NCT02553980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

February 17, 2015

Last Update Submit

July 23, 2019

Conditions

Sedentary Lifestyle

Keywords

Physical activityInformation technologyMiddle-agedHealth promotion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Changes of cardio-respiratory fitness as measured by the symptom limited maximal treadmill exercise test using 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 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

  • +13 more secondary outcomes

Study Arms (3)

Physical activity promotion I

EXPERIMENTAL

Participants in this group attended the "VT3" program (with Automatic HR detection)

Behavioral: Follow Your Virtual Trainer (FYVT) program

Physical activity promotion II

EXPERIMENTAL

Participants in this group attended the "VT2" program (self PA report)

Behavioral: Follow Your Virtual Trainer (FYVT) program

Control

PLACEBO COMPARATOR

Participants in this group did not receive any VT treatment, and live as usual.

Other: Daily PA recommendation & healthy lifestyle suggestions

Interventions

Follow Your Virtual Trainer (FYVT) programBEHAVIORAL

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.

Physical activity promotion IPhysical activity promotion II
Daily PA recommendation & healthy lifestyle suggestionsOTHER

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

Control

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 29431125DERIVED

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stanley Sai-chuen Hui, EdD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomly assigned into either treatment 1, treatment 2, or control. All participants were managed in individual basis, hence no interaction between any participants was guaranteed. Participants were informed only their treatment without knowing the existence of other treatment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2015

First Posted

September 18, 2015

Study Start

October 1, 2015

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

HK(1)