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

September 30, 2019 updated by: H. P. Van der Ploeg, Amsterdam UMC, location VUmc
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Apeldoorn, Netherlands
        • Achmea
      • Leeuwarden, Netherlands
        • Achmea
      • Leusden, Netherlands
        • Achmea
      • Tilburg, Netherlands
        • Achmea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention group
Participants in the intervention group will receive the Dynamic Working Intervention program, as described in the next section.
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 Names:
  • Dynamisch Werken
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change in sitting time between baseline and 12 month follow up assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
Total standing time
Time Frame: Assessed at baseline 3 months and 12 months
Objectively assessed by the activPAL activity tracker
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
Total stepping time
Time Frame: Assessed at baseline 3 months and 12 months
Objectively assessed by the activPAL activity tracker
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
Sitting time in bouts of 30 min
Time Frame: Assessed at baseline 3 months and 12 months
Objectively assessed by the activPAL activity tracker
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
Sitting time in bouts of 60 min
Time Frame: Assessed at baseline 3 months and 12 months
Objectively assessed by the activPAL activity tracker
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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)
Assessed at baseline 3 months and 12 months
Individual Work Performance
Time Frame: Assessed at baseline 3 months and 12 months
Will be assessed with the Individual Work Performance Questionnaire (IWPQ)
Assessed at baseline 3 months and 12 months
Need for recovery
Time Frame: Assessed at baseline 3 months and 12 months
This will be assessed with the Need For Recovery (NFR) questionnaire
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
Musculoskeletal complaints
Time Frame: Assessed at baseline 3 months and 12 months
This will be assessed with the Nordic Musculoskeletal questionnaire
Assessed at baseline 3 months and 12 months
Vitality
Time Frame: Assessed at baseline 3 months and 12 months
This will be assessed with the Vita-16© TNO questionnaire
Assessed at baseline 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
Absenteeism
Time Frame: Assessed at baseline 3 months and 12 months
This will be self-reported as well as assessed with company records
Assessed at baseline 3 months and 12 months
Healthcare consumption
Time Frame: Assessed at 3 months and 12 months
This includes general practitioner, allied health professionals, complementary medicine consumption
Assessed at 3 months and 12 months
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
Assessed at baseline 3 months and 12 months
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.
Assessed at 3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam UMC, location VUmc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Achmea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DynamicWork

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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