Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000401550
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
3/04/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled implementation study to support women at high-risk of cardiometabolic pregnancy complications
Scientific title
A pilot randomised controlled implementation study to support women at high-risk of cardiometabolic pregnancy complications in enhancing screening and lifestyle
Secondary ID [1] 311119 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 332276 0
Hypertensive Disorders of Pregnancy 332277 0
Type 2 Diabetes Mellitus 332278 0
Cardiovascular Disease 332279 0
Condition category
Condition code
Diet and Nutrition 328990 328990 0 0
Other diet and nutrition disorders
Cardiovascular 328991 328991 0 0
Hypertension
Public Health 328992 328992 0 0
Health service research
Metabolic and Endocrine 328993 328993 0 0
Diabetes
Reproductive Health and Childbirth 330052 330052 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled pragmatic implementation trial to optimise lifestyle management and screening of Diabetes Mellitus Type 2 (DM2) and Cardiovascular Disease (CVD) in women who are at high risk of developing Gestational Diabetes Mellitus (GDM) and Hypertensive Disorders in Pregnancy (HDP) during pregnancy.

The intervention includes health coaching support from enrolment in the study (late 1st trimester/early 2nd trimester) until seven months postpartum. There will be three 30-minute health coaching sessions at 17-weeks gestation, 18-weeks gestation and 36-weeks gestation. There will be one optional check-in session between 28-29-weeks gestation, which will run for approximately 30-minutes. In the postpartum period, there will be two core sessions at 3 and 4 months postpartum and three optional checks in sessions at 5, 6 and 7 months postpartum. All of these sessions will run for approximately 30-minutes each.

The health coaching will be delivered in person or via telehealth, and will use a mixture of synchronous sessions, asynchronous support (videos and resources) and text messaging. The health coaching includes automated reminders, techniques to support behavioural lifestyle change, and information related to understanding risk of cardiometabolic pregnancy conditions such as GDM or HDP, DM2 and CVD, healthy eating and physical activity, healthy gestational weight gain, breastfeeding and mental, social and environmental considerations through 1:1 participant contact, text messages and providing access to a website with resources.
The primary outcome for the RCT component is screening for DM2 or CVD at 12 months postpartum (yes screening occurred; vs not done).

Exposure to intervention:
Individuals in the intervention arm of the study will receive automated, and non-automated motivational push notification messages and reminders from their health coach. These text messages will be sent using a clinical study mobile phone. At the conclusion of each text message, participants will be asked to reply Y or N to whether the information was helpful (Y) or not (N) and/or Y or N (yes or no) to confirming that they will attend their upcoming appointment (depending on the type of text message was sent). These replies will be recorded in study databases by health coaches. At the conclusion of the study, the number and type of text message replies received from participants (Y or N) will be accessed and this data will be used to determine the total number of messages received by everyone and the engagement with message content (information, motivational, reminder). This will be used to generate an exposure index for each message type, for which the denominator will be the highest number of messages received by any one individual participant. Individuals in the intervention arm of the study will be sent pre-recorded videos and educational content prior to each coaching session. The pre-recorded videos will be uploaded to YouTube and then embedded into Qualtrics (delivery platform) so that researchers can measure how viewers/participants interact with the videos. The types of metrics that will be measured include impressions, view rate, “video played to”, engagement, and clicks.
• Impressions (in-feed): this metric is counted when the viewer views the thumbnail of the video.
• View rate: the view rate determines the percent of impressions that resulted in a view.
• “Video played to”: this metric counts the percentage of people who watched 25%, 50%, 75%, or 100% of the video out of the viewers who initiated the player. Quartile reporting can be used alongside other metrics, such as view rate and audience retention (in YouTube Analytics data) to check roughly where video users are dropping off.
• Engagement: for videos longer than 10 seconds, engagements give provides a sense of the frequency of viewers engaging beyond just the impression.
• Clicks: the number of times the video is “clicked on” or accessed.
The workbook material and additional resources will be available in a click-through format as well as downloadable PDF documents. The number of downloads will be reviewed to assess interaction with the intervention.
Intervention code [1] 327566 0
Lifestyle
Intervention code [2] 328290 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will receive one standardised consultation appointment with a health coach via telehealth or face-to-face. The timing of this session will align with antenatal appointment 1 (16 +1 weeks gestation) to facilitate the collection of case report forms (CRFs), maternal outcomes and questionnaires. Participants in the control group will receive a brief explanation of the GDM and HDP risk calculator tool that was used to screen and recruit them, along with a generic pamphlet for lifestyle management containing advice aligned with the Australian Dietary and Physical Activity Guidelines for pregnant women. They will also receive basic information on GDM and HDP screening, aligned with Monash Health usual care. Participant facing materials will be termed ‘low intensity program’ (as opposed to control or standard care) due to the nature of the information provided and to mitigate anxiety of receiving minimal lifestyle assistance following risk communication.
Further to this, participants in the control group will receive standard antenatal care with no additional lifestyle intervention. Reminder text messages will be sent to participants in the control group prior to timepoints for routine data collection. The standardised consultation will run for under 15-20 minutes in duration. There will be no strategies used to assess or monitor adherence to the intervention, however as this is a parallel-groups study, participants will complete the same questionnaires (data entry/outcomes) as participants who were randomised to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 336796 0
Preventative screening for Type 2 Diabetes Mellitus
Timepoint [1] 336796 0
12-months after birth of the baby (postpartum)
Primary outcome [2] 336797 0
Preventative screening for cardiovascular disease
Timepoint [2] 336797 0
12-months after birth of the baby (postpartum)
Primary outcome [3] 336798 0
Screening Uptake
Timepoint [3] 336798 0
12-months after birth of the baby (postpartum).
Secondary outcome [1] 430894 0
Gestational weight
Timepoint [1] 430894 0
Closest collected to delivery from medical records
Secondary outcome [2] 430895 0
Blood pressure
Timepoint [2] 430895 0
Final Assessments (12-months postpartum)
Secondary outcome [3] 430896 0
Dietary intake
Timepoint [3] 430896 0
Postpartum Appointment 5 Assessments (7-months postpartum; end of intervention)
Secondary outcome [4] 430897 0
Physical activity
Timepoint [4] 430897 0
Postpartum Appointment 5 Assessments (7-months postpartum; end of intervention)
Secondary outcome [5] 430898 0
Sleep
Timepoint [5] 430898 0
Postpartum Appointment 5 Assessments (7-months postpartum; end of intervention)
Secondary outcome [6] 430900 0
Risk communication and decision-making effectiveness
Timepoint [6] 430900 0
7 months Postpartum
Secondary outcome [7] 430901 0
Risk perception of cardiovascular disease
Timepoint [7] 430901 0
7 months Postpartum
Secondary outcome [8] 430902 0
Risk perception of type 2 diabetes mellitus
Timepoint [8] 430902 0
7 months Postpartum
Secondary outcome [9] 430903 0
Health Belief Model evaluation of self-management of a condition
Timepoint [9] 430903 0
7 months Postpartum
Secondary outcome [10] 430904 0
Self-evaluation of perceived capabilities, opportunities and motivations (COM-B model)
Timepoint [10] 430904 0
7 months Postpartum
Secondary outcome [11] 430905 0
Mental health (distress)
Timepoint [11] 430905 0
7 months Postpartum
Secondary outcome [12] 430906 0
Oral glucose tolerance
Timepoint [12] 430906 0
3 months postpartum
Secondary outcome [13] 430907 0
Diagnosis of GDM
Timepoint [13] 430907 0
28-29 weeks antenatal
Secondary outcome [14] 430908 0
Mode of delivery
Timepoint [14] 430908 0
Birth
Secondary outcome [15] 430909 0
Birth complications
Timepoint [15] 430909 0
Birth
Secondary outcome [16] 430910 0
Newborn anthropometry and body composition (PEAPOD)
Timepoint [16] 430910 0
Birth
Secondary outcome [17] 430911 0
Postpartum weight retention
Timepoint [17] 430911 0
Postpartum Appointment 5 Assessments (7-months postpartum; end of intervention)
Secondary outcome [18] 432180 0
Lifestyle Uptake
Timepoint [18] 432180 0
7-months postpartum
Secondary outcome [19] 432181 0
The Co-parenting Relationship Scale (CRS)
Timepoint [19] 432181 0
7-months postpartum

Eligibility
Key inclusion criteria
Eligibility for Pregnancy Program:
Pregnant women (>18 years old) attending maternity services at Monash Health, identified as a ‘high-risk’ for developing GDM or HDP during their current pregnancy, as defined by the Monash GDM and/or HDP Risk Screening Tool (submitted for publication, awaiting acceptance), ability to speak and read in English, not currently participating in any other lifestyle-related clinical trial, has access to the internet (to view website and download resources), owns a mobile phone (in order to receive text messages).

For Postpartum Program: Participated in pregnancy program, has re-entered the postpartum program within 3-6 months of giving birth, developed either GDM and/or HDP during current pregnancy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
For Pregnancy Program: Unable to provide written consent, established diabetes (DM1 or DM2), previously known, established high blood pressure or hypertension, previously known, current or prior history of cardiovascular, cerebrovascular or peripheral vascular disease, in psychiatric care for substance abuse or mental illness, within last 3-months, cancer (not in remission), greater than 24 weeks gestation, current multiple pregnancy (e.g. twin, triplets), any clinically relevant acute illness or pregnancy complications (e.g., ectopic pregnancies, uterine or tubal anomalies, gastrointestinal conditions).

For Postpartum Program: Established T1DM after giving birth

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be carried out by a study biostatistician who is blinded to the intervention allocation. Once an individual has expressed willingness to participate in the study, the biostatistician will use a password-protected, computer-based randomisation tool to randomise the participant to the intervention or control group. Allocation concealment will be ensured by this being password protected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based randomisation tool to randomise the participant to the intervention or control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 230 women attending Monash Health antenatal care clinics will be randomised to either: intervention (risk communication and lifestyle intervention during pregnancy and postpartum) OR Control (general healthy eating information in line with pregnancy and postpartum guidelines and standard care). A sample of 225 women will be sufficiently powered to detect a 22% difference between groups assuming 80% power and significance of 0.05 with 33% drop-out rate. Previous studies have shown that screening rates for diabetes at 12 months postpartum can be increased by 24-39% (Frazzitta, Anderson, & Egan, 2013; Tawfik, 2017; O’Reilly et al., 2022). This figure incorporates an assumed retention rate of no less than 67%. Additionally, the total sample size calculation assumes that up to 40% of women will develop GDM and/or HDP during their pregnancy. This figure is based on the analysis of Monash Health BOS data, as well as the results of RCTs (HeLP-her)(Goldstein et al., 2021). Women who do not develop these conditions will not be included in the follow up of primary outcomes at 12 months postpartum, therefore the underlying event rate (of GDM/HDP) has been considered and the sample size adjusted appropriately to ensure the study was not underpowered to see an effect.
The total sample size has been increased by 225 women to 230 to ensure even numbers are recruited to each study group (n=115 per group). Based on previous experience recruiting women from this setting and examining the potential numbers of eligible women using the current Monash Health rate of women scoring 3+ on the GDM screening tool (~33%) (Cooray et al., 2023), we are confident that this is a realistic recruitment period.

The primary outcome for the RCT component is screening for DM2 and/or CVD at 12 months postpartum (yes screening occurred; vs not done). It is a dichotomous outcome indicating if one or more of the following occurred: (1) completed a DM2 screening test; or (2) completed a CVD screening test within 12 months after the delivery of their baby.

The intervention arm will be tested against usual care. Intention to treat (ITT) and per protocol (PP) analyses will be planned for both primary and secondary outcomes. The statistical analysis will consist of a between-group repeated measures analysis. An unstructured variance-covariance matrix, over time, will be estimated, in the absence of strong a priori knowledge of the correlations from time-point to time-point. The loss of degrees of freedom in the estimation of each variance and covariance parameter separately is preferable to a misspecification of the structure. The trial result will be decided by a contrast of the change over time, between arms. The impact of loss to follow-up will be minimised by using a marginal model, which is not subject to list-wise deletion: each participant will contribute all time-specific measurements made to the model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26219 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 42186 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 315376 0
Charities/Societies/Foundations
Name [1] 315376 0
National Heart Foundation
Country [1] 315376 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lisa Moran
Address
NA
Country
Australia
Secondary sponsor category [1] 317724 0
None
Name [1] 317724 0
Address [1] 317724 0
Country [1] 317724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314293 0
Monash Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 314293 0
Ethics committee country [1] 314293 0
Australia
Date submitted for ethics approval [1] 314293 0
22/11/2023
Approval date [1] 314293 0
07/05/2024
Ethics approval number [1] 314293 0
HREC/104115/MonH-2024-420179

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

Contacts
Principal investigator
Name 131090 0
A/Prof Lisa Moran
Address 131090 0
Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168.
Country 131090 0
Australia
Phone 131090 0
+61 385722664
Fax 131090 0
Email 131090 0
[email protected]
Contact person for public queries
Name 131091 0
Lisa Moran
Address 131091 0
Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168.
Country 131091 0
Australia
Phone 131091 0
+61 385722664
Fax 131091 0
Email 131091 0
[email protected]
Contact person for scientific queries
Name 131092 0
Lisa Moran
Address 131092 0
Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168.
Country 131092 0
Australia
Phone 131092 0
+61 385722664
Fax 131092 0
Email 131092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will not to provide individual participant data (IPD) to the Australian New Zealand Clinical Trials Registry (ANZCTR) is due to confidentiality concerns and ethical considerations. Protecting the privacy and confidentiality of participants is paramount. Releasing individual participant data could potentially compromise their privacy, especially in sensitive studies or those involving personal health information. Furthermore, our ethical approval has not approved the release of raw data, particularly if it contains identifiable information about participants. Ensuring that our research is conducted ethically includes safeguarding the rights and well-being of participants, which may involve restricting access to certain data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.