- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00556569
Evaluation of CHAM JAM Increasing Physical Activity Levels in Students
Evaluation of CHAM JAM (Previously Known as the Moving Smart) Intervention in Increasing Physical Activity in Bronx Elementary School Students
Study Overview
Detailed Description
Background: Medical and national public health authorities recommend daily school physical education for all ages due to well-known health benefits of physical activity. Nevertheless, daily physical education among elementary and secondary school students is not common in United States' (US) schools. Moreover, some of the schools in many US cities, such as the Bronx, do not even have gymnasiums or physical education teachers.
Objective: We propose to implement and test the effectiveness and feasibility of the "Moving Smart" (MS) program, a daily, 10-minute classroom-based physical activity program led by teachers that integrate academic objectives with physical activity, on increasing physical activity (PA) levels during the school day in Bronx elementary school students.
Design/ Methods: A cluster-randomized, wait-listed control trial of four Bronx elementary schools with one-year follow-up longitudinal study. Students in two intervention schools will receive the MS 3-times daily, for 10-minutes each time, in addition to regular physical education classes. Two wait-listed control schools will receive their regular physical education classes only. Subjects in the wait-listed control group will be offered the MS after the program is withdrawn from the intervention group at the end of the first year of study. A pedometer, an objective measure of PA in children, will be used to determine mean number of steps each student takes during school hours for 5 consecutive days at baseline, and every 3-months during the 2-year study period. For longitudinal follow-up, we will collect data from intervention group students and teachers on PA levels every 3-months for one-year after the intervention cessation. We will also collect yearly BMIs as a measure of overweight status. Descriptive statistics will be used to portray baseline characteristics of each group based on school, district, region, and NYC-wide data. The impact of the intervention on PA will be measured by comparing intervention and control schools using pedometer measurements as the primary dependent variable and students as the unit of analysis. We will collect fidelity measures by randomly selecting classes from the intervention schools and directly observing the level of PA present. We will determine the extent to which the MS becomes a part of the routine school policy by following the students and teachers from the intervention schools for 1-year after the intervention cessation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10452
- 4 Elementary Schools
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elementary school students in K-3 grade in the Bronx, New York
Exclusion Criteria:
- Inability to participate in basic exercise program
- Students whose parents signed the opt-out letter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
2 Intervention schools are cluster randomized to receive CHAM JAM (previously known as the Moving Smart Program) in Year 1
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CHAM JAM (previously known as Moving Smart" (MS) program) is a daily, 10-minute classroom-based physical activity program led by teachers that integrates academic objectives with physical activity
Other Names:
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No Intervention: Wait-Listed Control
2 Wait-Listed Control Schools will receive CHAM JAM (previously known as the Moving Smart Program) in Year 2 of the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pedometer-derived step count
Time Frame: baseline and every 3 months
|
mean number of step counts
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baseline and every 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index
Time Frame: baseline and 1 year later
|
formula for BMI that includes weight and height
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baseline and 1 year later
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fitness assessment for subset of students
Time Frame: baseline, 3 months and 12 months
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FitnessGRAM and step test
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baseline, 3 months and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip O Ozuah, M.D., Ph.D., Montefiore Medical Center/Albert Einstein College of Medicine
Publications and helpful links
General Publications
- Reznik M, Wylie-Rosett J, Kim M, Ozuah PO. A classroom-based physical activity intervention for urban kindergarten and first-grade students: a feasibility study. Child Obes. 2015 Jun;11(3):314-24. doi: 10.1089/chi.2014.0090. Epub 2015 Mar 6.
- Reznik M, Wylie-Rosett J, Kim M, Ozuah PO. Physical activity during school in urban minority kindergarten and first-grade students. Pediatrics. 2013 Jan;131(1):e81-7. doi: 10.1542/peds.2012-1685. Epub 2012 Dec 3.
Study record dates
Study Major Dates
Study Start
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-08-253
- RC1HD063607 (U.S. NIH Grant/Contract)
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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