ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Interactive Technologies to Increase Exercise Behavior

This study has been completed.
Information provided by The Miriam Hospital

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Interactive Technologies to Increase Exercise Behavior
Official Title  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.

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
Secondary Outcome Measure  Minutes of physical activity per week based on objective physical activity monitor (ActiGraph);
Minutes of walking on a treadmill; and Estimated Vo2 on treadmill test.
Condition  Cardiovascular Disease
Intervention  Behavioral: Internet and print-based interventions
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  240
Start Date  February 2003
Completion Date May 2006
Eligibility Criteria 

Inclusion Criteria:

  • Sedentary, defined as exercising less than 90 minutes per week
  • Lack of access to the Internet
  • Lack of access to receiving mail

Exclusion Criteria:

  • Coronary heart disease (history of myocardial infarction or symptoms of angina)
  • Diabetes
  • Stroke
  • Osteoarthritis
  • Osteoporosis
  • Orthopedic problems which would limit treadmill testing
  • Other medical or psychological problems that could make adherence with the study protocol difficult or dangerous
  • Consumption of three or more alcoholics drinks per day
  • Current or planned pregnancy
  • Planning to move from the area within the next year
  • Current suicidal ideation or psychosis
  • Current clinical depression
  • Recent hospitalization due to a psychiatric disorder
  • Taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00200317
Organization ID R01 HL69866
Secondary IDs ††
Study Sponsor  The Miriam Hospital
Collaborators †† University of Pittsburgh
Brown University
Investigators 
Principal Investigator:     Bess H Marcus, Ph.D.     Brown Medical School & The Miriam Hospital    
Information Provided By The Miriam Hospital
Verification Date September 2005
First Received Date  September 13, 2005
Last Updated Date April 27, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers