Physical Activity and Leisure-time Study (PALS)
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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 21, 2011 | ||||||||
| Last Updated Date | October 10, 2012 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Physical Activity (Steps/Day) [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ] Change in pedometer measured steps per day between 0 and 6 months |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01342471 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physical Activity and Leisure-time Study (PALS) | ||||||||
| Official Title ICMJE | TV Commercial Stepping: Can America's Top Sedentary Activity be Made More Active | ||||||||
| Brief Summary | Physical inactivity is a major public health problem and a primary contributing factor to the obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines (30 min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site "lack of time" as a barrier for engaging in PA. The Physical Activity and Leisure-time Study examines an approach convert sedentary TV watching into active TV watching time by having adults step in place during commercials (TV commercial stepping). |
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| Detailed Description | This randomized controlled trial will examine the effects of a PA prescription of TV commercial stepping for at least 90 min/day of TV programming, with that of walking at least 30 min/day (30 min walk) on daily step counts, TV viewing, and diet during a 24 week PA intervention. Sedentary, overweight or obese, adults will be randomly assigned to either the TV commercial stepping, or 30 min walk group during a 24-week behavioral PA intervention. Both groups will attend 8 sessions, but receive different PA goals. PA, TV watching time, diet, and anthropometric data will be collected at 0, 12, and 24 weeks. It is hypothesized that the TV commercial stepping condition will, show an equal increase in PA at 12 and 24 weeks as compared to the 30-min walk condition. Neither group is hypothesized to demonstrate changes in TV viewing time, dietary intake, or weight. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Steeves JA, Bassett DR, Fitzhugh EC, Raynor HA, Thompson DL. Can sedentary behavior be made more active? A randomized pilot study of TV commercial stepping versus walking. Int J Behav Nutr Phys Act. 2012 Aug 6;9:95. doi: 10.1186/1479-5868-9-95. | ||||||||
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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 | 58 | ||||||||
| Completion Date | June 2011 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 65 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 | NCT01342471 | ||||||||
| Other Study ID Numbers ICMJE | UTennessee | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Tennessee | ||||||||
| Study Sponsor ICMJE | University of Tennessee | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Tennessee | ||||||||
| Verification Date | October 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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