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Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation (Move-It)

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: NCT04038658
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief 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 (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.


Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Move-It Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomised control trial
Masking: Single (Outcomes Assessor)
Masking Description: Statistical analysis undertaken by researcher blinded to group allocation.
Primary Purpose: Prevention
Official Title: Move-It: A Cluster-randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : October 7, 2013
Actual Study Completion Date : January 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group (MoveIt)
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
Behavioral: Move-It
No Intervention: Wait-list control group
No intervention for 12 weeks. Then received the MoveIt Intervention for 12 weeks.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Health and Work Performance Questionnaire (HPQ). [ Time Frame: Overall performance rating for the days worked over the past 4 weeks. ]

    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?'.


  2. Weekday sitting hours [ Time Frame: 1 day (average) ]
    Self-reported average sitting hours per day: participants report number of hours (to the nearest whole hour) spent sitting on a typical workday.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Employee of participating organisation

Exclusion Criteria:

Not an employee of participating organisation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038658


Locations
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United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG7 2HA
Sponsors and Collaborators
University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04038658    
Other Study ID Numbers: Lai/27/6/13
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will adhere to data sharing regulations of target journal
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Study registered online at clinical trials.gov (permanent). This includes statistical analysis plan. Data accessible on request - available for 7 years.
Access Criteria: Data accessible on request - available for 7 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
exercise
worksite
digital
health promotion