Clinical trial NCT02553980: Virtual Trainer System (3rd Version) for Physical Activity Promotion in Middle-aged Hong Kong Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Physical activity
Information technology
Middle-aged
Health promotion
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 261
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Secondary outcomes:
measure: Changes of cardio-respiratory fitness as measured by the symptom limited maximal treadmill exercise test using the metabolic analyzer (Cosmed K4b2, Italy)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of resting VO2 (ml•min-1•kg-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of resting kilocalorie expenditure (KCal in KCal•min-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of resting heart rate (HR in beats•min-1) as measured by heart rate monitor
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of body weight as measured by weighting scale
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of body mass index (BMI) as measured by the calculation of weight (kg) divided by the square of height (cm)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of waist circumference as measured by standardized tape measure
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of hip circumference as measured by standardized tape measure
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of body fat percentage as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of body mass as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of waist hip ratio (WHR) as measured by the calculation of dividing the waist circumference (cm) by the hip circumference (cm)
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of blood pressure as measured by the mercury sphygmomanometer
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of health-related quality of life as measured by the SF-36
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of sleep quality as measured by the Pittsburgh Sleep Quality Index
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of sleep quantity as measured by a 7-day Daily Sleep Log
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Changes of self-perceived fatigue as measured by the Numeric Rating Scale (NRS)-fatigue
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
measure: Maintenance of physical activity as measured a self-administered questionnaire
timeFrame: Measures will be done at two time points: 6 months and 9 months
measure: Behavior mediators as measured by a self-administered questionnaire
timeFrame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Stanley Sai-chuen Hui, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.