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Interactive Technologies to Increase Exercise Behavior

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ClinicalTrials.gov Identifier: NCT00200317
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 1, 2007
Sponsor:
Collaborators:
University of Pittsburgh
Brown University
Information provided by:
The Miriam Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Internet and print-based interventions Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interactive Technologies to Increase Exercise Behavior
Study Start Date : February 2003
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.

Secondary Outcome Measures :
  1. Minutes of physical activity per week based on objective physical activity monitor (ActiGraph);
  2. Minutes of walking on a treadmill; and Estimated Vo2 on treadmill test.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200317


Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
University of Pittsburgh
Brown University
Investigators
Principal Investigator: Bess H Marcus, Ph.D. Brown Medical School & The Miriam Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00200317     History of Changes
Other Study ID Numbers: R01HL069866 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 1, 2007
Last Verified: September 2005

Keywords provided by The Miriam Hospital:
Exercise
Internet
Print
Randomized Controlled Trial
Exercise Intervention

Additional relevant MeSH terms:
Cardiovascular Diseases