Assessment of a Fruit and Vegetable Prescription Program for Children

NCT04767282 | Completed Results

• 2 other identifiers: STUDY00003370R01HD102527
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to address gaps in knowledge related to the influence of pediatric fruit and vegetable prescription programs on food security, child dietary patterns, and weight status. To do this, we will compare demographically similar pediatric patient groups from three large clinics in a low-income urban city based on their exposure to a fruit and vegetable prescription program (FVPP) that provides one $15 prescription for fresh fruits and vegetable to every child at every office visit. Three clusters will be identified based on child exposure to the pediatric FVPP at baseline: high exposure (\>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. We will test the hypothesis that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of obesity among children. The first aim will compare baseline dietary intake, food security, and weight status between high exposure, moderate exposure, no exposure groups. The second aim will measure changes in diet, food security, and weight status at 6-, 12-, 18-, and 24-months among children newly exposed to the FVPP. The third aim will compare follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.

Conditions

Exposure to Fruit and Vegetable Prescription Program

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  Baseline, 6 months,12 months

• Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP

  Baseline, 6 months, 12 months, 18 months, 24 months

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

  Baseline, 6 months, 12 months

• Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP

  Baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (1)

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.

Other: Fruit and Vegetable Prescription

Interventions

Fruit and Vegetable Prescription OTHER

$15 voucher for fruit and vegetables

Fruit and Vegetable Prescription

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Hurley Children's Clinic

Flint, Michigan, 48502, United States

Location

Mott Children's Health Center

Flint, Michigan, 48503, United States

Location

Akpinar Children's Clinic

Flint, Michigan, 48532, United States

Location

Related Publications (8)

• 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.

  PMID: 29667562 BACKGROUND

• 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.

  PMID: 31242555 BACKGROUND

• 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.

  PMID: 31877635 BACKGROUND

• 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.

  PMID: 32545578 BACKGROUND

• 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.

  PMID: 35062926 BACKGROUND

• 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.

  PMID: 39314532 BACKGROUND

• 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.

  PMID: 39653792 RESULT

• 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.

  PMID: 38585045 RESULT

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Amy Custack, Associate Professor
• Organization: Michigan State University

saxeamym@msu.edu

8106005656

Study Officials

• Amy Saxe-Custack, PhD, MPH, RD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: February 23, 2021
• Primary Completion: May 30, 2024
• Study Completion: June 25, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication of final study results for a period of one year.
• Access Criteria: 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.

Locations

US (3)