SedentaryNCT02071420
Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
A study testing Active Workstation Intervention, Ergonomic Intervention and Email Intervention in people with Sedentary and Overweight, run by University of Iowa at 1 site in United States.
Trial summary
Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary, Overweight
- What is being tested?
- Active Workstation Intervention, Ergonomic Intervention and Email Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We will recruit overweight/obese (body mass index 25.0-40.0 kg/m2) adults (18-65 years) working in full-time (minimum 35 hours/week), sedentary (self-report sitting >75% work time) occupations at an independent work site.
Who cannot join
- Working in an office that will not meet the space or electrical requirements of the active workstation, acute or chronic illness not under treatment of a provider, orthopedic limitations that prohibit physical activity, current or planned pregnancy, hospitalization from a physical or mental disorder in the past six months and/or taking medication that may impair physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.
Read the detailed description
Primary Aim: To compare the effects of providing sedentary employees with seated active workstations in combination with an ergonomic intervention and regular motivational emails (experimental group) against the ergonomic intervention and regular emails only (active control group) on occupational sedentary behavior over 16 weeks.
Hypothesis: The addition of a seated active workstation will result in significant reductions in daily occupational sedentary time compared to the active control group.
Secondary Aims: To compare the effects of the experimental group against the active control group on secondary measures of cardiometabolic disease risk factors, musculoskeletal discomfort, cognitive function and work productivity.
Hypothesis 1: The experimental group will result in reduced cardiometabolic disease risk, musculoskeletal discomfort and work limitations compared to the active control group.
- Conditions
- Sedentary, Overweight
- Being tested
- Active Workstation Intervention, Ergonomic Intervention, Email Intervention, Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.
- Medical subject headings
- Sedentary Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Workstation InterventionBehavioural
Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.
Ergonomic InterventionBehavioural
Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.
Email InterventionBehavioural
Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).
Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.Device
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks. Receives: Behavioral: Active Workstation Intervention; Behavioral: Ergonomic Intervention; Behavioral: Email Intervention; Device: Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application. |
| Active Control | Active comparator | This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation. Receives: Behavioral: Ergonomic Intervention; Behavioral: Email Intervention; Device: Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Occupational Physical Activity From Baseline to 16 Weeks
Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedentaryStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Carr, University of Iowa
- Investigators
- Lucas Carr, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071420
- Sponsor's protocol ID
- 201306711
- Status last verified
- Sep 2017
- First submitted
- 21 Feb 2014
- Last updated
- 23 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carr LJ, Leonhard C, Tucker S, Fethke N, Benzo R, Gerr F. Total Worker Health Intervention Increases Activity of Sedentary Workers. Am J Prev Med. 2016 Jan;50(1):9-17. doi: 10.1016/j.amepre.2015.06.022. Epub 2015 Aug 7.
PubMed 26260492
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
- ClinicalTrials.gov ID
- NCT02071420
- Acronym / sponsor ID
- 201306711
- Conditions
- Sedentary, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Posted 23 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.
Detailed description
Primary Aim: To compare the effects of providing sedentary employees with seated active workstations in combination with an ergonomic intervention and regular motivational emails (experimental group) against the ergonomic intervention and regular emails only (active control group) on occupational sedentary behavior over 16 weeks.
Hypothesis: The addition of a seated active workstation will result in significant reductions in daily occupational sedentary time compared to the active control group.
Secondary Aims: To compare the effects of the experimental group against the active control group on secondary measures of cardiometabolic disease risk factors, musculoskeletal discomfort, cognitive function and work productivity.
Hypothesis 1: The experimental group will result in reduced cardiometabolic disease risk, musculoskeletal discomfort and work limitations compared to the active control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Active Workstation Intervention, Behavioral: Ergonomic Intervention, Behavioral: Email Intervention, Device: Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks. |
| Active Control | Active comparator | Behavioral: Ergonomic Intervention, Behavioral: Email Intervention, Device: Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will recruit overweight/obese (body mass index 25.0-40.0 kg/m2) adults (18-65 years) working in full-time (minimum 35 hours/week), sedentary (self-report sitting >75% work time) occupations at an independent work site.
Key exclusion criteria (1 listed)
- Working in an office that will not meet the space or electrical requirements of the active workstation, acute or chronic illness not under treatment of a provider, orthopedic limitations that prohibit physical activity, current or planned pregnancy, hospitalization from a physical or mental disorder in the past six months and/or taking medication that may impair physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Workstation InterventionParticipants in the experimental group will receive a seated active workstation at their work setting for 16 weeks. | Behavioural | Experimental Group |
| Ergonomic InterventionParticipants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station. | Behavioural | Active Control, Experimental Group |
| Email InterventionParticipants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles). | Behavioural | Active Control, Experimental Group |
| Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application. | Device | Active Control, Experimental Group |
Primary outcome
Change in Occupational Physical Activity From Baseline to 16 Weeks
Time frame: Baseline and 16 weeks
Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26260492Carr LJ, Leonhard C, Tucker S, Fethke N, Benzo R, Gerr F. Total Worker Health Intervention Increases Activity of Sedentary Workers. Am J Prev Med. 2016 Jan;50(1):9-17. doi: 10.1016/j.amepre.2015.06.022. Epub 2015 Aug 7.
Related trials for Sedentary
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Carr, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Workstation Intervention, Ergonomic Intervention and Email Intervention in people with Sedentary and Overweight, run by University of Iowa at 1 site in United States.
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 1 inclusion and 1 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Occupational Physical Activity From Baseline to 16 Weeks (time frame: Baseline and 16 weeks). 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 NCT02071420, which also lists 1 linked publication.
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 23 Oct 2017.