Condition category
Not Applicable
Date applied
21/05/2016
Date assigned
24/05/2016
Last edited
26/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sedentary behaviour (taking part in less than an hour a week of physical activity) is associated with an increased risk of heart disease, type 2 diabetes and some forms of cancer, as well as poorer mental wellbeing. It is a growing problem, and is thought to contribute significantly to the high levels of obesity worldwide. It is well known that physical activity (PA) is greatly beneficial to health. Despite this however, the PA levels of young people have been reported to be below the levels sufficient to gain the health benefits exercise can offer. Use of Internet to promote PA is a promising area but studies looking into its effectiveness have produced mixed results. The aim of this study is to examine the effectiveness of an internet-based physical activity promotion programme.

Who can participate?
Full time undergraduate students with a sedentary lifestyle.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group take part in an internet-based behaviour change program designed to promote PA. It is made up of 20 sessions which include reading material about the benefits of exercise and a workbook to complete. Those in the second group receive the same materials as the first group, but the sessions are delivered in weekly, hour-long, face-to-face group classes. Those in the third group continue as usual and do not take part in any behaviour change programs. At the start of the study and again after three and six months, all participants complete a number of questionnaires in order to find out if their physical activity levels have changed.

What are the possible benefits and risks of participating?
Participants may benefit from improving their levels of physical activity. There are no notable risks involved with participating in this study.

Where is the study run from?
The Chinese University of Hong Kong (China)

When is the study starting and how long is it expected to run for?
September 2007 to April 2009

Who is funding the study?
The Chinese University of Hong Kong (China)

Who is the main contact?
Dr Elean Leung
elean@cuhk.edu.hk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elean Leung

ORCID ID

http://orcid.org/0000-0001-6561-3017

Contact details

Physical Education Unit
The Chinese University of Hong Kong
Shatin
Hong Kong
852
China
+852 3943 6088
elean@cuhk.edu.hk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4450244

Study information

Scientific title

The Efficacy of the Internet for Physical Activity Promotion among University Students - Randomized Controlled Trial

Acronym

Study hypothesis

Participants in the internet-based intervention group will demonstrate an improvement in physical activity participation to a similar extent as their counterparts in the face-to-face intervention group.

Ethics approval

The Survey and Behavioural Research Ethics Committee of the Chinese University of Hong Kong, 07/10/2010, ref: 4450244

Study design

Three-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Physical activity level of university students

Intervention

Participants are stratified by gender and stage of behavior change before being randomly allocated via a computer-generated randomization sequence (GraphPad Software, Inc.) into one of the three groups by a statistician who was blinded to the intervention assignment. The participants were notified by e-mail about their randomization allocation.

Internet-based intervention group: Participants are provided with a 20-session online behaviour change program entitled the Active Living Every Day (ALED) program. This involves read the program materials and to then complete the activities via the Internet at a convenient time and place at a rate of one session per week. A complimentary copy of the ALED workbook is provided with the online course. The program contents are designed for learning the behavior modification skills.

Face-to-face intervention group: Participants receive the same information as the internet-based group but in a face-to-face class. They take part in weekly hour-long session for 14 weeks at a university. The discussion class is instructed by a licensed ALED facilitator and is also complemented by the ALED workbook. During the classes, cognitive and behavioral skills for adopting and maintaining an active lifestyle are discussed.

Control group: Participants do not take part in any intervention and continue as usual for the duration of the study.

Follow up involves sending online IPAQ and Stage of Change questionnaires three and six months after the commencement of the intervention to all participants.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Physical activity levels are assessed by the International Physical Activity Questionnaire short form at baseline, 3 and 6 months

Secondary outcome measures

Stage of change assessed by Stage of Exercise Change Questionnaire at baseline, 3 and 6 months.

Overall trial start date

10/09/2007

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Having access to the Internet
2. Being a current full-time undergraduate student
3. Not having any physical conditions that would severely restrict the ability to be physically active
4. Having a total PA score of less than 3,000 MET·minutes per week, at the low- or moderate-activity category of the guidelines for data processing and analysis of the IPAQ

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

1. Having any physical condition that would severely restrict the ability to be physically active
2. Having a total PA score of more than 3,000 MET·minutes per week

Recruitment start date

08/09/2008

Recruitment end date

30/10/2008

Locations

Countries of recruitment

China

Trial participating centre

The Chinese University of Hong Kong
Shatin
Hong Kong
852
China

Sponsor information

Organisation

The Chinese University of Hong Kong

Sponsor details

Shatin
Hong Kong
852
China

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

The Chinese University of Hong Kong

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN33935970_BasicResults_25May16

Publication summary

Publication citations

Editorial Notes

26/05/2016: The basic results of this trial have been uploaded as an additional file.