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Produce Voucher for Child Malnutrition (KPRxHawaii Trial)

N/A

Recruiting

Research Sponsored by University of Hawaii

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

2 to 8 years of age

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months from enrollment

Awards & highlights

KPRxHawaii Trial Summary

This trial will study whether giving parents vouchers to buy fresh fruits and vegetables for their children will improve the children's diets and health.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves providing produce vouchers without medical treatments or drugs, there are no direct side effects expected from participating in this clinical trial.

KPRxHawaii Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2 and 8 years old.

KPRxHawaii Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months from enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months from enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Child Fruit and Vegetable Intake at six months

Secondary outcome measures

Change in Gut Microbiome- Child

Change in Gut Microbiome- Parent

Change in Household food security status

+4 more

KPRxHawaii Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Produce VouchersExperimental Treatment1 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 ControlActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of HawaiiLead Sponsor

115 Previous Clinical Trials

54,489 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

246,922 Total Patients Enrolled

Marla Berry, PhDStudy DirectorUniversity of Hawaii at Manoa

Media Library

Produce Prescription Program Clinical Trial Eligibility Overview. Trial Name: NCT05442424 — N/A

Child Malnutrition Research Study Groups: Produce Vouchers, Wait-List Control

Child Malnutrition Clinical Trial 2023: Produce Prescription Program Highlights & Side Effects. Trial Name: NCT05442424 — N/A

Produce Prescription Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05442424 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities to participate in this research?

"According to the details uploaded on clinicaltrials.gov, this medical trial is still enrolling patients; it was first made available on November 1st 2022 and its requirements were last modified on that same date."

Answered by AI

Are geriatric patients excluded from this experiment?

"Prospective participants of this study must be between the ages 2 and 8. Of note, there are 256 clinical trials for minors (under 18) and 674 studies recruiting older adults (>65)."

Answered by AI

What is the most extensive participant count for this clinical research endeavor?

"Affirmative. Per data hosted on clinicaltrials.gov, this medical trial is actively seeking patients and was initially posted on November 1st 2022 before being amended recently. The study seeks to recruit 100 people from a single site."

Answered by AI

Could I possibly enroll in this experimental research endeavor?

"This trial is recruiting 100 individuals, aged 2 to 8 years old, who are food-insecure. In order for a patient to be admitted they must meet the following criteria: enrolled in WCCHC Pediatric Clinic, live on Wai'anae Coast of Oahu Island and able to communicate fluently in English language; have BMI ≥ 85th percentile (the measurement should be recorded in EMR at the time of recruitment)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

2022. "Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442424.

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