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NCT Number: NCT06896292

Testing a Digital Tool to Support Healthy Pregnancies

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maitland Hospital Maternity Services, Maitland, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid care model

Behavioral

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.

Usual Care

Other

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.

Primary outcomes

  1. Receipt of preventive care (Assessment of health risks)

    Time frame: 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.

  2. Receipt of preventive care (Advice about health risks)

    Time frame: 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.

  3. Receipt of preventive care (Help to address health risks)

    Time frame: 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.

Other outcomes

  1. Process Measures

    Time frame: 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.

    A range of process measures will be collected to better understand acceptability and participant preferences for the digital support tool. Process measures have been informed by the Design and Evaluation Framework for Digital Health Interventions. The following measures will be assessed:

    • use/adoption
    • barriers
    • enablers
    • acceptability
    • preferences (content and function)

Sponsors and collaborators

Lead sponsor

Hunter and New England Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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