- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02596737
WittyFit - Live Your Work Differently (WittyFit)
November 3, 2015 updated by: University Hospital, Clermont-Ferrand
Individuals spend one third of their life working.
Age of retirement is regularly pushed back.
The main challenge in the nearest future will be to maintain workers health to deal with their work till retirement.
Morbidity before retirement has a huge cost, both in public health and economically for companies.
Numerous factors increase morbidity such as stress at work, sedentary and low physical activity, and poor nutrition habits.
Nowadays, digital world wildly invades lives and offer a no-limit possibility to interact with individuals, everywhere.
Thus, a software able to understand an individual in its globality seems to address this challenge.
Moreover, managers need to understand the actions needed within their company.
The objective of WittyFit is to increase life expectancy and well-being.
WittyFit will constitute a powerful database to build strong evidence and new knowledge on the relationships between work, behavior, and health, based on a large amount of epidemiological data.
Study Overview
Detailed Description
- Whereas other interventional software focus on a specific aim (relaxation, musculo-skeletal disorder, etc), Wittyfit has the ambition to promote health with a global understanding of workers, based on continuous and updated scientific knowledge (evidence based medicine). A feedback is given on targets screened from questionnaires through e-learning and personalized motivating messages.
- The second novelty of WittyFit is that managers will also have an anonymous feedback on the general state of health and problems encountered by its employees, in general or by department if the sample size is sufficiently high. Managers will indeed be able to target specific actions such as promoting physical activity at work or helping its employees to quit smoking.
- Third, WittyFit is a prevention tool in collaboration with occupational medicine, which may help to detect a high risk toward the integrity of an employee.
- Moreover, WittyFit is in fact based on two databases: "WittyFit" which deals with behavioral data, and "WittyFit Research" which deals with medical data. To guarantee the highest level of security, the two databases are separate and do not communicate together; physicians from the CHU of Clermont-Ferrand will be the only individuals with an access to medical data.
- When a worker will leave Wittyfit, the company will encode three possibilities: retirement, move for another company, or premature death. Therefore, WittyFit will have the ability to have mortality as a primary outcome.
- Finally, WittyFit may constitute a powerful database to build strong evidence and new knowledge on the relationships between lifestyle and health, based on huge amount of epidemiological data.
- At last, WittyFit will evolve with the waves of connected objects further increasing its data accuracy, with the use of devices such as pedometers, heart rate monitors, accelerometers, thermometer, etc.
- WittyFit is building a rainbow: work (shiftwork, sedentary job, particular occupations, etc) / psychology and physiology / statistics modeling / public health, and in general, health.
Study Type
Interventional
Enrollment (Anticipated)
100
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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Clermont-Ferrand, France, 63003
- Recruiting
- Chu Clermont-Ferrand
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All workers who want to participate to the WittyFit concept will be included.
Exclusion Criteria:
-
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: workers
Workers will fulfil a visual analog scale of Well-being regarding 3 main categories: "Physically", "Mentally", "At Work".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
all cause mortality
Time Frame: every year, up to 10 years
|
When a worker will leave Wittyfit, the company will encode three possibilities: retirement, move for another company, or premature death.
|
every year, up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale of physical well-being
Time Frame: every 15 days, up to 10 years
|
However individuals will be able to spontaneously complete this data more frequently
|
every 15 days, up to 10 years
|
|
visual analog scale of mental well-being
Time Frame: every 15 days, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 15 days, up to 10 years
|
|
visual analog scale of well-being at-work
Time Frame: every 15 days, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 15 days, up to 10 years
|
|
Nutritional intake measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
Physical activity measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
Sleep measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
Musculo-skeletal disorders measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
Every participant can fulfil questionnaires when he wants.
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
Hospital and Anxiety Depression Scale
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
Stress and Mood measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
job strain measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
latitude decision measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
work organization and tasks measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
social support measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
recognition measured by questionnaire
Time Frame: every 6 months, up to 10 years
|
however individuals will be able to spontaneously complete this data more frequently
|
every 6 months, up to 10 years
|
|
disease and medical history measured by questionnaire
Time Frame: every 12 months, up to 10 years
|
every 12 months, up to 10 years
|
|
|
routine medications measured by questionnaire
Time Frame: every 12 months, up to 10 years
|
every 12 months, up to 10 years
|
|
|
number of days of sick leave provided by the employer
Time Frame: every 12 months, up to 10 years
|
every 12 months, up to 10 years
|
|
|
sales turnover of the company, provided by the employer
Time Frame: every 12 months, up to 10 years
|
every 12 months, up to 10 years
|
|
|
net income or net gain of the company, provided by the employer
Time Frame: every 12 months, up to 10 years
|
every 12 months, up to 10 years
|
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
- Dutheil F, Pereira B, Bouillon-Minois JB, Clinchamps M, Brousses G, Dewavrin S, Cornet T, Mermillod M, Mondillon L, Baker JS, Schmidt J, Moustafa F, Lanhers C. Validation of Visual Analogue Scales of job demand and job control at the workplace: a cross-sectional study. BMJ Open. 2022 Mar 17;12(3):e046403. doi: 10.1136/bmjopen-2020-046403.
- Colin-Chevalier R, Pereira B, Benson AC, Dewavrin S, Cornet T, Dutheil F. The Protective Role of Job Control/Autonomy on Mental Strain of Managers: A Cross-Sectional Study among Wittyfit's Users. Int J Environ Res Public Health. 2022 Feb 14;19(4):2153. doi: 10.3390/ijerph19042153.
- Serole C, Auclair C, Prunet D, Charkhabi M, Lesage FX, Baker JS, Mermillod M, Gerbaud L, Dutheil F. The Forgotten Health-Care Occupations at Risk of Burnout-A Burnout, Job Demand-Control-Support, and Effort-Reward Imbalance Survey. J Occup Environ Med. 2021 Jul 1;63(7):e416-e425. doi: 10.1097/JOM.0000000000002235.
- Clinchamps M, Auclair C, Prunet D, Pfabigan D, Lesage FX, Baker JS, Parreira L, Mermillod M, Gerbaud L, Dutheil F. Burnout Among Hospital Non-Healthcare Staff: Influence of Job Demand-Control-Support, and Effort-Reward Imbalance. J Occup Environ Med. 2021 Jan 1;63(1):e13-e20. doi: 10.1097/JOM.0000000000002072.
- Dutheil F, Duclos M, Naughton G, Dewavrin S, Cornet T, Huguet P, Chatard JC, Pereira B. WittyFit-Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion. JMIR Res Protoc. 2017 Apr 13;6(4):e58. doi: 10.2196/resprot.6267.
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
May 1, 2015
Primary Completion (Anticipated)
October 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
October 15, 2015
First Submitted That Met QC Criteria
November 3, 2015
First Posted (Estimate)
November 4, 2015
Study Record Updates
Last Update Posted (Estimate)
November 4, 2015
Last Update Submitted That Met QC Criteria
November 3, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU-0247
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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