Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000069752
Ethics application status
Approved
Date submitted
17/01/2013
Date registered
18/01/2013
Date last updated
18/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Facebook-delivered Physical Activity Intervention for Post-partum Women
Scientific title
Effect of a Facebook-delivered Physical Activity Intervention for Post-partum Women on Objective Physical Activity (accelerometer step counts) and Secondary Outcomes Including Sleep Quality and
Quantity, Mood, Weight and Wellbeing
Secondary ID [1] 281790 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of physical inactivity 288114 0
Condition category
Condition code
Public Health 288489 288489 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recruitment will occur on a rolling basis over a 6-12 month period. The team forming process occurs in two stages. Stage one involves recruitment of team captains, via advertising flyers in community-based health and family services around greater metropolitan Adelaide. Potential participants who respond to the flyer will be directed to the Mums Step it Up Facebook app, where they will view an online information video and complete a brief online form to confirm their eligibility, at which point they will become a “team captain”. They will then use the Facebook app to invite eligible friends from their existing Facebook network to join their team (Stage two of team formation). The Facebook app will send invitations to the nominated potential team members inviting them to join their friend’s (the team captain’s) team. These women will view an informative video, register their details and provide preliminary consent to participate in the study.

Team captains receive daily emails informing them of their friends’ responses to the invitations. Once at least 3 friends have joined the team, the team captain uses the app to finalize their team. At this point, all participants in the team will be contacted to arrange a face to face appointment with the Principal Investigator where full informed consent will be gained and baseline assessments completed. Once this assessment has been completed for all members of a team, the team will be randomly allocated (using block randomization) to one of three conditions

Arm 1: Mums Step it Up Program. This is a 50 day team-based physical activity intervention delivered via a Facebook app. Participants randomised to this intervention group will be given a pedometer and encouraged to take 10,000 steps per day with the cumulative goal of 500,000 steps. Participants will use the Facebook app to record their daily step counts, monitor their own progress as well as their teams and to interact with their team mates and other women in the Mums Step it Up Program.

Arm 2: Pedometer only. Participants randomised to this group will be given written advice on the health benefits of achieving 10,000 steps per day and tips on how to achieve this and will recieve a pedometer and log book to record their daily step counts. They will be asked to wear the pedometer and record their steps on a daily basis for a total of 50 days.
Intervention code [1] 286332 0
Prevention
Intervention code [2] 286333 0
Lifestyle
Intervention code [3] 286334 0
Behaviour
Comparator / control treatment
Arm 3: Waitlist Control group. Participants randomised to this group will be given written advice on the health benefits of achieving 10,000 steps per day and tips on how to achieve this. They will be placed on a waiting list and given access to the Mums Step it Up Facebook app once data collection has been completed.
Control group
Active

Outcomes
Primary outcome [1] 288646 0
Accelerometer step counts (objective physical activity). Measured using Actigraph GTX3+ accelerometers.
Timepoint [1] 288646 0
Baseline, six weeks and six months after intervention commencement
Secondary outcome [1] 300689 0
Secondary outcome 1: Sleep quality and quantity measured using the General Sleep Disturbance Scale
Timepoint [1] 300689 0
Secondary outcome 1: baseline, 6 weeks and 6 months after intervention commencement
Secondary outcome [2] 300690 0
Secondary Outcome 2: Mood, measured using the Edinburgh Post-natal Depression Scale
Timepoint [2] 300690 0
Secondary Outcome 2: baseline, 6 weeks and 6 months after intervention commencement
Secondary outcome [3] 300691 0
Secondary Outcome 3: Quality of Life, measured using the AQoL 8D
Timepoint [3] 300691 0
Secondary Outcome 3: baseline, 6 weeks and 6 months after intervention commencement
Secondary outcome [4] 300692 0
Secondary Outcome 4: Weight, determined through height (Victa Stadiometer) and weight (Tanita HD332 electronic scales) measurements taken according to International Society for the Advancement of Kinanthropometry protocols
Timepoint [4] 300692 0
Secondary Outcome 4: baseline, 6 weeks and 6 months after intervention commencement
Secondary outcome [5] 300693 0
Feasibility of the Mums Step it Up Program. This will be assessed on the basis of participants’ recall, use and satisfaction with the program, using self-report items developed and used previously by the investigators
Timepoint [5] 300693 0
6 weeks after intervention commencement
Secondary outcome [6] 300694 0
Engagement with the Mums Step it Up Program. This will be assessed on the basis of login statistics. Specifically, the number and duration of logins, frequency of logging daily steps and number of interactions with team members will be recorded.
Timepoint [6] 300694 0
At the completion of the intervention

Eligibility
Key inclusion criteria
To be eligible women must be: 1) up to 12 months post-partum, whether it is their first or subsequent child, 2) current Facebook users, 3) able to read and understand English, 4) and live in greater metropolitan Adelaide.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women should not have a medical condition that would prevent them from participating in a walking program or be pregnant, or planning to fall pregnant in the next three months.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intention to treat principle will be used for data analysis whereby all participants randomized at the commencement of the trial will remain in the sample for analysis. Random effect mixed modeling will be used to determine the effectiveness of the intervention program. The relationship between primary and secondary outcomes and demographic variables will be assessed and where relationships exist the demographic variables will be used as covariates.

Feasibility and engagement data for the Mums Step it Up Program will be descriptively analyzed. In addition, sub group analysis will be undertaken to determine whether the intervention effectiveness is related to dosage and/or compliance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
1/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286574 0
University
Name [1] 286574 0
School of Health Sciences
University of South Australia
Country [1] 286574 0
Australia
Primary sponsor type
University
Name
School of Health Sciences, University of South Australia
Address
City East Campus
GPO Box 2471,
Adelaide 5001
Country
Australia
Secondary sponsor category [1] 285358 0
None
Name [1] 285358 0
Address [1] 285358 0
Country [1] 285358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288643 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288643 0
Ethics committee country [1] 288643 0
Australia
Date submitted for ethics approval [1] 288643 0
Approval date [1] 288643 0
16/08/2012
Ethics approval number [1] 288643 0
0000030420

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

Contacts
Principal investigator
Name 37110 0
Mrs Jocelyn Kernot
Address 37110 0
School of Health Sciences
University of South Australia
GPO Box 2471,
Adelaide SA 5001
Country 37110 0
Australia
Phone 37110 0
0061 08 8302 1289
Fax 37110 0
0061 08 8302 2645
Email 37110 0
[email protected]
Contact person for public queries
Name 37111 0
Jocelyn Kernot
Address 37111 0
School of Health Sciences
University of South Australia
GPO Box 2471,
Adelaide SA 5001
Country 37111 0
Australia
Phone 37111 0
+61 8 8302 1289
Fax 37111 0
+61 08 8302 2645
Email 37111 0
[email protected]
Contact person for scientific queries
Name 37112 0
Carol Maher
Address 37112 0
School of Health Sciences
University of South Australia
GPO Box 2471,
Adelaide SA 5001
Country 37112 0
Australia
Phone 37112 0
+61 8 8302 2315
Fax 37112 0
+61 8 8302 2315
Email 37112 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
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