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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | April 27, 2007 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00200317 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Interactive Technologies to Increase Exercise Behavior | ||||
| Official Title ICMJE | Interactive Technologies to Increase Exercise Behavior | ||||
| Brief Summary | The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults. |
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| Detailed Description | As many as 75% of Americans do not engage in regular physical activity and 25% are completely inactive. The risk of cardiovascular disease is almost doubled among people who are physically inactive, comparable to the risk associated with increased systolic blood pressure, cigarette smoking, and elevated serum cholesterol. To make an impact on physical activity prevalence at the population level, research must focus at the interface between clinical efficacy trials and large-scale dissemination studies. Studies at this interface must compare proven interventions with new innovations that have the potential to reach large numbers of sedentary Americans. The objective of this study is to determine the differential effect of intervention delivery channel (Tailored Internet versus Tailored Print) on physical activity adoption and maintenance in previously sedentary adults. To our knowledge, no studies have examined the efficacy of a Tailored Internet-based physical activity intervention. Thus, we will conduct a randomized controlled clinical trial comparing three groups, 1) Internet-based motivationally-tailored individualized feedback (Tailored Internet); 2) print-based motivationally-tailored individualized feedback which has previously shown to be efficacious (Tailored Print); and 3) websites currently available to the public (Standard Internet comparison group). Two hundred and forty healthy, sedentary women and men ages 18-65 will be randomly assigned to one of the three groups. The Tailored Internet and Tailored Print arms will be matched on frequency and content of contact. Data will be collected at baseline, 6, and 12 months using well-established physical activity and physical performance measures, as well as a comprehensive set of psychosocial questionnaires. Our primary hypothesis is that individuals randomized to the Tailored Internet arm will exhibit significantly higher levels of physical activity participation at 6 and 12 months than individuals in the Tailored Print arm due to the enhanced capabilities of the Internet (e.g., immediacy of feedback and enhanced graphics). And, in addition, subjects randomized to the Tailored Internet or Tailored Print conditions will exhibit significantly higher levels of physical activity participation at 6 and 12 months than those in the Standard Internet comparison condition. Other questions of interest will include an examination of potential moderators and mediators of the intervention-physical activity relationship. This study will contribute important information regarding the relative efficacy of Internet and print-based interventions, each of which can be utilized for widespread public health dissemination. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Cardiovascular Disease | ||||
| Intervention ICMJE | Behavioral: Internet and print-based interventions | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 240 | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 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 ID ICMJE | NCT00200317 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 HL69866 | ||||
| Study Sponsor ICMJE | The Miriam Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | The Miriam Hospital | ||||
| Verification Date | September 2005 | ||||
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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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