- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366437
Evaluating the Implementation and Impact of an Enhanced SNAP-Ed Delivered Curriculum in Low-income Preschools
Study Overview
Status
Intervention / Treatment
Detailed Description
This evaluation project aims to assess the impact of the Child Health Research Center's final year of the SNAP-Ed funded nutrition education program in low-income preschool classrooms across Pennsylvania. This is the final year of SNAP-Ed funding in Pennsylvania (made possible by state carryforward funds) due to the elimination of this funding as a result of the 2025 Big Beautiful Bill.
The intervention program, known as the Rainbow Veggie Club, is designed to enhance children's vegetable knowledge, acceptance, and intake through a comprehensive approach that combines structured nutrition education lessons, repeated exposure to a variety of vegetables, and associative conditioning techniques such as offering low-fat dips to make vegetables more appealing. The program will be implemented in a subset of classrooms where teachers and staff will receive training and follow a lesson calendar for the 2025-2026 school year.
The consent process for children includes four communications sent home to parents/guardians within a two-week period, using both electronic and paper formats, a newsletter, a consent document, and a flyer with a QR code linking to a REDCap survey. Teachers can also participate in survey data collection, in which an implied consent process will be used.
The first data collection visit includes a pre-tasting activity and Veggie Meter measurements to assess skin carotenoid levels as an objective indicator of vegetable intake. Trained staff members will conduct the Veggie Meter protocol, which is expected to take approximately one hour per classroom of 18 children, and results will be recorded on a standardized roster organized by child ID. These procedures ensure consistent data collection and allow researchers to evaluate whether the combination of education, exposure, and conditioning strategies leads to measurable improvements in children's dietary behaviors.
Data from the pre-tasting data collection will inform which vegetable will be selected for an intake assessment in visit 2. During this visit, trained staff members will conduct individual hunger assessments and measure child intake of the selected vegetable by pre- and post-weighing each food sample. Children will have an 8-minute free access period to eat the vegetable served.
After baseline data is collected, classrooms will receive a series of educational lessons from our SNAP-Ed educators from the Coordinated Approach to Child Health (CATCH) Early Childhood curriculum. These lessons will be enhanced with repeated exposure of a variety of vegetables served alongside a dip, "Taster's Awards" and other non-food rewards, and other related materials and supplies to increase learning and engagement.
Outcome measurement (tasting, Veggie Meter, and intake assessment) is repeated after the educational program to evaluate change. In addition to child-level outcomes, feasibility and implementation data will be collected throughout the program to assess how practical and sustainable this intervention is in real-world preschool settings. These data include staff adherence to protocols, time required for each activity, supply needs, and teacher engagement. Collecting feasibility and implementation metrics is critical because it informs whether the Rainbow Veggie Club model can be scaled and replicated beyond the study classrooms, ensuring that future SNAP-Ed or similar programs can adopt evidence-based strategies that are both effective and operationally realistic.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Altoona, Pennsylvania, United States, 16601
- The Learning Express
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child enrolled in a participating low-income preschool classroom
- Teacher employed in a participating low-income preschool classroom
Exclusion Criteria:
- Food allergies that would restrict the participation in the data collection procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rainbow Veggie Club
The Rainbow Veggie Club arm is the name of the educational program provided by Penn State's Child Health Research Center.
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The CATCH EC curriculum is an evidence-based program designed to promote healthy eating, physical activity, and overall wellness in early childhood and school settings.
A subset of lessons from this curriculum that focus on vegetables are implemented as part of the Rainbow Veggie Club, and additional enhancements were added to the standard CATCH lessons to specifically target vegetable exposure and acceptance.
These enhancements include repeated exposure of vegetables, associative conditioning by serving vegetables alongside a familiar dip, behavioral reinforcement with non-food rewards, and integration of evaluation activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vegetable Knowledge (questions developed for study)
Time Frame: From enrollment to the end of intervention (approximately 5 months)
|
Children will be asked if they know the name of each vegetables served before intervention and after intervention.
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From enrollment to the end of intervention (approximately 5 months)
|
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Vegetable Acceptance (Tasting Assessment)
Time Frame: From enrollment to the end of intervention (approximately 5 months)
|
Acceptance of vegetables served will be measured during a tasting assessment.
Research personnel will record if child refuses or tastes each food provided and then will have child rank preference of each food tasted.
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From enrollment to the end of intervention (approximately 5 months)
|
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Vegetable Intake Assessment
Time Frame: From enrollment to the end of intervention (approximately 5 months)
|
Children will be served 60g of a vegetable that has been pre-weighed.
We will post-weigh to calculate exact intake.
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From enrollment to the end of intervention (approximately 5 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of delivering this educational program
Time Frame: From enrollment to the end of intervention (approximately 5 months)
|
We will measure feasibility of implementing this program in real-world setting via teacher questionnaire.
This questionnaire will be developed in-house to include data specific to this educational program.
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From enrollment to the end of intervention (approximately 5 months)
|
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Implementation data
Time Frame: From enrollment to the end of intervention (approximately 5 months)
|
We will collect data via questionnaire after each educational lesson related to engagement, modifications made, attendance, etc.
These questions will be specific to the educational lessons of the program.
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From enrollment to the end of intervention (approximately 5 months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB STUDY00027835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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