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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical activity promotion I
Participants in this group attended the "VT3" program (with Automatic HR detection)
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.
Experimental: Physical activity promotion II
Participants in this group attended the "VT2" program (self PA report)
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.
Placebo Comparator: Control
Participants in this group did not receive any VT treatment, and live as usual.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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)
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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)
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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)
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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)
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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)
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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)
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
Time Frame: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months
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
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.
Measures will be done at two time points: 6 months and 9 months
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.
Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPF14ICF14

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