Sedentary LifestyleNCT02553980
Virtual Trainer System (3rd Version) for Physical Activity Promotion in Middle-aged Hong Kong Adults
A study testing Follow Your Virtual Trainer (FYVT) program and Daily PA recommendation & healthy lifestyle suggestions in people with Sedentary Lifestyle, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Practicing a habitual physical activity is important for health. A Virtual Trainer (VT) online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for encouraging an active lifestyle. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Follow Your Virtual Trainer (FYVT) program and Daily PA recommendation & healthy lifestyle suggestions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2015to 30 Oct 2017
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 40 to 65 years
- able to understand Cantonese and read Chinese
- self-reported inactivity (no habitual exercise experience for at least 6 months)
- the baseline resting energy expenditure (REE) is less than 1.05 kcal•min-1 for men and 0.85 kcal•min-1 for women
- reachable by telephone
- have basic computer skills
- have smartphone and always surf internet (at least 4 times per week)
- will not leave Hong Kong for a long time (longer than 2 months) during the study period
Who cannot join
- self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, and osteoarthritis
- receiving medically prescribed diet or PA intervention
- blood pressure ≥ 160/100 mmHg
- using of medication that may influence exercise performance
- for women, currently pregnant or plan to become pregnant in the next 1 years, and those receiving hormonal therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Dissemination of an Online Exercise and Health Promotion Program for Hong Kong Middle-aged Chinese: The Virtual Trainer System 3rd Version
Practicing a habitual physical activity is important for health. A Virtual Trainer (VT) online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for encouraging an active lifestyle. This project intends to further improve the VT (3rd version) which incorporates more effective psychological and e-health theories, and disseminate it to Hong Kong middle-aged adults.
Read the detailed description
Hong Kong is a highly urbanized city that many people work long hours daily and over the week, especially for those middle-aged adults. The limited time and lack of professional exercise instruction are always the barriers for them to participate in physical activity (PA). With the advances in information technology (IT), the knowledge of PA can be rapidly disseminated through the Internet and smartphone. We design an IT- instruction based lifestyle intervention program, with the purpose to improve PA level and health status in a sample of middle-aged Hong Kong adults. A two-arm parallel individual level randomized controlled trial (RCT) named "Follow Your Virtual Trainer (FYVT)" will be conducted among 200 healthy and sedentary Chinese adults aged from 40 to 65 years. The participants will be randomly allocated into intervention group or control group. Those in intervention group will under the instruction of a web-based computer software termed "Virtual Trainer", which interact with their smartphone apps, to conduct a 3-month self-planned PA training program. A serious of online video seminars with healthy lifestyle themes will be released to the participants biweekly among 3 months. After that, 6 months observation will be followed. Those in control group will only receive a written advice of standard PA recommendation, and the textual content of the seminars. The assessments will be implemented at baseline, 3, 6, and 9 month. Primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire; the second outcomes include cardio-respiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behavior mediators, and maintenance of PA.
- Conditions
- Sedentary Lifestyle
- Being tested
- Follow Your Virtual Trainer (FYVT) program, Daily PA recommendation & healthy lifestyle suggestions
- Keywords
- Physical activity, Information technology, Middle-aged, Health promotion
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow Your Virtual Trainer (FYVT) programBehavioural
Participants in intervention group will under the instruction of a web-based computer software termed "Virtual Trainer", which interact with their smartphone apps, to conduct a 3-month self-planned PA training program. A serious of online video seminars related to healthy lifestyle advice will be released to the participants among 3 months. After that, 6 months observation will be followed.
Daily PA recommendation & healthy lifestyle suggestionsOther
A written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity promotion I | Experimental | Participants in this group attended the "VT3" program (with Automatic HR detection) Receives: Behavioral: Follow Your Virtual Trainer (FYVT) program |
| Physical activity promotion II | Experimental | Participants in this group attended the "VT2" program (self PA report) Receives: Behavioral: Follow Your Virtual Trainer (FYVT) program |
| Control | Placebo comparator | Participants in this group did not receive any VT treatment, and live as usual. Receives: Other: Daily PA recommendation & healthy lifestyle suggestions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Secondary outcomes (18)
Changes of cardio-respiratory fitness as measured by the symptom limited maximal treadmill exercise test using the metabolic analyzer (Cosmed K4b2, Italy)
The maximal oxygen intake (VO2 max in ml•min-1•kg-1) is used as indicator of cardio-respiratory fitness in our study.
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of resting VO2 (ml•min-1•kg-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of resting kilocalorie expenditure (KCal in KCal•min-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of resting heart rate (HR in beats•min-1) as measured by heart rate monitor
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body weight as measured by weighting scale
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body mass index (BMI) as measured by the calculation of weight (kg) divided by the square of height (cm)
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of waist circumference as measured by standardized tape measure
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of hip circumference as measured by standardized tape measure
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body fat percentage as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body mass as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of waist hip ratio (WHR) as measured by the calculation of dividing the waist circumference (cm) by the hip circumference (cm)
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of blood pressure as measured by the mercury sphygmomanometer
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of health-related quality of life as measured by the SF-36
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of sleep quality as measured by the Pittsburgh Sleep Quality Index
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of sleep quantity as measured by a 7-day Daily Sleep Log
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of self-perceived fatigue as measured by the Numeric Rating Scale (NRS)-fatigue
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Maintenance of physical activity as measured a self-administered questionnaire
A self-administered questionnaire will be given to the participants at 3 and 6 months to evaluate their maintenance of physical activity.
Measured: Measures will be done at two time points: 6 months and 9 months
Behavior mediators as measured by a self-administered questionnaire
The possible behavior mediators will be examined by a self-administered questionnaire that bases on Ajzen's guideline for developing a Theory of Planned Behavior questionnaire. We will structure these mediator variables according to attitude, subjective norms and perceived behavioral control, to understand their intention to active participation in physical activities.
Measured: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
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 Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Model description
- From 1,300 recruitment questionnaires, 261 met inclusion criteria, and 119 were randomly assigned into either n=53 in group 1 (VT3 intervention), 38 in group 2 (VT2 intervention), or 28 control (no-VT).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Sai-Chuen Hui, Chinese University of Hong Kong
- Investigators
- Stanley Sai-chuen Hui, EdD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553980
- Sponsor's protocol ID
- KPF14ICF14
- Status last verified
- Jul 2019
- First submitted
- 17 Feb 2015
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hui SS, Xie YJ, Kwok RC, Tam EW, Mak WWS, Mo PK. Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese. BMJ Open. 2018 Feb 3;8(2):e017908. doi: 10.1136/bmjopen-2017-017908.
PubMed 29431125
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Dissemination of an Online Exercise and Health Promotion Program for Hong Kong Middle-aged Chinese: The Virtual Trainer System 3rd Version
- ClinicalTrials.gov ID
- NCT02553980
- Acronym / sponsor ID
- KPF14ICF14
- Conditions
- Sedentary Lifestyle
- Keywords
- Physical activity, Information technology, Middle-aged, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
Practicing a habitual physical activity is important for health. A Virtual Trainer (VT) online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for encouraging an active lifestyle. This project intends to further improve the VT (3rd version) which incorporates more effective psychological and e-health theories, and disseminate it to Hong Kong middle-aged adults.
Detailed description
Hong Kong is a highly urbanized city that many people work long hours daily and over the week, especially for those middle-aged adults. The limited time and lack of professional exercise instruction are always the barriers for them to participate in physical activity (PA). With the advances in information technology (IT), the knowledge of PA can be rapidly disseminated through the Internet and smartphone. We design an IT- instruction based lifestyle intervention program, with the purpose to improve PA level and health status in a sample of middle-aged Hong Kong adults. A two-arm parallel individual level randomized controlled trial (RCT) named "Follow Your Virtual Trainer (FYVT)" will be conducted among 200 healthy and sedentary Chinese adults aged from 40 to 65 years. The participants will be randomly allocated into intervention group or control group. Those in intervention group will under the instruction of a web-based computer software termed "Virtual Trainer", which interact with their smartphone apps, to conduct a 3-month self-planned PA training program. A serious of online video seminars with healthy lifestyle themes will be released to the participants biweekly among 3 months. After that, 6 months observation will be followed. Those in control group will only receive a written advice of standard PA recommendation, and the textual content of the seminars. The assessments will be implemented at baseline, 3, 6, and 9 month. Primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire; the second outcomes include cardio-respiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behavior mediators, and maintenance of PA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- From 1,300 recruitment questionnaires, 261 met inclusion criteria, and 119 were randomly assigned into either n=53 in group 1 (VT3 intervention), 38 in group 2 (VT2 intervention), or 28 control (no-VT).
| Arm | Type | Receives |
|---|---|---|
| Physical activity promotion I | Experimental | Behavioral: Follow Your Virtual Trainer (FYVT) programParticipants in this group attended the "VT3" program (with Automatic HR detection) |
| Physical activity promotion II | Experimental | Behavioral: Follow Your Virtual Trainer (FYVT) programParticipants in this group attended the "VT2" program (self PA report) |
| Control | Placebo comparator | Other: Daily PA recommendation & healthy lifestyle suggestionsParticipants in this group did not receive any VT treatment, and live as usual. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 40 to 65 years
- able to understand Cantonese and read Chinese
- self-reported inactivity (no habitual exercise experience for at least 6 months)
- the baseline resting energy expenditure (REE) is less than 1.05 kcal•min-1 for men and 0.85 kcal•min-1 for women
- reachable by telephone
Key exclusion criteria (5 listed)
- self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, and osteoarthritis
- receiving medically prescribed diet or PA intervention
- blood pressure ≥ 160/100 mmHg
- using of medication that may influence exercise performance
- for women, currently pregnant or plan to become pregnant in the next 1 years, and those receiving hormonal therapy
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 |
|---|---|---|
| Follow Your Virtual Trainer (FYVT) programParticipants in intervention group will under the instruction of a web-based computer software termed "Virtual Trainer", which interact with their smartphone apps, to conduct a 3-month self-planned PA training program. A serious of online video seminars related to healthy lifestyle advice will be released to the participants among 3 months. After that, 6 months observation will be followed. | Behavioural | Physical activity promotion I, Physical activity promotion II |
| Daily PA recommendation & healthy lifestyle suggestionsA written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants. | Other | Control |
Primary outcome
Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
18 secondary outcomes
Changes of cardio-respiratory fitness as measured by the symptom limited maximal treadmill exercise test using the metabolic analyzer (Cosmed K4b2, Italy)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of resting VO2 (ml•min-1•kg-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of resting kilocalorie expenditure (KCal in KCal•min-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of resting heart rate (HR in beats•min-1) as measured by heart rate monitor
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body weight as measured by weighting scale
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body mass index (BMI) as measured by the calculation of weight (kg) divided by the square of height (cm)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of waist circumference as measured by standardized tape measure
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of hip circumference as measured by standardized tape measure
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body fat percentage as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of body mass as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of waist hip ratio (WHR) as measured by the calculation of dividing the waist circumference (cm) by the hip circumference (cm)
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of blood pressure as measured by the mercury sphygmomanometer
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of health-related quality of life as measured by the SF-36
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of sleep quantity as measured by a 7-day Daily Sleep Log
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Changes of self-perceived fatigue as measured by the Numeric Rating Scale (NRS)-fatigue
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Maintenance of physical activity as measured a self-administered questionnaire
Time frame: Measures will be done at two time points: 6 months and 9 months
Behavior mediators as measured by a self-administered questionnaire
Time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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 25 Jul 2019.
- Derived from this study: PubMed 29431125Hui SS, Xie YJ, Kwok RC, Tam EW, Mak WWS, Mo PK. Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese. BMJ Open. 2018 Feb 3;8(2):e017908. doi: 10.1136/bmjopen-2017-017908.
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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.
Stanley Sai-chuen Hui, EdD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow Your Virtual Trainer (FYVT) program and Daily PA recommendation & healthy lifestyle suggestions in people with Sedentary Lifestyle, run by Chinese University of Hong Kong 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 8 inclusion and 5 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 25 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire (time frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months). 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 NCT02553980, 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 25 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.