Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001156976
Ethics application status
Not yet submitted
Date submitted
20/09/2011
Date registered
4/11/2011
Date last updated
4/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Diary trial. Does a diary help pregnant women achieve ideal weight gain in pregnancy and reduce gestational diabetes.
Scientific title
The Diary trial. Does a diary help pregnant women achieve ideal weight gain in pregnancy and reduce gestational diabetes.
Secondary ID [1] 263079 0
No secondary IDs
Universal Trial Number (UTN)
Trial acronym
The Diary trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight gain in pregnancy 270829 0
Gestational diabetes 270830 0
Condition category
Condition code
Reproductive Health and Childbirth 271012 271012 0 0
Antenatal care
Metabolic and Endocrine 279288 279288 0 0
Diabetes
Reproductive Health and Childbirth 279289 279289 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A diary given to pregnant women at their booking visit at hospital (20 weeks gestation) in which their weight gain and diet are documented for feedback at each antenatal visit. Diet is documented by food frequency questionnaire. Antenatal visits occur as per three centre guidelines for antenatal care protocols or more frequently as directed by pregnancy complications. The diary is provided in addition to current best practice.
Intervention code [1] 269431 0
Prevention
Comparator / control treatment
Routine best practice antenatal care
Control group
Active

Outcomes
Primary outcome [1] 279671 0
Weight gain in pregnancy in accordance with IOM 2009 recommendations
Timepoint [1] 279671 0
Immediately before delivery
Primary outcome [2] 279672 0
Gestational diabetes assessed using GTT (75g) with fasting, 1hour and 2 hour as per HAPO guidelines and IADIPS
Timepoint [2] 279672 0
32 weeks gestation
Secondary outcome [1] 294168 0
Mean weight basin in pregnancy in kg
Timepoint [1] 294168 0
immediately before delivery
Secondary outcome [2] 294169 0
birthweight
Timepoint [2] 294169 0
delivery

Eligibility
Key inclusion criteria
Pregnant woman
singelton pregnancy
able to speak and read english
no known fatal anomalies
presents before 20 weeks gestational care for her booking visit
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple pregnancy
Known fetal anomaly
Not pregnant
presents greater than 20 weeks gestation for care
Cannot read o speak english

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)
computer generated numbered sealed opaque envelopes for randomisation
randomisation following informed consent
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269903 0
Self funded/Unfunded
Name [1] 269903 0
Julie Quinlivan
Country [1] 269903 0
Australia
Primary sponsor type
Hospital
Name
Joondalup Health Campus
Address
Suite 112 Private Consulting Suites Joondalup health Campus Shenton Avenue Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 268914 0
None
Name [1] 268914 0
Address [1] 268914 0
Country [1] 268914 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271875 0
Ethics committee address [1] 271875 0
Ethics committee country [1] 271875 0
Date submitted for ethics approval [1] 271875 0
01/11/2010
Approval date [1] 271875 0
Ethics approval number [1] 271875 0

Summary
Brief summary
The aim of the study is to develop a simple diary than can accompany antenatal care to help pregnant women attain weight gains in pregnancy consistent with IOM recommednations and to reduce rates of gestational diabetes.
Trial website
Trial related presentations / publications
Quinlivan JA, Fisher JW, Lam LT. A randomized trial of a 4-step multidisciplinary intervention for the management of obesity in pregnancy. ANZJOG 2011; DOI: 10.1111/j.1479-828X.2010.01268.x
Quinlivan JA, Julania S, Lam L. Do antenatal dietary interventions in obese pregnant women affect gestational weight gain and newborn birth weight? Obstetrics and Gynecology 2011 (in press).
Public notes

Contacts
Principal investigator
Name 33187 0
Address 33187 0
Country 33187 0
Phone 33187 0
Fax 33187 0
Email 33187 0
Contact person for public queries
Name 16434 0
Prof Julie Quinlivan
Address 16434 0
Suite 112 Private Consulting Suites Joondalup health Campus Shenton Avenue Joondalup, WA 6027
Country 16434 0
Australia
Phone 16434 0
61 8 94009400
Fax 16434 0
61 8 94009955
Email 16434 0
[email protected]
Contact person for scientific queries
Name 7362 0
Quinlivan Julie
Address 7362 0
Suite 112 Private Consulting Suites Joondalup health Campus Shenton Avenue Joondalup, WA 6027
Country 7362 0
Australia
Phone 7362 0
61 8 94009400
Fax 7362 0
61 8 9400 9955
Email 7362 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.