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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994565
Other study ID # CoAct1RCT
Secondary ID
Status Completed
Phase N/A
First received October 13, 2009
Last updated June 21, 2011
Start date August 2009
Est. completion date November 2010

Study information

Verified date June 2011
Source Helsinki University of Technology
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 544
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 61 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Finland BIT Research Center Espoo

Sponsors (3)

Lead Sponsor Collaborator
Helsinki University of Technology Pohjola Insurance Ltd, The Finnish Funding Agency for Technology and Innovation (TEKES)

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity One year No
Secondary Health related productivity loss One year No
Secondary Healthcare utilization One Year No
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