Testing a Digital Tool to Support Healthy Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-04-30

Brief Summary

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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. We 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, we will also explore the feasibility, acceptability, barriers/enablers to use and content and functional preferences of the digital support tool for pregnant people.

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Detailed Description

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Conditions

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Preventive Behaviors Antenatal Care and Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Hybrid care model

The Hybrid care model will involve guideline-recommended preventive care (AAH) for smoking, nutrition, alcohol, physical activity and gestational weight gain- standard care as it is currently delivered within antenatal appointments conducted by maternity services + use of a digital support tool. The digital tool will allow patients to undertake self-assessment of smoking, nutrition, alcohol, physical activity and gestational weight gain risks, receive information and make self-referrals to support services at a time and in a way that suits them. Self-assessment results and information on self-referrals will be provided to antenatal clinicians prior to appointments to support clinician follow-up. The provision of preventive care via the digital support tool will facilitate more streamlined appointments by addressing priority issues and freeing up appointment time to address issues most relevant to the participant.

Group Type EXPERIMENTAL

Hybrid care model

Intervention Type 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 model

Usual guideline-recommended preventive care (AAH) for smoking, nutrition, alcohol, physical activity and gestational weight gain- standard care as it is currently delivered within antenatal appointments conducted by maternity services

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No