Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001105639
Ethics application status
Approved
Date submitted
22/09/2014
Date registered
17/10/2014
Date last updated
17/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fit4Two - Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among pregnant women.
Scientific title
Fit4Two - Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among pregnant women.
Secondary ID [1] 285379 0
Nil
Universal Trial Number (UTN)
U1111-1162-0529
Trial acronym
Fit4Two
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy
 293112 0
Sedentary behaviour
 293183 0
Physical inactivity 293184 0
Condition category
Condition code
Reproductive Health and Childbirth 293383 293383 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a 4 week pilot 2-arm RCT investigating the acceptability, feasibility and preliminary efficacy of an online behaviour change intervention designed to promote exercise among women during pregnancy. Participants will be recruited from the Rockhampton region of Australia through collaboration with partnering organisations.The primary outcome is weekly physical activity levels measured using accelerometers. The trial will be conducted and reported according to CONSORT guidelines.

Arm 1- Fit4Two Intervention Group

Participants randomised into this condition will be given access to a theory-based computer-tailored program over a 4 week period. Each week participants will complete modules that will provide advice and feedback unique to the individual that relates to key determinants of physical activity adoption and maintenance among breast cancer survivors (as stipulated by previous research in the field and Social Cognitive Theory). The advice participants receive will be tailored using information derived from individual weekly assessments. Each module will take approximately 30 minutes for participants to complete. This also includes the participants receiving and reading through their tailored feedback.

Arm 2 – Fit4Two Control Group

Participants randomised into this group will receive usual care and be given access to the resources section of the website only for the duration of the study. Upon completion, participants in this group will also be given full access to the website.

Adherence to the intervention will be monitored through computer software that can see how often participants logged on, what modules they completed / did not complete, how long they spent on the site etc.
Intervention code [1] 290292 0
Behaviour
Intervention code [2] 290350 0
Lifestyle
Comparator / control treatment
Participants randomised into this group will receive usual care and be given access to the resources section of the website only for the duration of the study. Upon completion of the 4 week intervention period, participants in this group will also be given full access to the website.
Control group
Active

Outcomes
Primary outcome [1] 293216 0
The primary outcome variables, minutes of PA (aerobic and resistance) per week will be assessed using an adapted version (Liebreich, Plotnikoff et al. 2009) of the validated Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Godin and Shepard 1997).

The adapted version will incorporate a resistance training (RT) measure (Plotnikoff, Taylor et al. 2006; Liebreich, Plotnikoff et al. 2009) that asks participants to report the frequency (times per week) and duration (average times per session) of resistance training activities on average over the last month

GeneActiv Accelerometers will also be used to measure PA at baseline and immediate follow up (4 week post baseline) for 7 days at each point.
Timepoint [1] 293216 0
Baseline, and immediate follow-up (4 weeks post baseline)
Secondary outcome [1] 310603 0
Adherence to PA guidelines

Participants will be categorised as "inactive" (not doing any activity), "insufficiently active (not meeting the guidelines)" or "sufficiently active (meeting the guidelines)" based on whether they meet the exercise during pregnancy guidelines (outlined by Motolla 2011).
Timepoint [1] 310603 0
Baseline, week 1-4 and follow-up (4 weeks post baseline)
Secondary outcome [2] 310604 0
Social Cognitive Determinants of Physical Activity (outcome expectations, self-efficacy and goal setting)

Outcome expectations:
Measured on a 5 point Likert scale where 1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree. Based on validated work of Fjeldsoe, Miller and Marshall, 2013.

Self-efficacy:
Measured on a 5 point Likert scale where 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, 5=extremely confident. Based on validated work of Plotnikoff, Blanchard, Hotz and Rhodes, 2001.

Goal Setting:
Measured on a 5 point Likert scale where 1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree. Based on validated work of Rhodes, Hunt Matherson and Mark (2010).
Timepoint [2] 310604 0
Baseline, week 1-4 and follow-up (4 weeks post baseline)
Secondary outcome [3] 310605 0
Usability and Acceptability of website (SUS - The system Usability Scale, Brooke (1986) modified for the current study) will be determined by a series of questions as a part of the follow-up questionnaire. The questions are multiple-choice based (example item: 'did the material catch your attention?') requiring participants to rate their responses on a Likert scale (e.g., '1 = not at all' - '5 = very much'). The assessment will also contain one open-ended questions inviting participants to provide additional feedback.
Timepoint [3] 310605 0
5 weeks post-baseline (Immediate post-intervention follow-up)

Eligibility
Key inclusion criteria
Eligibality Criteria:
must be currently pregnant
must be 18+ years of age
must be able to read and write in english
must be between 10-20 weeks gestation
must be considered healthy and free of pregancy contraindications, or have medical approval to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:
not currently pregnant
not 18+ years of age
not able to read and write in english
not between 10-20 weeks gestation
not considered healthy and free of pregancy contraindications, or have medical approval to participate

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)
Willing participants will log onto intervention website where they will be required to complete a screening eligibality questionnaire. If eligible, participants then register their contact details. Participants are then contacted and enrolled into intervention. Software randomly allocates the participants to either intervention or control upon successful enrollment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Software randomly allocated the participants to either intervention or control upon successful enrollment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Standard data cleaning procedures will be used. Descriptive statistics will be conducted on all baseline variables. ANCOVA will be used to assess between group differences at the primary endpoint. Only baseline physical activity will be included as a covariate in the model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
1/10/2014
Date of last participant enrolment
Anticipated
30/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8721 0
4700 - Rockhampton
Recruitment postcode(s) [2] 8720 0
4701 - North Rockhampton
Recruitment postcode(s) [3] 8722 0
4702 - Gracemere
Recruitment postcode(s) [4] 8723 0
4703 - Yeppoon
Recruitment postcode(s) [5] 8724 0
4714 - Mount Morgan

Funding & Sponsors
Funding source category [1] 289989 0
University
Name [1] 289989 0
CQUniversity
Country [1] 289989 0
Australia
Primary sponsor type
Government body
Name
Central Queensland Medicare Local
Address
Level 1
44A William Street
Rockhampton QLD 4700
Country
Australia
Secondary sponsor category [1] 288674 0
None
Name [1] 288674 0
Address [1] 288674 0
Country [1] 288674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291697 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 291697 0
CQUniversity
Bruce Highway
Rockhampton, QLD, 4702
Ethics committee country [1] 291697 0
Australia
Date submitted for ethics approval [1] 291697 0
Approval date [1] 291697 0
09/09/2014
Ethics approval number [1] 291697 0
H14/02-031

Summary
Brief summary
The 'Fit4Two - Usability and initial efficacy testing of a website-delivered behaviour change intervention. The Fit4Two study is a 4 week pilot 2-arm RCT investigating the acceptability, feasibility and preliminary efficacy of a behaviour change intervention designed to promote exercise among women during pregnancy. Participants will be recruited from the Rockhampton region of Australia through collaboration with partnering organisations. The primary outcome is
weekly physical activity levels measured using valid and reliable accelerometers. The trial will be conducted and reported
according CONSORT guidelines. Participants randomly allocated to the Fit4Two intervention group will receive a web-based
intervention, which will provide them with personalised advice based on information derived from an online assessment.
Participants randomly allocated to the control group will receive usual care, access to the resources library of the program, but
no computer-tailored feedback. The program will be delivered at no cost to participants. Participants will now also receive resources and referrals to other programs, services,
and avenues for support. Each program participant will be provided with tailored physical activity advice and feedback to help them make a positive lifestyle change, which inturn might improve their health and the health of their baby and reduce chronic disease.
All respondents will be clearly informed that they SHOULD NOT participate in the study if they believe it may be unsafe or unhealthy for them to do so. This screening procedure has been used by similar studies. No adverse events have occurred. There is substantial evidence that increasing physical activity is safe and leads to health benefits rather than health damage in pregnant women. The information provided to participants will be evidence-based and reflect the physical activity guidelines for pregnant women. The trial will be aimed at pregnant women in their second trimester. The benefits (the evaluation of a potentially effective physical activity intervention that might improve health outcomes among pregnant women and their child) of this research largely outweigh the minimal risk to participants. Should there be any unanticipated difficulties, all participants are provided with contact details for the principal researcher.
Trial website
www.fit4two.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51594 0
Mrs Melanie Hayman
Address 51594 0
Building 18/1.31
School of Medical and Applied Sciences
Bruce Highway
CQUniversity, Rockhampton Campus, QLD 4702
Country 51594 0
Australia
Phone 51594 0
+61749232185
Fax 51594 0
Email 51594 0
m.j.hayman@cqu.edu.au
Contact person for public queries
Name 51595 0
Mrs Melanie Hayman
Address 51595 0
Building 18/1.31
School of Medical and Applied Sciences
Bruce Highway
CQUniversity, Rockhampton Campus, QLD 4702
Country 51595 0
Australia
Phone 51595 0
+61749232185
Fax 51595 0
Email 51595 0
m.j.hayman@cqu.edu.au
Contact person for scientific queries
Name 51596 0
Mrs Melanie Hayman
Address 51596 0
Building 18/1.31
School of Medical and Applied Sciences
Bruce Highway
CQUniversity, Rockhampton Campus, QLD 4702
Country 51596 0
Australia
Phone 51596 0
+61749232185
Fax 51596 0
Email 51596 0
m.j.hayman@cqu.edu.au

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
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4496Study results articleYes Hayman, M., Reaburn, P., Browne, M. et al. Feasibi... [More Details]

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