Sedentary Behaviour Clinical Trial
Official title:
A Co-created Digital Intervention to Reduce Home-office Workers' Sedentary Behaviour: Protocol for the Click2Move Programme, a Cluster Randomised Controlled Trial
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).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | March 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Vic - Central University of Catalonia | National Institute for Public Health and the Environment (RIVM), Technological University of the Shannon, Athlone, Ireland, University of Ljubljana |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. |
3 months, 6 months and 12 months | |
Other | 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). | Baseline | |
Primary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Primary | 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. | Baseline, 3 months, 6 months and 12 months. | |
Primary | 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. | Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. |
Baseline, 3 months, 6 months and 12 months. | |
Secondary | 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. | Baseline, 3 months, 6 months and 12 months | |
Secondary | 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. | Baseline, 3 months, 6 months and 12 months | |
Secondary | 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). | Baseline, 3 months, 6 months and 12 months | |
Secondary | 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. | Baseline, 3 months, 6 months and 12 months | |
Secondary | 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. | Baseline, 3 months, 6 months and 12 months |
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