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Lifestyle-related ConditionNCT03115645

Evaluation of the Dynamic Work Intervention for Office Workers to Reduce Sedentary Behaviour

A study testing Dynamic Work in people with Lifestyle-related Condition, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Long-term sitting has been associated with multiple health risks. To reduce sitting time for office workers in a Dutch insurance company, an intervention will be implemented. The goal of this study is to evaluate this intervention on the short term (3 months) and long-term (12 months). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lifestyle-related Condition
What is being tested?
Dynamic Work
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
4 sitesNetherlands
Study dates
23 Jan 2017to 18 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Already access to the Dynamic Working Intervention
  • Unable to stand or walk for longer time periods (i.e. wheelchair bound)
  • Pregnancy

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Achmea

    Apeldoorn

  • Achmea

    Leeuwarden

  • Achmea

    Leusden

  • Achmea

    Tilburg

Other trials in Netherlands

About this study

Long-term sitting has been associated with multiple health risks. To reduce sitting time for office workers in a Dutch insurance company, an intervention will be implemented. The goal of this study is to evaluate this intervention on the short term (3 months) and long-term (12 months).

Read the 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.

Being tested
Dynamic Work
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic WorkOther

    Also called Dynamisch Werken

    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.

Study groups in NCT03115645
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention group will receive the Dynamic Working Intervention program, as described in the next section.
Receives: Other: Dynamic Work
Control groupNo interventionParticipants in the control group will not receive any intervention and will perform their work in the same manner as before.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sitting time

    Total sitting time will be measured objectively with the activPAL activity tracker

    Measured: Change in sitting time between baseline and 12 month follow up assessment

Secondary outcomes (26)

  1. Occupational sitting time

    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  2. Non-occupational sitting time

    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  3. Total standing time

    Objectively assessed by the activPAL activity tracker

    Measured: Assessed at baseline 3 months and 12 months

  4. Occupational standing time

    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  5. Non-occupational standing time

    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  6. Total stepping time

    Objectively assessed by the activPAL activity tracker

    Measured: Assessed at baseline 3 months and 12 months

  7. Occupational stepping time

    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  8. Non-occupational stepping time

    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  9. Sitting time in bouts of 30 min

    Objectively assessed by the activPAL activity tracker

    Measured: Assessed at baseline 3 months and 12 months

  10. Occupational sitting time in bouts of 30 min

    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  11. Non-occupational sitting time in bouts of 30 min

    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  12. Sitting time in bouts of 60 min

    Objectively assessed by the activPAL activity tracker

    Measured: Assessed at baseline 3 months and 12 months

  13. Occupational sitting time in bouts of 60 min

    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  14. Non-occupational sitting time in bouts of 60 min

    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary

    Measured: Assessed at baseline 3 months and 12 months

  15. Waist circumference and body height

    Waist circumference and body height will be objectively measured in cm

    Measured: Assessed at baseline 3 months and 12 months

  16. Body weight

    Body weight will be objectively measured in kg and used to calculate body mass index (BMI)

    Measured: Assessed at baseline 3 months and 12 months

  17. Individual Work Performance

    Will be assessed with the Individual Work Performance Questionnaire (IWPQ)

    Measured: Assessed at baseline 3 months and 12 months

  18. Need for recovery

    This will be assessed with the Need For Recovery (NFR) questionnaire

    Measured: Assessed at baseline 3 months and 12 months

  19. Effort-reward imbalance

    This will be assessed with the short Effort-Reward Imbalance (ERI-short) questionnaire

    Measured: Assessed at baseline 3 months and 12 months

  20. Musculoskeletal complaints

    This will be assessed with the Nordic Musculoskeletal questionnaire

    Measured: Assessed at baseline 3 months and 12 months

  21. Vitality

    This will be assessed with the Vita-16© TNO questionnaire

    Measured: Assessed at baseline 3 months and 12 months

  22. Quality of life measured with EQ-5D-5L

    This will be assessed with the EQ-5D-5L questionnaire

    Measured: Assessed at baseline 3 months and 12 months

  23. Absenteeism

    This will be self-reported as well as assessed with company records

    Measured: Assessed at baseline 3 months and 12 months

  24. Healthcare consumption

    This includes general practitioner, allied health professionals, complementary medicine consumption

    Measured: Assessed at 3 months and 12 months

  25. Sitting, physical activity and work related outcomes

    These will be assessed with custom sitting, physical activity and work questions

    Measured: Assessed at baseline 3 months and 12 months

  26. Process evaluation

    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.

    Measured: Assessed at 3 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start23 Jan 2017
  3. Primary completion18 Apr 2018
  4. Study completion18 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115645
Sponsor's protocol ID
DynamicWork
Status last verified
Sep 2019
First submitted
8 Feb 2017
Last updated
3 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 35724470

  • 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.

    PubMed 35546228

  • 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.

    PubMed 31987512

  • 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.

    PubMed 30760231

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Work in people with Lifestyle-related Condition, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sitting time (time frame: Change in sitting time between baseline and 12 month follow up assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115645, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.

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