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Trial registered on ANZCTR


Registration number
ACTRN12617001489381
Ethics application status
Approved
Date submitted
26/09/2017
Date registered
20/10/2017
Date last updated
20/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth physical activity intervention for pregnant women integrated into clinical practice – a randomised controlled trial
Scientific title
Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth physical activity intervention for pregnant women integrated into clinical practice – a randomised controlled trial
Secondary ID [1] 292974 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 304872 0
Physical Activity 304957 0
Condition category
Condition code
Public Health 304184 304184 0 0
Health promotion/education
Public Health 304185 304185 0 0
Health service research
Reproductive Health and Childbirth 304186 304186 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants complete a 10 minute online questionnaire on physical activity levels before pregnancy and current physical activity levels via an iPad Kiosk whilst waiting in the reception area prior to their appointment with their practitioner.

Intervention Group 1:
Tailored advice without practitioner endorsement.
Once participants complete their baseline survey, they will be instructed to collect their print-based personally-tailored physical activity advice (based on participant information collected during baseline survey) from the reception desk at the conclusion of the consultation with their medical practitioner. Their highly personalised tailored physical activity advice will cover the same content as those in the control group received, however the information will be tailored and personalise, as well as additional information on the benefits of physical activity during pregnancy, aerobic and resistance-based exercise recommendations, advice for active living during pregnancy and a number of strategies to help increase physical activity levels. Furthermore, all of this information will be presented in a highly personalised and tailored way in relation to the individual’s physical activity behaviours. The physical activity advice will include a summary page at the beginning of the document of personalised and tailored physical activity recommendations and will also encourage participants to visit the Fit4Two website.

Intervention Group 2:
Tailored advice with practitioner endorsement (Obstetrician or Midwife).
Upon completing the baseline assessment, participants in this group will be provided with the same print-based personally-tailored physical activity advice and information as those in intervention group 1. However, their tailored physical activity advice will be instantaneously sent from the iPad to a wireless printer located within the practitioners’ consultation office, where the practitioner has the opportunity to briefly look over the contents provided prior to the patient coming in. The tailored physical activity advice can then be directly handed to participant by their practitioner. Practitioners will then be asked to go over the advice with the patients and to endorse the contents. Practitioners will also endorse the Fit4Two website and encourage participants in this group to log into the Fit4Two website and actively participate in each of the weekly modules.

The Fit4Two Website:
The Fit4Two website consists of four weekly behaviour change modules, guided by the Social Cognitive Theory (SCT), that have previously been identified as successful at increasing physical activity in pregnant women. At the completion of each module, participants are provided with tailored feedback that is based on their responses to the survey questions that participants answer at the beginning of each weekly module. The four additional Fit4Two website modules include: (1) goal setting and action planning where participants are encouraged to make physical activity plans including when they will exercise, who they might exercise with, where the exercise will take place, and what barrier/s might come up and how they will overcome them; (2) overcoming barriers such as environmental barriers and lack of time; (3) developing social support networks including work colleagues, family and friends; and (4) physical activity reinforcement such as identifying the exercise during pregnancy guidelines, the benefits associated with meeting the guidelines and the participants exercise behaviours. Each of these modules apply behaviour change constructs that have previously been identified as effective to increasing physical activity among pregnant women. In addition to the weekly module, participants will also receive access to a weekly action planning tool, which guides participants in setting detailed SMART goals and an action plan for their physical activity over the coming week.

The tailored advise is developed and generated by the Fit4Two web-based software (based on algorithms and coding), and developed in conjunction with behaviour change and exercise during pregnancy experts.

For the purpose of this study practitioners are referred to as Obstetricians and Midwives.

Data collected at baseline includes activity behaviours (aerobic and resistance-based activity) before pregnancy and current activity behaviours.
Intervention code [1] 299212 0
Behaviour
Intervention code [2] 299276 0
Lifestyle
Comparator / control treatment
Generic advice without practitioner endorsement (wait list control group):
Upon completing the baseline assessment, participants will be instructed to collect their non-tailored (generic) physical activity advice from the reception desk at the conclusion of the consultation with their medical practitioner. This physical activity advice, printed on plain A4 paper, will provide standard information on current physical activity guidelines for pregnant women. This ‘minimal’ intervention can be considered as ‘wait list control’ and is unlikely to significantly increase the physical activity of the participants. Participants will be provided with full access to the Fit4Two website upon the completion of their 3 month follow-up survey.
Control group
Active

Outcomes
Primary outcome [1] 303496 0
Feasibility will be assessed by undertaking semi-structured interview with practitioners and support staff. At baseline, they will be asked about their initial perceptions regarding the intervention. At follow up, they will be asked if they implemented the intervention as intended, and whether or not they believed the intervention was feasible to deliver based on its operational requirements.
Timepoint [1] 303496 0
October 2016 - April 2018
Time points include baseline and immediate follow-up (6 weeks port intervention)
Primary outcome [2] 303497 0
Acceptability will be measured by a number of composite outcomes including intervention adherence (by the number of consenting participants successfully completing the tailoring questionnaire on the ipad), website engagement (total no. of visits, clicks and total time spent on website), website usability (SUS - System Usability Scale - validated instrument) and satisfaction items relating to website quality, relevance and usefulness (a modified version of the eHealth Engagement Scale survey instrument, used in previous web-based computer-tailored interventions).
Timepoint [2] 303497 0
October 2017 - April 2018
Time points include baseline, 2 weeks after completing baseline survey, and immediate follow-up (6 weeks post intervention)
Primary outcome [3] 303558 0
Efficacy will be assessed by examining changes in self-reported amounts of physical activity from baseline to follow-up, using a modified version of the Active Australia Questionnaire (AAQ).
Timepoint [3] 303558 0
October 2017 - April 2018
Time points include baseline, 2 weeks after completing baseline survey, and immediate follow-up (6 weeks port intervention)
Secondary outcome [1] 339360 0
There are no secondary outcome measures for this study.
Timepoint [1] 339360 0
N/A

Eligibility
Key inclusion criteria
To be eligible, participants will be required to be proficient in English, aged 18-45 years, currently pregnant with a gestation age of 12-32 weeks, and considered healthy (free of any medical or obstetric contraindications) and able to participate in physical activity. To ascertain contraindications, potential participants will be required to complete an online version of the Physical Activity Readiness Medical Examination for Pregnancy (PARMed-X for Pregnancy). If participants answer 'yes' to any of the screening questions, they will be advised that they are unable to participate in the study at this stage, and that they might like to discuss their ineligibility with their practitioner. If approval is sub-sequentially provided by their practitioner to participate, the participant can then register.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not currently pregnant
Pregnant, but with a gestational age not within 12-32 weeks
Participants not proficient in English
Not within 18-45 years of age
Not considered to have a healthy pregnancy
Not receiving antenatal care from one of the participating study sites (clinics)

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)
Following baseline assessment, participants will be automatically randomised into one of the three study groups via software that is part of the intervention website. which uses a block randomisation sequence (with block sizes of four) on a 1:1:1 ratio. All project team members will be blinded to this process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation sequence (with block sizes of four) on a 1:1:1 ratio will be used. All project team members will be blinded to this process.
Masking / blinding
Blinded (masking 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
Differences in moderate to vigorous physical activity (MVPA) between groups will be determined using a time X group interaction model (zero-inflated negative binomial regression will be used for data that is not of a normal distribution). Chi-square (categorical outcomes) and analyses of variance (continuous outcomes) will be performed to determine between group differences for feasibility, acceptability and usability outcomes. Where there is evidence of a significant difference between groups, post-hoc tests will be conducted to determine which of the three groups are different from each other. All statistical tests will be conducted using SPSS Version 20 (IBM Corp, NY). Statistical significance will be set at p<0.05. Interviews will be transcribed and analysed by thematic analysis to identify common themes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297600 0
University
Name [1] 297600 0
CQUniversity
Address [1] 297600 0
Bruce Highway
Rockhampton QLD 4701
Country [1] 297600 0
Australia
Primary sponsor type
University
Name
CQUniversity
Address
Bruce Highway
Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 296614 0
None
Name [1] 296614 0
Address [1] 296614 0
Country [1] 296614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298693 0
CQUniveristy Human Research Ethics Committee
Ethics committee address [1] 298693 0
CQUniversity
Bruce Highway Rockhampton QLD 4701
Ethics committee country [1] 298693 0
Australia
Date submitted for ethics approval [1] 298693 0
Approval date [1] 298693 0
25/09/2017
Ethics approval number [1] 298693 0
H1611304

Summary
Brief summary
Inactivity during pregnancy is associated with adverse health and pregnancy related outcomes for the mother and her unborn child. This innovative randomised controlled trial aims to increase physical activity in pregnant women by integrating an already examined eHealth intervention (Fit4Two) into clinical practice. This intervention will provide participants with highly personalised and automated physical activity feedback, endorsed by their practitioner. As such, participants will receive high quality care in a convenient, credible and time efficient manner, whilst placing very little additional burden on practitioners.
Trial website
www.fit4two.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77910 0
Dr Melanie Hayman
Address 77910 0
CQUniversity
Bld 6.2/39
Bruce Highway, Rockhampton QLD 4701
Country 77910 0
Australia
Phone 77910 0
+61 7 49306912
Fax 77910 0
Email 77910 0
m.j.hayman@cqu.edu.au
Contact person for public queries
Name 77911 0
Dr Melanie Hayman
Address 77911 0
CQUniversity
Bld 6.2/39
Bruce Highway, Rockhampton QLD 4701
Country 77911 0
Australia
Phone 77911 0
+61 7 49306912
Fax 77911 0
Email 77911 0
m.j.hayman@cqu.edu.au
Contact person for scientific queries
Name 77912 0
Dr Melanie Hayman
Address 77912 0
CQUniversity
Bld 6.2/39
Bruce Highway, Rockhampton QLD 4701
Country 77912 0
Australia
Phone 77912 0
+61 7 49306912
Fax 77912 0
Email 77912 0
m.j.hayman@cqu.edu.au

No data has been provided for results reporting
Summary results
Not applicable