WittyFit—Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion

Background Morbidity before retirement has a huge cost, burdening both public health and workplace finances. Multiple factors increase morbidity such as stress at work, sedentary behavior or low physical activity, and poor nutrition practices. Nowadays, the digital world offers infinite opportunities to interact with workers. The WittyFit software was designed to understand holistic issues of workers by promoting individualized behavior changes at the workplace. Objective The shorter term feasibility objective is to demonstrate that effective use of WittyFit will increase well-being and improve health-related behaviors. The mid-term objective is to demonstrate that WittyFit improves economic data of the companies such as productivity and benefits. The ultimate objective is to increase life expectancy of workers. Methods This is an exploratory interventional cohort study in an ecological situation. Three groups of participants will be purposefully sampled: employees, middle managers, and executive managers. Four levels of engagement are planned for employees: commencing with baseline health profiling from validated questionnaires; individualized feedback based on evidence-based medicine; support for behavioral change; and formal evaluation of changes in knowledge, practices, and health outcomes over time. Middle managers will also receive anonymous feedback on problems encountered by employees, and executive top managers will have indicators by division, location, department, age, seniority, gender and occupational position. Managers will be able to introduce specific initiatives in the workplace. WittyFit is based on two databases: behavioral data (WittyFit) and medical data (WittyFit Research). Statistical analyses will incorporate morbidity and well-being data. When a worker leaves a workplace, the company documents one of three major explanations: retirement, relocation to another company, or premature death. Therefore, WittyFit will have the ability to include mortality as an outcome. WittyFit will evolve with the waves of connected objects further increasing its data accuracy. Ethical approval was obtained from the ethics committee of the University Hospital of Clermont-Ferrand, France. Results WittyFit recruitment and enrollment started in January 2016. First publications are expected to be available at the beginning of 2017. Conclusions The name WittyFit came from Witty and Fitness. The concept of WittyFit reflects the concept of health from the World Health Organization: being spiritually and physically healthy. WittyFit is a health-monitoring, health-promoting tool that may improve the health of workers and health of companies. WittyFit will evolve with the waves of connected objects further increasing its data accuracy with objective measures. WittyFit may constitute a powerful epidemiological database. Finally, the WittyFit concept may extend healthy living into the general population. Trial Registration Clinicaltrials.gov: NCT02596737; https://www.clinicaltrials.gov/ct2/show/NCT02596737 (Archived by WebCite at http://www.webcitation.org/6pM5toQ7Y)


9.2.
Description of the parameters of safety assessment ________ Erreur ! Signet non défini.

9.5.
Monitoring of subjects with an adverse event ______________ Erreur ! Signet non défini.

Access rights to source data and documents _____________ Erreur ! Signet non défini.
10.1. Data access _____________________________________________ Erreur ! Signet non défini.

Diet
There are numerous and extensive literature on benefits of a healthy diet. Nearly all aspects of food intake and health have been investigated: from the influence of the breakfast 4 to the influence of dietary sugars 6 or coffee 5 on heart disease. Some working conditions, such as shift work, are associated with abnormal eating behavior such as alterations to timing of meals and type of food eaten, 32 promoting an increased risk of developing obesity and metabolic disorders. 33 In addition, stress also promotes unhealthy eating behaviors and development of obesity. 34 However, those studies were mainly cross-sectional.
Interventional studies on a huge number of participants remain scarce. Moreover, WittyFit should provide the first interventional study with an epidemiological cohort frame including specific details on working conditions. This is in agreement with recommendations promoting more health preventive initiatives focusing on dietary counseling, 32 particularly on individuals more exposed to stress. 35

Physical activity
The American College of Sports Medicine recommends a minimum of 150 minutes of moderate, or 75 minutes of vigorous intensity of physical activity per week to achieve and maintain global health for adults, and at least 30 minutes of moderate intensity a day. 36 Moreover, even smaller amount, 37 and even only standing 3 without further physical activity have shown benefits on life-expectancy.
However, the more physical activity is done, the longer life expectancy and health benefits are obtained, even if sedentary individuals start to train at a high level after 50 years of age. 38 Therefore, any form of physical activity is better than no activity, 3,36,37 and it is never too late to start exercising. 38 The benefits of physical activity on mental health have been well documented. 39 Along with reducing workplace absenteeism, 39,40 a strong negative association exists between physical activity and mood states. 41 This is highlighted by the broad public opinion that physical activity is an effective coping mechanism for stress. 42

Hypothesis
We hypothesize that WittyFit will increase life expectancy and well-being.

Benefits and adverse effects
Benefits: Benefits are an increased life expectancy and well-being.
Adverse effects: Adverse effects are improbably to occur.

Expected long-term impacts
Both collectively and for the participants, WittyFit will change the relations with work and build a different way to live our job. Expected long-term impacts are global: economically for the companies by decreasing absenteeism, work-related injuries and occupational diseases, and personally for the participants by increasing well-being and life expectancy. WittyFit could be a major public health component at work.

Objectives
The global aim is to build an epidemiological database combining major lifestyle parameters.

Primary objective
The objective of WittyFit is to decrease premature mortality.

Secondary objectives
WittyFit will decrease morbidity and improve well-being. WittyFit will constitute the most powerful database of the world to build strong evidence and new knowledge on the relationships between work, behavior, and health, based on a large amount of epidemiological data.

Description of the study: observational study
Observational epidemiological study.

Inclusion criteria
All workers who want to participate to the WittyFit concept will be included

Exclusion criteria
Patient's refusal to participate

Premature shutdown of the research
Intermediate analysis will be conduct several times per year and although improbable, any adverse effects will be extensively studied

Period of exclusion and participation in another research
Another protocol could be bone simultaneously.

Compensation of volunteers
No indemnity.

Recruitment procedures and Number of centers for this study
WittyFitt will deliver his process to the entire workforce of worldwide companies.
Data will be analyzed at The Clinical Research and Innovation Direction, CHU Clermont-Ferrand, France.

Duration of participation per individual
Unlimited. However, data will be extensively studied in order to product a considerable amount of advanced knowledge.

Main outcome
Life expectancy

Secondary outcomes
Workers will fulfill a visual analog scale (VAS) of Well-being regarding 3 main categories: "Physically", "Mentally", "At Work".
Each main category is divided in subcategories: -"Physically" explores Nutrition, Activity, Sleep, Musculo-skelettal. Nutrition will be assessed through day-recording food intake. Physical activity will be at-work and during leisure time, as well as sedentary. Sleep will be assessed from Pittsburg questionnaire. 28 Specific questions will complete these questionnaires -"Mentally" explores Stress and Mood, with the use of validated questionnaires such as Hospital and Anxiety Depression Scale. 43 -"At Work" explores job strain, latitude decision, work organization and tasks, social support, and recognition. Validated questionnaires will be used, such as Karasek 15,16,44 and Sieigrist 12,17,45 questionnaires.
All medical data are only accessible from WittyFit Research (medical history, treatments, etc). All data are anonymous and the name of the employee is absolutely never implemented in the database, at any time. The database is implemented from the human resource (HR) number, which is moreover automatically converted in another number on the WittyFit database. When a number disappear, the company will provide the information of retirement, change for another company, or death (premature mortality).

Time of measurements
Every participant can fulfill questionnaires when he wants. However, participants will be asked to fulfill general VAS ("Physically", "Mentally", "At Work") every 15 days; and detailed questionnaires every 6 months.

A global understanding of workers
Whereas other interventional software focus on a specific aim (relaxation, musculo-skelettal 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 or "did you know" informations, based on personalized analyses of questionnaires.
Each E-learning module is based on a 3 steps approach: -First, answer a quiz (pretest) -Second, understand the issue, -Third, act on the issue, -Fourth, answer a quiz.
The employee has access to his own personal data on a panel of indicators displaying his progress and his success. The employee may also input new ideas in the "Digital Idea Box" and "likes" ideas of others. He may participate to poles issued by the company regarding evolution and changes. When actions are needed, a red dot will appear on the access button of the relevant topic.

A manager feedback
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.

The Middle Management
-Has access to his department average for each main VAS ("Physical", "Mental" and "At work") and subcategories of "At Work" -Gets warning on a low average VAS showing a weakness of his team in a specific category -Gets feedback of the relevant issues in his department -Has access to a best practice database -Has access to the Forum Manager anonymous community to share experience -Has a Go/No Go functionality regarding the proposals in the "Digital Idea Box". If not in position to decide, the middle management can promote an idea for the top management

The Top Management
-Real time and historical access to average VAS results of "Physical", "Mental" and "At work" indicators and subcategories of "At Work" by division, location, department, age, seniority, gender, job title… -Gets feedback of the relevant issues by division, location, department, age, seniority, gender, job title… -Monitor the turn-over and absenteeism in regard to the VAS evolutions -Access the "Digital Idea Box" and put in motion relevant ideas -Use the "what's new" editing tool (pole) to involve the work force in the changes to come.

Collaborate with Occupational medicine
-Real time and historical access to average VAS results of "Physical", "Mental" and "At work" indicators and all subcategories by division, location, department, age, seniority, gender, job title… -Gets feedback of the relevant issues by division, location, department, age, seniority, gender, job title… -Monitor the turn-over and absenteeism in regard to the VAS evolutions -No access to the "Digital Idea Box" -No access to the "what's new" editing tool (pole) -If a high risk is detected toward the integrity of an employee, he is the only one with the ability to break anonymity.

WittyFit Research
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.

Epidemiological database
WittyFit may constitute the most powerful database of the world to build strong evidence and new knowledge on the relationships between lifestyle and health, based on huge amount of epidemiological data

Connected objects
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

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

Number of subjects needed
100 000 followed over 5 years regarding life expectancy. However, the study will be unlimited regarding its epidemiological design. Some precisions could be proposed according to previous works 46 studying leisure time spent sitting in relation to total mortality in a prospective cohort of US adults 3 and job strain among blue-collar and white-collar employees as a determinant of total mortality with a 28-year population-based follow-up. 47 Also, to study the aim objective to decrease premature mortality, statistical power estimation bad on Hazard Ratio used for censored data (HR among 1.25 and 2) and according to the literature data described previously (HR) was be proposed for type-I error of 5% (two-sided) and statistical power equals 95%.

Generalities on analyses
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be bilateral and a p <0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, average, median, standard deviation, and range. Graphic representations will be complete presentations of results.

Primary analyses
The aim objective of this protocol is to decrease premature mortality. Considering this censored data, estimation will be performed using Kaplan-Meier. Comparison with historical cohorts and previous works will be realized considering 95% confidence interval. WittyFit's effect will be also study considering log-rank comparisons and Cox proportional hazards model. The multivariate model will be considered according to statistical relevance (univariate results) and clinical/epidemiological relevance.

Secondary analyses
To study WittyFit's effect on morbidity and well-being, analyses considered on one hand comparisons with historical cohorts and literature and on other hand comparisons in paired situation in which each subject will be his own witness. To study longitudinal evolution of parameters associated to morbidity and well-being, models for repeated data will be performed using randomeffects model (linear or generalized linear) to study fixed effects and taking into account within and between subject variability.
When appropriate, comparisons between subgroups will be proposed. Usual statistical tests will be applied: Chi-squared or Fisher exact tests for comparisons between groups for categorical parameters and anova or Kruskal-Wallis test for quantitative variables. For censored data, comparisons were performed like aim analysis by log-rank test and Cox proportional hazards model.
Considering repeated correlated data, marginal models may be preferred.

Method taking into account missing, unused or invalid data
A sensitivity analysis of missing data will be considered in order to assess the level of attrition and to characterize the statistical nature (Missing At Random, Missing Completely At Random, Not Missing At Random) to propose the method of imputation most appropriate. 48-50

Measures to reduce or avoid bias
-Worker de-identification to blind assessors of participant status when processing data -Large sample size -Generalizability 9. Ethics

Ethics Committee
The protocol, information and consent form as well as the CRF for the study will be submitted for review to the Ethics Committee of Clermont-Ferrand (South-East VI) -Comité de Protection des Personnes Sud Est VI.
Notification of the approval of the Ethics Committee will be sent to the study promotor and the competent authority. An application for authorization shall be sent by the Promoter to the competent authority before the start of the study.

Information letter and consent form
Patients should be informed fully and fairly, in understandable terms, of the objectives and constraints of the study, possible risks, monitoring measures, and of their rights to refuse to participate in the study or the opportunity to withdraw at any time. The investigator must also inform the individuals of the approval of the ethics committee.
All these informations are in the message written on the website when entering WittyFit Research.

Protocol amendments
Changes to the protocol will be considered as substantial or not. They will, by their nature, subject to a new opinion of the Ethics Committee and/or permission of the competent authority.

Support for research
This is an observational study in ecological environment, without randomization.

Collection and processing of data
Data will be entered by participants on WittyFit® and WIttyFit Research®.
Statistical analysis will be performed by members of the team.

CNIL
This study is part of the "Reference Methodology" (MR-001) under the provisions of the Act of 6 August 2004 on the protection of individuals with regard to the processing of personal data and

Digital Preservation
The following documents will be archived by the name of the study in the offices of the occupational medicine department of the Clermont-Ferrand University Hospital until the end of the period of practical use (duration of the study + the time required for data analysis).
These documents are: No displacement or destruction shall be made without the consent of the Promoter. After 15 years, the developer will be consulted for destruction. All data, all documents and reports will be subject to audit or inspection.

Costs and Funding
WittyFit is a private-public partnership with no-cost for the CHU Clermont-Ferrand. WittyFit provides the data. The CHU provides its expertise and publishes in high impact factor journals.

Communication and publishing rules
The data will be disclosed after prior joint agreement of the investigator and promotor. The results will be communicated and publicated. The study will be pre-registered on an open access website: Clinical trials.gov.

Feasibility of this study
Skills of the research team: Dutheil