LifestyleNCT02933385
Active Your Health: A Workplace Healthy Lifestyle Program
A study testing Health Risks assessement, Web-based health discussions and SOScuisine website in people with Lifestyle and Exercise, run by Université de Montréal.
Trial summary
Currently there are very few studies that integrate classical interventions (screening clinics) and online tools in order to obtain sustainable lifestyle changes in workers efficiently. The current project aims to evaluate the efficiency of a combined approach versus the more traditional approach. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- What is being tested?
- Health Risks assessement, Web-based health discussions and SOScuisine website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,737 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2021
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- French Speaking, work in the participating company.
Who cannot join
- pregnant women.
About this study
Official title: Activate Your Health Program : A Workplace Healthy Lifestyle Program
Currently there are very few studies that integrate classical interventions (screening clinics) and online tools in order to obtain sustainable lifestyle changes in workers efficiently. The current project aims to evaluate the efficiency of a combined approach versus the more traditional approach. Health Data collected by CAPSANA in the workplace between 2012 and 2014 showed that, out of 4231 workers, 69% should aim to do more active lifestyle and 74% to a better nutrition profile. In addition, 53% of the sampled population were overweight. In this context, the current project aims to motivate aims to motivate and follow individuals towards a healthier lifestyle. To do so, the Activate Your Health will be implemented and tested using various options (limited to more complete) in several companies.
Read the detailed description
Currently, lifestyle habits of workers does not only represents a personal concern, but also a concern of the company. Currently there are very few studies that efficiently integrate classical interventions (screening) and online tools in order to obtain sustainable lifestyle changes in workers. The current project aims to evaluate efficacy of a combined approach versus more traditional approaches. Health Data collected by CAPSANA in the workplace between 2012 and 2014 showed that, out of 4231 workers, 69% should aim at a more active lifestyle and 74% at a better nutritional profile. In addition, 53% of the sampled population were overweight.
In this context, the current project aims to motivate and follow individuals towards a healthier lifestyle. To do so, the Activate Your Health will be implemented and tested using various options (limited to more complete) in several companies. It is planned to compare to a control group receiving no intervention to the other groups containing little to complete set of interventions. The content of the interventions involves health assessment, electronic tools (SOScuisine and social media platform), health screening, activity monitor tool and closing events. The companies had to pick which option they would like to provide their employees. It is anticipated that the complete option will yield better results for the activity profile and other lifestyle habits. For example, changes in eating habits toward better habits are expected.
- Being tested
- Health Risks assessement, Web-based health discussions, SOScuisine website, Health screening, Closing events
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Risks assessementBehavioural
Home made questionnaire questioning about the participant's lifestyle habits, risk factors and other.
Web-based health discussionsBehavioural
Create interactions between the employees.
SOScuisine websiteBehavioural
Site that is personalized to the employee. It provides menus, grocery shopping list and other.
Health screeningBehavioural
Screen for diabetes, cholesterol, blood pressure and body weight.
Closing eventsBehavioural
these aim to motivate the employees to continue into the program.
CoachingBehavioural
The first year participant will be coached by a nurse, second year by a nutritionist, and third year by a kinesiologist.
Social Health platformBehavioural
Accelerometer providedBehavioural
Social Health Platform: employees can challenge themselves or each other.
| Study group | Role | What they receive |
|---|---|---|
| Full lifestyle program | Experimental | Participants receive all the intervention tools that aimed to enhance lifestyle profile. Receives: Behavioral: Health Risks assessement; Behavioral: Web-based health discussions; Behavioral: SOScuisine website; Behavioral: Health screening; Behavioral: Closing events; Behavioral: Coaching; Behavioral: Social Health platform; Behavioral: Accelerometer provided |
| High lifestyle program | Experimental | Participants receive most of the intervention tools that aimed to enhance lifestyle profile. Receives: Behavioral: Health Risks assessement; Behavioral: Web-based health discussions; Behavioral: SOScuisine website; Behavioral: Health screening; Behavioral: Closing events; Behavioral: Coaching; Behavioral: Social Health platform |
| Moderate lifestyle program | Experimental | Participants receive some intervention tools that aimed to enhance lifestyle profile. Receives: Behavioral: Health Risks assessement; Behavioral: Web-based health discussions; Behavioral: SOScuisine website; Behavioral: Closing events; Behavioral: Coaching |
| Light lifestyle program | Experimental | Participants receive little intervention tools that aimed to enhance lifestyle profile. Receives: Behavioral: Health Risks assessement; Behavioral: Web-based health discussions; Behavioral: SOScuisine website |
| Control group | No intervention | Participants receive none of the intervention tools that aimed to enhance lifestyle profile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity profile (intensity, frequency and duration) measured by questionnaire
Based on a questionnaire we will be able to calculate physical activity duration, intensity and frequency will be obtained.
Measured: 365 days
Secondary outcomes (1)
Nutritional profile (fruit and vegetables intake) will be obtained by questionnaire
Based on a questionnaire we will be able to calculate nutrition parameters (# of fruits and vegetables per day).
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start1 Jan 2016
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 5 options are offered, however one option was not chosen by the companies so 4 will be analyzed in future studies
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Ève Mathieu, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933385
- Sponsor's protocol ID
- University of Montreal
- Status last verified
- Mar 2019
- First submitted
- 5 Oct 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kugathasan TA, Lecot F, Laberge S, Tremblay J, Mathieu ME. Activate Your Health, a 3-year, multi-site, workplace healthy lifestyle promotion program: study design. BMC Public Health. 2019 Aug 19;19(1):1140. doi: 10.1186/s12889-019-7393-x.
PubMed 31426771
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activate Your Health Program : A Workplace Healthy Lifestyle Program
- ClinicalTrials.gov ID
- NCT02933385
- Acronym / sponsor ID
- University of Montreal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,737 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 14 Oct 2016 (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.
Currently there are very few studies that integrate classical interventions (screening clinics) and online tools in order to obtain sustainable lifestyle changes in workers efficiently. The current project aims to evaluate the efficiency of a combined approach versus the more traditional approach. Health Data collected by CAPSANA in the workplace between 2012 and 2014 showed that, out of 4231 workers, 69% should aim to do more active lifestyle and 74% to a better nutrition profile. In addition, 53% of the sampled population were overweight. In this context, the current project aims to motivate aims to motivate and follow individuals towards a healthier lifestyle. To do so, the Activate Your Health will be implemented and tested using various options (limited to more complete) in several companies.
Detailed description
Currently, lifestyle habits of workers does not only represents a personal concern, but also a concern of the company. Currently there are very few studies that efficiently integrate classical interventions (screening) and online tools in order to obtain sustainable lifestyle changes in workers. The current project aims to evaluate efficacy of a combined approach versus more traditional approaches. Health Data collected by CAPSANA in the workplace between 2012 and 2014 showed that, out of 4231 workers, 69% should aim at a more active lifestyle and 74% at a better nutritional profile. In addition, 53% of the sampled population were overweight.
In this context, the current project aims to motivate and follow individuals towards a healthier lifestyle. To do so, the Activate Your Health will be implemented and tested using various options (limited to more complete) in several companies. It is planned to compare to a control group receiving no intervention to the other groups containing little to complete set of interventions. The content of the interventions involves health assessment, electronic tools (SOScuisine and social media platform), health screening, activity monitor tool and closing events. The companies had to pick which option they would like to provide their employees. It is anticipated that the complete option will yield better results for the activity profile and other lifestyle habits. For example, changes in eating habits toward better habits are expected.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 5 options are offered, however one option was not chosen by the companies so 4 will be analyzed in future studies
| Arm | Type | Receives |
|---|---|---|
| Full lifestyle program | Experimental | Behavioral: Health Risks assessement, Behavioral: Web-based health discussions, Behavioral: SOScuisine website, Behavioral: Health screening, Behavioral: Closing events, Behavioral: Coaching, Behavioral: Social Health platform, Behavioral: Accelerometer providedParticipants receive all the intervention tools that aimed to enhance lifestyle profile. |
| High lifestyle program | Experimental | Behavioral: Health Risks assessement, Behavioral: Web-based health discussions, Behavioral: SOScuisine website, Behavioral: Health screening, Behavioral: Closing events, Behavioral: Coaching, Behavioral: Social Health platformParticipants receive most of the intervention tools that aimed to enhance lifestyle profile. |
| Moderate lifestyle program | Experimental | Behavioral: Health Risks assessement, Behavioral: Web-based health discussions, Behavioral: SOScuisine website, Behavioral: Closing events, Behavioral: CoachingParticipants receive some intervention tools that aimed to enhance lifestyle profile. |
| Light lifestyle program | Experimental | Behavioral: Health Risks assessement, Behavioral: Web-based health discussions, Behavioral: SOScuisine websiteParticipants receive little intervention tools that aimed to enhance lifestyle profile. |
| Control group | No intervention | –Participants receive none of the intervention tools that aimed to enhance lifestyle profile. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- French Speaking, work in the participating company.
Key exclusion criteria (1 listed)
- pregnant women.
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 |
|---|---|---|
| Health Risks assessementHome made questionnaire questioning about the participant's lifestyle habits, risk factors and other. | Behavioural | Full lifestyle program, High lifestyle program, Light lifestyle program, Moderate lifestyle program |
| Web-based health discussionsCreate interactions between the employees. | Behavioural | Full lifestyle program, High lifestyle program, Light lifestyle program, Moderate lifestyle program |
| SOScuisine websiteSite that is personalized to the employee. It provides menus, grocery shopping list and other. | Behavioural | Full lifestyle program, High lifestyle program, Light lifestyle program, Moderate lifestyle program |
| Health screeningScreen for diabetes, cholesterol, blood pressure and body weight. | Behavioural | Full lifestyle program, High lifestyle program |
| Closing eventsthese aim to motivate the employees to continue into the program. | Behavioural | Full lifestyle program, High lifestyle program, Moderate lifestyle program |
| CoachingThe first year participant will be coached by a nurse, second year by a nutritionist, and third year by a kinesiologist. | Behavioural | Full lifestyle program, High lifestyle program, Moderate lifestyle program |
| Social Health platform | Behavioural | Full lifestyle program, High lifestyle program |
| Accelerometer providedSocial Health Platform: employees can challenge themselves or each other. | Behavioural | Full lifestyle program |
Primary outcome
Physical activity profile (intensity, frequency and duration) measured by questionnaire
Time frame: 365 days
Based on a questionnaire we will be able to calculate physical activity duration, intensity and frequency will be obtained.
1 secondary outcome
Nutritional profile (fruit and vegetables intake) will be obtained by questionnaire
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Derived from this study: PubMed 31426771Kugathasan TA, Lecot F, Laberge S, Tremblay J, Mathieu ME. Activate Your Health, a 3-year, multi-site, workplace healthy lifestyle promotion program: study design. BMC Public Health. 2019 Aug 19;19(1):1140. doi: 10.1186/s12889-019-7393-x.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Health Risks assessement, Web-based health discussions and SOScuisine website in people with Lifestyle and Exercise, run by Université de Montréal.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 profile (intensity, frequency and duration) measured by questionnaire (time frame: 365 days). 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 NCT02933385, which also lists 1 linked publication.
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 28 Mar 2019.