- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242658
Computerized Health Education to Promote Physical Activity
November 7, 2012 updated by: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
394
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Jefferson Family Medicine Associates
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Philadelphia, Pennsylvania, United States, 19107
- Jefferson Medical College, Department of Health Policy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored Physical Activity Intervention Group
Four feedback reports aimed to increase physical activity.
|
Tailored physical activity computer reports will be provided to patients and physicians.
Other Names:
|
No Intervention: No Tailored Physical Activity Intervention Group
General reports on preventive screening based on responses to preventive screening questions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-Day Physical Activity Recall (7-Day PAR)
Time Frame: 6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavioral Processes of Change Between Baseline and 6 Months
Time Frame: Baseline and 6 months
|
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.
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Christopher N. Sciamanna, MD, MPH, Jefferson Medical College, Department of Health Policy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 19, 2005
First Posted (Estimate)
October 20, 2005
Study Record Updates
Last Update Posted (Estimate)
November 12, 2012
Last Update Submitted That Met QC Criteria
November 7, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 269
- 7R01HL067005-03 (U.S. NIH Grant/Contract)
- 02F.214 CHIP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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