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

Sedentary Lifestyle Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553980
• Other study ID #: KPF14ICF14
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 30, 2017

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Follow Your Virtual Trainer (FYVT) program
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.

Other:
• Daily PA recommendation & healthy lifestyle suggestions
A written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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