Fit4Two - Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among pregnant women.
Central Queensland Medicare Local
64 participants
Oct 1, 2014
Interventional
Conditions
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.
Eligibility
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Interventions
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.
Locations(1)
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ACTRN12614001105639