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Completed

NCT Number: NCT02553980

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow Your Virtual Trainer (FYVT) program

Behavioral

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 suggestions

Other

A written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    The maximal oxygen intake (VO2 max in ml•min-1•kg-1) is used as indicator of cardio-respiratory fitness in our study.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

    A self-administered questionnaire will be given to the participants at 3 and 6 months to evaluate their maintenance of physical activity.

  18. 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

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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