NCT00432133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

6 years

First QC Date

February 5, 2007

Last Update Submit

April 26, 2012

Conditions

Physical ActivityBehavior Change

Keywords

Physical ActivityBehavior ChangeMechanismEnvironmentalEcological Model of Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Physical Activity: CHAMPS self report measure and Actigraph Accelerometers

    6 & 12 months

Secondary Outcomes (2)

  • Dollar amounts to include cost of intervention delivery by condition.

    6 months

  • Heart Rate Recovery.

    6 months

Study Arms (3)

1

EXPERIMENTAL

Protection motivation theory-based tailored intervention to promote physical activity delivered via interactive technology (computer interactive session, automated telephone counseling, tailored newsletters).

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).

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).

Behavioral: Protection Motivation Theory-Based InterventionBehavioral: Environmenta

Interventions

Protection Motivation Theory-Based InterventionBEHAVIORAL

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.

13
EnvironmentaBEHAVIORAL

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.

23

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No chest pains during stress testing
  • Normal ECG During Stress Testing.
  • Inactive or insufficiently active (\<150 moderate intensity PA/week)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado, Institute for Health Research

Denver, Colorado, 80231, United States

Location

Related Publications (1)

  • 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.

    PMID: 26303347DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Paul A Estabrooks, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 7, 2007

Study Start

February 1, 2006

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(1)