Evaluation of CHAM JAM (Previously Known as the Moving Smart) Intervention in Increasing Physical Activity in Bronx Elementary School Students
| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2007 | ||||
| Last Updated Date | December 12, 2012 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pedometer-derived step count [ Time Frame: baseline and every 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
pedometer-derived step count [ Time Frame: baseline and every 3 months ] | ||||
| Change History | Complete list of historical versions of study NCT00556569 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Body mass index [ Time Frame: baseline and 1 year later ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Body mass index [ Time Frame: baseline and 1 year later ] | ||||
| Current Other Outcome Measures ICMJE |
Fitness assessment for subset of students [ Time Frame: baseline, 3 months and 12 months ] [ Designated as safety issue: No ] FitnessGRAM and step test |
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| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of CHAM JAM (Previously Known as the Moving Smart) Intervention in Increasing Physical Activity in Bronx Elementary School Students | ||||
| Official Title ICMJE | Evaluation of CHAM JAM (Previously Known as the Moving Smart) Intervention in Increasing Physical Activity in Bronx Elementary School Students | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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
Other Names:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10098 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 10 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00556569 | ||||
| Other Study ID Numbers ICMJE | 07-08-253 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Montefiore Medical Center | ||||
| Study Sponsor ICMJE | Montefiore Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Montefiore Medical Center | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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