Assessment of a Fruit and Vegetable Prescription Program for Children

Michigan State University

Status: Completed

Conditions: Exposure to Fruit and Vegetable Prescription Program

Treatments: Other: Fruit and Vegetable Prescription

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04767282

STUDY00003370

R01HD102527 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Child between age 8 and 16 years and their caregiver;
• Child active patient at clinic;
• Child received at least one fruit and vegetable prescription;
• Child and caregiver English-speaking

Exclusion criteria

• Caregiver or child not English speaking;
• Legal guardian not present at enrollment;
• Child assent refused;
• Sibling previously enrolled (one caregiver and one child per household);
• Movement between participating clinics

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 1 patient group

Fruit and Vegetable Prescription

Other group

Description:

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.

Treatment:

Other: Fruit and Vegetable Prescription