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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU clermont-ferrand

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: workers
Workers will fulfil a visual analog scale of Well-being regarding 3 main categories: "Physically", "Mentally", "At Work".
Behavioral: wittyFit concept

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Australian Catholic University
WittyFit

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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