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Testing a Digital Tool to Support Healthy Pregnancies

NCT06896292 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Preventive Behaviors
  • Antenatal Care and Delivery

Interventions

BEHAVIORAL

Hybrid 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.

OTHER

Usual 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 & Collaborators

  • Hunter and New England Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896292 on ClinicalTrials.gov