Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001132639
Ethics application status
Approved
Date submitted
1/09/2023
Date registered
2/11/2023
Date last updated
2/11/2023
Date data sharing statement initially provided
2/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
ENRICH ME STUDY- Examining the impact of an Early Intervention on incidence of poor cardiovascular health outcomes in women with pre-eclampsia and gestational hypertension.
Scientific title
Examining whether education will improve cardiovascular health in women with pre eclampsia & gestational hypertension.
Secondary ID [1] 310458 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ENRICH ME STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 331252 0
Pre-eclampsia 331565 0
Gestational hypertension 331566 0
Condition category
Condition code
Cardiovascular 328011 328011 0 0
Coronary heart disease
Reproductive Health and Childbirth 328301 328301 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two one-hour face to face participant education and health counselling sessions will be provided by the Cardiovascular nurse/research nurse to include: Diet and exercise to optimise cardiovascular risk factors in women who have been diagnosed with pre-eclampsia and gestational hypertension during pregnancy.
Use of educational materials from The Australian heart foundation on management of hypertension and cholesterol. Health eating diet literature/heart smart.
Review of Cardiovascular risk factors including blood pressure and Cholesterol levels and treating as per current best practice.
The sessions are face to face one on one sessions in the obstetric outpatients dept. The first session is at Visit 1 which is 3 months post-delivery. The second session at visit 2 is 9 months later when the baby is 12 months old.
Topics to be covered include diet review. Using a MEDAS questionnaire. Looking at quantities of red & white meat consumption, Nuts, tomatoes, olive oil. fruits and vegetables, sweetened beverages, pulses and fish, and fast food on a daily and weekly basis.
Weight review, BMI salt intake and processed foods will also be reviewed aiming for long tern weight control.
Two visits over a nine-month period as required one 3 months post-delivery of the baby and 9 months later.
Activity and gentle exercise including moderate and vigorous will be discussed. Advice will be provided on the importance of keeping active. Aiming for participates to be a active as possible. Aiming for 150 minutes of moderate activity weekly which can be incorporated into their daily routine for example brisk walking- pushing the pram/buggy as well as home exercises. Pilates, dancing and cycling.
The cardiovascular nurse specialist will provide support through the study via email, zoom and phone contact on an individual basis. Providing encouragement throughout the study and to try and maintain adherence. The outcomes will be self-reported by participants.
Intervention code [1] 326857 0
Behaviour
Comparator / control treatment
Uncontrolled trial- No historical data collected.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335873 0

The primary outcome will be a measured in the MEDAS questionnaire between the 3-month and 12-month assessments. The English version of the MEDAS (Mediterranean Diet Adherence Screener)
Change in dietary awareness of a heart healthy diet as determined by a dietary MEDAS assessment (as per Heart Foundation Heart Healthy Eating Recommendations)
Timepoint [1] 335873 0
3 months post the delivery of the baby at visit 1.
Visit 2 is 12 months post-delivery of baby.
Two separate time points
Secondary outcome [1] 426261 0

Any change in Mean BMI, (Height determined by stadiometer and weight determined using balanced scales.
Timepoint [1] 426261 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)
Secondary outcome [2] 427092 0
Waist circumference measured in cm. Measured with a Tape measure.
Timepoint [2] 427092 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)
Secondary outcome [3] 427093 0
Any change in mean blood pressure determined using a sphygmomanometer.
Timepoint [3] 427093 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)
Secondary outcome [4] 427094 0
Any change in lipid profile assesses by a fasting blood test
Timepoint [4] 427094 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)
Secondary outcome [5] 427095 0
Any change in diabetic markers determined by a fasting blood test assessing mean HbA1c.
Timepoint [5] 427095 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)
Secondary outcome [6] 427096 0
Any change in exercise profile from moderate and vigorous exercise per week in hours as collected in an activity questionnaire.
Timepoint [6] 427096 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)
Secondary outcome [7] 427098 0
Any change in participant awareness of their long-term cardiovascular risk as determined by semi-structured one-on-one interviews.
Timepoint [7] 427098 0
Time points between visit 1 at 3 months post-delivery and visit 2 at 9 months (when baby is 12 months old)

Eligibility
Key inclusion criteria
Women over the age of 18 years with a recent pregnancy with a diagnosis of
• Gestational hypertension defined as new-onset hypertension in pregnancy (systolic blood pressure of 140mmHg or above and/or diastolic of 90mmHg or above
• Pre-eclampsia defined as new-onset hypertension in pregnancy (systolic blood pressure of 140mmHg or above and/or diastolic more than or equal to 90mmHg or with proteinuria, other specific end-organ dysfunction, or uteroplacental dysfunction, after 20 weeks of gestation.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant women
• Women under the age of 18 years at delivery
• Women with any unstable medical conditions defined as any condition that changes frequently or rapidly or requires constant monitoring or frequent treatment regimens or conditions resulting in limited life expectancy. Or any medical condition that would preclude diet and exercise participation. Such as, any pre-existing cardiac disease with an abnormal cardiac function on Echocardiogram, Left ventricular failure (LVF) Congested cardiac failure (CCF).
• Insulin dependent diabetic (IDDM)with poor glycemic control, and recurrent episodes of hypoglycemia.
• Renal transplant patients, on multiple immunosuppressive medications.
• Chronic lung disease with impaired exercise tolerance.
• Women with cognitive impairment or who are unable to provide consent

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
Statistical methods / analysis
Binary and categorical data will be summarized using counts and percentages. Continuous data will be summarized using means and standard deviations, or medians and interquartile ranges (the difference between the 25th and 75th percentiles) if data are found to be skewed. The primary endpoint of change in MEDAS score between 3 and 9 months will be analysed using linear mixed models (Twisk, 2019)16, also employed by Goni et al (2020)13. Under specified conditions, this technique is comparable to a paired samples t-test, employed by Roset-Salla et al (2015)14, but is more flexible and does not require complete data across timepoints.
Analysis of secondary endpoint will employ regression methods appropriate to the type of outcome variable, such as binary logistic regression for binary outcomes, Poisson or negative binomial regression for counts, or median quantile or robust regression if the outcome variable is found to be skewed. All regressions will take possible clustering of observations due to repeated measurements across time, into account.
All statistical analysis will be conducted by, or under the direct supervision of Epworth HealthCare biostatistician A/Prof Dean McKenzie using a standard statistical package such as Stata 18 (Stata Corporation, College Station, Texas, 2023) or higher. Alpha or level of statistical significance will be set at 0.05, 2 tailed. 95% confidence intervals will be reported wherever possible. No interim analysis is planned.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/10/2023
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
80
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25482 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment postcode(s) [1] 41294 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 314665 0
Hospital
Name [1] 314665 0
Epworth Freemasons
Country [1] 314665 0
Australia
Primary sponsor type
Hospital
Name
Epworth medical foundation
Address
Epworth HospitalEpworth Medical FoundationEpworth Freemasons320 Victoria ParadeEast MelbourneVIC 3002
Country
Australia
Secondary sponsor category [1] 316631 0
None
Name [1] 316631 0
Address [1] 316631 0
Country [1] 316631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313684 0
Monash Health
Ethics committee address [1] 313684 0
Ethics committee country [1] 313684 0
Australia
Date submitted for ethics approval [1] 313684 0
30/03/2023
Approval date [1] 313684 0
04/04/2023
Ethics approval number [1] 313684 0
HREC/94909/MonH-2023-360010 (v1)
Ethics committee name [2] 313740 0
Epworth
Ethics committee address [2] 313740 0
Ethics committee country [2] 313740 0
Australia
Date submitted for ethics approval [2] 313740 0
04/09/2023
Approval date [2] 313740 0
07/09/2023
Ethics approval number [2] 313740 0
HREC ID 94909 Epworth ID EH2023-1038

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

Contacts
Principal investigator
Name 129002 0
Dr Sze Wey Lee
Address 129002 0
Obstetrics & Gynocology 108/320 1st floor, Epworth freemasons Hospital, Victoria parade, East Melbourne, VIC 3002
Country 129002 0
Australia
Phone 129002 0
+61 0402125081
Fax 129002 0
Email 129002 0
[email protected]
Contact person for public queries
Name 129003 0
Caroline Steer
Address 129003 0
Epworth Research 185-187 Hoddle St, Richmond, VIC 3002
Country 129003 0
Australia
Phone 129003 0
+61 466511865
Fax 129003 0
Email 129003 0
[email protected]
Contact person for scientific queries
Name 129004 0
Sze Wey Lee
Address 129004 0
Obstetrics & Gynocology 108/320 1st floor, Epworth freemasons Hospital, Victoria parade, East Melbourne, VIC 3002
Country 129004 0
Australia
Phone 129004 0
+61 0402125081
Fax 129004 0
Email 129004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data will be shared of published results and primary and secondary outcomes
When will data be available (start and end dates)?
Analysis will be performed at the end of the study December 2024. Data will be available until Dec 2039 (15 years from the end of the study)
Available to whom?
Published in medical journals and the main findings disseminated to participants who enrolled in the study.
Available for what types of analyses?
Statistical analyses through REDCAP databases
How or where can data be obtained?
Data can be obtained by contacting the primary Investigator Dr Sze Wey Lee via email with any reasonable requests for the purpose of research considered.
Email : [email protected]


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.