- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994565
The Effectiveness of Physical Activity Monitoring and Distance Counseling in an Occupational Health Setting (CoAct)
June 21, 2011 updated by: Helsinki University of Technology
The Effectiveness of Physical Activity Monitoring and Distance Counselling in an Occupational Health Setting - a Randomised Controlled Trial (CoAct)
The CoAct study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counseling via telephone and secure web messages.
The main purpose of this study is to evaluate the effectiveness of lifestyle counseling on the level of physical activity in an occupational health setting.
The purposes include also analyzing the potential effects of changes in physical activity on productivity at work and sickness absence, and health care costs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
CoAct is a randomized controlled trial with two arms: a control group and intervention group with daily activity monitoring and distance counseling.
The intervention focuses on lifestyle modification and takes 12 months.
The study population consists of those volunteering from 1100 eligible employees from a Finnish insurance company.
The primary outcomes are change in physical activity measured in MET hours per week, work productivity and sickness absence, and health care utilization.
Secondary outcomes include various physiological measures.
Cost-effectiveness analysis will also be performed.
The outcomes will be measured by questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained from the employer's registers.
Study Type
Interventional
Enrollment (Actual)
544
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Espoo, Finland, 02015
- BIT Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 61 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 years or older
- Paid employment of at least 8 hours a week
- Not scheduled to retire in the next two years or have applied for disability pension
- Have completed a health risk appraisal and physical testing
Exclusion Criteria:
- Pregnancy
- Diagnosis or treatment of cancer
- Any disorder that makes physical activity impossible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Usual care
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Active Comparator: Activity monitoring and distance counseling
|
The physical activity monitoring and distance counseling concept combines the use of a personal activity monitor with web-based tailored physical activity advice.
Users can interactively plan and evaluate their own activity advice based on their actual PA scores and their PA preferences and goals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical Activity
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health related productivity loss
Time Frame: One year
|
One year
|
|
Healthcare utilization
Time Frame: One Year
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reijonsaari K, Vehtari A, Kahilakoski OP, van Mechelen W, Aro T, Taimela S. The effectiveness of physical activity monitoring and distance counseling in an occupational setting - results from a randomized controlled trial (CoAct). BMC Public Health. 2012 May 11;12:344. doi: 10.1186/1471-2458-12-344.
- Reijonsaari K, Vehtari A, van Mechelen W, Aro T, Taimela S. The effectiveness of physical activity monitoring and distance counselling in an occupational health setting--a research protocol for a randomised controlled trial (CoAct). BMC Public Health. 2009 Dec 31;9:494. doi: 10.1186/1471-2458-9-494.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
October 13, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (Estimate)
October 14, 2009
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- CoAct1RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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