ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

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]

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]

Reduction in gestational diabetes as diagnosed by glucose tolerance test

Timepoint [1]

At 28 weeks gestation and measured at delivery

Secondary outcome [1]

1. Pooled adverse events in pregnancy

Timepoint [1]

Measured at delivery.

Secondary outcome [2]

2. Pooled adverse events in fetus or newborn

Timepoint [2]

Measured 6 weeks postpartum.

Secondary outcome [3]

3. Initiation of breastfeeding and breastfeeding at hospital discharge

Timepoint [3]

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?

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]

Commercial sector/Industry

Name [1]

Telstra Community Develpment Fund

Address [1]

19 Mouat St Fremantle WA 6959

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor J Quinlivan

Address

19 Mouat St Fremantle WA 6959

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Notre Dame Australia

Address [1]

19 Mouat St Fremantle WA 6959

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Womens

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Sunshine hospitals

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Julie Quinlivan

Address

University of Notre Dame
PO Box 589
East Melbourne VIC 3002

Country

Australia

Phone

+61 3 94956563

Fax

[email protected]

Contact person for scientific queries

Name

Professor Julie Quinlivan

Address

University of Notre Dame
PO Box 589
East Melbourne VIC 3002

Country

Australia

Phone

+61 3 94956563

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Combined diet and exercise interventions for preventing gestational diabetes mellitus.	2017	https://dx.doi.org/10.1002/14651858.CD010443.pub3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically