- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02553980
Virtual Trainer System (3rd Version) for Physical Activity Promotion in Middle-aged Hong Kong Adults
July 23, 2019 updated by: Stanley Sai-Chuen Hui, Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
261
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical activity promotion I
Participants in this group attended the "VT3" program (with Automatic HR detection)
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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.
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Experimental: Physical activity promotion II
Participants in this group attended the "VT2" program (self PA report)
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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.
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Placebo Comparator: Control
Participants in this group did not receive any VT treatment, and live as usual.
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A written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The maximal oxygen intake (VO2 max in ml•min-1•kg-1) is used as indicator of cardio-respiratory fitness in our study.
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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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
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A self-administered questionnaire will be given to the participants at 3 and 6 months to evaluate their maintenance of physical activity.
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Measures will be done at two time points: 6 months and 9 months
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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
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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.
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Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
October 30, 2017
Study Completion (Actual)
October 30, 2017
Study Registration Dates
First Submitted
February 17, 2015
First Submitted That Met QC Criteria
September 17, 2015
First Posted (Estimate)
September 18, 2015
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- KPF14ICF14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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