NCT02746939

Brief Summary

The study is designed to examine whether curriculum, designed in partnership with teachers at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. This information will be collected in surveys before and after the students are given the curriculum during the school day.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

April 8, 2016

Last Update Submit

January 2, 2019

Conditions

Keywords

program evaluationhealth literacyfitnessnutritioneducation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with completion of ISEO Fitness and Nutrition Curriculum

    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.

    9 months

Study Arms (2)

Pre-curriculum assessment

NO INTERVENTION

Assessments will be administered to 3rd and 4th grade students prior to receiving curriculum training in fitness and nutrition.

Post-curriculum assessment

EXPERIMENTAL

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.

Behavioral: InSciEd Out Fitness and Nutrition Curriculum

Interventions

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.

Post-curriculum assessment

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher K Pierret

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Department of Biochemistry and Molecular Biology

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 21, 2016

Study Start

March 29, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

January 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations