Expired Study
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Bronx, New York 10452


Purpose:

The purpose of this study is to determine if the "Moving Smart" program, a daily 10-minute classroom-based exercise program, increases physical activity levels during the school day in Bronx elementary school students.


Study summary:

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 Subjects in the wait-listed control group will be offered the MS after the program is withdrawn from the intervention group at the end of the first year of study.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.


Criteria:

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 is Available At:


Original ID:

07-08-253


NCT ID:

NCT00556569


Secondary ID:

RC1HD063607


Study Acronym:


Brief Title:

Evaluation of CHAM JAM Increasing Physical Activity Levels in Students


Official Title:

Evaluation of CHAM JAM (Previously Known as the Moving Smart) Intervention in Increasing Physical Activity in Bronx Elementary School Students


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

5 Years


Maximum Age:

10 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Montefiore Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

10098


Enrollment Type:

Actual


Overall Contact Information

Official Name:Philip O Ozuah, M.D., Ph.D.
Principal Investigator
Montefiore Medical Center, Albert Einstein College of Medicine

Study Dates

Start Date:December 2007
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 20, 2018
First Received Date:November 9, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Body mass index
Time Frame:baseline and 1 year later
Safety Issues:False
Description:formula for BMI that includes weight and height
Outcome Type:Primary Outcome
Measure:pedometer-derived step count
Time Frame:baseline and every 3 months
Safety Issues:False
Description:mean number of step counts

Study Interventions

Intervention Type:Other
Name:CHAM JAM
Description: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
Arm Name:Intervention
Other Name:Moving Smart Program

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention
Description:2 Intervention schools are cluster randomized to receive CHAM JAM (previously known as the Moving Smart Program) in Year 1
Study Arm Type:No Intervention
Arm Name:Wait-Listed Control
Description:2 Wait-Listed Control Schools will receive CHAM JAM (previously known as the Moving Smart Program) in Year 2 of the study

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Montefiore Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:23209101
Reference Type:Results Reference
Citation: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.
PMID:25747719

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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