- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391270
A Blended Intervention to Promote Physical Activity, Health and Work Productivity Among Office Employees
A Blended Intervention to Promote Physical Activity, Health and Work Productivity Among Office Employees Using Intervention Mapping: A Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Regular participation in moderate-to-vigorous physical activity (MVPA) is related to decreased risk of morbidity and mortality. Among working populations, lack of MVPA may also be a risk factor for absenteeism and presenteeism. Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity. However, several challenges limit their application in real world contexts. A 'blended' intervention approach combining the two intervention strategies is proposed to overcome these limitations. The proposed intervention aims to utilize the blended approach to increase participation in MVPA, health-related outcomes, and work productivity among inactive workers.
Methods: The study will comprise of a three group cluster randomized controlled trial (cluster-RCT), comprising a three-month actual intervention and a nine-month behavioral follow-up period. The three groups will be: a web-based intervention group, a blended intervention group combining the web-based components with face-to-face workshops, and a control group. Physically inactive office employees (N = 141) from will be recruited and randomly assigned to the three groups by cluster randomization. The intervention mapping (IM) framework will be used for selecting and applying effective health behavioural theories and behavioural change techniques (BCTs) to the development, implementation and assessment of the intervention, which will be personally tailored. The primary outcome variable will be objectively measured MVPA using an accelerometer. Secondary outcomes will consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, and health-related quality of life, and work-related variables including absenteeism and presenteeism.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kowloon Tong, Hong Kong
- Department of Sport, Physical Education, and Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- physically inactive (do NOT meet the WHO's recommended MVPA levels)
- office employees in Hong Kong.
Exclusion Criteria:
- participants are engaging other ongoing programs involving MVPA promotion
- if they report any conditions preventing them from being active.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: web-based intervention group
Except "Library", the participants in this group will also have access to the "Intervention" sub-section of the website.
It will consist of six sessions delivered every two weeks following the same time schedule as the essay delivery in "Library".
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A web-based intervention only referred to the use of internet without traditional face-to-face workshops and posters
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Experimental: blended intervention group
Except visiting "Library" and "Intervention" of the website, the participants in this group will also receive three face-to-face workshops (40 min per session) held at their workplaces.
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A blended intervention group combining the web-based components with face-to-face workshops and posters
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No Intervention: Control group
The participants in the control group will have access to the "Library" sub-section of the website.
General information of MVPA, health and work productivity will be provided with 18 short essays, which can be downloaded and printed out.
The information will be factual and non-personally tailored.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
moderate-to-vigorous physical activity (MVPA) levels
Time Frame: baseline, 13 weeks, 25 weeks
|
examine between-group differences in changes of objectively measured MVPA levels (min/week) among a randomly selected sample of office employees who are physically inactive in Hong Kong
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baseline, 13 weeks, 25 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes of self-report MVPA levels (min/week)
Time Frame: baseline, 13 weeks, 25 weeks
|
To examine between-group differences in changes of self-reported MVPA levels (min/week) in different domains among the sample.
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baseline, 13 weeks, 25 weeks
|
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Height in meters
Time Frame: baseline, 13 weeks, 25 weeks
|
Height will be measured to the nearest 0.1 cm using a stadiometer.
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baseline, 13 weeks, 25 weeks
|
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Weight in kilograms
Time Frame: baseline, 13 weeks, 25 weeks
|
Weight will be measured to the nearest 0.1 kg on a calibrated digital balance scale (Seca, max.
200 kg, Germany) with the participants wearing lightweight clothing and no shoes.
|
baseline, 13 weeks, 25 weeks
|
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Body mass index (BMI, kg/m2)
Time Frame: baseline, 13 weeks, 25 weeks
|
Body mass index (BMI, kg/m2) will be calculated from weight and height.
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baseline, 13 weeks, 25 weeks
|
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Waist circumference (cm)
Time Frame: baseline, 13 weeks, 25 weeks
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Waist circumference (cm) will be measured midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration
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baseline, 13 weeks, 25 weeks
|
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%Body fat
Time Frame: baseline, 13 weeks, 25 weeks
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%BF will be assessed by a Tanita TBF-410 Body Composition Analyzer (Tanita Corporation, Tokyo, Japan) using foot-to-foot bioelectrical impedance analysis (BIA).
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baseline, 13 weeks, 25 weeks
|
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Blood pressure (mmHg)
Time Frame: baseline, 13 weeks, 25 weeks
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Blood pressure will be measured using the Omron M6 Compact (HEM-7000-E, Omron Healthcare Corporation, Kyoto, Japan) following standard measurement protocols.
|
baseline, 13 weeks, 25 weeks
|
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Hemoglobin A1C (%)
Time Frame: baseline, 13 weeks, 25 weeks
|
Hemoglobin A1C will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK).
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baseline, 13 weeks, 25 weeks
|
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Depression, anxiety and stress
Time Frame: baseline, 13 weeks, 25 weeks
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Depression, anxiety and stress will be measured using the Chinese version of the Depression Anxiety Stress Scale (DASS-21)
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baseline, 13 weeks, 25 weeks
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Presenteeism
Time Frame: baseline, 13 weeks, 25 weeks
|
It will be assessed using presenteeism questions derived from the WHO's Heath and Work Performance Questionnaire (HPO).
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baseline, 13 weeks, 25 weeks
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High-density lipoprotein (mmol/L)
Time Frame: baseline, 13 weeks, 25 weeks
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high-density lipoprotein will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK).
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baseline, 13 weeks, 25 weeks
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Triglyceride (mmol/L)
Time Frame: baseline, 13 weeks, 25 weeks
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Triglyceride will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK).
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baseline, 13 weeks, 25 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin S. Hagger, Dr., University of California, Merced
- Principal Investigator: Xiangyan Chen, Dr., The Hong Kong Polytechnic University
- Principal Investigator: Xiu Ming Fong, Dr., Hong Kong Nang Yan College of Higher Education, Hong Kong, China
- Principal Investigator: Chunqing Zhang, Dr., Hong Kong Baptist University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12609919
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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