Changes in Habitual Physical Activity and Inactivity (START)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 10, 2012 |
| Last Updated Date | April 19, 2012 |
| Start Date ICMJE | March 2010 |
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01580930 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Changes in Habitual Physical Activity and Inactivity |
| Official Title ICMJE | Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention |
| Brief Summary | The purpose of this study is to determine if individuals involved in exercise training change habitual activity and inactivity behavior outside of exercise training. Eligible participants were randomly assigned to one of four groups: control, exercise training, sedentary time reduction, or exercise training plus sedentary time reduction. It was hypothesized that participants in the exercise training group will compensate for exercise training by reducing free-living physical activity behavior and increasing sedentary time. Participant free-living behavior was monitored for one week at baseline, 3, 6, 9 and 12 weeks using an activPAL wearable monitor. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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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 | 57 |
| Completion Date | May 2011 |
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: Eligible participants were those at increased risk of cardiovascular disease, based on meeting two of the following three criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 20 Years to 60 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 | NCT01580930 |
| Other Study ID Numbers ICMJE | Kozey-Keadle, RC1HL099557 |
| Has Data Monitoring Committee | No |
| Responsible Party | University of Massachusetts, Amherst |
| Study Sponsor ICMJE | University of Massachusetts, Amherst |
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Massachusetts, Amherst |
| Verification Date | April 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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