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NCT05442424: KPRxHawaii
Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii
NA trial testing Produce Voucher in Malnutrition, Child in 170 participants. Completed in 30 January 2025.
30 January 2025
Quick facts
| Lead sponsor | University of Hawaii |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 1 November 2022 |
| Primary completion | 30 January 2025 |
| Estimated completion | 30 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Produce Voucher
- Wait-List Control
Conditions studied
- Malnutrition, Child — all drugs for Malnutrition, Child →
- Obesity — all drugs for Obesity →
- Food Selection — all drugs for Food Selection →
- Nutrition Poor — all drugs for Nutrition Poor →
Sponsor
University of Hawaii
Who can join
Adults 2 to 8, any sex, with Malnutrition, Child or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05442424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Hawaii trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05442424 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Hawaii
- Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05442424.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing