An interventional study of Click2Move in Sedentary Behaviour, sponsored by University of Vic - Central University of Catalonia. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by University of Vic - Central University of Catalonia · Not applicable, Interventional, and Treatment
The goal of this clinical evaluate the effectiveness of the Ckick2Move Programme, a multicomponent digital-based intervention, to reduce sedentary behaviour among home-office workers, and the impact on employees physcial activity patterns, musculoskeletal risk and work-related outcomes (i.e., absenteeism, presenteeism, occupational fatigue and job satisfaction). The study will take place in four countries along Europe (Spain, Ireland, Netherlands, and Slovenia).
This study will be conducted, analysed, and reported according to the Consolidation Standards of Reporting Trials (CONSORT) statement for cluster RCTs. A two-arm cluster randomised controlled trial will be undertaken. Participants will be randomised by cluster to receive the intervention or act as a control group and maintain their usual work. The protocol was approved by the Research Ethics Committee of the University of Vic - Central University of Catalonia (278/2023).
The primary objectives are a) to evaluate the effectiveness of the Click2Move intervention on reducing occupational sedentary time in home-office workers, and b) to assess the process evaluation of the Click2Move intervention in hybrid office workers.
The secondary objectives are a) to investigate whether the Click2Move intervention impacts on employee's physical activity and sedentary behaviours, and b) to evaluate the impact of the Click2Move intervention on employees' musculoskeletal health and work-related outcomes.
Sample size: Based on an assumed mean reduction of 55.92 minutes/day sitting in the intervention group and a standard deviation in both groups of 90 minutes/day, a power of 80%, a two-sided alpha of 0.05, and a 20% dropout rate, we need 200 participants across 4 companies at baseline. Within each company, randomization in the intervention group or control group takes place at the unit level (clusters) through a hierarchic clustering between units in a company, assuming a low intra-cluster correlation coefficient (ICC) of 0.05 for the unit and 0.2 for the company. Per company, 1 control unit and 1 intervention unit will be included with the total number of participants being equal per company (n=50). The total sample size will be equally distributed across both conditions (intervention group or control group).
Recruitment process: Each national coordinator will send a first email to potential country-representative companies from a variety of sectors in their own language with a flyer and a short survey with the eligible companies' criteria. This email will have attached the company information statement. Those who expressed their interest to participate will receive an email (if they meet the inclusion criteria) to organise an appointment to explain the project in greater detail and resolve any possible doubts or issues the company may have. If a commitment is made, the company will have access to the overall materials of the programme. As for the participants recruitment, the company will receive a template email to share with their own workers. This email will contain a flyer and a link with a short survey, including the information statement and the informed consent. The national coordinator will review all the responses and will identify those that meet the eligibility criteria. Those participants who meet the inclusion criteria and signed the informed consent digitally through the survey, will be included in a list of participants. Subsequently, they will receive a second email to thank them for their interest and will be invited to make a group appointment in the company for the baseline assessments in March (first meeting). This email will contain a link with the measurement survey participants will be asked to complete before the appointment. Those participants who have not answered the survey will be asked to answer it during the meeting.
Allocation: After baseline measurements take place (March 2024) participants will be randomised by clusters (units) 1:1, to either intervention or control group at the company level to reduce the risk of contamination. The randomisation will be taken by the principal investigator. Participants will receive information according to the allocated group the last week of March by email. Participants allocated in the intervention group, will be arranged for a second group meeting in the company on the first week of April 2024, where they will be provided with an activity tracker, the App link with the username and password accompanied by a usage tutorial. The control group will not attend a second meeting. Control group participants will not receive any device, nor will they have to download the mobile phone application. After the year of the intervention, they will be able to receive the intervention if they choose.
Blinding: Given the nature of the study, it is not possible to blind participants to which intervention they receive. However, the randomisation will be taken at the unit level to reduce the risk of contamination. Measurement team members will not be blinded to group allocation.
Intervention: The Click2Move intervention consists of a mobile phone application (C2M App) compatible with Android and iOS in combination with a wearable monitor (an activity tracker) provided by the project. Click2Move is a multicomponent intervention that covers behavioural change elements at the social environmental, organisational, and individual level.
The C2M App will be downloaded in the intervention group participants' devices. They will access the App using their email address and the password received during the second meeting (April 2024). An initial wizard will guide the user through the activity tracker synchronization. The App will include a wide range of functionalities:
Strategies: The "Strategies" section will include a list of two different types of strategies: specific and general strategies. Strategies preferred by the participants can be marked as "liked", and the most popular strategies will appear on the bottom of the different sections.
In parallel to the C2M App, intervention group participants will receive email communication at two levels: a) An initiation email from the company with an encouraging video from the CEO or staff leader of a similar rank and Periodic (monthly), and b) emails send by the C2M team with educational material (videos and infographics) showing the benefits of reducing occupational sedentary behaviour.
Data collection: Data will be collected at four time points for both intervention and control group participants: at baseline (March 2024), after 3 months (June 2024), 6 months (September 2024), and 12 months (March 2025) to both groups. Self-report questionnaires will be delivered through the REDCap (Research Electronic Data Capture) via email prior to the face-to-face appointment. In this meeting, trained researchers will provide participants with the activPAL device and the diary log. The researcher will ensure that participants have completed the questionnaires online, otherwise they will be asked to complete them in the meeting.
Data management: Data will be measured by each country and collected centrally by the REDCap project platform allocated at the UVic-UCC server. Our data management plan will align with the FAIR data principle for its data management approach (Findability, Accessibility, Interoperability, and Reusability). Data management will also align with all EU General Data Protection Regulations (GDPR).
Data analysis: Data will be assessed for normality using the Kolmogorov-Smirnov method, with manual inspection of histograms and box plots for the whole group and within clusters. Descriptive characteristics for demographic, work environment, behavioural measures, health and work will be described using frequencies, mean and standard deviations and median and interquartile range. Independent samples t-tests (or the non-parametric Mann-Whitney U test) will be used to determine differences between clusters at baseline. Linear mixed models, accounting for any covariates (including baseline values), will be employed to determine the effects of the intervention. Effect sizes will be calculated by dividing the difference in group means by the average standard deviation of the pooled data. All statistical analysis will be conducted using STATA MP (StataCorp, College Station, TX, USA) or SPSS (v 28, IBM, Chicago, IL, USA). For the process evaluation, questionnaire data will be summarised using frequency counts and means (± SD) where appropriate. Audio-recordings of focus groups will be transcribed verbatim and analysed using the principles of Thematic Analysis. MAXQDA 2024 (HRB 78781, AG Berlin Charlottenburg, Germany) will be employed for the qualitative analysis.
Financial disclose: The Click2Move Project was funded by the Erasmus+ Programme call: ERASMUS-SPORT-2021-SCP, grant number 101050490.
University of Vic - Central University of Catalonia is the lead sponsor of 36 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Experimental group will receive the Click2Move intervention for one year, including a wearable (provided by the research group) and mobile phone application downloaded in the participants own mobile phone. Click2Move intervention comprises elements at three levels: environmental (activity tracking and app provision, reminders, cooperative challenges, and social chat), organisational level (organisational support and motivational messages), and at individual level (educational materials, self-monitoring, feedback provision, demonstration videos and a list of strategies).
Behavioral: Click2Move
Participants in the control arm will be asked to complete the same study measurements as those in the intervention arms, at the same time points. The control arm participants will not receive any device, nor will they have to download the mobile phone application. After the year of the intervention, they will be able to receive the intervention if they agree.
One year multicomponent intervention including a wearable, and a mobile phone application downloaded in the own mobile phone. Participants will have activity tracking and app provision, sedentary reminders, cooperative challenges, organisational support and motivational messages, educational material, self-monitoring, feedback provision, demonstration videos and strategies.
Occupational sitting time
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Leisure sitting time
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the leisure sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.
Time frame: Baseline, 3 months, 6 months and 12 months.
Total sitting time
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the leisure sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.
Time frame: Baseline, 3 months, 6 months and 12 months.
Occupational physical activity (MVPA, LIPA and stepping)
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational physical activity patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Leisure-time physical activity (MVPA, LIPA and stepping)
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational physical activity patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Total physical activity (MVPA, LIPA and stepping)
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational physical activity patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Occupational standing time
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational physical activity patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Leisure standing time
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational physical activity patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Total standing time
The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational physical activity patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.
Time frame: Baseline, 3 months, 6 months and 12 months.
Presenteeism
Health and Work Performance Questionnaire, which showed its validity, but also its reliability and sensitivity to change. Two questions that ask employers to rate working in their job on a 0-10 scale of work performance (worst to best), and rank themselves over the past 4 weeks during the time they were at work. Absolute presenteeism will be calculated as the difference between the score for self over the past 4 weeks and the score for the average worker in the same job. A higher score indicated lower amount of lost performance.
Time frame: Baseline, 3 months, 6 months and 12 months
Occupational fatigue
Need for Recovery scale was shown to be valid to measure occupational fatigue and showed a good psychometric quality. Additionally, the Need for Recovery scale has shown favourable test-retest reliability and sensitivity to detect change. The Need for Recovery comprises of eleven items with yes/no answering categories. A score is calculated by adding all the scores of the individual items and transforming these into a scale from 0 to 100. Higher scores indicate a higher need for recovery after work.
Time frame: Baseline, 3 months, 6 months and 12 months
Job satisfaction
Single-item 5-point Likert scale, where 1 is extremely dissatisfied and 5 extremely satisfied. The standard satisfaction scale ranging from 1 to 5 will be converted into 0 to 100 scales using the formula: AdjSS = 100 x (stsSS-1) / (5-1), where adjSS and stdSS will be "adjusted satisfaction score" and "standard satisfaction score", respectively. With the new scoring method, job satisfaction fell into 5 categories: "extremely dissatisfied" ((adjSS: 10-29), "dissatisfied" (30-49), "generally satisfied or not" (50-59), "satisfied" (70-89), and "extremely satisfied" (90-100).
Time frame: Baseline, 3 months, 6 months and 12 months
Musculoskeletal symptoms
Pain intensity will be measured through 11-point Numeric Rating Scale. Standardised Nordic Questionnaire, an internationally self-administered, will measure musculoskeletal symptoms, designed primarily in the working population, and under no circumstances was it designed for clinical diagnosis. The general questionnaire consists of 8 questions with dichotomous and Likert-type (4 to 5 levels of response) answers. The questions refer to the presence of discomfort, its duration and each episode of pain, the duration of temporary disability, the need for treatment, and the cause of discomfort. The Standard Nordic Questionnaire has proved to be valid, realiable and feasible tool that allows musculoskeletal problems among different anatomical areas in epidemiological and ergonomic studies.
Time frame: Baseline, 3 months, 6 months and 12 months
Absenteeism
Health and Work Performance Questionnaire, which showed its validity, but also its reliability and sensitivity to change. Three open questions about how many hours participants work the past 4 weeks, how many hours the employer expects employer work in the past 7 days or in a typical 7-day week and number of entire or partial days missed in the past 4 weeks for mental or physical health, for other reasons (e.g., vacations) will be used to score the absolute absenteeism (4\*hours your employer expect to work - hours did employers work the past 4 weeks). Absolut absenteeism (i.e., number of missed workdays) is scored in terms of hours lost per month, a high score indicates a higher amount of absenteeism. HPQ showed its validity, but also its reliability and sensitivity to change.
Time frame: Baseline, 3 months, 6 months and 12 months
Process evaluation
Self-reported questionnaire, at 3 months, will assess usability, acceptability, perceived usefulness and satisfaction through 7-point Likert scales. At 6 and 12 months, participant's' opinions of the intervention components will be also assessed with 7-point Likert scales. Participants allocated to the intervention groups (and who were still taking part in 12 month follow-up) will be also offered the opportunity (via email) to take part in a focus group to examine engagement in what worked and what did not work, and suggestions to improve, along with the impeding or enhancing factors for behaviour sustainability considering the Medical Research Council guidance (MRC) (context, implementation and mechanisms of impact) (18, 19). Separate online focus groups will be conducted for each country partner with 6-10 participants per each group.
Time frame: 3 months, 6 months and 12 months
Socio demographic
At baseline, participants will be asked for their: age, sex, educational level, current job role, occupational sector, length of time in post in the company, working hours, how often they usually work from home, physical work environment , commute (distance from home to work, time and transport).
Time frame: Baseline
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University of Vic - Central University of Catalonia