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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115645
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Achmea
Information provided by (Responsible Party):
H. P. Van der Ploeg, VU University Medical Center

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE January 23, 2017
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Sitting time [ Time Frame: Change in sitting time between baseline and 12 month follow up assessment ]
Total sitting time will be measured objectively with the activPAL activity tracker
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Occupational sitting time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational sitting time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Total standing time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational standing time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational standing time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Total stepping time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational stepping time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational stepping time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Sitting time in bouts of 30 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational sitting time in bouts of 30 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational sitting time in bouts of 30 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Sitting time in bouts of 60 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational sitting time in bouts of 60 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational sitting time in bouts of 60 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Waist circumference and body height [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Waist circumference and body height will be objectively measured in cm
  • Body weight [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Body weight will be objectively measured in kg and used to calculate body mass index (BMI)
  • Individual Work Performance [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Will be assessed with the Individual Work Performance Questionnaire (IWPQ)
  • Need for recovery [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the Need For Recovery (NFR) questionnaire
  • Effort-reward imbalance [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the short Effort-Reward Imbalance (ERI-short) questionnaire
  • Musculoskeletal complaints [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the Nordic Musculoskeletal questionnaire
  • Vitality [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the Vita-16© TNO questionnaire
  • Quality of life measured with EQ-5D-5L [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the EQ-5D-5L questionnaire
  • Absenteeism [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be self-reported as well as assessed with company records
  • Healthcare consumption [ Time Frame: Assessed at 3 months and 12 months ]
    This includes general practitioner, allied health professionals, complementary medicine consumption
  • Sitting, physical activity and work related outcomes [ Time Frame: Assessed at baseline 3 months and 12 months ]
    These will be assessed with custom sitting, physical activity and work questions
  • Process evaluation [ Time Frame: Assessed at 3 months and 12 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Occupational sitting time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational sitting time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Total standing time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational standing time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational standing time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Total stepping time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational stepping time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational stepping time [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Sitting time in bouts of 30 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational sitting time in bouts of 30 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational sitting time in bouts of 30 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Sitting time in bouts of 60 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker
  • Occupational sitting time in bouts of 60 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, occupational time will be recorded and linked with a diary
  • Non-occupational sitting time in bouts of 60 min [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Objectively assessed by the activPAL activity tracker, non-occupational time will be recorded and linked with a diary
  • Waist circumference and body height [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Waist circumference and body height will be objectively measured in cm
  • Body weight [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Body weight will be objectively measured in kg and used to calculate body mass index (BMI)
  • Individual Work Performance [ Time Frame: Assessed at baseline 3 months and 12 months ]
    Will be assessed with the Individual Work Performance Questionnaire (IWPQ)
  • Need for recovery [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the Need For Recovery (NFR) questionnaire
  • Effort-reward imbalance [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the short Effort-Reward Imbalance (ERI-short) questionnaire
  • Musculoskeletal complaints [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the Nordic Musculoskeletal questionnaire
  • Vitality [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the Vita-16© TNO questionnaire
  • Quality of life [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be assessed with the EQ-5D-5L questionnaire
  • Absenteeism [ Time Frame: Assessed at baseline 3 months and 12 months ]
    This will be self-reported as well as assessed with company records
  • Healthcare consumption [ Time Frame: Assessed at 3 months and 12 months ]
    This includes general practitioner, allied health professionals, complementary medicine consumption
  • Sitting, physical activity and work related outcomes [ Time Frame: Assessed at baseline 3 months and 12 months ]
    These will be assessed with custom sitting, physical activity and work questions
  • Process evaluation [ Time Frame: Assessed at 3 months and 12 months ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Dynamic Work Intervention for Office Workers to Reduce Sedentary Behaviour
Official Title  ICMJE Evaluation of the Dynamic Work Intervention for Office Workers to Reduce Sedentary Behaviour
Brief 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Lifestyle-related Condition
Intervention  ICMJE 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.
Other Name: Dynamisch Werken
Study Arms  ICMJE
  • Experimental: Intervention group
    Participants in the intervention group will receive the Dynamic Working Intervention program, as described in the next section.
    Intervention: Other: Dynamic Work
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2017)
244
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
250
Actual Study Completion Date  ICMJE April 18, 2018
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03115645
Other Study ID Numbers  ICMJE DynamicWork
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party H. P. Van der Ploeg, VU University Medical Center
Study Sponsor  ICMJE VU University Medical Center
Collaborators  ICMJE Achmea
Investigators  ICMJE Not Provided
PRS Account VU University Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP