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OpenTrials
Completed

NCT Number: NCT00200317

Interactive Technologies to Increase Exercise Behavior

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Internet and print-based interventions

Behavioral

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Brown University
  • University of Pittsburgh

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
May 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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