Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000161426
Ethics application status
Approved
Date submitted
12/10/2006
Date registered
9/03/2007
Date last updated
11/12/2019
Date data sharing statement initially provided
11/12/2019
Date results information initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial.
Scientific title
Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial
Secondary ID [1] 273225 0
The LIMIT trial
Universal Trial Number (UTN)
Trial acronym
LIMIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight or obese pregnant women. 1663 0
Condition category
Condition code
Diet and Nutrition 1768 1768 0 0
Obesity
Reproductive Health and Childbirth 1769 1769 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the Dietary and Lifestyle Advice Group will receive a comprehensive intervention to limit weight gain in pregnancy that includes a combination of dietary, exercise and behavioural strategies, delivered by a research dietician and trained research assistants. Women will be provided with dietary advice consistent with current Australian dietary standards, that maintains a balance of carbohydrates, fat and protein. Women will be encouraged to reduce their intake of 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. Exercise advice will focus on encouraging women to adopt a more active lifestyle, primarily by increasing the amount of walking. 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 1 hour planning session with a research dietician, in which women are 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. Additionally, women will be encouraged to identify potential barriers and enablers to facilitate the implementation of their goals. This information will be reinforced during subsequent inputs at regular intervals during pregnancy, provided by the research dietician (at 28 weeks’ gestation) and trained research assistants (via telephone call at 22, 24, and 32 weeks’ gestation and a face-face visit at 36 weeks’ gestation).
Intervention code [1] 1399 0
Lifestyle
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
Control group
Active

Outcomes
Primary outcome [1] 2475 0
Infant large for gestational age at birth (defined as birth weight = 90th centile for gestational age).
Timepoint [1] 2475 0
At birth
Secondary outcome [1] 4244 0
1) Adverse outcomes for the infant including preterm birth (defined as birth at less than 37 weeks gestation); mortality (defined as 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)); congenital anomalies; infant birth weight >4000 grams; 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.
Timepoint [1] 4244 0
All measured once, at primary hospital discharge or death.
Secondary outcome [2] 4245 0
2) 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 (defined as a positive oral glucose tolerance test with fasting blood glucose level >5.5mmol/L, or 2 hour blood glucose level = 7.8mmol/L); need for and length of antenatal hospital stay; antepartum haemorrhage requiring hospitalisation; preterm prelabour ruptured membranes; prelabour ruptured membranes at term; chorioamnionitis requiring antibiotic use during labour; need and reason for induction of labour; any antibiotic use during labour; caesarean section; postpartum haemorrhage (defined as blood loss >600mL); perineal trauma; wound infection; endometritis; use of postnatal antibiotics; length of postnatal hospital stay; thromboembolic disease; maternal death.
Timepoint [2] 4245 0
All measured once, at primary hospital discharge.

Eligibility
Key inclusion criteria
Pregnant women with a singleton, live gestation between 10+0 - 20 weeks who are obese or overweight (defined as a body mass index greater that 25kg/m2).
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with multiple pregnancy, or type 1 or type 2 diabetes diagnosed prior to pregnancy.There is no age range criteria for this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2008
Actual
28/05/2008
Date of last participant enrolment
Anticipated
Actual
8/02/2012
Date of last data collection
Anticipated
Actual
18/12/2012
Sample size
Target
2180
Accrual to date
Final
2212
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15453 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 15454 0
Lyell McEwin Hospital - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 1921 0
University
Name [1] 1921 0
Discipline of Obstetrics & Gynaecology, Faculty of Health Sciences, University of Adelaide
Country [1] 1921 0
Australia
Funding source category [2] 304507 0
Government body
Name [2] 304507 0
NHMRC
Country [2] 304507 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital, Adelaide, SA.
Address
72 King William Road,
North Adelaide,
SA 5006
Country
Australia
Secondary sponsor category [1] 1732 0
None
Name [1] 1732 0
Nil
Address [1] 1732 0
Country [1] 1732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3575 0
Women's and Children's Hospital
Ethics committee address [1] 3575 0
Adelaide, SA,
Ethics committee country [1] 3575 0
Australia
Date submitted for ethics approval [1] 3575 0
Approval date [1] 3575 0
01/08/2006
Ethics approval number [1] 3575 0
REC1839/6/09

Summary
Brief summary
AIMS OF THE RESEARCH
Being overweight or obese is a major health issue for Australian women during pregnancy and childbirth. There are well documented risks associated with obesity during pregnancy, including for the mother high blood pressure, diabetes and caesarean section. Babies of mothers who are overweight or obese are more likely to be large for gestational age, need admission to the nursery and to require treatment for jaundice and low blood sugar levels.
This randomised trial will assess whether implementing a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit weight gain is effective in improving maternal, fetal and infant health outcomes.
EXPECTED OUTCOMES OF THE RESEARCH
If dietary and lifestyle advice is effective this would be a highly beneficial and cost effective treatment to redice the burden of disease to mothers and their infants caused by obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27626 0
Prof Jodie Dodd
Address 27626 0
University of Adelaide, Obstetrics & Gynaecology Women's and Children's Hospital Level 1, Queen Victoria Building 72 King William Road North Adelaide SA 5006
Country 27626 0
Australia
Phone 27626 0
+61881617619
Fax 27626 0
+61881617652
Email 27626 0
jodie.dodd@adelaide.edu.au
Contact person for public queries
Name 10588 0
Ms Andrea Deussen
Address 10588 0
University of Adelaide, Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1, Queen Victoria Building
72 King William Road
North Adelaide SA 5006
Country 10588 0
Australia
Phone 10588 0
+61 8 8161 7657
Fax 10588 0
+61 8 8161 7652
Email 10588 0
andrea.deussen@adelaide.edu.au
Contact person for scientific queries
Name 1516 0
Prof Dr Jodie Dodd
Address 1516 0
University of Adelaide, Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1, Queen Victoria Building
72 King William Road
North Adelaide SA 5006
Country 1516 0
Australia
Phone 1516 0
+61 8 8161 7619
Fax 1516 0
+61 8 8161 7652
Email 1516 0
jodie.dodd@adelaide.du.au

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 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 is available - no end date set.
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?
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?
De-identified data will be made available electronically in a format acceptable to both parties. Data will be password protected.


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolDodd JM, Turnbull DA, McPhee AJ, Wittert G, Crowther CA, Robinson JS Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial. BMC Pregnancy and Childbirth 2011 Oct 26;11(1):79.https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/1471-2393-11-79jodie.dodd@adelaide.edu.au N/A 81642-(Uploaded-05-12-2019-11-55-37)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 10th February 2014 Dodd JM, Turnbull D, McPhee AJ... [More Details] 81642-(Uploaded-05-12-2019-11-15-56)-Journal results publication.pdf
Study results articleYes 13 October 2014 Dodd JM, McPhee AJ, Turnbull D, Y... [More Details] 81642-(Uploaded-05-12-2019-11-18-57)-Journal results publication.pdf
Study results articleYes 13 October 2014 Dodd JM, Cramp C, Sui Z, Yelland ... [More Details] 81642-(Uploaded-05-12-2019-11-19-48)-Journal results publication.pdf
Study results articleYes 13 October 2014 Dodd JM, Cramp C, Sui Z, Yelland ... [More Details] 81642-(Uploaded-05-12-2019-11-19-49)-Journal results publication.pdf
Basic resultsNo 81642-(Uploaded-09-11-2018-16-56-57)-Basic results summary.docx
Plain language summaryNo We conducted a study to determine whether a dietar... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of a lifestyle intervention on pregnancy and postpartum dietary patterns determined by factor analysis.2017https://dx.doi.org/10.1002/oby.21848
EmbaseThe effect of an antenatal lifestyle intervention in overweight and obese women on circulating cardiometabolic and inflammatory biomarkers: Secondary analyses from the LIMIT randomised trial.2017https://dx.doi.org/10.1186/s12916-017-0790-z
EmbaseThe mediating effects of gestational diabetes on fetal growth and adiposity in women who are overweight and obese: secondary analysis of the LIMIT randomised trial.2018https://dx.doi.org/10.1111/1471-0528.15288
EmbaseThe characterisation of overweight and obese women who are under reporting energy intake during pregnancy.2018https://dx.doi.org/10.1186/s12884-018-1826-x
EmbasePrenatal diet and child growth at 18 months.2018https://dx.doi.org/10.1542/peds.2018-0035
EmbaseEffects of an antenatal dietary intervention in overweight and obese women on 6 month infant outcomes: follow-up from the LIMIT randomised trial.2018https://dx.doi.org/10.1038/s41366-018-0019-z
EmbaseAntenatal dietary and lifestyle advice for women who are overweight or obese and the effect on fetal growth and adiposity: The LIMIT randomised trial.2016https://dx.doi.org/10.1111/1471-0528.13777
EmbaseThe effect of antenatal lifestyle advice for women who are overweight or obese on secondary measures of neonatal body composition: The LIMIT randomised trial.2016https://dx.doi.org/10.1111/1471-0528.13796
EmbaseUse of a DVD to provide dietary and lifestyle information to pregnant women who are overweight or obese: A nested randomised trial.2014https://dx.doi.org/10.1186/s12884-014-0409-8
EmbaseThe cost-effectiveness of providing antenatal lifestyle advice for women who are overweight or obese: The LIMIT randomised trial.2015https://dx.doi.org/10.1186/s40608-015-0046-4
EmbaseEffect of an antenatal diet and lifestyle intervention and maternal BMI on cord blood DNA methylation in infants of overweight and obese women: The LIMIT Randomised Controlled Trial.2022https://dx.doi.org/10.1371/journal.pone.0269723
EmbaseEffects of an antenatal dietary intervention in women with obesity or overweight on child outcomes at 8-10 years of age: LIMIT randomised trial follow-up.2023https://dx.doi.org/10.1186/s12887-023-04466-4
EmbaseEffects of an antenatal dietary intervention in women with obesity or overweight on child outcomes at 3-5 years of age: LIMIT randomised trial follow-up.2020https://dx.doi.org/10.1038/s41366-020-0560-4
EmbaseIn overweight and obese women, fetal ultrasound biometry accurately predicts newborn measures.2020https://dx.doi.org/10.1111/ajo.13025
Dimensions AIDeveloping a tool for obtaining maternal skinfold thickness measurements and assessing inter-observer variability among pregnant women who are overweight and obese2013https://doi.org/10.1186/1471-2393-13-42
N.B. These documents automatically identified may not have been verified by the study sponsor.