Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001215718
Ethics application status
Approved
Date submitted
4/11/2013
Date registered
5/11/2013
Date last updated
17/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A healthy mind in a healthy body: A two-group randomised pilot trial evaluating web-based physical activity interventions to improve mental and physical health in people with depression
Scientific title
A two-group randomised trial evaluating web-based physical activity interventions to improve mental and physical health in people with depression – A pilot study.
Secondary ID [1] 283510 0
None
Universal Trial Number (UTN)
U1111-1149-8571
Trial acronym
HMHB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Symptoms 290427 0
Condition category
Condition code
Mental Health 290819 290819 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After providing informed consent and completing the baseline survey, participants will be randomly directed to one of two different web-based physical activity programs. The web-based programs are the Walk 2.0 and MyPAA (My Physical Activity Advice) websites developed from previous research projects. Both websites consist of physical activity-related content (e.g., information about goal-setting, the benefits of physical activity). The homepages of both websites will include information about accessing counseling services for depression. The WALK2.0 website is more focused on delivering the material in an interactive manner (providing discussion forums, feedback on goal accomplishment, self-monitoring, etc.) whereas the MyPAA website is more focused on delivering the material with computer-tailoring features (e.g., provides information relevant for that specific person based on that person's behaviour, motivation, etc.). Participants will be able to access the websites as much as they want for as long as they want. Follow-up assessments will occur at 1 and 3 months after baseline.
Intervention code [1] 288215 0
Behaviour
Comparator / control treatment
Two different web-based physical activity programs will be compared to one another.
Control group
Active

Outcomes
Primary outcome [1] 290815 0
Depressive Symptoms as per the CESD-r, a self-report measure of symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-IV) for
a major depressive episode
Timepoint [1] 290815 0
1 month from baseline
Secondary outcome [1] 305356 0
Physical activity behavior will be assessed with the Australian Institute of Health and Welfare's Active Australia Physical Activity self-report measure.
Timepoint [1] 305356 0
3 months from baseline
Secondary outcome [2] 305357 0
Health-related Quality of Life will be measured with the Veterans Rand 12-item health survey
Timepoint [2] 305357 0
1 and 3 months following baseline

Eligibility
Key inclusion criteria
must be 18 years or older and not have a limiting medical condition that makes it unsafe to increase physical activity.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
younger than 18 years or have a limiting medical condition that makes it unsafe for them to increase physical activity. No exclusion criteria are based on depressive symptoms, but recruitment materials will be made to target people with depressive symptoms.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will recruit participants using a Facebook advertisement. After clicking on the web-based advertisement, participants will be directed to the baseline survey. At the end of the survey, a link will direct them to one of two physical activity websites. The allocation concealment method is done via central randomsation by computer. All parties are blinded to this.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The double-blind randomization will be conducted through a randomization system in the URLs that direct them from the survey to the web-based programs.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2013
Actual
1/12/2013
Date of last participant enrolment
Anticipated
15/11/2014
Actual
17/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288212 0
University
Name [1] 288212 0
Central Queensland University Health Collaborative Research Network
Country [1] 288212 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Bruce Highway
Rockhampton, QLD, 4702
Country
Australia
Secondary sponsor category [1] 286935 0
None
Name [1] 286935 0
Address [1] 286935 0
Country [1] 286935 0
Other collaborator category [1] 277683 0
Individual
Name [1] 277683 0
Nicola Burton
Address [1] 277683 0
The School of Human Movement Studies
Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 277683 0
Australia
Other collaborator category [2] 277684 0
Individual
Name [2] 277684 0
Corneel Vandelanotte
Address [2] 277684 0
IHSSR
Building 18
Bruce Highway
Central Queensland University
Rockhampton QLD 4702
Country [2] 277684 0
Australia
Other collaborator category [3] 277685 0
Individual
Name [3] 277685 0
Mitch Duncan
Address [3] 277685 0
IHSSR
Building 18
Bruce Highway
Central Queensland University
Rockhampton QLD 4702
Country [3] 277685 0
Australia
Other collaborator category [4] 277686 0
Individual
Name [4] 277686 0
Camille Short
Address [4] 277686 0
IHSSR
Building 18
Central Queensland University
Bruce Highway
Rockhampton QLD 4702
Australia
Country [4] 277686 0
Australia
Other collaborator category [5] 277687 0
Individual
Name [5] 277687 0
Brenda Happell
Address [5] 277687 0
IHSSR
Building 18
Central Queensland University
Bruce Highway
Rockhampton QLD 4702
Australia
Country [5] 277687 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290122 0
CQUniversity's Human Research Ethics Committee
Ethics committee address [1] 290122 0
Ethics committee country [1] 290122 0
Australia
Date submitted for ethics approval [1] 290122 0
Approval date [1] 290122 0
21/10/2013
Ethics approval number [1] 290122 0
H1308-147

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44062 0
Dr Amanda Rebar
Address 44062 0
Building 18 Room 1.33
Central Queensland University
Bruce Highway
Rockhampton, QLD
4702
Country 44062 0
Australia
Phone 44062 0
+61 7 4923 2182
Fax 44062 0
Email 44062 0
[email protected]
Contact person for public queries
Name 44063 0
Amanda Rebar
Address 44063 0
Building 18 Room 1.33
Central Queensland University
Bruce Highway
Rockhampton, QLD
4702
Country 44063 0
Australia
Phone 44063 0
+61 7 4923 2182
Fax 44063 0
Email 44063 0
[email protected]
Contact person for scientific queries
Name 44064 0
Amanda Rebar
Address 44064 0
Building 18 Room 1.33
Central Queensland University
Bruce Highway
Rockhampton, QLD
4702
Country 44064 0
Australia
Phone 44064 0
+61 7 4923 2182
Fax 44064 0
Email 44064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDepressive symptoms associated with psychological correlates of physical activity and perceived helpfulness of intervention features.2015https://dx.doi.org/10.1016/j.mhpa.2015.08.001
EmbaseHealthy mind, healthy body: A randomized trial testing the efficacy of a computer-tailored vs. interactive web-based intervention for increasing physical activity and reducing depressive symptoms.2016https://dx.doi.org/10.1016/j.mhpa.2016.08.001
N.B. These documents automatically identified may not have been verified by the study sponsor.