Trial from ANZCTR


Trial ID ACTRN12611000481976
Trial Status: Registered
Date Submitted: 27/04/2011
Date Registered: 10/05/2011
Retrospectively registered

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Public title Helping women with young children meet their physical activity goals: a randomised, controlled trial of a personalised program delivered by mobile telephone text messaging
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format MobileMums: evaluating the effects of a personalised program delivered by mobile telephone text messaging on the physical activity levels of women with young children compared with a usual care control
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Secondary ID [1] 252889 0
nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Prevention of cardiovascular disease 258421 0
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Condition category: Condition code:
Public Health Health promotion/education
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Cardiovascular Other cardiovascular diseases
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Descriptions of intervention(s) / exposure MobileMums begins with a one-on-one face-to-face goal-setting session with an exercise counsellor (lasting approximately 45 minutes), and is then followed by a 12-week personalised SMS program (4 to 6 SMS per week) with a brief follow-up telephone consultation with her assigned counsellor at 6 weeks. The text messages emphasise cognitive-behavioural skills such as self-efficacy, use of social support networks, and self-reward. The SMS are tailored based on the woman's exercise goal, outcome expectancies, rewards, and also promote mum-friendly exercise opportunities in her neighbourhood. A support person nominated by the participant during the goal-setting session also receives 3 SMS per week for the duration of the program with tips on how to support the participant to reach her exercise goal.
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Intervention Code:
Lifestyle 257418 0
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Behaviour 257419 0
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Intervention Code:
Prevention 257420 0
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Comparator / control treatment Usual care control participants receive print materials on physical activity at baseline only, and access to the program website which includes information on physical activity for mums, a forum and an exercise directory. The website will be available to participants until the end of the trial.
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Control group Active
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Primary Outcome: Weekly duration of moderate to vigorous physical activity as measured by the Actigraph GT1M activity monitor and walking for exercise (minutes per week) as measured by the Australian Women's Activity Survey 259436 0
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Timepoint: Baseline, immediately post intervention and 6 months post-intervention 259436 0
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Primary Outcome: Program viability and fidelity: All participants recall, use and satisfaction with the program will be assessed using self-report items developed and used previously by the investigators. Responses to program SMS will also be monitored. 259437 0
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Timepoint: immediately post-intervention 259437 0
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Primary Outcome: Cost-effectiveness: Costs incurred through program delivery, text messages, and staff costs will be monitored. Participants will also answer questions relating to use of health care services and any other costs associated with taking up physical activity. Participants will also complete the SF-12 Health Survey. 259438 0
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Timepoint: Monitoring of spending throughout program delivery.

Interview and self-complete data will be collected at baseline, immediately post-intervention and 6 months post-intervention
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Secondary Outcome: Because the intervention targets constructs of Social Cognitive Theory, the following constructs will be measured: physical activity self-efficacy; social support; outcome expectancy; goal setting skills;and perceived environmental opportunity for physical activity. These constructs will be measured via self-report items as a part of a self-complete questionnaire which have been developed and used previously by the research team, and have shown good measurement properties. 265986 0
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Timepoint: Baseline, immediately post intervention and 6 months post-intervention 265986 0
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Key inclusion criteria To be eligible, women must:
1. Have at least one child 5 years old or under (but older than 6 weeks)
2. Live within a 31km radius of Caboolture, Queensland
3. Own a mobile telephone
4. Be able to read and understand English
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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 will be excluded if they:
1. Have received doctor's advice not to exercise
2. Are currently pregnant
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Study type Interventional
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Purpose of the study Prevention
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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) Following a telephone screening, consenting and eligible participants are allocated a participant ID and complete their baseline assessment. Participant IDs are linked to treatment allocation in a separate spreadsheet, which is not revealed until completion of the baseline assessment when participants are either assigned to an exercise counsellor or are sent an information pack if they are in the control group.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Particpants will be randomised to one of two groups: control or intervention. Stratified allocation will be employed based on participants' baseline physical activity levels. Participants will be classified into one of three groups: no physical activity, some physical activity, or sufficient physical activity. For these three groups a randomisation list will be created using the R software package using random permuted blocks.
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Masking / blinding
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Who is / are masked / blinded (choose all that apply)


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Assignment
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 3/03/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Target sample size 400
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 4019 3329 0
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Postcode: 4020 3330 0
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Postcode: 4021 3331 0
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Recruitment outside Australia

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Funding Source: Government body 257858 0
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Name: National Health and Medical Research Council 257858 0
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Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country: Australia 257858 0
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Primary Sponsor University
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Name: Queensland University of Technology
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Address: Victoria Park Rd Kelvin Grove QLD 4059
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Country: Australia
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Secondary Sponsor: University 257063 0
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Name: University of Queensland 257063 0
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Address: Brisbane QLD 4072 257063 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Queensland University of Technology Human Ethics Committee 259891 0
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Address: Governance Services
Queensland University of Technology
GPO Box 2434
2 George Street
Brisbane Q 4001
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Country: Australia 259891 0
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Approval Date: 24/08/2010 259891 0
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Submitted Date: 259891 0
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HREC: 0900001407 259891 0
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Brief summary This project is a randomised controlled trial evaluating the effects of "MobileMums": an intervention delivered predominantly by mobile telephone text messaging. The aim of this study is to determine the effects of the program on physical activity levels of women with young children, relative to a control group. We hypothesise that MobileMums will increase the amount of time women spend doing moderate-to-vigorous intensity physical activity each week.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Jasmine O'Brien
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Address: School of Public Health Queensland University of Technology Victoria Park Rd Kelvin Grove QLD 4059 Australia
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Country: Australia
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Tel: + 61 73138 3016
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Email: jasmine.obrien@qut.edu.au
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Contact person for scientific queries
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Name: Associate Professor Alison Marshall
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Address: School of Public Health Queensland University of Technology Victoria Park Rd Kelvin Grove QLD 4059 Australia
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Country: Australia
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Tel: +61 7 3138 5856
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Email: alison.marshall@qut.edu.au
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Contact person responsible for updating information
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Name: Associate Professor Alison Marshall
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Address: School of Public Health Queensland University of Technology Victoria Park Rd Kelvin Grove QLD 4059 Australia
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Country: Australia
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Email: alison.marshall@qut.edu.au
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Addition Cancer fields
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