Trial from ANZCTR


Trial ID ACTRN12613000069752
Trial Status: Registered
Date Submitted: 17/01/2013
Date Registered: 18/01/2013
Prospectively registered

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Public title Effectiveness of a Facebook-delivered Physical Activity Intervention for Post-partum Women
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 281790 0
None
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Prevention of physical inactivity 288114 0
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Condition category: Condition code:
Public Health Health promotion/education
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Descriptions 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.
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Intervention Code:
Prevention 286332 0
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Intervention Code:
Lifestyle 286333 0
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Intervention Code:
Behaviour 286334 0
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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.
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Control group Active
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Primary Outcome: Accelerometer step counts (objective physical activity). Measured using Actigraph GTX3+ accelerometers. 288646 0
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Timepoint: Baseline, six weeks and six months after intervention commencement 288646 0
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Secondary Outcome: Secondary outcome 1: Sleep quality and quantity measured using the General Sleep Disturbance Scale 300689 0
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Timepoint: Secondary outcome 1: baseline, 6 weeks and 6 months after intervention commencement 300689 0
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Secondary Outcome: Secondary Outcome 2: Mood, measured using the Edinburgh Post-natal Depression Scale 300690 0
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Timepoint: Secondary Outcome 2: baseline, 6 weeks and 6 months after intervention commencement 300690 0
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Secondary Outcome: Secondary Outcome 3: Quality of Life, measured using the AQoL 8D 300691 0
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Timepoint: Secondary Outcome 3: baseline, 6 weeks and 6 months after intervention commencement 300691 0
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Secondary Outcome: 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 300692 0
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Timepoint: Secondary Outcome 4: baseline, 6 weeks and 6 months after intervention commencement 300692 0
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Secondary Outcome: 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 300693 0
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Timepoint: 6 weeks after intervention commencement 300693 0
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Secondary Outcome: 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. 300694 0
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Timepoint: At the completion of the intervention 300694 0
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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.
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Minimum age No limit
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Maximum age No limit
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Gender Females
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Healthy volunteers? Yes
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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.
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Study type Interventional
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Purpose of the study Educational / counselling / training
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation is not concealed.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Block randomisation
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply) The people receiving the treatment/s


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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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.
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/03/2013
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled 1/09/2014
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Actual date last participant recruited/enrolled
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Target sample size 126
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s) SA
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Recruitment outside Australia

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Funding Source: University 286574 0
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Name: School of Health Sciences University of South Australia 286574 0
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Address: City East Campus
GPO Box 2471,
Adelaide 5001
286574 0
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Country: Australia 286574 0
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Primary Sponsor University
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Name: School of Health Sciences, University of South Australia
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Address: City East Campus
GPO Box 2471,
Adelaide 5001
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Country: Australia
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Secondary Sponsor: None 285358 0
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Name: 285358 0
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Address: 285358 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of South Australia Human Research Ethics Committee 288643 0
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Address: Research and Innovation Services
Mawson Lakes Campus
University of South Australia
GPO Box 2471, Adelaide, SA, 5001
288643 0
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Country: Australia 288643 0
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Approval Date: 16/08/2012 288643 0
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Submitted Date: 288643 0
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HREC: 0000030420 288643 0
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Brief summary Background: Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4-8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program.

Method/Design: A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention to treat basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined.

Discussion: This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public.
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Trial website
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Public Notes
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Principal Investigator
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Name: Jocelyn Kernot
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Address: School of Health Sciences University of South Australia GPO Box 2471, Adelaide SA 5001
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Country: Australia
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Tel: 0061 08 8302 1289
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Fax: 0061 08 8302 2645
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Email: Jocelyn.Kernot@unisa.edu.au
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Contact person for public queries
Title: Mrs
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Name: Jocelyn Kernot
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Address: School of Health Sciences University of South Australia GPO Box 2471, Adelaide SA 5001
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Tel: +61 8 8302 1289
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Email: Jocelyn.Kernot@unisa.edu.au
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Contact person for scientific queries
Title: Dr
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Name: Carol Maher
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Address: School of Health Sciences University of South Australia GPO Box 2471, Adelaide SA 5001
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Tel: +61 8 8302 2315
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Email: Carol.Maher@unisa.edu.au
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Contact person responsible for updating information
Title: Mrs
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Name: Jocelyn Kernot
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Address: School of Health Sciences University of South Australia GPO Box 2471, Adelaide SA 5001
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Country: Australia
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Tel: +61 8 8302 1289
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Fax: +61 08 8302 2645
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Email: Jocelyn.Kernot@unisa.edu.au
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Addition Cancer fields
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