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Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth lifestyle behaviours intervention for pregnant women integrated into clinical practice – a randomised controlled trial

Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth lifestyle behaviours intervention for pregnant women integrated into clinical practice – a randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000610235
Enrollment
80
Registered
2018-04-19
Start date
2018-04-20
Completion date
2019-02-28
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 s

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.

Sponsors

Central Queensland University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026