Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000252415p
Ethics application status
Submitted, not yet approved
Date submitted
26/03/2025
Date registered
7/04/2025
Date last updated
7/04/2025
Date data sharing statement initially provided
7/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
EMPOWERED-GP: Evaluating the Effectiveness of Education through online Media around Pregnancy planning and cOntraception for Women's EmpoweRmEnt in Diabetes in General Practice: a feasibility, acceptability and efficacy study.
Scientific title
EMPOWERED-GP: Evaluating the Effectiveness of Education through online Media around Pregnancy planning and cOntraception for Women's EmpoweRmEnt in Diabetes in General Practice: a feasibility, acceptability and efficacy study.
Secondary ID [1] 313958 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 336676 0
pregnancy planning 336677 0
contraception 336678 0
Condition category
Condition code
Reproductive Health and Childbirth 333170 333170 0 0
Contraception
Metabolic and Endocrine 333171 333171 0 0
Diabetes
Reproductive Health and Childbirth 333172 333172 0 0
Fetal medicine and complications of pregnancy
Public Health 333391 333391 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. A brief reproductive planning conversation instigated by a general practitioner (GP) with women with diabetes. Topics to be covered include:
- key steps in pregnancy planning and effective contraceptive methods
- complications with poorly controlled glycemic levels during pregnancy.

GPs will be prompted to initiate the conversation by being alerted through the electronic medical record (eMR) to the fact that they are seeing a women with diabetes of reproductive age.

The conversation should be revisited yearly. Women may choose to or not to book a follow up visit their GP for further discussion on reproductive planning. The duration of the conversation is expected to be be less than or equal to 15 minutes. The mode of administration will be one-on-one face-to-face consultation.

Strategies to monitor adherence to the intervention will be the 1-month follow up questionnaire (in which a question asking the conversation has occurred) and an audit of the GP eMR.

2. Provision of access to the educational online video resources regarding contraception and pregnancy planning for women with diabetes on the National Diabetes Services Scheme (NDSS) website.
There are 2 online video resources, in which each of them are 13 minutes in duration. Viewing these will be at the participants discretion. They may view them as frequently as they wish. Strategies to monitor adherence to the intervention will be the 1-month and 6-month follow up questionnaire (in which a question asking whether they have seen the videos)
Intervention code [1] 330609 0
Prevention
Comparator / control treatment
Pre- and post-intervention study design
Participants pre-intervention will act as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340735 0
Change in women’s knowledge of contraception measured by the proportion and number of women who are able to identify contraceptive agents with at least 90% efficacy in preventing pregnancy post-intervention
Timepoint [1] 340735 0
Questionnaires will be performed at - baseline - 1 month post-reproductive planning conversation - 6 month post-reproductive planning conversation - 2 years post-reproductive planning conversation - 5 years post-reproductive planning conversation Most of the questions in the follow-up questionnaires are the same as in the baseline questionnaire. However, the baseline questionnaire contains some demographic data questions and questions about pregnancy history and contraception use. The follow-up questionnaires include questions asking whether women have had the reproductive planning conversation with their GPs, and whether they have watched the videos In addition, the 6-month, 2-year and 5-year follow-up questionnaires, ask women whether they have a pregnancy since the baseline questionnaire and details of the pregnancy.
Primary outcome [2] 340736 0
Change in women’s knowledge of pregnancy planning, measured by the change in the proportion and number of women who can identify 2 or more key steps in pregnancy planning (improving glycaemic control measured by HbA1c less than or equal to 6.5%, starting high-dose folic acid, stopping teratogenic medications)
Timepoint [2] 340736 0
The 1-month follow-up questionnaire will be administered 1 month after the completion date of the reproductive planning conversation. If the reproductive planning intervention has not occurred by 3 months post-recruitment, the 1-month post-intervention questionnaire will be administered at that 4-month post-recruitment (3 months plus 1 month post-reproductive planning conversation).
Secondary outcome [1] 444944 0
Behaviour change: for women not wanting to become pregnant or planning a pregnancy, the change in the proportion (and number) of women using a more effective contraceptive agent than pre-intervention.
Timepoint [1] 444944 0
Questionnaires will be administered at 6-months post-reproductive planning conversation. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment, the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post-recruitment plus 6 months)
Secondary outcome [2] 444945 0
For women who become pregnant, change in the number and proportion of women who report a planned pregnancy rather than unplanned
Timepoint [2] 444945 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive planning conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [3] 444946 0
Change in the proportion and number of women who have adverse pregnancy outcomes out of the number who become pregnant. Examples of adverse events are miscarriage, stillbirth, fetal malformation. They will be assessed through the follow up questionnaires completed by women. Confirmation will be sought from the GP eMR.
Timepoint [3] 444946 0
Questionnaires will be administered at 6 months, 2 years and 5 years post-reproductive planning conversation. The 6 months, 2 years and 5 years follow-up questionnaires, ask women whether they have a pregnancy since the baseline questionnaire and details of the pregnancy.
Secondary outcome [4] 445650 0
For women who become pregnant, change in the number and proportion of women who achieve HbA1c in 3 months prior to or in 1st trimester of pregnancy less than or equal to 6.5% and less than or equal to 7%
Timepoint [4] 445650 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [5] 445653 0
Behaviour change: For women who become pregnant, change in the number and proportion of women who ceased teratogenic medication.
Timepoint [5] 445653 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [6] 445654 0
For women who become pregnant, change in the number and proportion of women who are taking folic acid supplements (5 mg daily or 2nd daily)
Timepoint [6] 445654 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [7] 445655 0
For women who become pregnant, change in the number and proportion of women who are taking sufficient iodine supplements (150ug daily)
Timepoint [7] 445655 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [8] 445656 0
Behaviour change: For women who become pregnant, change in the number and proportion of women who are seeing an endocrinologist or diabetes educator.
Timepoint [8] 445656 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [9] 445657 0
Behaviour change: For women who become pregnant, change in the number and proportion of women who have been referred to diabetes clinic at the local maternity hospital
Timepoint [9] 445657 0
Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)
Secondary outcome [10] 445658 0
Behaviour change: The mean HbA1c for women in the 3 months prior to or in 1st trimester of pregnancy pre-intervention compared with post intervention
Timepoint [10] 445658 0
6-months, 2-years and 5-years post-reproductive planning conversation

Eligibility
Key inclusion criteria
INCLUSION CRITERIA (WOMEN PARTICIPANTS)
1. Women with pre-existing diabetes
2. Female sex assigned at birth
3. Of reproductive age 16 - 49 years old
4. Has capacity to provide informed consent, participate and comply with the study requirements
5. Has access to a mobile phone or computer capable of receiving text messages and viewing online videos.

INCLUSION CRITERIA (GENERAL PRACTITIONERS)
1. General Practitioners with electronic medical records for audit purposes.
2. General Practitioners with practices equipped to send text messages to potential women participants.
Minimum age
16 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
EXCLUSION CRITERIA (WOMEN PARTICIPANTS)
1. Women without diabetes
2. Women under 16 years of age or older than 49 years of age
3. Women who are currently pregnant
4. Women who have had gestational diabetes, which resolved post-partum
5. Women who have been diagnosed as having undergone menopause
6. Women from non-English speaking backgrounds who do not have an English comprehension level adequate to understand the consent process, the content of a reproductive planning conversation or the content of educational videos and booklets
7. Women who lack capacity (eg. cognitive impairment due to any reason) to provide informed consent as determined by their treating clinician
8. Women who do not have access to a mobile phone or computer capable of receiving text messages and viewing online videos

EXCLUSION CRITERIA (GENERAL PRACTITIONERS)
1. General Practitioners who do not have electronic medical records for audit purposes.
2. General Practitioners with practices not equipped to send text messages to women participants.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
1/06/2031
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318456 0
Hospital
Name [1] 318456 0
Department of Endocrinology Trust Fund at Nepean Hospital.
Country [1] 318456 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320930 0
None
Name [1] 320930 0
Address [1] 320930 0
Country [1] 320930 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317071 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317071 0
Ethics committee country [1] 317071 0
Australia
Date submitted for ethics approval [1] 317071 0
18/11/2024
Approval date [1] 317071 0
Ethics approval number [1] 317071 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139902 0
A/Prof Emily Hibbert
Address 139902 0
Department of Endocrinology, Nepean Hospital, Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Level 3, 62 Derby Street, Kingswood, NSW, 2747.
Country 139902 0
Australia
Phone 139902 0
+61247344754
Fax 139902 0
Email 139902 0
[email protected]
Contact person for public queries
Name 139903 0
Ya Yun Siow
Address 139903 0
Ya Yun Siow, Department of Endocrinology, Nepean Hospital, Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Level 3, 62 Derby Street, Kingswood, NSW, 2747
Country 139903 0
Australia
Phone 139903 0
+612411667913
Fax 139903 0
Email 139903 0
[email protected]
Contact person for scientific queries
Name 139904 0
Emily Hibbert
Address 139904 0
A/Prof Emily Hibbert, Department of Endocrinology, Nepean Hospital, Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Level 3, 62 Derby Street, Kingswood, NSW, 2747
Country 139904 0
Australia
Phone 139904 0
+61247344754
Fax 139904 0
Email 139904 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• to researchers with a proposal that is approved by the research team on this project

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified questionnaire data

What types of analyses could be done with individual participant data?
• for a research proposal that is approved by the research team on this project or for meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
start date immediately after publication of results


To:
end date 15 years post-study closure.

Where can requests to access individual participant data be made, or data be obtained directly?
• contact Primary Investigator Emily Hibbert via email - [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24575Other    REDCap Code Book by emailing the Primary Investiga... [More Details]



Results publications and other study-related documents

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