Virtual Trainer System (3rd Version) for Physical Activity Promotion in Middle-aged Hong Kong Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Dissemination of an Online Exercise and Health Promotion Program for Hong Kong Middle-aged Chinese: The Virtual Trainer System 3rd Version

Conditions
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Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Follow Your Virtual Trainer (FYVT) program
* Other: Daily PA recommendation & healthy lifestyle suggestions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity promotion I<br>Participants in this group attended the VT3 program (with Automatic HR detection) | Behavioral: Follow Your Virtual Trainer (FYVT) program<br>* 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.<br>|
| Experimental: Physical activity promotion II<br>Participants in this group attended the VT2 program (self PA report) | Behavioral: Follow Your Virtual Trainer (FYVT) program<br>* 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.<br>|
| Placebo Comparator: Control<br>Participants in this group did not receive any VT treatment, and live as usual. | Other: Daily PA recommendation & healthy lifestyle suggestions<br>* A written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire |  | Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months | 

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) | The maximal oxygen intake (VO2 max in ml•min-1•kg-1) is used as indicator of cardio-respiratory fitness in our study. | 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) |  | 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) |  | 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 |  | 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 |  | 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) |  | 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 |  | 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 |  | 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) |  | 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) |  | 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) |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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. | 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. | Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Information technology, Middle-aged, Health promotion