Security Odds Ratio

Measure	No/Low Exposure n = 142
Odds ratios for higher food security (6 months versus baseline)	0.86 (0.39 to 1.90)
Odds ratios for higher food security (12 months versus baseline)	0.64 (0.32 to 1.28)
Odds ratios for higher food security (18 months versus baseline)	0.48 (0.25 to 0.95)
Odds ratios for higher food security (24 months versus baseline)	0.39 (0.19 to 0.78)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 1,360 (0%)	0 of 1,360 (0%)	0 of 1,360
Children With High Exposure to the FVPP	0 of 201 (0%)	0 of 201 (0%)	0 of 201
Caregivers With High Expsoure to the FVPP	0 of 201 (0%)	0 of 201 (0%)	0 of 201
Children With Moderate Exposure to the FVPP	0 of 175 (0%)	0 of 175 (0%)	0 of 175
Caregivers With Moderate Exposure to the FVPP	0 of 175 (0%)	0 of 175 (0%)	0 of 175
Children With No/Low Exposure to the FVPP	0 of 304 (0%)	0 of 304 (0%)	0 of 304
Caregivers With No/Low Exposure to the FVPP	0 of 304 (0%)	0 of 304 (0%)	0 of 304

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29667562Saxe-Custack A, Lofton HC, Hanna-Attisha M, Victor C, Reyes G, Ceja T, LaChance J. Caregiver perceptions of a fruit and vegetable prescription programme for low-income paediatric patients. Public Health Nutr. 2018 Sep;21(13):2497-2506. doi: 10.1017/S1368980018000964. Epub 2018 Apr 18.
Background: PubMed 31242555Saxe-Custack A, LaChance J, Hanna-Attisha M, Ceja T. Fruit and Vegetable Prescriptions for Pediatric Patients Living in Flint, Michigan: A Cross-Sectional Study of Food Security and Dietary Patterns at Baseline. Nutrients. 2019 Jun 25;11(6):1423. doi: 10.3390/nu11061423.
Background: PubMed 31877635Saxe-Custack A, LaChance J, Hanna-Attisha M. Child Consumption of Whole Fruit and Fruit Juice Following Six Months of Exposure to a Pediatric Fruit and Vegetable Prescription Program. Nutrients. 2019 Dec 20;12(1):25. doi: 10.3390/nu12010025.
Background: PubMed 32545578Saxe-Custack A, Sadler R, LaChance J, Hanna-Attisha M, Ceja T. Participation in a Fruit and Vegetable Prescription Program for Pediatric Patients is Positively Associated with Farmers' Market Shopping. Int J Environ Res Public Health. 2020 Jun 12;17(12):4202. doi: 10.3390/ijerph17124202.
Background: PubMed 35062926Saxe-Custack A, Todem D, Anthony JC, Kerver JM, LaChance J, Hanna-Attisha M. Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. BMC Public Health. 2022 Jan 21;22(1):150. doi: 10.1186/s12889-022-12544-y.
Background: PubMed 39314532Saxe-Custack A, Egan S, Farmer B, Pulka K, Sampson A. Caregiver-reported barriers to engagement in a paediatric fresh fruit and vegetable prescription programme. J Nutr Sci. 2024 Sep 18;13:e33. doi: 10.1017/jns.2024.33. eCollection 2024.
Results publication: PubMed 39653792Saxe-Custack A, Todem D, LaChance J, Kerver J, Anthony J. Association between youth blood pressure and exposure to pediatric fruit and vegetable prescriptions. Pediatr Res. 2025 Aug;98(2):654-662. doi: 10.1038/s41390-024-03671-w. Epub 2024 Dec 10.
Results publication: PubMed 38585045Sadler RC, Saxe-Custack A. 'Nobody Shops at the Neighborhood Store': Leveraging a Community's Pediatric Fresh Produce Prescription Program to Inform Future Participating Store Redemption Locations. Cities Health. 2024;8(1):70-81. doi: 10.1080/23748834.2023.2281764. Epub 2023 Nov 23.
Individual participant dataSharing planned: Yes. Although the final dataset will be removed of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of participants. Therefore, we will make all individual participant data that underlie results in publications available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Saxe-Custack, PhD, MPH, RD principal investigator

Michigan State University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fruit and Vegetable Prescription in people with Exposure to Fruit and Vegetable Prescription Program, run by Michigan State University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767282, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.