Obesity Clinical Trial
— KPRxHawaiiOfficial 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
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 30, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 8 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Hawaii at Manoa | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
University of Hawaii | National Institute of General Medical Sciences (NIGMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Parent- Blood Pressure at six months | systolic and diastolic blood pressure | baseline and 6 months from enrollment | |
Secondary | Change in Parent- Lipids at six months | Total cholesterol, HDL and LDL cholesterol | baseline and 6 months from enrollment | |
Secondary | Change in Parents- Glucose Control | Hemoglobin A1c | baseline and 6 months from enrollment | |
Secondary | 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. | baseline and 6 months from enrollment | |
Secondary | 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 | baseline and 6 months from enrollment | |
Secondary | Change in Gut Microbiome- Parent | Parents' abundance and richness of the gut microbiome, a-diversity, Firmicutes to Bacteroidetes ratio, and the relative abundance of each member of the microbial communities from phyla to species level | baseline and 6 months from enrollment | |
Secondary | Change in Gut Microbiome- Child | Child's abundance and richness of the gut microbiome, a-diversity, Firmicutes to Bacteroidetes ratio, and the relative abundance of each member of the microbial communities from phyla to species level | baseline and 6 months from enrollment |
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