Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200317
Status:
COMPLETED
Last Update Posted:
2007-05-01
First Post:
2005-09-13
Brief Title:
Interactive Technologies to Increase Exercise Behavior
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Interactive Technologies to Increase Exercise Behavior
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None