Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432133
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2007-02-05
Brief Title:
Individual and Environmental Mechanisms of PA Change
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Behavioral 2X2 Randomized Controlled Trial to Determine Individual and Environmental Mechanisms of Physical Activity Behavior Change
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 n500 will be randomized to an individual I environmental E combination IE 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 3000000 individualsyear 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK70553 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DK070553 |
| R01DK070553 | NIH | None | None |