RecruitingACTRN12614001105639

Fit4Two - Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among pregnant women.


Sponsor

Central Queensland Medicare Local

Enrollment

64 participants

Start Date

Oct 1, 2014

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a website called Fit4Two that is designed to encourage pregnant women to be more physically active. Staying active during pregnancy is safe and beneficial for both mother and baby, but many women reduce their activity levels when pregnant. Participants will be randomly assigned to either receive personalised exercise advice through the website or continue with their usual care. Physical activity will be tracked using a wristband device. You may be eligible if: - You are currently pregnant - You are 18 years or older - You are between 10 and 20 weeks pregnant - You are in good health with no medical conditions that prevent exercise, or you have medical clearance to exercise - You can read and write in English You may NOT be eligible if: - You are not currently pregnant - You are less than 18 years old - You are less than 10 weeks or more than 20 weeks pregnant - You have a medical condition that prevents exercise, without medical clearance Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 p

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)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614001105639


Related Trials