KPRxHawaii: Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

Sponsor
University of Hawaii (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05442424
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH)
100
1
2
10.9
9.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Produce Voucher
  • Behavioral: Wait-List Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Keiki (Pediatric) Produce Prescription (KPRx) Program: Quantifying Health Impacts of Healthy Food Prescriptions on Food Security, Health, and Microbiome and Parent-Child Dyads in Hawaii
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Produce Vouchers

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
see arm/group description

Active Comparator: Wait-List Control

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
see arm/group description

Outcome Measures

Primary Outcome Measures

  1. Change in Child Fruit and Vegetable Intake at six months [baseline and 6 months from enrollment]

    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.

Secondary Outcome Measures

  1. Change in Parent- Blood Pressure at six months [baseline and 6 months from enrollment]

    systolic and diastolic blood pressure

  2. Change in Parent- Lipids at six months [baseline and 6 months from enrollment]

    Total cholesterol, HDL and LDL cholesterol

  3. Change in Parents- Glucose Control [baseline and 6 months from enrollment]

    Hemoglobin A1c

  4. Change in Household food security status [baseline and 6 months from enrollment]

    food security measured with Food Security in the United States: Current Population Survey. United States Department of Agriculture Economic Research Service. Unit of measure is the change in percentage of households who are food secure, have low food security, and very low food security.

  5. Change in Parent Fruit and Vegetable Intake [baseline and 6 months from enrollment]

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

  6. Change in Gut Microbiome- Parent [baseline and 6 months from enrollment]

    Parents' abundance and richness of the gut microbiome, α-diversity, Firmicutes to Bacteroidetes ratio, and the relative abundance of each member of the microbial communities from phyla to species level

  7. Change in Gut Microbiome- Child [baseline and 6 months from enrollment]

    Child's abundance and richness of the gut microbiome, α-diversity, Firmicutes to Bacteroidetes ratio, and the relative abundance of each member of the microbial communities from phyla to species level

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patient of the Waianae Coast Comprehensive Health Center (WCCHC) Pediatric Clinic

  • 2 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.

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hawaii at Manoa Honolulu Hawaii United States 96822

Sponsors and Collaborators

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

Investigators

  • Study Director: Marla Berry, PhD, University of Hawaii at Manoa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT05442424
Other Study ID Numbers:
  • Precision Nutrition KPRx
  • 1P20GM139753-01A1
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Hawaii
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022