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Computerized Health Education to Promote Physical Activity

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Thomas Jefferson University
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00242658
First received: October 19, 2005
Last updated: November 7, 2012
Last verified: November 2012
History of Changes

October 19, 2005
November 7, 2012
May 2005
December 2007   (final data collection date for primary outcome measure)
7-Day Physical Activity Recall (7-Day PAR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.
Physiologic testing and self-report will be used to assess physical activity behavior, fitness, and selected cognitive-behavioral mediators.
Complete list of historical versions of study NCT00242658 on ClinicalTrials.gov Archive Site
Change in Behavioral Processes of Change Between Baseline and 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never.
Blood pressure control and preventive service utilization are methods in which outcomes will be measured.
Not Provided
Not Provided
 
Computerized Health Education to Promote Physical Activity
Computerized Physical Activity Promotion in Primary Care

This study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions. The health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.

The main objective of this study is to determine, via a 6-month randomized controlled study, the efficacy of providing tailored physical activity computer reports to patients and physicians. The primary outcome is minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Hypertension
Behavioral: Tailored Physical Activity Intervention
Tailored physical activity computer reports will be provided to patients and physicians.
Other Name: Exercise Intervention
  • Experimental: Tailored Physical Activity Intervention Group
    Four feedback reports aimed to increase physical activity.
    Intervention: Behavioral: Tailored Physical Activity Intervention
  • No Intervention: No Tailored Physical Activity Intervention Group
    General reports on preventive screening based on responses to preventive screening questions.
Carroll JK, Lewis BA, Marcus BH, Lehman EB, Shaffer ML, Sciamanna CN. Computerized tailored physical activity reports a randomized controlled trial. Am J Prev Med. 2010 Aug;39(2):148-56.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
394
March 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to speak and read English
  • Current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate)
  • Ability to complete all written surveys
  • Accessible for follow-up telephone surveys
  • Ability to undergo exercise testing

Exclusion Criteria:

  • Currently participating in another research study
  • Planning to move out of the Philadelphia area
  • Unable to walk without pain
  • Pregnant or planning to become pregnant in the year following study entry
  • Excessive drinking
  • Coronary heart disease
  • Congestive heart failure
  • Peripheral vascular disease
  • Cerebrovascular disease
  • Chronic obstructive pulmonary disease
  • Arrhythmia
  • Recurrent seizures
  • Dizziness
  • Balance problems
  • Psychoses
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00242658
269, 7R01HL067005-03, 02F.214 CHIP
No
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Thomas Jefferson University
Study Chair: Christopher N. Sciamanna, MD, MPH Jefferson Medical College, Department of Health Policy
Milton S. Hershey Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP