Physical InactivityCoActNCT00994565
The Effectiveness of Physical Activity Monitoring and Distance Counseling in an Occupational Health Setting
A study testing Activity monitoring and distance counseling in people with Physical Inactivity, run by Helsinki University of Technology at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Activity monitoring and distance counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Diagnosis or treatment of cancer
- Any disorder that makes physical activity impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Activity monitoring and distance counseling
- Keywords
- Physical activity, health behaviour, lifestyle, productivity, outcomes
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity monitoring and distance counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Activity monitoring and distance counseling | Active comparator | Not described Receives: Behavioral: Activity monitoring and distance counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Measured: One year
Secondary outcomes (2)
Health related productivity loss
Measured: One year
Healthcare utilization
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Finnish Funding Agency for Technology and Innovation, Pohjola Insurance Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994565
- Sponsor's protocol ID
- CoAct1RCT
- Acronym
- CoAct
- Status last verified
- Jun 2011
- First submitted
- 13 Oct 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22578104Reijonsaari 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.
PubMed 20043831
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Physical Activity Monitoring and Distance Counselling in an Occupational Health Setting - a Randomised Controlled Trial (CoAct)
- ClinicalTrials.gov ID
- NCT00994565
- Acronym / sponsor ID
- CoAct / CoAct1RCT
- Conditions
- Physical Inactivity
- Keywords
- Physical activity, health behaviour, lifestyle, productivity, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Helsinki University of TechnologyUniversity, hospital or other
- Collaborators
- The Finnish Funding Agency for Technology and Innovation, Pohjola Insurance Ltd
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Activity monitoring and distance counseling | Active comparator | Behavioral: Activity monitoring and distance counseling |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Diagnosis or treatment of cancer
- Any disorder that makes physical activity impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity monitoring and distance counselingThe 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. | Behavioural | Activity monitoring and distance counseling |
Primary outcome
Physical Activity
Time frame: One year
2 secondary outcomes
Health related productivity loss
Time frame: One year
Healthcare utilization
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Derived from this study: PubMed 22578104Reijonsaari 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.
- Derived from this study: PubMed 20043831Reijonsaari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity monitoring and distance counseling in people with Physical Inactivity, run by Helsinki University of Technology at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.