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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

Children living in food-insecure homes, defined as at some time during the last year their household not having enough food, money, or resources to feed the family experience low intake of fresh fruits and vegetables (FV), and a trajectory for increased risk of obesity and chronic diseases in adulthood. In Hawai'i, a higher proportion of Native Hawaiian (NH) and other Pacific Islander (OPI) children live in food-insecure households when compared with the state average (30% and 50%, respectively vs. 18%) and NHOPI adults suffer disproportionately from chronic disease. Produce prescription programs, provide vouchers to individuals to purchase fresh FV, are promising strategies to improve diet quality and reduce chronic disease risk among food insecure populations. The long-term objective of this research is to reduce nutrition-related health disparities via clinical-community based programming. The Keiki (child) Produce Prescription (KPRx) program was developed and implemented by enlisting University and community researchers and health care providers at the Waianae Coast Comprehensive Health Center (WCCHC). The current study builds on the community-academic partnership to achieve the following specific aim, to measure effectiveness of the KPRx on FV intake, gut microbiome composition, and health related biomarkers in 100 parent-child dyads in the context of household food insecurity from a predominantly NHOPI community in Hawai'i. A community based participatory research approach to carry out a randomized controlled trial that measures the effect of the KPRx on child diet and microbiome, and parent/caregiver diet and health-related biomarkers on 100 parent-child dyads in the context of household food insecurity will be conducted. The community-informed research study will provide data to inform local and state healthcare and nutrition assistance programming policies aimed at reducing food insecurity and health disparities among NHOPI and minority populations.

Research Team

Marla Berry, PhD

Principal Investigator

University of Hawaii at Manoa

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+