Interactive Technologies to Increase Exercise Behavior

Cardiovascular Disease Clinical Trial

Official title:

Interactive Technologies to Increase Exercise Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200317
• Other study ID #: R01HL069866
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: April 27, 2007
• Start date: February 2003
• Est. completion date: May 2006

Study information

• Verified date: September 2005
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Internet and print-based interventions

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
Secondary	Minutes of physical activity per week based on objective physical activity monitor (ActiGraph);
Secondary	Minutes of walking on a treadmill; and Estimated Vo2 on treadmill test.