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Trial registered on ANZCTR


Registration number
ACTRN12618000610235
Ethics application status
Approved
Date submitted
12/04/2018
Date registered
19/04/2018
Date last updated
19/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth lifestyle behaviours intervention for pregnant women integrated into clinical practice – a randomised controlled trial
Scientific title
Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth lifestyle behaviours intervention for pregnant women integrated into clinical practice – a randomised controlled trial
Secondary ID [1] 294575 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 307355 0
physical activity 307356 0
nutrition 307357 0
Condition category
Condition code
Diet and Nutrition 306465 306465 0 0
Obesity
Reproductive Health and Childbirth 306466 306466 0 0
Antenatal care
Public Health 306467 306467 0 0
Health promotion/education
Public Health 306468 306468 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants complete a 15-20 minute online questionnaire on physical activity and nutritional levels before pregnancy and current physical activity and nutritional behaviours via an iPad whilst waiting in the reception area prior to their appointment with their practitioner. Participants will be screened for eligibility during this time and data collected at this time point will include participants physical activity and nutritional behaviours before pregnancy and at present, as well as basic socio-demographic details including age, gestational age, weight and height to determine BMI, education, income and relationship status.

Upon completing the baseline assessment, a personalised and tailored 'Health Behaviours Report' will be automatically generated (based on the participants self-reported physical activity and nutritional behaviours), and print from a printer that is located in the clinics reception area. This report is then forwarded onto the appropriate practitioner to embed into the participants consultation. At the completion of the consultation, participants are then instructed to collect additional information about the Fit4Two project from the reception area, where they are then provided with an information pack that includes a Fitbit device to wear throughout the duration of the program, as well as additional information about the Fit4Two project.

The Fit4Two Website:
The Fit4Two website consists of eight (8) weekly behaviour change modules, guided by the Social Cognitive Theory (SCT) based on improving physical activity and nutritional behaviours among pregnant women such as developing social support networks and overcoming perceived barriers. 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. Each of these modules apply behaviour change constructs that have previously been identified as effective to increasing physical activity and nutrition 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 and nutritional behaviours over the coming week.

Throughout the project, participants in the intervention group will also be provided with 3 x 20 minute virtual consultations with the project leader. The sessions can be conducted via phone or computer and will be hosted through the conferencing program Zoom.

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 and nutrition during pregnancy experts.
Intervention code [1] 300866 0
Lifestyle
Intervention code [2] 300867 0
Behaviour
Comparator / control treatment
The participants in the control group will receive exactly the same intervention as those participants in the intervention group EXCEPT that they will not be provided with the 3 x 20 minute virtual consultation sessions.
Control group
Active

Outcomes
Primary outcome [1] 305473 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] 305473 0
April 2018 - April 2019
Time points include baseline and immediate follow-up (10 weeks post intervention)
Primary outcome [2] 305474 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] 305474 0
April 2018 - April 2019
Time points include baseline and immediate follow-up (10 weeks post intervention)
Primary outcome [3] 305475 0
Efficacy will be assessed as a composite outcome of changes in self-reported amounts of physical activity and nutrition from baseline to follow-up, using a modified version of the Godin Leisure Time Questionnaire and a modified version of the National Health Survey Australia / Monitoring Food Habits Questionnaire.
Timepoint [3] 305475 0
October 2017 - April 2018
Time points include baseline and immediate follow-up (10 weeks port intervention)
Secondary outcome [1] 345382 0
There are no secondary outcome measures for this study
Timepoint [1] 345382 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 the participating clinic

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 two 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 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 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
Not yet 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
Recruitment postcode(s) [1] 22366 0
4720 - Emerald

Funding & Sponsors
Funding source category [1] 299192 0
University
Name [1] 299192 0
Central Queensland University
Address [1] 299192 0
Bruce Highway
Rockhampton QLD 4701
Country [1] 299192 0
Australia
Funding source category [2] 299196 0
Hospital
Name [2] 299196 0
Emerald Medical Centre
Address [2] 299196 0
LOT 1 Pilot Farm Road, Emerald QLD 4720
Country [2] 299196 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Bruce Highway
Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 298455 0
Hospital
Name [1] 298455 0
Emerald Medical Centre
Address [1] 298455 0
LOT 1 Pilot Farm Road, Emerald QLD 4720
Country [1] 298455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300116 0
Central Queensland Human Research Ethics Committee
Ethics committee address [1] 300116 0
Central Queensland University
Bruce Highway Rockhampton QLD 4701
Ethics committee country [1] 300116 0
Australia
Date submitted for ethics approval [1] 300116 0
09/01/2018
Approval date [1] 300116 0
10/01/2018
Ethics approval number [1] 300116 0
H16/11-304

Summary
Brief summary
Inactivity and poor nutrition during pregnancy are 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 and improve nutritional behavours 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 and nutritional 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 82618 0
Dr Melanie Hayman
Address 82618 0
Central Queensland University
Bld 6.2/39
Bruce Highway, Rockhampton QLD 4701
Country 82618 0
Australia
Phone 82618 0
+61 7 49306912
Fax 82618 0
Email 82618 0
m.j.hayman@cqu.edu.au
Contact person for public queries
Name 82619 0
Dr Melanie Hayman
Address 82619 0
Central Queensland University
Bld 6.2/39
Bruce Highway, Rockhampton QLD 4701
Country 82619 0
Australia
Phone 82619 0
+61 7 49306912
Fax 82619 0
Email 82619 0
m.j.hayman@cqu.edu.au
Contact person for scientific queries
Name 82620 0
Dr Melanie Hayman
Address 82620 0
Central Queensland University
Bld 6.2/39
Bruce Highway, Rockhampton QLD 4701
Country 82620 0
Australia
Phone 82620 0
+61 7 49306912
Fax 82620 0
Email 82620 0
m.j.hayman@cqu.edu.au

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