Physically Well But WorriedNCT04391270
A Blended Intervention to Promote Physical Activity, Health and Work Productivity Among Office Employees
A study testing blended intervention and web-based intervention in people with Physically Well But Worried, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
The primary objective of this study is to 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physically Well But Worried
- What is being tested?
- blended intervention and web-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2022to 30 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- physically inactive (do NOT meet the WHO's recommended MVPA levels)
- office employees in Hong Kong.
Who cannot join
- participants are engaging other ongoing programs involving MVPA promotion
- if they report any conditions preventing them from being active.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Sport, Physical Education, and Health
Kowloon Tong
About this study
Official title: 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
The primary objective of this study is to 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.
Read the 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.
- Conditions
- Physically Well But Worried
- Being tested
- blended intervention, web-based intervention
- Keywords
- physical activity, 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.
blended interventionBehavioural
A blended intervention group combining the web-based components with face-to-face workshops and posters
web-based interventionBehavioural
A web-based intervention only referred to the use of internet without traditional face-to-face workshops and posters
| Study group | Role | What they receive |
|---|---|---|
| web-based intervention group | Experimental | 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". Receives: Behavioral: web-based intervention |
| blended intervention group | Experimental | 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. Receives: Behavioral: blended intervention |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
moderate-to-vigorous physical activity (MVPA) levels
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
Measured: baseline, 13 weeks, 25 weeks
Secondary outcomes (12)
changes of self-report MVPA levels (min/week)
To examine between-group differences in changes of self-reported MVPA levels (min/week) in different domains among the sample.
Measured: baseline, 13 weeks, 25 weeks
Height in meters
Height will be measured to the nearest 0.1 cm using a stadiometer.
Measured: baseline, 13 weeks, 25 weeks
Weight in kilograms
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.
Measured: baseline, 13 weeks, 25 weeks
Body mass index (BMI, kg/m2)
Body mass index (BMI, kg/m2) will be calculated from weight and height.
Measured: baseline, 13 weeks, 25 weeks
Waist circumference (cm)
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
Measured: baseline, 13 weeks, 25 weeks
%Body fat
%BF will be assessed by a Tanita TBF-410 Body Composition Analyzer (Tanita Corporation, Tokyo, Japan) using foot-to-foot bioelectrical impedance analysis (BIA).
Measured: baseline, 13 weeks, 25 weeks
Blood pressure (mmHg)
Blood pressure will be measured using the Omron M6 Compact (HEM-7000-E, Omron Healthcare Corporation, Kyoto, Japan) following standard measurement protocols.
Measured: baseline, 13 weeks, 25 weeks
Hemoglobin A1C (%)
Hemoglobin A1C will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK).
Measured: baseline, 13 weeks, 25 weeks
Depression, anxiety and stress
Depression, anxiety and stress will be measured using the Chinese version of the Depression Anxiety Stress Scale (DASS-21)
Measured: baseline, 13 weeks, 25 weeks
Presenteeism
It will be assessed using presenteeism questions derived from the WHO's Heath and Work Performance Questionnaire (HPO).
Measured: baseline, 13 weeks, 25 weeks
High-density lipoprotein (mmol/L)
high-density lipoprotein will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK).
Measured: baseline, 13 weeks, 25 weeks
Triglyceride (mmol/L)
Triglyceride will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK).
Measured: baseline, 13 weeks, 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Sep 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
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 Physically Well But WorriedStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Yang, Hong Kong Baptist University
- Investigators
- Martin S. Hagger, Dr., Principal investigator, University of California, MercedXiangyan Chen, Dr., Principal investigator, The Hong Kong Polytechnic UniversityXiu Ming Fong, Dr., Principal investigator, Hong Kong Nang Yan College of Higher Education, Hong Kong, ChinaChunqing Zhang, Dr., Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391270
- Sponsor's protocol ID
- 12609919
- Status last verified
- Feb 2024
- First submitted
- 4 May 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Wang A, Yu S, Hagger MS, Chen X, Fong SSM, Zhang C, Huang WY, Baker JS, Dutheil F, Gao Y. A blended intervention to promote physical activity, health and work productivity among office employees using intervention mapping: a study protocol for a cluster-randomized controlled trial. BMC Public Health. 2020 Jun 25;20(1):994. doi: 10.1186/s12889-020-09128-z.
PubMed 32586293
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04391270
- Acronym / sponsor ID
- 12609919
- Conditions
- Physically Well But Worried
- Keywords
- physical activity, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 18 May 2020 (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 primary objective of this study is to 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| web-based intervention group | Experimental | Behavioral: web-based interventionExcept "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". |
| blended intervention group | Experimental | Behavioral: blended interventionExcept 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- physically inactive (do NOT meet the WHO's recommended MVPA levels)
- office employees in Hong Kong.
Key exclusion criteria (2 listed)
- participants are engaging other ongoing programs involving MVPA promotion
- if they report any conditions preventing them from being active.
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 |
|---|---|---|
| blended interventionA blended intervention group combining the web-based components with face-to-face workshops and posters | Behavioural | blended intervention group |
| web-based interventionA web-based intervention only referred to the use of internet without traditional face-to-face workshops and posters | Behavioural | web-based intervention group |
Primary outcome
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
12 secondary outcomes
changes of self-report MVPA levels (min/week)
Time frame: baseline, 13 weeks, 25 weeks
Height in meters
Time frame: baseline, 13 weeks, 25 weeks
Weight in kilograms
Time frame: baseline, 13 weeks, 25 weeks
Body mass index (BMI, kg/m2)
Time frame: baseline, 13 weeks, 25 weeks
Waist circumference (cm)
Time frame: baseline, 13 weeks, 25 weeks
%Body fat
Time frame: baseline, 13 weeks, 25 weeks
Blood pressure (mmHg)
Time frame: baseline, 13 weeks, 25 weeks
Hemoglobin A1C (%)
Time frame: baseline, 13 weeks, 25 weeks
Depression, anxiety and stress
Time frame: baseline, 13 weeks, 25 weeks
Presenteeism
Time frame: baseline, 13 weeks, 25 weeks
High-density lipoprotein (mmol/L)
Time frame: baseline, 13 weeks, 25 weeks
Triglyceride (mmol/L)
Time frame: baseline, 13 weeks, 25 weeks
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 1 Mar 2024.
- Derived from this study: PubMed 32586293Sun Y, Wang A, Yu S, Hagger MS, Chen X, Fong SSM, Zhang C, Huang WY, Baker JS, Dutheil F, Gao Y. A blended intervention to promote physical activity, health and work productivity among office employees using intervention mapping: a study protocol for a cluster-randomized controlled trial. BMC Public Health. 2020 Jun 25;20(1):994. doi: 10.1186/s12889-020-09128-z.
- Individual participant dataSharing planned: No
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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.
Martin S. Hagger, Dr. principal investigator
University of California, Merced
Xiangyan Chen, Dr. principal investigator
The Hong Kong Polytechnic University
Xiu Ming Fong, Dr. principal investigator
Hong Kong Nang Yan College of Higher Education, Hong Kong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blended intervention and web-based intervention in people with Physically Well But Worried, run by Hong Kong Baptist University at 1 site in Hong Kong.
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 2 inclusion and 2 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 1 Mar 2024. 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 Hong Kong. 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?
moderate-to-vigorous physical activity (MVPA) levels (time frame: baseline, 13 weeks, 25 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 NCT04391270, 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 1 Mar 2024.