Produce Vouchers for Child Nutrition

(KPRxHawaii Trial)

Overseen By Monica Esquivel, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Age > 8, Food security, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program that provides families in food-insecure households with vouchers to purchase fresh fruits and vegetables. The goal is to determine if these vouchers, part of the Produce Prescription Program, can enhance the diet and health of children and their parents in the Wai'anae Coast community in Hawai'i, particularly among Native Hawaiian and Pacific Islander families. Families participating in the trial will receive vouchers either immediately or after a waiting period. The trial seeks families with children aged 2 to 8 years who are patients at the Waianae Coast Comprehensive Health Center, show signs of food insecurity, or have a child with a BMI (body mass index) at or above the 85th percentile.

As an unphased trial, this study allows families to directly contribute to improving community health and nutrition.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on providing produce vouchers to improve nutrition, so it's unlikely that medication changes are required.

What prior data suggests that the Produce Prescription Program is safe for children?

Research has shown that programs like the one in this study, which provide vouchers for fresh fruits and vegetables, are generally safe and beneficial. These programs help people improve their diet and ensure access to healthy food.

Studies have found that these programs can increase fruit and vegetable consumption, especially among children in low-income families. This is important because eating more fruits and vegetables can lead to better health, such as improved heart health and better diabetes management.

No reports of harmful effects from these programs exist. Instead, they help families eat healthier and feel more secure about their food supply. Thus, joining a trial like this is likely safe and may lead to positive changes in eating habits and overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Produce Prescription Program because it offers a fresh approach to improving child nutrition by directly empowering families to purchase fresh fruits and vegetables. Unlike traditional nutrition interventions, which might involve supplements or education alone, this program provides financial support in the form of vouchers, making healthy food more accessible and affordable. By fostering direct access to fresh produce, it has the potential to enhance dietary habits and improve health outcomes more effectively than existing methods that don't address financial barriers.

What evidence suggests that the Produce Prescription Program is effective for improving child nutrition?

Research shows that programs providing prescriptions for fruits and vegetables can help people eat better by increasing their intake of these foods. Studies have found that these programs can also reduce food insecurity, which means not having enough food or money to buy food. Participants in similar programs have experienced improvements in heart health and metabolism. In this trial, one group of parent-child dyads will receive produce vouchers immediately, while another group will be on a wait-list control. Evidence suggests that participating in a produce prescription program for six months can lead to eating more fruits and vegetables and experiencing less food insecurity. Overall, these programs are linked to better eating habits and health, making them a promising way to address health differences related to nutrition. ^{4 5 6 7 8}

Who Is on the Research Team?

Marla Berry, PhD

Principal Investigator

University of Hawaii at Manoa

Are You a Good Fit for This Trial?

This trial is for children aged 2-8 who live with a parent on the Wai'anae Coast of O'ahu, are patients at WCCHC Pediatric Clinic, and face food insecurity or obesity. They must speak English and have a BMI in the 85th percentile or higher.

Inclusion Criteria

I am between 2 and 8 years old.

English-speaking

Positive screen for food insecurity using a validated two-question tool and/or has overweight or obese (BMI ≥ 85th percentile) measurement recorded in Electronic Medical Record (EMR) on day of clinic visit when recruitment occurs

Exclusion Criteria

My child is not a patient at WCCHC.

My child does not always have enough food to eat.

I am older than 8 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (phone)

Baseline Assessment

Participants complete baseline surveys, stool sample collection, and health measurements

1 week

2 visits (1 phone, 1 in-person)

Intervention

Intervention group receives $60 monthly vouchers for fresh fruits and vegetables for 6 months

6 months

Monthly voucher distribution

Control

Control group receives a $50 gift card initially and $60 monthly vouchers after 6 months

6 months

Monthly voucher distribution after 6 months

Follow-up

Participants complete follow-up assessments including surveys, stool samples, and health measurements

1 week

2 visits (1 phone, 1 in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Produce Prescription Program

Trial Overview The KPRx program provides vouchers to buy fresh fruits and vegetables to improve diet quality. The study will assess its effectiveness on kids' fruit/veg intake, gut health, and certain health markers in a randomized controlled trial involving 100 parent-child pairs.

How Is the Trial Designed?

Group I: Produce Vouchers Experimental Treatment 1 Intervention

Half of parent-child dyads will receive $60 per month for 6 months, to purchase fresh fruits and vegetables from a local farmers' market.

Group II: Wait-List Control Active Control 1 Intervention

Half of parent-child dyads will be placed on a 6 month wait list and will receive $60 per month for 6 months, to purchase fresh fruits and vegetables from a local farmers' market, after completing the 6 month waiting period and follow up data collection.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11035140/

Pediatric produce prescription initiatives in the U.S. Pediatric PRx interventions show promising potential to reduce FI and improve diet quality and health-related outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325001681

Healthy Food Voucher Programs: Global Evidence on ... Most evidence indicates that HFVPs increase the purchase and consumption of healthy foods, improve food security, and enhance nutrition ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... Produce prescriptions may improve cardiometabolic health by increasing fruit and vegetable (F&V) consumption and food insecurity.

4. ajpmfocus.org ajpmfocus.org/article/S2773-0654(25)00053-7/fulltext

Pediatric Produce Prescription Program Grounded in ... Results showed that 6 months of PRx program participation was associated with higher FV consumption and decreased food insecurity, with mean FV ...

5. diabetesjournals.org diabetesjournals.org/care/article/48/10/1783/163117/Health-and-Economic-Impact-and-Cost-effectiveness

Health and Economic Impact and Cost-effectiveness of ... Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.

6. nature.com nature.com/articles/s41390-023-02920-8

Pediatric produce prescription initiatives in the U.S. Pediatric PRx interventions show promising potential to reduce FI and improve diet quality and health-related outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11536491/

Impact of a Pediatric Produce Prescription Intervention on ... PRx are emerging clinical tools to improve FS and diet quality, but their impact in families with children is not well established.

8. cdc.gov cdc.gov/pcd/issues/2019/18_0555.htm

Effect of a Fruit and Vegetable Prescription Program on ... Fruit and vegetable prescription programs in clinical settings may increase fruit and vegetable consumption among children in low-income households.