- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746939
Student Outcomes in Fitness and Nutrition ISEO
Student Behavior Outcomes in Fitness and Nutrition Integrated Science Education Outreach (InSciEd Out, ISEO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research will implement a short battery of two survey inventories to measure student outcomes under InSciEd Out Fitness and Nutrition curriculum that is currently administered in 3rd and 4th grade at Lincoln K-8 Choice School. One is a grade-level adapted version of the National Youth Physical Activity and Nutrition Survey (NYPANS) authored by the United States Center for Disease Control (CDC). The other is a grade-level adapted version of the Newest Vital Sign (NVS) health literacy assessment authored by Pfizer and adapted by Dr. Linda Aldoory at the University of Maryland.
These assessments will help inform the health promotion activities of the InSciEd Out partnership within Lincoln K-8 Choice in Rochester, Minnesota (MN) and Moreland Elementary in West St. Paul, MN who originally wrote the curriculum. These assessments will be key to curricular revision and expansion to other schools that partner with InSciEd Out. As such, this study is a single cohort, internally controlled pre-post assessment of an existing behavioral intervention. Pending pilot study success, future follow-up studies are projected to be parallel-group, nonrandomized clinical trials of a treatment school versus a control school with grade levels expansion. This study will inform activities within the InSciEd Out network inside Rochester Public Schools (RPS), where grades Kindergarten through 2nd and 5th through 8th curricula is currently being built. Previously RPS-approved Mayo Clinic Institutional Review Board (IRB) #13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and Lincoln K-8 Choice/Moreland Elementary administrators, teachers, students, and parents.
IRB#13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and administration, teachers, and students at Lincoln K-8 Choice Elementary.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN who assent to the study
Exclusion Criteria:
- Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN whose parents chose to opt-out of the study or who do not assent to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Pre-curriculum assessment
Assessments will be administered to 3rd and 4th grade students prior to receiving curriculum training in fitness and nutrition.
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Experimental: Post-curriculum assessment
Assessments will be administered to 3rd and 4th grade students (matched from pre-curriculum assessment) after receiving 4-6 week InSciEd Out Fitness and Nutrition Curriculum.
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Science curriculum is designed in partnership with 3rd and 4th grade teachers and InSciEd Out scientists.
The curriculum is designed to focus on inquiry driven science, and also aims to decrease high risk behaviors that can lead to obesity in the students.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with completion of ISEO Fitness and Nutrition Curriculum
Time Frame: 9 months
|
students will undergo 4-6 weeks of ISEO fitness and nutrition curriculum as part of their 3rd or 4th grade coursework.
Classroom teachers will decide when to administer the curriculum, but should be completed by January 2017 in our target classrooms.
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9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher K Pierret, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16-001162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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