Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000128897
Ethics application status
Approved
Date submitted
5/09/2018
Date registered
8/02/2021
Date last updated
3/02/2023
Date data sharing statement initially provided
8/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pre-pregnancy dietary advice and regular exercise in women with overweight or obesity on pregnancy outcomes: the BEGIN BETTER randomised trial.
Scientific title
The effect of pre-pregnancy dietary advice and regular exercise in women with overweight or obesity on pregnancy outcomes: the BEGIN BETTER randomised trial.
Secondary ID [1] 296001 0
nil known
Universal Trial Number (UTN)
U1111-1219-9576
Trial acronym
BEGIN BETTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity in pregnancy 309520 0
Preconception health 309521 0
Condition category
Condition code
Reproductive Health and Childbirth 308350 308350 0 0
Other reproductive health and childbirth disorders
Diet and Nutrition 308840 308840 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the Lifestyle Intervention Group will receive written and verbal advice based on current RACGP's guideline on Preventative activities prior to pregnancy from a registered midwife at the trial entry appointment, in which information will be provided to encourage women to stop smoking and use of illicit substances, limit alcohol intake, commence folate supplementation, and ensure immunisations (particularly rubella) and cervical cytology are current, consistent with best clinical practice.
The comprehensive dietitian prescribed intervention will combine dietary, exercise and behavioural strategies to promote weight loss.
Behavioural Goals
We will encourage and support behavioural strategies to increase physical activity and improve diet.
Dietary and Weight Loss Goals
Dietary advice will be dietitian prescribed, consistent with current Australian guidelines, and designed to encourage weight loss. The dietary intervention will be individualised for each woman.
Physical Activity Goals
Women will be instructed to increase physical activity by their health coach to meet the recommendations of Australia’s Physical Activity & Sedentary Behaviour Guidelines for Adults.
Weight Loss Maintenance
Strategies will promote ongoing healthy dietary and physical behaviours, and will involve regular ongoing face to face, telephone and SMS contact with research staff.

Adherence to diet and physical activity advice will be assessed by food frequency and physical activity questionnaires at the commencement and completion of the intervention period.
Details intentionally brief to protect contamination of the control group. Further information about this intervention is available from the trial contact staff named in this registration.
Intervention code [1] 312328 0
Lifestyle
Intervention code [2] 312329 0
Behaviour
Comparator / control treatment
Women randomised to the Educational Control Group will receive written and verbal advice based on current RACGP's guideline on Preventative activities prior to pregnancy from a registered midwife at the trial entry appointment, in which information will be provided to encourage women to stop smoking and use of illicit substances, limit alcohol intake, commence folate supplementation, and ensure immunisations (particularly rubella) and cervical cytology are current, consistent with best clinical practice.
Women will receive limited information about a healthy diet and exercise prior to pregnancy.
Changes in diet and physical activity will be assessed by at the commencement of study participation and 6 months later.
Control group
Active

Outcomes
Primary outcome [1] 307337 0
The primary outcome is birth weight z-score. Birth weight will be measured by the attending midwife using digital scales as per usual practice across maternity units in Australia. This birth weight will be converted to a z score using population birth weight means and standard deviations for infant sex and gestational age. While providing a robust indicator of future child obesity risk, It also controls for any confounding which may arise due to any effect of the intervention on gestational age at birth.
Timepoint [1] 307337 0
At birth of infant of women who achieve pregnancy during study participation and follow up.
Secondary outcome [1] 351496 0
Please note this is not a composite and all outcomes will be measured separately.

Women will complete a study questionnaire, designed specifically for this study, asking about pre-conception and early pregnancy health including time to conceive, miscarriage, and use of assisted reproduction, Weight will be measured at the time of trial entry, 6 months after trial entry by study staff using calibrated scales and bi-monthly (participant self report) until conception occurs or for a period of 2 years. Blood pressure will be measured using a digital blood pressure monitor, including change from trial entry until the completion of the 6 month intervention/participation period.


Timepoint [1] 351496 0
Study questionnaire will be completed at trial entry. Weight and blood pressure will be measured at trial entry, 6 months after trial entry and bi-monthly until conception or 2 years after trial entry whichever occurs first
Secondary outcome [2] 351498 0
Please note this not a composite and all outcomes will be measured separately and obtained from the woman's medical record of pregnancy and birth.
Pregnancy outcomes including gestational weight gain; hypertension and pre-eclampsia (systolic blood pressure greater than or equal to 140 mm Hg and / or diastolic greater than or equal to 90 mm Hg); gestational diabetes (positive OGTT as per current SA Perinatal Practice Guidelines); antepartum haemorrhage; induction of labour; caesarean section; postpartum haemorrhage; perineal trauma; wound infection; endometritis; maternal death.
Timepoint [2] 351498 0
Gestational weight gain will be the difference between the most recent pre-pregnancy weight and weight at 36 weeks of gestation. The occurrence of pregnancy complications and pregnancy and birth outcomes up to 6 weeks postpartum will be recorded.
Usual antenatal care includes blood pressure measurement at all antenatal visits to screen for hypertensive disorders of pregnancy, and screening for gestational diabetes at 28 weeks gestation.
Labour and birth outcomes and complications are routinely recorded in Australian maternity units.
Secondary outcome [3] 351500 0
Please note this is not a composite and all outcomes will be measured separately.

Maternal changes in diet and physical activity measured by the Harvard Semi-quantitative Food Frequency Questionnaire and SQUASH Questionnaire.
Timepoint [3] 351500 0
All outcomes measured at trial entry, 6 months after trial entry and at 28 and 36 weeks of pregnancy for women who become pregnant.
Secondary outcome [4] 351502 0
Please note this is not a composite and all outcomes will be measured separately.

Maternal quality of life and emotional well being assessing quality of life (SF12), depression and anxiety using the DASS21.
Timepoint [4] 351502 0
All outcomes measured at trial entry, 6 months after trial entry and at 28 and 36 weeks of pregnancy for women who become pregnant.
Secondary outcome [5] 351504 0
Please note this is not a composite and all outcomes will be measured separately and obtained from the woman's medical record of pregnancy and birth.

Neonatal outcomes including preterm birth (<37 weeks); mortality or infant death; birth weight greater than 4.0kg; birth weight less than 2.5kg; large for gestational age (>90th centile for age and sex); small for gestational age (less than the 10th centile for age and sex); hypoglycaemia; nursery admission; neonatal jaundice requiring phototherapy; birth trauma; shoulder dystocia; neonatal encephalopathy; seizures; breast feeding.
Timepoint [5] 351504 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal. These data are obtained from hospital medical records as recorded by clinical staff.
Secondary outcome [6] 351505 0
Please note this is not a composite and all outcomes will be measured separately. Infant growth and development at six and 18 months of age will be assessed by a study specific questionnaire completed by the woman relating to infant feeding practices including breast and formula feeding, introduction of solids (using a questionnaire developed for this study), movement, activity and sleep (using a questionnaire developed for this study), infant development (as measured by the Ages and Stages Questionnaire), blood pressure (measured by oscillometric blood pressure monitor), and infant height, weight and anthropometric assessment (including skin-fold thickness of biceps, triceps, subscapular, suprailiac, abdominal and thigh skinfold sites using skinfold calipers, body circumference measurement of chest, abdomen, head, and mid upper arm will be measured using a measuring tape, and bioimpedance assessment of fat mass and adiposity).
Timepoint [6] 351505 0
All outcomes measured at 6 and 18 months of age.
Secondary outcome [7] 351508 0

Please note this is not a composite and all outcomes will be measured separately.

Biomarkers of maternal adipoinsular axis function and cardiometabolic risk will be assessed including fasting glucose, insulin, total cholesterol, HDL, triglycerides, non esterified fatty acids, C reactive protein and inflammatory cytokines, from blood samples collected from women at trial entry at the end of the intervention or 6 months after trial entry for the control group.
Timepoint [7] 351508 0
All outcomes measured at trial entry, 6 months after trial entry and at 36 weeks of pregnancy.
Secondary outcome [8] 418084 0
Maternal risk of depression will be assessed postnatally using the Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [8] 418084 0
EPDS at 6 months and 18 months postnatal.

Eligibility
Key inclusion criteria
Women with BMI greater than or equal to 25kg/m2 who are considering pregnancy.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with BMI <25kg/m2; currently pregnant; less than 8 weeks postpartum; inability to provide written informed consent.

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)
Online randomisation system that will confirm eligibility and allocate treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with balanced variable block sizes prepared by investigator not involved with recruitment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A pre-specified data analysis plan will be published prior to any analyses being undertaken. Analyses will be conducted using SAS v(current) (Cary, NC, US) using standard analytical methods relevant to RCTs,

Analysis will be by intention to treat, women will be analysed in the groups to which they have been assigned.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2021
Actual
29/06/2021
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
15/02/2027
Actual
Sample size
Target
864
Accrual to date
281
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11783 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 11784 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 11785 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23909 0
5006 - North Adelaide
Recruitment postcode(s) [2] 23910 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 23911 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300595 0
Government body
Name [1] 300595 0
MRFF, Australian Government Department of Health
Country [1] 300595 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
72 King William Rd, North Terrace, Adelaide 5005 South Australia
Country
Australia
Secondary sponsor category [1] 300094 0
None
Name [1] 300094 0
Address [1] 300094 0
Country [1] 300094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301380 0
Women's and Children's Health Network HREC
Ethics committee address [1] 301380 0
Ethics committee country [1] 301380 0
Australia
Date submitted for ethics approval [1] 301380 0
01/11/2017
Approval date [1] 301380 0
17/08/2018
Ethics approval number [1] 301380 0
HREC/17/WCHN/177

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

Contacts
Principal investigator
Name 86818 0
Prof Jodie Dodd
Address 86818 0
The University of Adelaide and the Women's and Children's Hospital
72 King William St,
North Adelaide SA 5006
Country 86818 0
Australia
Phone 86818 0
+61881617615
Fax 86818 0
+61881617615
Email 86818 0
[email protected]
Contact person for public queries
Name 86819 0
Megan Mitchell
Address 86819 0
The University of Adelaide
72 King William St,
North Adelaide SA 5006
Country 86819 0
Australia
Phone 86819 0
+61 883131389
Fax 86819 0
+61881617652
Email 86819 0
[email protected]
Contact person for scientific queries
Name 86820 0
Jodie Dodd
Address 86820 0
The University of Adelaide and the Women's and Children's Hospital
72 King William St,
North Adelaide SA 5006
Country 86820 0
Australia
Phone 86820 0
+61881617615
Fax 86820 0
+61881617652
Email 86820 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 individual participant data, including all data underlying published results, may be shared following researcher requests to the chief investigator for consideration on an individual basis.
When will data be available (start and end dates)?
Data will be available following publication of the results and analyses to be conducted by the primary research team. No end date to availability planned.
Available to whom?
Researchers who provide a methodologically sound proposal in writing for consideration on case-by-case basis at the discretion of chief investigator and the trial steering committee.
Available for what types of analyses?
To achieve the aims of methodlogically sound proposals as approved by the chief investigator and the trial steering committee.
How or where can data be obtained?
The de-identified data will be made available electronically in a format compatible to both parties. Data will be password protected.
Contact principal investigator, Jodie Dodd ([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.