Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000481976
Ethics application status
Approved
Date submitted
27/04/2011
Date registered
10/05/2011
Date last updated
10/05/2011
Type of registration
Retrospectively registered

Titles & IDs
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
Scientific title
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
Secondary ID [1] 252889 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of cardiovascular disease 258421 0
Condition category
Condition code
Public Health 258588 258588 0 0
Health promotion/education
Cardiovascular 265953 265953 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 257418 0
Lifestyle
Intervention code [2] 257419 0
Behaviour
Intervention code [3] 257420 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 259436 0
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
Timepoint [1] 259436 0
Baseline, immediately post intervention and 6 months post-intervention
Primary outcome [2] 259437 0
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.
Timepoint [2] 259437 0
immediately post-intervention
Primary outcome [3] 259438 0
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.
Timepoint [3] 259438 0
Monitoring of spending throughout program delivery.

Interview and self-complete data will be collected at baseline, immediately post-intervention and 6 months post-intervention
Secondary outcome [1] 265986 0
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.
Timepoint [1] 265986 0
Baseline, immediately post intervention and 6 months post-intervention

Eligibility
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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women will be excluded if they:
1. Have received doctor's advice not to exercise
2. Are currently pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3329 0
4019
Recruitment postcode(s) [2] 3330 0
4020
Recruitment postcode(s) [3] 3331 0
4021
Recruitment postcode(s) [4] 3332 0
4022
Recruitment postcode(s) [5] 3333 0
4036
Recruitment postcode(s) [6] 3334 0
4500
Recruitment postcode(s) [7] 3335 0
4501
Recruitment postcode(s) [8] 3336 0
4502
Recruitment postcode(s) [9] 3337 0
4503
Recruitment postcode(s) [10] 3338 0
4504
Recruitment postcode(s) [11] 3339 0
4505
Recruitment postcode(s) [12] 3340 0
4506
Recruitment postcode(s) [13] 3341 0
4507
Recruitment postcode(s) [14] 3342 0
4508
Recruitment postcode(s) [15] 3343 0
4509
Recruitment postcode(s) [16] 3344 0
4510
Recruitment postcode(s) [17] 3345 0
4511
Recruitment postcode(s) [18] 3346 0
4512
Recruitment postcode(s) [19] 3347 0
4514
Recruitment postcode(s) [20] 3348 0
4516
Recruitment postcode(s) [21] 3349 0
4517
Recruitment postcode(s) [22] 3350 0
4518

Funding & Sponsors
Funding source category [1] 257858 0
Government body
Name [1] 257858 0
National Health and Medical Research Council
Country [1] 257858 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 257063 0
University
Name [1] 257063 0
University of Queensland
Address [1] 257063 0
Brisbane QLD 4072
Country [1] 257063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259891 0
Queensland University of Technology Human Ethics Committee
Ethics committee address [1] 259891 0
Ethics committee country [1] 259891 0
Australia
Date submitted for ethics approval [1] 259891 0
Approval date [1] 259891 0
24/08/2010
Ethics approval number [1] 259891 0
0900001407

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

Contacts
Principal investigator
Name 31787 0
Address 31787 0
Country 31787 0
Phone 31787 0
Fax 31787 0
Email 31787 0
Contact person for public queries
Name 15034 0
Jasmine O'Brien
Address 15034 0
School of Public Health
Queensland University of Technology
Victoria Park Rd Kelvin Grove QLD 4059 Australia
Country 15034 0
Australia
Phone 15034 0
+ 61 73138 3016
Fax 15034 0
Email 15034 0
[email protected]
Contact person for scientific queries
Name 5962 0
Associate Professor Alison Marshall
Address 5962 0
School of Public Health
Queensland University of Technology
Victoria Park Rd Kelvin Grove QLD 4059 Australia
Country 5962 0
Australia
Phone 5962 0
+61 7 3138 5856
Fax 5962 0
Email 5962 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
EmbaseMoving MobileMums forward: protocol for a larger randomized controlled trial of an improved physical activity program for women with young children.2013https://dx.doi.org/10.1186/1471-2458-13-593
Dimensions AIThe cost-effectiveness of the MobileMums intervention to increase physical activity among mothers with young children: a Markov model informed by a randomised controlled trial2015https://doi.org/10.1136/bmjopen-2014-007226
EmbaseHow does MobileMums work? Mediators of a physical activity intervention.2020https://dx.doi.org/10.1080/08870446.2019.1687698
N.B. These documents automatically identified may not have been verified by the study sponsor.