Clinical trial NCT00432133: Individual and Environmental Mechanisms of PA Change
Official title: Behavioral 2X2 Randomized Controlled Trial to Determine Individual and Environmental Mechanisms of Physical Activity Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Behavior Change
Keywords: Physical Activity
Behavior Change
Mechanism
Environmental
Ecological Model of Physical Activity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-02-07
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity: CHAMPS self report measure and Actigraph Accelerometers
timeFrame: 6 & 12 months
Secondary outcomes:
measure: Dollar amounts to include cost of intervention delivery by condition.
timeFrame: 6 months
measure: Heart Rate Recovery.
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado, Institute for Health Research
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Paul A Estabrooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.