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Testing a Digital Tool to Support Healthy Pregnancies

Efficacy, Feasibility, and Acceptability of a Hybrid Patient Care Model in Improving Access to Guideline Recommended Antenatal Preventive Care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06896292
Enrollment
372
Registered
2025-03-26
Start date
2025-04-01
Completion date
2026-05-01
Last updated
2026-04-20

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

Conditions

Antenatal Care and Delivery, Preventive Behaviors

Brief 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.

Interventions

BEHAVIORALHybrid care model

Participants will receive usual antenatal care (in-person), plus the digital support tool. A co-design process was used to develop the tool based on consumer feedback. The tool is based on the recommended Assess/ask, Advise, Help approach to preventive care for smoking, nutrition, alcohol, physical activity and gestational weight gain. Participants will be prompted (via SMS) to use the digital support tool at regular intervals throughout their pregnancy to self-assess health risks and be reminded of recommendations and available coaching services.

OTHERUsual Care

Participants will receive usual antenatal care (in-person), which is recommended to include the delivery of preventive care using the AAH model for smoking, nutrition, alcohol, physical activity and gestational weight gain.

Sponsors

Hunter and New England Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Data collection staff that are involved in undertaking telephone interviews with control and intervention group participants will not be aware of their group allocation when collecting data for primary outcome measures.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Any pregnant person (aged 18 years and over) with a scheduled first antenatal appointment at one of the two participating maternity services * Sufficient level of English language proficiency to access and use the digital support tool and complete follow-up surveys.

Exclusion criteria

* Any pregnant person who has had an adverse pregnancy outcome. As per previous studies undertaken by the research team, this criterion will be assessed by review of relevant medical record fields and anyone who meets this criterion will be flagged to exclude from invitation to the study or from being included in any trial related data collection or contacts. * No registered mobile phone number

Design outcomes

Primary

MeasureTime frameDescription
Receipt of preventive care (Assessment of health risks)Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.The percentage of pregnant people (N=840) receiving assessment of all health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) via the digital support tool or their antenatal provider.
Receipt of preventive care (Advice about health risks)Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.The percentage of pregnant people (N=840) receiving advice on all relevant health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) via the digital support tool or their antenatal provider.
Receipt of preventive care (Help to address health risks)Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.The percentage of pregnant people (N=840) who are referred to at least one preventive health service for an identified health risk (clinician referral or self-referral) via the digital support tool or their antenatal provider.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026