Physical ActivityNCT00432133
Individual and Environmental Mechanisms of PA Change
A study testing Protection Motivation Theory-Based Intervention and Environmenta in people with Physical Activity and Behavior Change, run by Kaiser Permanente at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Behavior Change
- What is being tested?
- Protection Motivation Theory-Based Intervention and Environmenta
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No chest pains during stress testing
- Normal ECG During Stress Testing.
- Inactive or insufficiently active (<150 moderate intensity PA/week)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Colorado, Institute for Health Research
Denver, Colorado, 80231
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, Behavior Change
- Being tested
- Protection Motivation Theory-Based Intervention, Environmenta
- Keywords
- Physical Activity, Behavior Change, Mechanism, Environmental, Ecological Model of Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protection Motivation Theory-Based InterventionBehavioural
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.
EnvironmentaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Protection motivation theory-based tailored intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters). Receives: Behavioral: Protection Motivation Theory-Based Intervention |
| 2 | Experimental | Environmental access and awareness intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters). Receives: Behavioral: Environmenta |
| 3 | Experimental | 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). Receives: Behavioral: Protection Motivation Theory-Based Intervention; Behavioral: Environmenta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity: CHAMPS self report measure and Actigraph Accelerometers
Measured: 6 & 12 months
Secondary outcomes (2)
Dollar amounts to include cost of intervention delivery by condition.
Measured: 6 months
Heart Rate Recovery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startFeb 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul A Estabrooks, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432133
- Sponsor's protocol ID
- DK70553
- Other IDs
- R01DK070553, DK70553
- Status last verified
- Apr 2012
- First submitted
- 5 Feb 2007
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Almeida FA, Smith-Ray RL, Dzewaltowski DA, Glasgow RE, Lee RE, Thomas DS, Xu S, Estabrooks PA. An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Aug 24;17(8):e206. doi: 10.2196/jmir.3759.
PubMed 26303347
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral 2X2 Randomized Controlled Trial to Determine Individual and Environmental Mechanisms of Physical Activity Behavior Change
- ClinicalTrials.gov ID
- NCT00432133
- Acronym / sponsor ID
- DK70553
- Conditions
- Physical Activity, Behavior Change
- Keywords
- Physical Activity, Behavior Change, Mechanism, Environmental, Ecological Model of Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Protection Motivation Theory-Based InterventionProtection motivation theory-based tailored intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters). |
| 2 | Experimental | Behavioral: EnvironmentaEnvironmental access and awareness intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters). |
| 3 | Experimental | Behavioral: Protection Motivation Theory-Based Intervention, Behavioral: EnvironmentaCombination intervention combining protection motivation and environmental intervention components to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No chest pains during stress testing
- Normal ECG During Stress Testing.
- Inactive or insufficiently active (<150 moderate intensity PA/week)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protection Motivation Theory-Based InterventionTargets 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. | Behavioural | 1, 3 |
| EnvironmentaTargets 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. | Behavioural | 2, 3 |
Primary outcome
Physical Activity: CHAMPS self report measure and Actigraph Accelerometers
Time frame: 6 & 12 months
2 secondary outcomes
Dollar amounts to include cost of intervention delivery by condition.
Time frame: 6 months
Heart Rate Recovery.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- Derived from this study: PubMed 26303347Almeida FA, Smith-Ray RL, Dzewaltowski DA, Glasgow RE, Lee RE, Thomas DS, Xu S, Estabrooks PA. An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Aug 24;17(8):e206. doi: 10.2196/jmir.3759.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Estabrooks, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protection Motivation Theory-Based Intervention and Environmenta in people with Physical Activity and Behavior Change, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity: CHAMPS self report measure and Actigraph Accelerometers (time frame: 6 & 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.