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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03115645
Other study ID # DynamicWork
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 23, 2017
Est. completion date April 18, 2018

Study information

Verified date September 2019
Source VU University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date April 18, 2018
Est. primary completion date April 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dynamic Work
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.

Locations

Country Name City State
Netherlands Achmea Apeldoorn
Netherlands Achmea Leeuwarden
Netherlands Achmea Leusden
Netherlands Achmea Tilburg

Sponsors (2)

Lead Sponsor Collaborator
VU University Medical Center Achmea

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sitting time Total sitting time will be measured objectively with the activPAL activity tracker Change in sitting time between baseline and 12 month follow up assessment
Secondary Occupational sitting time Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary Assessed at baseline 3 months and 12 months
Secondary Non-occupational sitting time Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary Assessed at baseline 3 months and 12 months
Secondary Total standing time Objectively assessed by the activPAL activity tracker Assessed at baseline 3 months and 12 months
Secondary Occupational standing time Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary Assessed at baseline 3 months and 12 months
Secondary Non-occupational standing time Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary Assessed at baseline 3 months and 12 months
Secondary Total stepping time Objectively assessed by the activPAL activity tracker Assessed at baseline 3 months and 12 months
Secondary Occupational stepping time Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary Assessed at baseline 3 months and 12 months
Secondary Non-occupational stepping time Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary Assessed at baseline 3 months and 12 months
Secondary Sitting time in bouts of 30 min Objectively assessed by the activPAL activity tracker Assessed at baseline 3 months and 12 months
Secondary 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 Assessed at baseline 3 months and 12 months
Secondary 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 Assessed at baseline 3 months and 12 months
Secondary Sitting time in bouts of 60 min Objectively assessed by the activPAL activity tracker Assessed at baseline 3 months and 12 months
Secondary 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 Assessed at baseline 3 months and 12 months
Secondary 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 Assessed at baseline 3 months and 12 months
Secondary Waist circumference and body height Waist circumference and body height will be objectively measured in cm Assessed at baseline 3 months and 12 months
Secondary Body weight Body weight will be objectively measured in kg and used to calculate body mass index (BMI) Assessed at baseline 3 months and 12 months
Secondary Individual Work Performance Will be assessed with the Individual Work Performance Questionnaire (IWPQ) Assessed at baseline 3 months and 12 months
Secondary Need for recovery This will be assessed with the Need For Recovery (NFR) questionnaire Assessed at baseline 3 months and 12 months
Secondary Effort-reward imbalance This will be assessed with the short Effort-Reward Imbalance (ERI-short) questionnaire Assessed at baseline 3 months and 12 months
Secondary Musculoskeletal complaints This will be assessed with the Nordic Musculoskeletal questionnaire Assessed at baseline 3 months and 12 months
Secondary Vitality This will be assessed with the Vita-16© TNO questionnaire Assessed at baseline 3 months and 12 months
Secondary Quality of life measured with EQ-5D-5L This will be assessed with the EQ-5D-5L questionnaire Assessed at baseline 3 months and 12 months
Secondary Absenteeism This will be self-reported as well as assessed with company records Assessed at baseline 3 months and 12 months
Secondary Healthcare consumption This includes general practitioner, allied health professionals, complementary medicine consumption Assessed at 3 months and 12 months
Secondary Sitting, physical activity and work related outcomes These will be assessed with custom sitting, physical activity and work questions Assessed at baseline 3 months and 12 months
Secondary 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. Assessed at 3 months and 12 months
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