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

Primary Purpose

Malnutrition, Child, Obesity, Food Selection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Produce Voucher
Wait-List Control
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition, Child focused on measuring food insecurity, obesity, nutrition

Eligibility Criteria

2 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Hawaii at ManoaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Produce Vouchers

Wait-List Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Parent- Blood Pressure at six months
systolic and diastolic blood pressure
Change in Parent- Lipids at six months
Total cholesterol, HDL and LDL cholesterol
Change in Parents- Glucose Control
Hemoglobin A1c
Change in Household food security status
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.
Change in Parent Fruit and Vegetable Intake
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
Change in Gut Microbiome- Parent
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
Change in Gut Microbiome- Child
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

Full Information

First Posted
June 9, 2022
Last Updated
November 1, 2022
Sponsor
University of Hawaii
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05442424
Brief Title
Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii
Acronym
KPRxHawaii
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
This Randomized Clinical Trial will recruit and enroll 100 parent-child dyads into 1 of 2 groups, intervention and delayed intervention (control). Participants will be recruited from the Waianae Coast Comprehensive Health Center (WCCHC) pediatrics clinic by pediatricians and primary care providers. Pediatricians will notify study staff of interested participants through the electronic medical record. Study staff will contact participants to share more study information and schedule a time for enrollment. The first enrollment appointment will take place via phone. Prior to the appointment participants will be sent the informed consent and baseline study surveys. These will be administered by a trained researcher over the phone. Baseline survey responses will be recorded in RedCAP. Participants will then be instructed to pick up the stool collection kits at WCCHC and scheduled to come in for an in-person specimen drop off and further data collection. At this second appointment participants will drop off stool samples (one for parent and one for child). Parents and children will also be asked to complete a reflective spectroscopy test (VeggieMeter) and parents' will complete the following measures: blood pressure, weight, finger stick lipids (AccuCheck) and hemoglobin A1c (A1C now). Trained staff will follow the study procedure for conducting the finger stick to obtain the blood sample and follow all safety protocols for handling blood. Measures will be recorded in RedCap by study staff. Participants will be notified of randomization group (intervention or control). Intervention participants will receive their first $60 voucher for fresh fruits and vegetables and be instructed on how to redeem it at the farmers market. Control participants will receive a $50 gift card to a local store. Intervention participants will receive $60 each month for 6 months of the intervention. These funds will be uploaded onto a gift card. Participants will be able to use the gift card at produce vendors at the farmers' market. The funds will expire each month. Six months after enrollment, all participants will be schedule to complete the baseline assessments again. This will include the survey, stool samples, and Veggie Meter reading for parents and children; and the lipids, A1c, blood pressure, and weight for parents. Intervention group participants will receive a $50 gift card to a local store. Control group participants will receive their first of six $60 vouchers for fresh fruits and vegetables and be instructed on how to redeem it at the farmers market. Baseline and 6 month Survey questions will include the Current Population Survey's food security questions and the Dietary Screener Questionnaire for assessing fruit and vegetable consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child, Obesity, Food Selection, Nutrition Poor
Keywords
food insecurity, obesity, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Produce Vouchers
Arm Type
Experimental
Arm Description
Half of parent-child dyads will receive $60 per month for 6 months, to purchase fresh fruits and vegetables from a local farmers' market.
Arm Title
Wait-List Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Produce Voucher
Intervention Description
see arm/group description
Intervention Type
Behavioral
Intervention Name(s)
Wait-List Control
Intervention Description
see arm/group description
Primary Outcome Measure Information:
Title
Change in Child Fruit and Vegetable Intake at six months
Description
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.
Time Frame
baseline and 6 months from enrollment
Secondary Outcome Measure Information:
Title
Change in Parent- Blood Pressure at six months
Description
systolic and diastolic blood pressure
Time Frame
baseline and 6 months from enrollment
Title
Change in Parent- Lipids at six months
Description
Total cholesterol, HDL and LDL cholesterol
Time Frame
baseline and 6 months from enrollment
Title
Change in Parents- Glucose Control
Description
Hemoglobin A1c
Time Frame
baseline and 6 months from enrollment
Title
Change in Household food security status
Description
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.
Time Frame
baseline and 6 months from enrollment
Title
Change in Parent Fruit and Vegetable Intake
Description
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
Time Frame
baseline and 6 months from enrollment
Title
Change in Gut Microbiome- Parent
Description
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
Time Frame
baseline and 6 months from enrollment
Title
Change in Gut Microbiome- Child
Description
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
Time Frame
baseline and 6 months from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Esquivel, PhD
Phone
8089892459
Email
monicake@hawaii.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marla Berry, PhD
Organizational Affiliation
University of Hawaii at Manoa
Official's Role
Study Director
Facility Information:
Facility Name
University of Hawaii at Manoa
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Esquivel, PhD
Phone
808-989-2459
Email
monicake@hawaii.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

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