Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

NCT05442424 | Completed

• 2 other identifiers: Precision Nutrition KPRx1P20GM139753-01A1
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition, Child; Obesity; Food Selection; Nutrition Poor

Keywords

food insecurity; obesity; nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Child Fruit and Vegetable Intake at six months

  daily fruit and vegetable intake (servings per day) of child measured with (Dietary Screener Questionnaire (DSQ) 2009-10. National Cancer Institute). Unit of measure will be the change in number of servings of fruits and vegetables consumed per day by child.

  baseline and 6 months from enrollment

Secondary Outcomes (7)

• Change in Parent- Blood Pressure at six months

  baseline and 6 months from enrollment

• Change in Parent- Lipids at six months

  baseline and 6 months from enrollment

• Change in Parents- Glucose Control

  baseline and 6 months from enrollment

• Change in Household food security status

  baseline and 6 months from enrollment

• Change in Parent Fruit and Vegetable Intake

  baseline and 6 months from enrollment

Study Arms (2)

Produce Vouchers

EXPERIMENTAL

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

Behavioral: Produce Voucher

Wait-List Control

ACTIVE COMPARATOR

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.

Behavioral: Wait-List Control

Interventions

Produce Voucher BEHAVIORAL

see arm/group description

Produce Vouchers

Wait-List Control BEHAVIORAL

see arm/group description

Wait-List Control

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• patient of the Waianae Coast Comprehensive Health Center (WCCHC) Pediatric Clinic
• to 8 years of age
• positive screen for food insecurity using a validated two-question tool,44 and/or has overweight or obese, BMI ≥ 85th percentile, measurement recorded in Electronic Medical Record (EMR) on day of clinic visit when recruitment occurs)
• resides with the parent on the Wai'anae Coast of O'ahu
• English-speaking.

You may not qualify if:

• individuals \> 8 years of age
• children who are not WCCHC pediatric patients
• children who do not experience food security
• non-English speaking children
• children living outside of the Wai'anae Coast of O'ahu

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Hawaii at Manoa

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Child Nutrition Disorders; Obesity; Food Preferences; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Marla Berry, PhD

  University of Hawaii at Manoa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial, 100 parent-child dyads will receive either $60 per month in vouchers to purchase fresh fruits and vegetables from the community farmers market for 6 months (intervention) or $360 gift certificate to the local grocery store.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 5, 2022
• Study Start: November 1, 2022
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)