WittyFit - Live Your Work Differently

Mortality Clinical Trial

— WittyFit  

Official title:

WittyFit - Live Your Work Differently

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02596737
• Other study ID #: CHU-0247
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2015
• Last updated: November 3, 2015
• Start date: May 2015
• Est. completion date: October 2018

Study information

• Verified date: November 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. WittyFit is building a rainbow: work (shiftwork, sedentary job, particular occupations, etc) / psychology and physiology / statistics modeling / public health, and in general, health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All workers who want to participate to the WittyFit concept will be included.

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mortality

Intervention

Behavioral:
• wittyFit concept

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Australian Catholic University, WittyFit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality	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	No
Secondary	visual analog scale of physical well-being	However individuals will be able to spontaneously complete this data more frequently	every 15 days, up to 10 years	No
Secondary	visual analog scale of mental well-being	however individuals will be able to spontaneously complete this data more frequently	every 15 days, up to 10 years	No
Secondary	visual analog scale of well-being at-work	however individuals will be able to spontaneously complete this data more frequently	every 15 days, up to 10 years	No
Secondary	Nutritional intake measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	Physical activity measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	Sleep measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	Musculo-skeletal disorders measured by questionnaire	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	No
Secondary	Hospital and Anxiety Depression Scale	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	Stress and Mood measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	job strain measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	latitude decision measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	work organization and tasks measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	social support measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	recognition measured by questionnaire	however individuals will be able to spontaneously complete this data more frequently	every 6 months, up to 10 years	No
Secondary	disease and medical history measured by questionnaire		every 12 months, up to 10 years	No
Secondary	routine medications measured by questionnaire		every 12 months, up to 10 years	No
Secondary	number of days of sick leave provided by the employer		every 12 months, up to 10 years	No
Secondary	sales turnover of the company, provided by the employer		every 12 months, up to 10 years	No
Secondary	net income or net gain of the company, provided by the employer		every 12 months, up to 10 years	No