Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-27 @ 9:43 PM
Study NCT ID:
NCT06896292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2025-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Digital Tool to Support Healthy Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 840}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Process Measures', 'timeFrame': '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.', 'description': 'We will collect a range of process measures 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. We will assess:\n\n* use/adoption\n* barriers\n* enablers\n* acceptability\n* preferences (content and function)'}], 'primaryOutcomes': [{'measure': 'Receipt of preventive care (Assessment of health risks)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Receipt of preventive care (Advice about health risks)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Receipt of preventive care (Help to address health risks)', 'timeFrame': '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.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preventive Behaviors', 'Antenatal Care and Delivery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any pregnant person (aged 18 years and over) with a scheduled first antenatal appointment at one of the two participating maternity services\n* Sufficient level of English language proficiency to access and use the digital support tool and complete follow-up surveys.\n\nExclusion Criteria:\n\n* 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.\n* No registered mobile phone number'}, 'identificationModule': {'nctId': 'NCT06896292', 'briefTitle': 'Testing a Digital Tool to Support Healthy Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Hunter and New England Health'}, 'officialTitle': 'Efficacy, Feasibility, and Acceptability of a Hybrid Patient Care Model in Improving Access to Guideline Recommended Antenatal Preventive Care', 'orgStudyIdInfo': {'id': '2025/ETH00079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid care model', 'description': '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.', 'interventionNames': ['Behavioral: Hybrid care model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care model', 'description': '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', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Hybrid care model', 'type': 'BEHAVIORAL', 'description': '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.\n\nThe tool is based on the recommended Assess/ask, Advise, Help approach to preventive care for smoking, nutrition, alcohol, physical activity and gestational weight gain.\n\nParticipants 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.', 'armGroupLabels': ['Hybrid care model']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Usual care model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2323', 'city': 'Maitland', 'state': 'New South Wales', 'country': 'Australia', 'contacts': [{'name': 'Melanie Kingsland, PhD', 'role': 'CONTACT', 'email': 'melanie.kingsland@health.nsw.gov.au', 'phone': '+61 2 4924 6499'}], 'facility': 'Maitland Hospital Maternity Services', 'geoPoint': {'lat': -32.73308, 'lon': 151.5574}}, {'zip': '2430', 'city': 'Taree', 'state': 'New South Wales', 'country': 'Australia', 'contacts': [{'name': 'Melanie Kingsland, PhD', 'role': 'CONTACT', 'email': 'melanie.kingsland@health.nsw.gov.au', 'phone': '+61 2 4924 6499'}], 'facility': 'Manning Hospital Maternity Services', 'geoPoint': {'lat': -31.91099, 'lon': 152.45387}}], 'centralContacts': [{'name': 'Melanie Kingsland, PhD', 'role': 'CONTACT', 'email': 'melanie.kingsland@health.nsw.gov.au', 'phone': '+61 2 4924 6499'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'If data is requested by other researchers following the publication of study results, a reasonable request in writing to the Chief Investigator (Dr Kingsland) will be required. Only deidentified data will be provided. Ongoing custody of the data will remain with the Chief Investigator- Dr Kingsland.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter and New England Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Manager', 'investigatorFullName': 'Dr Melanie Kingsland', 'investigatorAffiliation': 'Hunter and New England Health'}}}}