Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001278426
Ethics application status
Approved
Date submitted
7/09/2016
Date registered
12/09/2016
Date last updated
12/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Factors affecting health behaviours and healthy weight during pregnancy and post-partum
Scientific title
Are we missing opportunities: understanding health behaviours associated with overweight in pregnancy- the New Beginnings Healthy Mothers and Babies Study
Secondary ID [1] 290107 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 300201 0
weight gain 300203 0
Condition category
Condition code
Diet and Nutrition 300084 300084 0 0
Obesity
Reproductive Health and Childbirth 300085 300085 0 0
Breast feeding
Public Health 300086 300086 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pregnant women planning to deliver a baby at the Royal Brisbane and Women's Hospital will be asked to complete a questionnaire about their health and lifestyle habits, and feeding intentions at 16 and 36 weeks gestation during pregnancy and at 4 months after their baby is born. They will also be weighed at 16 and 36 weeks and have their delivery information gathered from a hospital database.
Intervention code [1] 295853 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299560 0
Excess gestational weight gain will be defined according to Institute of Medicine Guidelines for each pre-pregnancy BMI
Timepoint [1] 299560 0
36 weeks gestation minus self reported pre-pregnancy weight (reported at 16 weeks)
Primary outcome [2] 299561 0
Exclusive breastfeeding assessed by self administered questionnaire. Complete questionnaire collated for this study. Exclusive breastfeeding assessed using WHO indicators
Timepoint [2] 299561 0
4 months post partum
Primary outcome [3] 299562 0
Breastfeeding intentions measured using the validated Infant Feeding Intentions Scale (self reported questionnaire)
Timepoint [3] 299562 0
36 weeks gestation
Secondary outcome [1] 327508 0
self reported dietary behaviour using the validated Fat and Fibre Behaviour Questionnaire (Reeves M et al)
Timepoint [1] 327508 0
16 weeks and 36 weeks gestation, and 4 months post partum
Secondary outcome [2] 327509 0
Self reported physical activity using the Active Australia survey items
Timepoint [2] 327509 0
16 weeks and 36 weeks gestation, and 4 months post partum

Eligibility
Key inclusion criteria
All women planning to deliver a baby at the Royal Brisbane and Women's Hospital who are less than 20 weeks pregnant
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Requiring an interpreter to complete questionnaires
pre-existing type 1 or 2 diabetes

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/08/2010
Date of last participant enrolment
Anticipated
Actual
28/01/2011
Date of last data collection
Anticipated
Actual
28/10/2011
Sample size
Target
736
Accrual to date
Final
715
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6622 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 14243 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 294475 0
Charities/Societies/Foundations
Name [1] 294475 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 294475 0
Australia
Funding source category [2] 294476 0
Government body
Name [2] 294476 0
National Health and Medical Research Council
Country [2] 294476 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston, Qld 4029
Country
Australia
Secondary sponsor category [1] 293346 0
University
Name [1] 293346 0
Queensland University of Technology
Address [1] 293346 0
Victoria Park Road
Kelvin Grove, Qld 4059
Country [1] 293346 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295913 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 295913 0
Ethics committee country [1] 295913 0
Australia
Date submitted for ethics approval [1] 295913 0
29/03/2010
Approval date [1] 295913 0
12/05/2010
Ethics approval number [1] 295913 0
HREC/10/QRBW/139
Ethics committee name [2] 295914 0
Queensland University of Technology
Ethics committee address [2] 295914 0
Ethics committee country [2] 295914 0
Australia
Date submitted for ethics approval [2] 295914 0
21/05/2010
Approval date [2] 295914 0
21/06/2011
Ethics approval number [2] 295914 0
1000000558

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

Contacts
Principal investigator
Name 68882 0
Dr Susan de Jersey
Address 68882 0
Level 2 James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston, Qld 4029
Country 68882 0
Australia
Phone 68882 0
+61424949217
Fax 68882 0
Email 68882 0
s.croaker@connect.qut.edu.au
Contact person for public queries
Name 68883 0
Susan de Jersey
Address 68883 0
Level 2 James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston, Qld 4029
Country 68883 0
Australia
Phone 68883 0
+61424949217
Fax 68883 0
Email 68883 0
s.croaker@connect.qut.edu.au
Contact person for scientific queries
Name 68884 0
Susan de Jersey
Address 68884 0
Level 2 James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston, Qld 4029
Country 68884 0
Australia
Phone 68884 0
+61424949217
Fax 68884 0
Email 68884 0
s.croaker@connect.qut.edu.au

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.