Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000709640
Ethics application status
Approved
Date submitted
7/10/2005
Date registered
2/11/2005
Date last updated
13/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of a multidisciplinary teamcare approach involving obstetric, dietary and clinical psychological input in obese pregnant women to reduce the incidence of gestational diabetes
Scientific title
A multidisciplinary teamcare approach involving obstetric, dietary and clinical psychological input in obese pregnant women to reduce the incidence of gestational diabetes
Secondary ID [1] 216 0
Perinatal Trials Registry: PTR543
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese pregnant women 859 0
Condition category
Condition code
Diet and Nutrition 925 925 0 0
Obesity
Reproductive Health and Childbirth 926 926 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multidisciplinary antenatal care involving obstetric, dietary, clinical psychology input compared to current care, applied from the first antenatal visit until delivery of the baby applied at antenatal visits the number of which will be determined by medical indications for each woman
Intervention code [1] 703 0
Prevention
Comparator / control treatment
Normal antenatal care as defined by the three centres consensus on antenatal care (Victoria) which defines the type and number of antenatal visits
Control group
Active

Outcomes
Primary outcome [1] 1211 0
Reduction in gestational diabetes as diagnosed by glucose tolerance test
Timepoint [1] 1211 0
At 28 weeks gestation and measured at delivery
Secondary outcome [1] 2208 0
1. Pooled adverse events in pregnancy
Timepoint [1] 2208 0
Measured at delivery.
Secondary outcome [2] 2209 0
2. Pooled adverse events in fetus or newborn
Timepoint [2] 2209 0
Measured 6 weeks postpartum.
Secondary outcome [3] 2210 0
3. Initiation of breastfeeding and breastfeeding at hospital discharge
Timepoint [3] 2210 0
Measured on Day 5 postpartum.

Eligibility
Key inclusion criteria
BMI at booking visit greater than 25, speak english, no known fetal anomaly, able to attend for antenatal care, present less than 20 weeks gestation.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
numered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers program with allocation concealed in a numbered sealed opaque envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1020 0
Commercial sector/Industry
Name [1] 1020 0
Telstra Community Develpment Fund
Country [1] 1020 0
Australia
Primary sponsor type
Individual
Name
Professor J Quinlivan
Address
19 Mouat St Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 884 0
University
Name [1] 884 0
University of Notre Dame Australia
Address [1] 884 0
19 Mouat St Fremantle WA 6959
Country [1] 884 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2326 0
Royal Womens
Ethics committee address [1] 2326 0
Ethics committee country [1] 2326 0
Australia
Date submitted for ethics approval [1] 2326 0
Approval date [1] 2326 0
Ethics approval number [1] 2326 0
Ethics committee name [2] 2327 0
Sunshine hospitals
Ethics committee address [2] 2327 0
Ethics committee country [2] 2327 0
Australia
Date submitted for ethics approval [2] 2327 0
Approval date [2] 2327 0
Ethics approval number [2] 2327 0

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

Contacts
Principal investigator
Name 36359 0
Address 36359 0
Country 36359 0
Phone 36359 0
Fax 36359 0
Email 36359 0
Contact person for public queries
Name 9892 0
Professor Julie Quinlivan
Address 9892 0
University of Notre Dame
PO Box 589
East Melbourne VIC 3002
Country 9892 0
Australia
Phone 9892 0
+61 3 94956563
Fax 9892 0
Email 9892 0
[email protected]
Contact person for scientific queries
Name 820 0
Professor Julie Quinlivan
Address 820 0
University of Notre Dame
PO Box 589
East Melbourne VIC 3002
Country 820 0
Australia
Phone 820 0
+61 3 94956563
Fax 820 0
Email 820 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
SourceTitleYear of PublicationDOI
EmbaseCombined diet and exercise interventions for preventing gestational diabetes mellitus.2017https://dx.doi.org/10.1002/14651858.CD010443.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.