Individual and Environmental Mechanisms of PA Change

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00432133
First received: February 5, 2007
Last updated: April 26, 2012
Last verified: April 2012

February 5, 2007
April 26, 2012
February 2006
February 2012   (final data collection date for primary outcome measure)
Physical Activity: CHAMPS self report measure and Actigraph Accelerometers [ Time Frame: 6 & 12 months ] [ Designated as safety issue: No ]
  • Physical Activity
  • Actigraph - Accelerometers with PA diary
  • Seven-day PA recall
  • Proposed Mediators
  • Psychological constructs.
  • Environmental constructs.
Complete list of historical versions of study NCT00432133 on ClinicalTrials.gov Archive Site
  • Dollar amounts to include cost of intervention delivery by condition. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Heart Rate Recovery. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stress testing and Height & Weight
  • Dollar amounts to include cost of intervention delivery by condition.
  • Heart Rate Recovery.
Not Provided
Not Provided
 
Individual and Environmental Mechanisms of PA Change
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Physical Activity
  • Behavior Change
  • Behavioral: Protection Motivation Theory-Based Intervention
    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.
  • Behavioral: Environmenta
    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: 1
    Protection motivation theory-based tailored intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters).
    Intervention: Behavioral: Protection Motivation Theory-Based Intervention
  • Experimental: 2
    Environmental access and awareness intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters).
    Intervention: Behavioral: Environmenta
  • 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).
    Interventions:
    • Behavioral: Protection Motivation Theory-Based Intervention
    • Behavioral: Environmenta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
452
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432133
DK70553, R01DK070553, DK70553
Yes
Kaiser Permanente
Kaiser Permanente
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Paul A Estabrooks, PhD Kaiser Permanente
Kaiser Permanente
April 2012

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