Mediators and Moderators of Exercise Behavior Change (COSTRIDE)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 22, 2010 |
| Last Updated Date | March 22, 2010 |
| Start Date ICMJE | September 2004 |
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Self-reported physical activity [ Time Frame: 3,6,9,and 12 months post baseline ] [ Designated as safety issue: No ] After being randomly assigned to the exercise or health-and-wellness conditions, participants were followed up every three months for one year at which times they reported their current physical activity. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Mediators and Moderators of Exercise Behavior Change |
| Official Title ICMJE | Mediators and Moderators of Exercise Behavior Change |
| Brief Summary | Rates of cancer and cardiovascular disease have shown very little improvement over the past two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming rate. Recent reports estimate that approximately 30% of total cancer deaths are related to poor exercise and nutrition, and other reports have suggested that, when taking into consideration both cardiovascular disease and cancer, inactivity contributes to as many as 250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular physical activity in the prevention of cancer and other debilitating illnesses, 75% of the U.S. population do not get the recommended amount of physical activity as defined by 30 minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40% of the population is completely sedentary (USDHHS, 19960. The objective of the proposed research is to understand the mediators and moderators of a well-tested individually tailored, print-based intervention to increase exercise behavior among sedentary adults. Using a randomized, controlled intervention ton trial, the proposed study will address three primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals initiate and maintain a moderate intensity physical activity regimen, as compared to a health and wellness control intervention, 2) Increases in positive attitudes, perceived normative support, self-efficacy, and intentions to exercise will mediate the effectiveness of the intervention, 3) That increased positive mood, and better temperature, stress, and lactate regulation immediately after exercise challenge (assessed in the laboratory) will moderate the effectiveness of the intervention, and 4) Secondarily, we will test whether gender, race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the effectiveness of the intervention. The rigorous assessment of how and for whom an exercise promotion intervention is effective will provide information for future development of intervention strategies and content, as well as allow the targeting of exercise content to individuals for whom it is most likely to be effective. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) |
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: STRIDE |
| Study Arm (s) |
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| Publications * |
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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 | 238 |
| Completion Date | August 2009 |
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 45 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 | NCT01091857 |
| Other Study ID Numbers ICMJE | 0604.12, 1R01CA109858-01 |
| Has Data Monitoring Committee | No |
| Responsible Party | Angela Bryan, PhD, University of New Mexico |
| Study Sponsor ICMJE | University of New Mexico |
| Collaborators ICMJE | National Cancer Institute (NCI) |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of New Mexico |
| Verification Date | March 2010 |
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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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