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
22/09/2024
Date data sharing statement initially provided
22/09/2024
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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Decided not to proceed
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)
WA

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33187 0
Prof Not proceeding trial
Address 33187 0
Not proceeding trial
Country 33187 0
Australia
Phone 33187 0
+61 8 94009400
Fax 33187 0
Email 33187 0
Not proceeding trial
Contact person for public queries
Name 16434 0
Not proceeding trial
Address 16434 0
Not proceeding trial
Country 16434 0
Australia
Phone 16434 0
61 8 94009400
Fax 16434 0
61 8 94009955
Email 16434 0
Not proceeding trial
Contact person for scientific queries
Name 7362 0
Not proceeding trial
Address 7362 0
Not proceeding trial
Country 7362 0
Australia
Phone 7362 0
61 8 94009400
Fax 7362 0
61 8 9400 9955
Email 7362 0
Not proceeding trial

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.