- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03115645
Evaluation of the Dynamic Work Intervention for Office Workers to Reduce Sedentary Behaviour
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Large volumes of sitting time have been associated with multiple health risks such as diabetes, heart disease and premature death. Especially, in office workers sitting time per day can accumulate to over 10 hours a day. To reduce sitting time for office workers in a Dutch insurance company, an intervention will be implemented. The intervention contains the introduction of alternative workstations, intervention sessions with an occupational physiotherapist and an activity tracker with a self-help program booklet. The goal of this study is to evaluate the (cost) effectiveness of this intervention on the short term (3 months) and long-term (12 months). The primary outcome is objectively assessed sitting time.
In a cluster randomized controlled trial 250 employees of an insurance company will participate in the study. After baseline measurements, matched departments will be randomly assigned to the control or intervention group. The evaluation includes an economic and process evaluation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Apeldoorn, Netherlands
- Achmea
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Leeuwarden, Netherlands
- Achmea
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Leusden, Netherlands
- Achmea
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Tilburg, Netherlands
- Achmea
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Employed by the insurance company for at least the duration of the study (12 months)
- Employed at least 28 hours per week
- Employed at one of the participating departments
Exclusion Criteria:
- Already access to the Dynamic Working Intervention
- Unable to stand or walk for longer time periods (i.e. wheelchair bound)
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Intervention group
Participants in the intervention group will receive the Dynamic Working Intervention program, as described in the next section.
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The intervention consists of the introduction of sit-stand workstations and desk bikes in the participants work environment in a ratio of 1:2 with traditional desks and chairs.
Employees will receive a half hour intervention session at the start of the intervention from an occupational physiotherapist, who will provide further intervention support in the ensuing 12 weeks.
Intervention participants will also receive an activity tracker which provides feedback on sitting time and physical activity levels.
Other Names:
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NO_INTERVENTION: Control group
Participants in the control group will not receive any intervention and will perform their work in the same manner as before.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sitting time
Time Frame: Change in sitting time between baseline and 12 month follow up assessment
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Total sitting time will be measured objectively with the activPAL activity tracker
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Change in sitting time between baseline and 12 month follow up assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Occupational sitting time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Non-occupational sitting time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Total standing time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker
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Assessed at baseline 3 months and 12 months
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Occupational standing time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Non-occupational standing time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Total stepping time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker
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Assessed at baseline 3 months and 12 months
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Occupational stepping time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Non-occupational stepping time
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Sitting time in bouts of 30 min
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker
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Assessed at baseline 3 months and 12 months
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Occupational sitting time in bouts of 30 min
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Non-occupational sitting time in bouts of 30 min
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Sitting time in bouts of 60 min
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker
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Assessed at baseline 3 months and 12 months
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Occupational sitting time in bouts of 60 min
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Non-occupational sitting time in bouts of 60 min
Time Frame: Assessed at baseline 3 months and 12 months
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Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
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Assessed at baseline 3 months and 12 months
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Waist circumference and body height
Time Frame: Assessed at baseline 3 months and 12 months
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Waist circumference and body height will be objectively measured in cm
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Assessed at baseline 3 months and 12 months
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Body weight
Time Frame: Assessed at baseline 3 months and 12 months
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Body weight will be objectively measured in kg and used to calculate body mass index (BMI)
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Assessed at baseline 3 months and 12 months
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Individual Work Performance
Time Frame: Assessed at baseline 3 months and 12 months
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Will be assessed with the Individual Work Performance Questionnaire (IWPQ)
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Assessed at baseline 3 months and 12 months
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Need for recovery
Time Frame: Assessed at baseline 3 months and 12 months
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This will be assessed with the Need For Recovery (NFR) questionnaire
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Assessed at baseline 3 months and 12 months
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Effort-reward imbalance
Time Frame: Assessed at baseline 3 months and 12 months
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This will be assessed with the short Effort-Reward Imbalance (ERI-short) questionnaire
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Assessed at baseline 3 months and 12 months
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Musculoskeletal complaints
Time Frame: Assessed at baseline 3 months and 12 months
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This will be assessed with the Nordic Musculoskeletal questionnaire
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Assessed at baseline 3 months and 12 months
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Vitality
Time Frame: Assessed at baseline 3 months and 12 months
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This will be assessed with the Vita-16© TNO questionnaire
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Assessed at baseline 3 months and 12 months
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Quality of life measured with EQ-5D-5L
Time Frame: Assessed at baseline 3 months and 12 months
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This will be assessed with the EQ-5D-5L questionnaire
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Assessed at baseline 3 months and 12 months
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Absenteeism
Time Frame: Assessed at baseline 3 months and 12 months
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This will be self-reported as well as assessed with company records
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Assessed at baseline 3 months and 12 months
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Healthcare consumption
Time Frame: Assessed at 3 months and 12 months
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This includes general practitioner, allied health professionals, complementary medicine consumption
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Assessed at 3 months and 12 months
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Sitting, physical activity and work related outcomes
Time Frame: Assessed at baseline 3 months and 12 months
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These will be assessed with custom sitting, physical activity and work questions
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Assessed at baseline 3 months and 12 months
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Process evaluation
Time Frame: Assessed at 3 months and 12 months
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A process evaluation will be performed using qualitative (focus group interviews) and quantitative methods (questionnaires) in order to determine the level of implementation of the intervention as well as barriers and facilitators of this implementation.
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Assessed at 3 months and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Jelsma JGM, van der Ploeg HP, Renaud LR, Stijnman DPM, Loyen A, Huysmans MA, van der Beek AJ, van Nassau F. Mixed-methods process evaluation of the Dynamic Work study: A multicomponent intervention for office workers to reduce sitting time. Appl Ergon. 2022 Oct;104:103823. doi: 10.1016/j.apergo.2022.103823. Epub 2022 Jun 17.
- Mastenbroek VJEZ, Jelsma JGM, van der Ploeg HP, Stijnman DPM, Huysmans MA, van der Beek AJ, van Nassau F. Barriers and facilitators influencing the implementation of the occupational health intervention 'Dynamic Work': a qualitative study. BMC Public Health. 2022 May 11;22(1):947. doi: 10.1186/s12889-022-13230-9.
- Renaud LR, Jelsma JGM, Huysmans MA, van Nassau F, Lakerveld J, Spekle EM, Bosmans JE, Stijnman DPM, Loyen A, van der Beek AJ, van der Ploeg HP. Effectiveness of the multi-component dynamic work intervention to reduce sitting time in office workers - Results from a pragmatic cluster randomised controlled trial. Appl Ergon. 2020 Apr;84:103027. doi: 10.1016/j.apergo.2019.103027. Epub 2020 Jan 10.
- Jelsma JGM, Renaud LR, Huysmans MA, Coffeng JK, Loyen A, van Nassau F, Bosmans JE, Spekle EM, van der Beek AJ, van der Ploeg HP. The Dynamic Work study: study protocol of a cluster randomized controlled trial of an occupational health intervention aimed at reducing sitting time in office workers. BMC Public Health. 2019 Feb 13;19(1):188. doi: 10.1186/s12889-019-6467-0.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DynamicWork
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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