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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00556569
Other study ID # 07-08-253
Secondary ID RC1HD063607
Status Completed
Phase N/A
First received November 9, 2007
Last updated February 20, 2018
Start date December 2007
Est. completion date June 2012

Study information

Verified date February 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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 Subjects in the wait-listed control group will be offered the MS after the program is withdrawn from the intervention group at the end of the first year of study.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


Recruitment information / eligibility

Status Completed
Enrollment 10098
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
CHAM JAM
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

Locations

Country Name City State
United States 4 Elementary Schools Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Fitness assessment for subset of students FitnessGRAM and step test baseline, 3 months and 12 months
Primary pedometer-derived step count mean number of step counts baseline and every 3 months
Secondary Body mass index formula for BMI that includes weight and height baseline and 1 year later
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