Clinical trial NCT06247228: Click2Move Intervention to Reduce Home-office Workers' Sedentary Behaviour.
Official title: A Co-created Digital Intervention to Reduce Home-office Workers' Sedentary Behaviour: Protocol for the Click2Move Programme, a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sedentary Behaviour
Keywords: Sedentary behaviour
Home-office
Office work
Technology
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: National Institute for Public Health and the Environment (RIVM)
name: Technological University of the Shannon, Athlone, Ireland
name: University of Ljubljana
First posted: 2024-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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:

* Profile page: In the profile page users will be able to change their password and edit their profile including an avatar. Initially established working hours and days could be modified through the profile page. Finally, in this section, users will have the opportunity to share any comment, suggestion, or concern about the programme to their company.
* Self-monitoring and feedback provision: Time spent in a sedentary behaviour and the number of steps will be recorded in real-time through the activity tracker during the pre-established working hours. Once users open the C2M App, data will be synchronized and displayed through the "Home" page: number of steps, sedentary time, sedentary reminders (accepted and refused) and additional strategies for breaking sedentary time that they selected as completed without receiving reminders. This information will be visualised through a loop and the actual number records. Moreover, activity and sedentary history will be visualised through the "History" page.
* 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.

  * Specific strategies have the aim to break sitting time, requiring a minimum of movement from 1 to 5 minutes, containing different categories: walk, stretch, strength, mobility, stability or combination (i.e., including more than one of the above). Each strategy will contain an image, a tittle and description of the exercise, including the benefits of doing that exercise, the development instructions, the number of repetitions, and a video demonstration.
  * General strategies have the aim to reduce total sitting time during working or non-working hours (e.g., walking meetings).
* Sedentary reminders: Every hour without moving from the chair, participants will receive a reminder through a vibration of the activity tracker. After that, the user will have to open the App, where a message to invite him/her to break sedentary time and perform the proposed specific strategy, they will be able to accept or skip it. Employees who not receive reminders (i.e., they are sufficiently active), will receive a motivational message where users will be able to select the strategies that they have implemented during this day from those proposed or additionally select others for non-described strategies. Users will receive a push notification encouraging them to break their sitting time in case they ignored all the reminders.
* Cooperative challenges: These challenges will be done among all company workers who participate in the programme. Examples of the challenges include: to achieve a pre-determined number of steps during a month or that an individual does not receive more than a pre-determined number of inactivity reminders during a period. The duration of the challenges will not be more than a month. For each challenge, the tittle, the description of the challenge, and the duration (start date and end date) will appear. Moreover, in the challenge requirements will appear the achievement of the challenges among all the participants and the individual contribution to the challenge.
* Motivational messages: Once the challenge is completed, users will receive a motivational message (e.g., good job, you have done 6000 steps during the working day), which will be signed by the managers. Each challenge will include a forum where users will be able to share their experiences with other employees. Additionally, the company will select an individual from each department who will be the facilitator of the forum, encouraging participation in the challenges and leading by example.

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.

Eligibility criteria: Inclusion Criteria:

* Companies inclusion criteria: a) companies' size \>50 employees, b) with home-office policies, and c) having different units.
* Participants inclusion criteria: Adults, full or part-time home-office work, working from home at least 2 days per week, able to walk without the use of an assistive device or requiring assistance from another person.

Exclusion Criteria:

* Companies exclusion criteria: Involving in other initiatives to reduce sedentary behaviour.
* Participants exclusion criteria: Unable to read and understand language. Employees with an end date for employment until after the study has been completed.

Primary outcomes:
measure: Occupational sitting time
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Leisure sitting time
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Total sitting time
timeFrame: Baseline, 3 months, 6 months and 12 months.
Secondary outcomes:
measure: Occupational physical activity (MVPA, LIPA and stepping)
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Leisure-time physical activity (MVPA, LIPA and stepping)
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Total physical activity (MVPA, LIPA and stepping)
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Occupational standing time
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Leisure standing time
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Total standing time
timeFrame: Baseline, 3 months, 6 months and 12 months.
measure: Presenteeism
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Occupational fatigue
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Job satisfaction
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Musculoskeletal symptoms
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Absenteeism
timeFrame: Baseline, 3 months, 6 months and 12 months
Other outcomes:
measure: Process evaluation
timeFrame: 3 months, 6 months and 12 months
measure: Socio demographic
timeFrame: Baseline
Locations:
city: Manlleu
country: Spain
facility: Arthesis Group
state: Catalonia
Study officials:
affiliation: UVic-UCC
name: Judit Bort-Roig, PhD
role: PRINCIPAL_INVESTIGATOR
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