- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432133
Individual and Environmental Mechanisms of PA Change
April 26, 2012 updated by: Kaiser Permanente
Behavioral 2X2 Randomized Controlled Trial to Determine Individual and Environmental Mechanisms of Physical Activity Behavior Change
The focus of this study is to determine the mechanisms that underlie Physical Activity behavior change.
We have 2 primary objectives.
One, to test the effectiveness of brief, practical interventions to promote and maintain Physical Activity among individuals who are referred to a treadmill stress test but do not present symptoms of cardiac disease.
Two, to test the potential individual and environmental mediators and moderators of this effect.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is a dearth of information on the mechanisms, and potential moderators, of physical activity (PA) intervention effectiveness.
Understanding the mechanisms of PA change will aid in successful intervention development while understanding moderators will allow a matching of intervention components to individual needs of particular populations.
To definitively understand mechanisms and moderators of behavior change it is necessary to develop theory-based interventions that include specific strategies that target proposed mechanisms of change while monitoring the proposed mediating and moderating variables prior to and following intervention.
This proposal highlights the use of the Ecological Model of Physical Activity (EMPA) as a theoretical guide to strategy development.
The EMPA highlights the necessity to address individual (biological & psychosocial) and environmental variables (e.g., PA resource accessibility) when developing and implementing interventions.
Health care patients who have been referred for a treadmill cardiovascular stress test-but do not present abnormal ECG or chest pain during testing-will be will be stratified by diagnosis of low heart rate recovery, a potential biological moderator of intervention effectiveness.
To detect the potential independent and combined effects of individual motivation and environmental accessibility we will conduct a randomized 2X2 factorial trial to test proposed mediators of effectiveness.
Participants (n=500) will be randomized to an individual (I), environmental (E) , combination (I+E), or matched contact nutrition control.
All intervention conditions will include a CD-ROM session, 3 tailored mail, and 3 tailored automated telephone follow-ups over a 6-month period.
We will assess the reach, effectiveness, clinician adoption, and staff implementation of these interventions, individually, in combination, and when compared to controls among an understudied and high need population-individuals who are at an elevated risk, but have not yet suffered a serious cardiac event (approximately 3,000,000 individuals/year in the US).
The results of this project will identify the causal, and potentially additive, relationships of environmental and individual mediators of PA change and allow the examination of potential biological moderators of effectiveness.
Because intervention typically effects decrease over time and studies do not address setting-related issues necessary to ensure sustainability of delivery at the organizational level we will determine the maintenance of intervention effects on causal mechanisms and PA, 6 & 12 months following intervention.
The interventions will be developed for delivery within the regular scope of treadmill stress testing by typical medical staff and cost of delivery will be assessed for each intervention condition.
This project uniquely utilizes methods that will facilitate institutionalization of the intervention components following the successful completion of the trial and potential adoption of the intervention in other health care settings.
Study Type
Interventional
Enrollment (Actual)
452
Phase
- Not Applicable
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
-
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Colorado
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Denver, Colorado, United States, 80231
- Kaiser Permanente Colorado, Institute for Health Research
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No chest pains during stress testing
- Normal ECG During Stress Testing.
- Inactive or insufficiently active (<150 moderate intensity PA/week)
Exclusion Criteria:
- Age
- No access to telephone
- Not able to read or understand English.
- Home and Work address outside of 6-county area
- Have an active recreation center membership
- Any other contraindication to physical activity identified during stress testing.
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Protection motivation theory-based tailored intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters).
|
Targets perceptions of outcome severity and susceptibility, self-efficacy, response efficacy, response costs, and rewards of physical inactivity.
One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
|
Experimental: 2
Environmental access and awareness intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters).
|
Targets increased awareness and use of local parks and trials near the home and work environments.
Targets increased access by providing membership to a local fitness facility for 12 months.
One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
|
Experimental: 3
Combination intervention combining protection motivation and environmental intervention components to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters).
|
Targets perceptions of outcome severity and susceptibility, self-efficacy, response efficacy, response costs, and rewards of physical inactivity.
One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
Targets increased awareness and use of local parks and trials near the home and work environments.
Targets increased access by providing membership to a local fitness facility for 12 months.
One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical Activity: CHAMPS self report measure and Actigraph Accelerometers
Time Frame: 6 & 12 months
|
6 & 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dollar amounts to include cost of intervention delivery by condition.
Time Frame: 6 months
|
6 months
|
Heart Rate Recovery.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul A Estabrooks, PhD, Kaiser Permanente
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
February 1, 2006
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
February 5, 2007
First Submitted That Met QC Criteria
February 5, 2007
First Posted (Estimate)
February 7, 2007
Study Record Updates
Last Update Posted (Estimate)
April 27, 2012
Last Update Submitted That Met QC Criteria
April 26, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DK70553
- R01DK070553 (U.S. NIH Grant/Contract)
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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