Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000583640
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
30/05/2014
Date last updated
17/12/2019
Date data sharing statement initially provided
17/12/2019
Date results provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising gestational weight gain and
improving maternal and infant health outcomes
through antenatal dietary, lifestyle and exercise advice:
the OPTIMISE randomised trial.
Scientific title
Pregnant women with a normal BMI receiving dietary, lifestyle and exercise advice compared with routine antenatal care to improve maternal and infant health outcomes.
Secondary ID [1] 284495 0
None
Universal Trial Number (UTN)
Trial acronym
OPTIMISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal diet and exercise advice 291743 0
Condition category
Condition code
Reproductive Health and Childbirth 292113 292113 0 0
Normal pregnancy
Reproductive Health and Childbirth 292184 292184 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the Lifestyle Advice Group will receive comprehensive dietary advice to optimise gestational weight gain, utilising a combination of dietary, exercise and behavioural strategies. Women will be interviewed by a research dietitian and research assistants, and receive a multi-faceted series of inputs consisting of a combination of both individual and group face-to-face sessions, as outlined below. Over the course of pregnancy, each woman will receive 2 (1x1hr before 20 weeks, and 1x0.5hr at 28 weeks) sessions with the dietitian either one on one or as a small group of two to three women, and 4 one on one telephone contacts (at 22, 28, 34 and 36 weeks) with the research assistant. The intervention has been designed to maximise flexibility and choice for women, while providing advice that is both simple and easy to incorporate into each individual’s lifestyle. The timing and location of these sessions will again be designed to maximise flexibility and choice.

Dietary advice provided will be consistent with current Australian dietary standards, and designed to limit gestational weight gain. The dietary intervention will maintain a balance of carbohydrates, fat and protein, while specifically encouraging women to reduce their intake of energy dense and non-core foods high in refined carbohydrates and saturated fats, while increasing their intake of fibre, and promoting consumption of two serves of fruit and five serves of vegetables each day. Recommendations and dietary targets will be individualised, taking into account each woman’s basal metabolic rate and activity levels. Tailoring of the intervention will be informed by stage theories of health decision making that propose that individuals progress through a series of cognitive phases when undertaking behavioural change. Initially, there will be a planning session with a research dietitian, in which women will be provided with written dietary and activity information, an individual diet and physical activity plan, a food and activity diary, recipe book and example menu plans. Women will be encouraged to set achievable goals for dietary and exercise change, supported to make these lifestyle changes and to self-monitor their progress. Women will be encouraged to involve their partner or significant support person in the individual and group intervention sessions. These principles will be reinforced at subsequent dietitian visits and during the telephone sessions in a similar format to a community intervention for women in the postpartum period.

Women will be asked to complete a food frequency questionnaire, exercise diary, and quality of life assessments at trial entry, 28 and 36 weeks gestation, and six and 12 months postpartum. Their weight will be recorded at trial entry, and at each contact, including at 36 weeks gestation or nearest to birth, and 6 and 12 months post-partum. All women will be encouraged to attend for a research ultrasound at 28 and 36 weeks gestation that does not constitute routine clinical care, to monitor fetal growth and well-being, and in particular the development of small for gestational age infants. Care during pregnancy and birth will be according to the practices of the hospital at which the woman is booked to give birth. After birth, information will be obtained relating to birth and infant outcomes from the case notes by the research assistant and the delivery form completed. Similarly, the postnatal and neonatal forms will be completed for each live born infant after discharge from hospital. Data collection forms will be checked and signed by the local research coordinator. At six months and 1 year postpartum, women will be contacted to complete a questionnaire about their emotional wellbeing, infant feeding practices, infant development, and attend an assessment with a research assistant who will measure maternal and infant height/length, weight, anthropometry, and blood pressure.
Intervention code [1] 289254 0
Lifestyle
Intervention code [2] 289323 0
Behaviour
Comparator / control treatment
Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice.

Women will be asked to complete a food frequency questionnaire, exercise diary, and quality of life assessments at trial entry, 28 and 36 weeks gestation, and six and 12 months postpartum. Their weight will be recorded at trial entry, and at each contact, including at 36 weeks gestation or nearest to birth, and 6 and 12 months postpartum. All women will be encouraged to attend for a research ultrasound at 28 and 36 weeks gestation that does not constitute routine clinical care, to monitor fetal growth and well-being, and in particular the development of small for gestational age infants. Care during pregnancy and birth will be according to the practices of the hospital at which the woman is booked to give birth. After birth, information will be obtained relating to birth and infant outcomes from the case notes by the research assistant and the delivery form completed. Similarly, the postnatal and neonatal forms will be completed for each live born infant after discharge from hospital. Data collection forms will be checked and signed by the local research coordinator. At six months and 1 year post-partum, women will be contacted to complete a questionnaire about their emotional wellbeing, infant feeding practices, infant development, and attend an assessment with a research assistant who will measure maternal and infant height/length, weight, anthropometry, and blood pressure.
Control group
Active

Outcomes
Primary outcome [1] 291989 0
Infant birth weight greater than 4000 grams
Timepoint [1] 291989 0
At birth.
Secondary outcome [1] 307963 0
Please note this is not a composite and all outcomes will be reported separately, including:

Adverse outcomes for the infant including preterm birth (birth before 37 weeks gestation); mortality (either a stillbirth (intrauterine fetal death after trial entry and prior to birth), or infant death (death of a live born infant prior to hospital discharge, and excluding lethal congenital anomalies)); infant birth weight of 4500 grams or more; infant birth of 2500 grams or less; infant born large for gestational age; infant born small for gestational age; hypoglycaemia requiring intravenous treatment; admission to neonatal intensive care unit, or special care baby unit; hyperbilirubinaemia requiring phototherapy; nerve palsy; fracture; birth trauma; shoulder dystocia; corticosteroid use; respiratory distress syndrome, respiratory support, moderate or severe respiratory disease, discharged on oxygen therapy, patent ductus arteriosus, proven systemic infection, retinopathy of prematurity, necrotizing enterocolitis, neonatal encephalopathy, neonatal siezures, major congenital anomoly, exclusive breastfeeding on discharge.
Timepoint [1] 307963 0
At birth or up until primary hospital discharge.
Secondary outcome [2] 307968 0
Please note this is not a composite and all outcomes will be reported separately, including: Adverse outcomes for the woman including maternal hypertension and pre-eclampsia (in accordance with recognised Australasian Society for the Study of Hypertension in Pregnancy criteria); maternal gestational diabetes; need for and length of antenatal hospital stay; antepartum haemorrhage requiring hospitalisation; preterm prelabour ruptured membranes; chorioamnionitis; need and reason for induction of labour; any antibiotic use during labour; caesarean section; postpartum haemorrhage (blood loss of 600mL or more); perineal trauma; wound infection; endometritis; length of postnatal hospital stay; thromboembolic disease; maternal death.
Timepoint [2] 307968 0
From trial entry until six weeks postpartum.
Secondary outcome [3] 307971 0
Fetal growth and wellbeing at 28 and 36 weeks’ gestation assessed by ultrasound (fetal biometry, estimated weight, liquor volume, umbilical artery Doppler waveform, and adiposity).
Timepoint [3] 307971 0
At 28 and 36 weeks gestation.
Secondary outcome [4] 307972 0
Infant growth and development at six and 18 months of age as measured by questionnaires developed for this study and completed by the woman relating to infant feeding practices including breast and formula feeding, introduction of solids), infant development (as measured by the Ages and Stages Questionnaire), blood pressure, and infant height, weight and anthropometric assessment (including skin-fold thickness, body circumferences, and bio-impedance assessment of fat mass and adiposity).
Timepoint [4] 307972 0
At 6 and 18 months of age.
Secondary outcome [5] 308033 0
Please note this is not a composite and all outcomes will be assessed separately, including: Maternal quality of life and emotional wellbeing as measured by questionnaires completed by the woman at six months postpartum relating to quality of life (as measured using the SF12 Health Survey Questionnaire), preferences for treatment, satisfaction with care, anxiety (as measured by the Short Form Spielberger State Trait Inventory) and depression (as measured by the Edinburgh Postnatal Depression Scale). Women will be asked a series of questions about their satisfaction with the intervention, using items modified from a previous childbirth questionnaire.
Timepoint [5] 308033 0
At trial entry, 28 and 36 weeks gestation, 4-6 months postpartum and 18 months postpartum. Satisfaction with care and the intervention will be assessed at 4-6 months postpartum.
Secondary outcome [6] 308034 0
Please note this is not a composite and all outcomes will be assessed separately including: Gestational weight gain including total gestational weight gain; average weekly weight gain; and weight gain below, within, and above the IoM recommendations. Maternal health at 6 and 18 months postpartum. Maternal weight at 6, 12 and 18 months after birth to calculate postpartum weight retention, diet (using and Australian version of the Harvard Semi Quantitative Food Frequency Questionnaire (to be validated) and physical activity (SQUASH Questionnaire))
Timepoint [6] 308034 0
Gestational weight gain assessed from trial entry until birth. Maternal postpartum health at 6 and 18-24 months and maternal postpartum weight assessed at 6, 12 and 18 months postpartum.

Eligibility
Key inclusion criteria
Women with a singleton, live gestation between 10+0-20+0 weeks who are of normal BMI (defined as a BMI 18.5-24.9kg/m2), at the time of the first antenatal visit.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with a multiple pregnancy; type 1 or 2 diabetes diagnosed prior to pregnancy; or a BMI of 25.0kg/m2 or more will be excluded.

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)
Research staff will use a central online computer randomisation service provided by the University of Adelaide.
The central online randomisation service was prepared by researchers not involved in identifying or enrolling eligible women.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Balanced variable block permutation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The initial analysis will examine baseline characteristics of all randomised women, as an indication of comparable treatment groups, and include maternal age, parity, race, height, weight, smoking history, past obstetric history, and previous gestational diabetes. Primary and secondary outcomes will be analysed on an “intention to treat” basis, according to treatment allocation at randomisation. Relative risks and 95% confidence intervals will be reported for the major outcomes, and the number needed to treat to benefit or harm calculated. Regression techniques will examine the influence of prognostic factors on the major outcomes.
We will recruit a total of 624 women to the OPTIMISE trial. We estimate that the primary infant outcome of birth weight >4kg occurs with an incidence of approximately 8.72% in this population. Our sample size will allow us to detect a relative risk reduction of 61% to 3.89% (alpha 0.05; power 70%), accounting for 10% loss to follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
31/12/2017
Actual
18/04/2017
Date of last data collection
Anticipated
Actual
15/12/2018
Sample size
Target
624
Accrual to date
Final
641
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2362 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 8028 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 289135 0
University
Name [1] 289135 0
The Discipline of Obstetrics and Gynaecology, Faculty of Health Sciences, The University of Adelaide
Country [1] 289135 0
Australia
Primary sponsor type
University
Name
Discipline of Obstetrics and Gynaecology, Faculty of Health Sciences, The University of Adelaide
Address
72 King William St,
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 287801 0
None
Name [1] 287801 0
Address [1] 287801 0
Country [1] 287801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290913 0
Women's and Children's Health Network Human Research Ethics
Ethics committee address [1] 290913 0
Ethics committee country [1] 290913 0
Australia
Date submitted for ethics approval [1] 290913 0
Approval date [1] 290913 0
18/02/2014
Ethics approval number [1] 290913 0
HREC13/WCHN/152

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

Contacts
Principal investigator
Name 47946 0
Prof Jodie Dodd
Address 47946 0
Discipline of Obstetrics and Gynaecology, The University of Adelaide
72 King William St
North Adelaide, SA 5006
Country 47946 0
Australia
Phone 47946 0
+61881617619
Fax 47946 0
+61881617652
Email 47946 0
[email protected]
Contact person for public queries
Name 47947 0
Andrea Deussen
Address 47947 0
Discipline of Obstetrics and Gynaecology, The University of Adelaide
72 King William St
North Adelaide, SA 5006
Country 47947 0
Australia
Phone 47947 0
61883131429
Fax 47947 0
Email 47947 0
[email protected]
Contact person for scientific queries
Name 47948 0
Jodie Dodd
Address 47948 0
Discipline of Obstetrics and Gynaecology, The University of Adelaide
72 King William St
North Adelaide, SA 5006
Country 47948 0
Australia
Phone 47948 0
+61881617619
Fax 47948 0
Email 47948 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?
All baseline characteristics, primary and secondary trial outcomes.
When will data be available (start and end dates)?
From December 2020 - no end date.
Available to whom?
Researchers upon reasonable request
Available for what types of analyses?
Proposal protocols will be assessed by the trial steering committee.
How or where can data be obtained?
By contacting Jodie Dodd using Principal investigator contact details within this ANZCTR record.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6211Study protocolDodd, J.M.; Deussen, A.R.; Louise, J. Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: The optimise randomised controlled trial protocol. BMJ Open 2018, 8, e019583 [email protected]



Results publications and other study-related documents

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Documents added automatically
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