Physical ActivityMove-ItNCT04038658
Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation
A study testing Move-It in people with Physical Activity, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The aim of the study is to evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China. The intervention is informed by behaviour change theory, and is a digital workplace intervention (called Move-It) involving a 10-minute Qigong exercise session… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Move-It
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2013to 31 Jan 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employee of participating organisation
Who cannot join
- Not an employee of participating organisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Move-It: A Cluster-randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation
The aim of the study is to evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China.
The intervention is informed by behaviour change theory, and is a digital workplace intervention (called Move-It) involving a 10-minute Qigong exercise session (video demonstration via website) which is delivered twice a day at set break times during the working day for 12 consecutive weeks.
The setting is a large organisation with 2 sites (in Beijing and Guangzhou). The objectives are to examine the effect of a video-based intervention on employees' physical activity, time spent sitting and work performance. This is tested in a 2-group, randomised wait-list control trial. This means that employees at one site receive the intervention first (site 1 - intervention group), and when they have completed (12 weeks later), the other site then receives the same intervention (site 2 - wait-list control). At the end of the intervention, there is a process evaluation with the intervention group which includes focus groups with employees and managers to gather information about the way in which the intervention was implemented. The process evaluation is based on a framework called 'Reach Effectiveness Adoption Implementation Maintenance' (RE-AIM). Data were collected at baseline (before the intervention began) and after 12 weeks in both groups.
Read the detailed description
Aim The aim of the study is to deliver a digital video-based worksite exercise intervention in China and conduct outcome and process evaluation. The objectives are: [1] to examine the effect of a video-based intervention on physical activity (PA) and weekday sitting hours (individual level); [2] to examine the effect of a video-based intervention on individual work performance (individual level); [3] to conduct a process evaluation of the intervention implementation (individual and cluster level).
Design This is a 2-arm cluster-randomised wait-list control trial, with outcomes assessed in two groups: intervention and wait-list control (objectives 1 and 2).
Clusters (sites) will be randomly allocated to groups at 1:1 ratio using computer-generated random number sequence.
Setting 2 sites of a major organisation in China (one in Beijing, one in Guangzhou), with a total of 490 employees.
Data Collection Data will be collected through online questionnaires emailed to all employee participants (Time 1 = T1). Employees in both groups will complete a second online questionnaire (Time 2 = T2). For the intervention group T2 will be immediately post-intervention, for the wait-list control group this will be just prior to receiving the intervention.
Sample size At an individual level, the estimated sample size is a minimum 72 for intervention group and 72 for control group, alpha 0.05, beta 0.2 and power 0.8.
Intervention This digital intervention consists of a series of six video clips demonstrating Qigong exercises designed to be undertaken at set exercise break times during the working day. The intervention includes a specially designed logo and selected images to be used on promotional posters and a dedicated 'Move-It' webpage. The six promotional videos are designed to be posted in sequence, one every two weeks, on the Move-It website. A Move-It icon on each employee's desktop computer screen will be scheduled to pop up twice a day as a prompt to interrupt sitting. The intervention is designed to be completed within 12 weeks.
Measures Self-report measures of PA, work performance and weekday sitting hours are taken at T1 (baseline) and T2 (12 week follow-up).
Data analysis Intervention outcome data will be analysed using the Statistical Package for the Social Sciences (IBM SPSS) Version 24.
Outcomes will be compared between the pre- and post-intervention time points. Intracluster correlations and estimated effects sizes will be presented for each outcome. Data from both clusters will be included in all analyses, and analysis is by intention-to-treat.
Process evaluation Will take place at the end of the intervention (intervention site only). This will include up to 6 focus groups (up to n=35) with employees (both participants and non-participants), organisational committee members and senior management.
These will be aligned with the RE-AIM framework to explore intervention reach, effectiveness, adoption, implementation and maintenance.
- Conditions
- Physical Activity
- Being tested
- Move-It
- Keywords
- exercise, worksite, digital, health promotion
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Move-ItBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (MoveIt) | Experimental | 10-minute Qigong exercise session (video demonstration via website) delivered twice a day at set break times during the working day for 12 consecutive weeks Receives: Behavioral: Move-It |
| Wait-list control group | No intervention | No intervention for 12 weeks. Then received the MoveIt Intervention for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ) Taiwanese short form
Measure of self-reported physical activity. Includes culturally sensitive Chinese translations for the terms "moderate", "vigorous" and "physical activity" as well as to identify representative types of physical activity for Taiwanese. Content validity 0.994.
Measured: Covers a person's record of physical activity for a period of seven days
Secondary outcomes (2)
Health and Work Performance Questionnaire (HPQ).
Self-reported work performance. Single item was used from this scale. Item was measured on a 10-point scale ranging from 0=worst performance to 10=top performance.
Item is: 'how would you rate your overall performance on the days you worked during the past 4 weeks?'.
Measured: Overall performance rating for the days worked over the past 4 weeks.
Weekday sitting hours
Self-reported average sitting hours per day: participants report number of hours (to the nearest whole hour) spent sitting on a typical workday.
Measured: 1 day (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Mar 2013
- Primary completion7 Oct 2013
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Model description
- Cluster randomised control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Blake, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038658
- Sponsor's protocol ID
- Lai/27/6/13
- Acronym
- Move-It
- Status last verified
- Sep 2021
- First submitted
- 23 Jul 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will adhere to data sharing regulations of target journal
Publications
Blake H, Lai B, Coman E, Houdmont J, Griffiths A. Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation. Int J Environ Res Public Health. 2019 Sep 17;16(18):3451. doi: 10.3390/ijerph16183451.
PubMed 31533292
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move-It: A Cluster-randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation
- ClinicalTrials.gov ID
- NCT04038658
- Acronym / sponsor ID
- Move-It / Lai/27/6/13
- Conditions
- Physical Activity
- Keywords
- exercise, worksite, digital, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 7 Oct 2013 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China.
The intervention is informed by behaviour change theory, and is a digital workplace intervention (called Move-It) involving a 10-minute Qigong exercise session (video demonstration via website) which is delivered twice a day at set break times during the working day for 12 consecutive weeks.
The setting is a large organisation with 2 sites (in Beijing and Guangzhou). The objectives are to examine the effect of a video-based intervention on employees' physical activity, time spent sitting and work performance. This is tested in a 2-group, randomised wait-list control trial. This means that employees at one site receive the intervention first (site 1 - intervention group), and when they have completed (12 weeks later), the other site then receives the same intervention (site 2 - wait-list control). At the end of the intervention, there is a process evaluation with the intervention group which includes focus groups with employees and managers to gather information about the way in which the intervention was implemented. The process evaluation is based on a framework called 'Reach Effectiveness Adoption Implementation Maintenance' (RE-AIM). Data were collected at baseline (before the intervention began) and after 12 weeks in both groups.
Detailed description
Aim The aim of the study is to deliver a digital video-based worksite exercise intervention in China and conduct outcome and process evaluation. The objectives are: [1] to examine the effect of a video-based intervention on physical activity (PA) and weekday sitting hours (individual level); [2] to examine the effect of a video-based intervention on individual work performance (individual level); [3] to conduct a process evaluation of the intervention implementation (individual and cluster level).
Design This is a 2-arm cluster-randomised wait-list control trial, with outcomes assessed in two groups: intervention and wait-list control (objectives 1 and 2).
Clusters (sites) will be randomly allocated to groups at 1:1 ratio using computer-generated random number sequence.
Setting 2 sites of a major organisation in China (one in Beijing, one in Guangzhou), with a total of 490 employees.
Data Collection Data will be collected through online questionnaires emailed to all employee participants (Time 1 = T1). Employees in both groups will complete a second online questionnaire (Time 2 = T2). For the intervention group T2 will be immediately post-intervention, for the wait-list control group this will be just prior to receiving the intervention.
Sample size At an individual level, the estimated sample size is a minimum 72 for intervention group and 72 for control group, alpha 0.05, beta 0.2 and power 0.8.
Intervention This digital intervention consists of a series of six video clips demonstrating Qigong exercises designed to be undertaken at set exercise break times during the working day. The intervention includes a specially designed logo and selected images to be used on promotional posters and a dedicated 'Move-It' webpage. The six promotional videos are designed to be posted in sequence, one every two weeks, on the Move-It website. A Move-It icon on each employee's desktop computer screen will be scheduled to pop up twice a day as a prompt to interrupt sitting. The intervention is designed to be completed within 12 weeks.
Measures Self-report measures of PA, work performance and weekday sitting hours are taken at T1 (baseline) and T2 (12 week follow-up).
Data analysis Intervention outcome data will be analysed using the Statistical Package for the Social Sciences (IBM SPSS) Version 24.
Outcomes will be compared between the pre- and post-intervention time points. Intracluster correlations and estimated effects sizes will be presented for each outcome. Data from both clusters will be included in all analyses, and analysis is by intention-to-treat.
Process evaluation Will take place at the end of the intervention (intervention site only). This will include up to 6 focus groups (up to n=35) with employees (both participants and non-participants), organisational committee members and senior management.
These will be aligned with the RE-AIM framework to explore intervention reach, effectiveness, adoption, implementation and maintenance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (MoveIt) | Experimental | Behavioral: Move-It10-minute Qigong exercise session (video demonstration via website) delivered twice a day at set break times during the working day for 12 consecutive weeks |
| Wait-list control group | No intervention | –No intervention for 12 weeks. Then received the MoveIt Intervention for 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Employee of participating organisation
Key exclusion criteria (1 listed)
- Not an employee of participating organisation
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 |
|---|---|---|
| Move-It | Behavioural | Intervention Group (MoveIt) |
Primary outcome
International Physical Activity Questionnaire (IPAQ) Taiwanese short form
Time frame: Covers a person's record of physical activity for a period of seven days
Measure of self-reported physical activity. Includes culturally sensitive Chinese translations for the terms "moderate", "vigorous" and "physical activity" as well as to identify representative types of physical activity for Taiwanese. Content validity 0.994.
2 secondary outcomes
Health and Work Performance Questionnaire (HPQ).
Time frame: Overall performance rating for the days worked over the past 4 weeks.
Weekday sitting hours
Time frame: 1 day (average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Results publication: PubMed 31533292Blake H, Lai B, Coman E, Houdmont J, Griffiths A. Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation. Int J Environ Res Public Health. 2019 Sep 17;16(18):3451. doi: 10.3390/ijerph16183451.
- Individual participant dataSharing planned: Yes. Will adhere to data sharing regulations of target journal
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Move-It in people with Physical Activity, run by University of Nottingham at 1 site in United Kingdom.
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 14 Sep 2021. 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 Kingdom. 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?
International Physical Activity Questionnaire (IPAQ) Taiwanese short form (time frame: Covers a person's record of physical activity for a period of seven days). 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 NCT04038658, 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 14 Sep 2021.