Clinical Trial

Testing a Digital Tool to Support Healthy Pregnancies

Active, Not Recruiting
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Record status
This record was last updated April 20, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The delivery of preventive care for modifiable health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) is a critical part of antenatal care. Clinical guidelines recommend that preventive care is delivered using three elements: Ask, Advise, and Help (AAH). Unfortunately, the AAH model for modifiable risk factors is not routinely delivered to all pregnant people in face-to-face antenatal visits. The investigators will test if adding a digital support tool to usual antenatal care increases the provision of guideline-recommended preventive care for smoking, nutrition, alcohol, physical activity and gestational weight gain, compared to usual antenatal care at two maternity services based at Maitland Hospital and Manning Base Hospital in New South Wales, Australia. The digital support tool will provide the opportunity for pregnant people to self-assess smoking, nutrition, alcohol, physical activity and gestational weight gain risk prior to their antenatal visits, while also being provided with tailored guideline-based information and the opportunity to self-refer to support services. Use of the digital support tool may also prompt pregnant people and/or their antenatal clinicians to have discussions around smoking, nutrition, alcohol, physical activity and gestational weight gain risks at antenatal appointments. As well as assessing impact on receipt of care for smoking, nutrition, alcohol, physical activity and gestational weight gain, the investigators will also explore the feasibility, acceptability, barriers/enablers to use and content and functional preferences of the digital support tool for pregnant people.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-19.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-04-15
Trial Details
NCT Number NCT06896292
Lead Sponsor Hunter and New England Health
Conditions Preventive Behaviors, Antenatal Care and Delivery
Enrollment 372 participants
Start Date 2025-04-01
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-20