Malnutrition, ChildKPRxHawaiiNCT05442424
Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii
A study testing Produce Voucher in people with Malnutrition, Child and Obesity, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child, Obesity, Food Selection
- What is being tested?
- Produce Voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii at Manoa
Honolulu, Hawaii, 96822
About this study
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
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.
Read the 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.
- Conditions
- Malnutrition, Child, Obesity, Food Selection, Nutrition Poor
- Being tested
- Produce Voucher, Wait-List Control
- Keywords
- food insecurity, obesity, nutrition
- Medical subject headings
- Child Nutrition Disorders, Obesity, Food Preferences, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce VoucherBehavioural
see arm/group description
Wait-List ControlBehavioural
see arm/group description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Wait-List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months from enrollment
Secondary outcomes (7)
Change in Parent- Blood Pressure at six months
systolic and diastolic blood pressure
Measured: baseline and 6 months from enrollment
Change in Parent- Lipids at six months
Total cholesterol, HDL and LDL cholesterol
Measured: baseline and 6 months from enrollment
Change in Parents- Glucose Control
Hemoglobin A1c
Measured: baseline and 6 months from enrollment
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.
Measured: baseline and 6 months from enrollment
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
Measured: baseline and 6 months from enrollment
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
Measured: baseline and 6 months from enrollment
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
Measured: baseline and 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Nov 2022
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Marla Berry, PhD, Study director, University of Hawaii at Manoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442424
- Sponsor's protocol ID
- Precision Nutrition KPRx
- Other IDs
- 1P20GM139753-01A1
- Acronym
- KPRxHawaii
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05442424
- Acronym / sponsor ID
- KPRxHawaii / Precision Nutrition KPRx
- Conditions
- Malnutrition, Child, Obesity, Food Selection, Nutrition Poor
- Keywords
- food insecurity, obesity, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Produce Vouchers | Experimental | Behavioral: Produce VoucherHalf of parent-child dyads will receive $60 per month for 6 months, to purchase fresh fruits and vegetables from a local farmers' market. |
| Wait-List Control | Active comparator | Behavioral: Wait-List ControlHalf 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. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce Vouchersee arm/group description | Behavioural | Produce Vouchers |
| Wait-List Controlsee arm/group description | Behavioural | Wait-List Control |
Primary outcome
Change in Child Fruit and Vegetable Intake at six months
Time frame: 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.
7 secondary outcomes
Change in Parent- Blood Pressure at six months
Time frame: baseline and 6 months from enrollment
Change in Parent- Lipids at six months
Time frame: baseline and 6 months from enrollment
Change in Parents- Glucose Control
Time frame: baseline and 6 months from enrollment
Change in Household food security status
Time frame: baseline and 6 months from enrollment
Change in Parent Fruit and Vegetable Intake
Time frame: baseline and 6 months from enrollment
Change in Gut Microbiome- Parent
Time frame: baseline and 6 months from enrollment
Change in Gut Microbiome- Child
Time frame: baseline and 6 months from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marla Berry, PhD study director
University of Hawaii at Manoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Voucher in people with Malnutrition, Child and Obesity, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Fruit and Vegetable Intake at six months (time frame: baseline and 6 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.