Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000881932
Ethics application status
Not yet submitted
Date submitted
3/05/2010
Date registered
18/08/2011
Date last updated
18/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of regular weighing and dietary advice on clinical outcomes and feelings in overweight pregnant women :Facts, figures and feelings about weight gain in pregnancy
Scientific title
The effect of regular weighing and dietary advice on maternal health and complications of pregnancy in overweight pregnant women
Secondary ID [1] 253288 0
none
Universal Trial Number (UTN)
U1111-1118-5096
Trial acronym
FFF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight in pregnancy 257274 0
Condition category
Condition code
Reproductive Health and Childbirth 257422 257422 0 0
Fetal medicine and complications of pregnancy
Diet and Nutrition 257648 257648 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in both groups will be weighed at recruitment, before 20 weeks gestation. Women in the control group will be advised of their body mass index (BMI), and recommended weight gain for pregnacy based on Institute of medicine guidelines.
Women in the intervention group will have a single individual session lasting approximately 30 minutes with a dietitan or food technologist or trained midwife, consisting of a dietary history and simple dietary advice. They will be encouraged to weigh themselves regularly and record weight gain on a personalsed graph. Weight gain will be recorded in both groups at 36 weeks pregnancy
Intervention code [1] 256392 0
Lifestyle
Intervention code [2] 256588 0
Prevention
Comparator / control treatment
Women will be weighed in street clothes on a calibrated scale at the time of recruitment, which is before 20 weeks gestation
Control group
Active

Outcomes
Primary outcome [1] 258341 0
Composite maternal outcome of gestational diabetes, pregnancy induced hypertension (PIH), preeclampsia, eclampsia, mode of birth other than spontaneous vertex, shoulder dystocia, post partum haemorrhage (PPH) greater than 500ml, 3rd or 4th degree perineal trauma, admission to high dependency unit ( HDU ) or intensive care unit (ICU), postnatal stay birth suite greater than 6 hours, maternal death
This will be assessed from the Birth Outcomes System (BOS) , review of medical notes if required, review of ICU admissions
Timepoint [1] 258341 0
6 weeks post partum
Secondary outcome [1] 264058 0
Maternal C reactive protein, adiponectin, glucose tolerance, insulin in maternal blood
Timepoint [1] 264058 0
28 weeks gestation
Secondary outcome [2] 264059 0
Maternal well being - World Health Organisation Quality of Life BREF (WHO QOLBREF)
Timepoint [2] 264059 0
36 weeks gestation
Secondary outcome [3] 264060 0
Infant outcomes including birthweight, centiles, markers of adiposity, personalised centiles, gestational age, birth trauma, admission to special care nursery (SCN) or neonatal intensive care nursery (NICU), jaundice, hypoglycaemia (as defined by the treating team)
Timepoint [3] 264060 0
birth
Secondary outcome [4] 264061 0
maternal weight and well being - WHO - BREFQOL
Timepoint [4] 264061 0
6, 12 and 24 months post partum
Secondary outcome [5] 268621 0
markers of insulin resistance in umbilical cord blood
Timepoint [5] 268621 0
at birth

Eligibility
Key inclusion criteria
Pregnant women with body mass index (BMI) greater than 25kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre pregnancy diabetes, multifetal pregnancy, serious fetal anomaly

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)
Women approached in antenatal clinic . Allocation by opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator, stratified for overweight and obese
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
382
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256898 0
Charities/Societies/Foundations
Name [1] 256898 0
Royal Australian and New Zealand College of Obstetrics and Gynecology
Country [1] 256898 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley rd
Heidelberg 3048
Vic
Country
Australia
Secondary sponsor category [1] 256170 0
None
Name [1] 256170 0
Address [1] 256170 0
Country [1] 256170 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258908 0
Mercy Hospital for Women
Ethics committee address [1] 258908 0
Ethics committee country [1] 258908 0
Date submitted for ethics approval [1] 258908 0
03/05/2010
Approval date [1] 258908 0
Ethics approval number [1] 258908 0

Summary
Brief summary
Being overweight and gaining too much weight in pregnancy increase the chances of complications of the pregnnacy for the mother and baby.
We believe that by giving women simple dietary advice and encouraging them towards healthy weight gain targets in pregnancy, these outcomes may be improved
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31115 0
Address 31115 0
Country 31115 0
Phone 31115 0
Fax 31115 0
Email 31115 0
Contact person for public queries
Name 14362 0
Dr Alexis Shub
Address 14362 0
Mercy Hospital for Women
163 Studley rd
Heidelberg 3084
Vic
Country 14362 0
Australia
Phone 14362 0
61 3 8458 4248
Fax 14362 0
Email 14362 0
[email protected]
Contact person for scientific queries
Name 5290 0
Dr Alexis Shub
Address 5290 0
Mercy Hospital for Women
163 Studley rd
Heidelberg 3084
Vic
Country 5290 0
Australia
Phone 5290 0
61 3 8458 4248
Fax 5290 0
Email 5290 0
[email protected]

No information has been provided regarding IPD availability


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.