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Trial registered on ANZCTR
Registration number
ACTRN12616000053426
Ethics application status
Approved
Date submitted
15/01/2016
Date registered
20/01/2016
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Can omega-3 fatty acids reduce cardiovascular risk in children born with poor fetal growth: the Small baby Omega-3 (SO3) trial
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Scientific title
Effects of omega-3 fatty acid supplementation to improve cardiovascular risk markers in children born small-for-gestational-age.
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Secondary ID [1]
288328
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None
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Universal Trial Number (UTN)
U1111-1178-5213
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Trial acronym
SO3 trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small-for-gestational-age
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Increased aortic intima-media thickness
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Hypertension
297301
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Condition category
Condition code
Cardiovascular
297494
297494
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0
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Hypertension
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Reproductive Health and Childbirth
297495
297495
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0
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Childbirth and postnatal care
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Cardiovascular
297518
297518
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomized into groups to either the fish oil supplement (intervention) or no supplement (control) group from 6 months to 18 months of age.
The fish oil supplement will be provided to participants when infants are 6 months old in an encapsulated form containing 300 mg of omega-3 marine triglycerides (EPA 45mg, DHA 150mg), at a dose designed to achieve an omega-3 index of 8%, the optimum level for cardiovascular health. Parents/guardians will cleave the tail end of the capsule to dispense the liquid content into the infant's food or beverage.
Compliance will be measured by assessing blood fatty acid status and empty supplement bottle return.
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Intervention code [1]
293625
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Prevention
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Comparator / control treatment
The control group will not receive a supplement.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Aortic intima-media thickness using an ultrasound machine
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Assessment method [1]
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Timepoint [1]
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Aortic intima-media thickness will be measured at birth (enrolment), 6, 12, 18 months of age. The primary timepoint will be at 18 months of age.
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Secondary outcome [1]
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Systolic blood pressure using an automated device (CARESCAPE v100)
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Assessment method [1]
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Timepoint [1]
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Systolic blood pressure will be measured at birth (enrolment), 6, 12 and 18 months of age. The primary timepoint will be at 18 months of age.
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Secondary outcome [2]
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Infant weight will be measured as an exploratory outcome. Birth weight will be recorded from the patient medical records. Infant weight at 6, 12 and 18 months will be measured using digital scales (Seca 385 Infant Scales, Hamburg, Germany) from children wearing light clothes, no nappies and no shoes.
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Assessment method [2]
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Timepoint [2]
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Weight will be measured at birth (enrolment), 6, 12 and months of age as an exploratory outcome.
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Secondary outcome [3]
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Infant height will be measured as an exploratory outcome
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Assessment method [3]
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Timepoint [3]
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Infant's height will be measured at enrolment, 6, 12 and 18 months of age. Two length measurements will be taken supine (Seca 217 Infant Measuring Board, Hamburg, Germany) on a level floor and recorded to the nearest 0.1 cm.
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Secondary outcome [4]
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Autonomic control (heart rate variability) will be measured as an exploratory outcome where heart rate will be recorded using a 3-lead ECG over a total of 15 minutes. Heart rate variability will be determined using the Lab Chart software (version 8, AD Instruments, Australia).
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Assessment method [4]
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Timepoint [4]
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Autonomic control will be measured at enrolment, 6, 12 and 18 months of age.
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Secondary outcome [5]
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Cardiac structure and function will be measured as an exploratory outcome using an ultra sound machine
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Assessment method [5]
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Timepoint [5]
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Cardiac structure and function will be assessed at enrolment, 6 and 18 months of age
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Eligibility
Key inclusion criteria
Infants born at term (>37 weeks gestation) that are small-for-gestational-age (birth weight<10th percentile for sex and gestational age).
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Minimum age
No limit
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Maximum age
2
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Multiple births, infants requiring surgery, illness in infant requiring hospitalization for more than 2 weeks, infants with significant neonatal disease, infants with chromosomal abnormalities or congenital malformations, fish oil contraindicated in mother.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central computerized randomization system
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Intervention assignment will be via a central computerized system using minimization to balance treatment allocation with respect to hospital, newborn gender, ethnicity (Caucasian; non-Caucasian), gestational age (37-39 weeks; <40 weeks), and birth weight percentile (<3rd percentile; 3rd-10th percentile).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Given a sample size of 252 participants in each randomized group, and type I error probability of 0.05, this study will have: 88% power to detect a clinically relevant relative reduction in aortic IMT of 0.021 mm; 80% power to detect a population relevant 2.5 mm Hg reduction in systolic blood pressure in the omega-3 intervention group; and greater than 95% power to detect a clinically relevant 3.8 mm Hg reduction in systolic blood pressure. Based on our previous experience, we assume a 12.5% loss to follow-up at age 2 years. Thus, we need to randomize 288 participants per group (576 total).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/02/2017
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Actual
31/01/2018
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Date of last participant enrolment
Anticipated
28/01/2020
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Actual
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Date of last data collection
Anticipated
1/12/2020
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Actual
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Sample size
Target
576
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Accrual to date
28
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
12533
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2006 - The University Of Sydney
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Recruitment postcode(s) [2]
12534
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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The Children's Hospital at Westmead
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Address [1]
291433
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The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St Westmead,
NSW 2145
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Country [1]
291433
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Australia
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Other collaborator category [1]
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University
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Name [1]
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University of Turku
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Address [1]
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Research Centre of Applied and Preventative Cardiovascular Medicine,
University of Turku
Kiinamyllynkatu 10
20520 Turku
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Country [1]
278777
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Finland
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Lower Health District Ethics Commirttee (Royal Prince Alfred Hospital Zone)
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Ethics committee address [1]
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Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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10/02/2015
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Approval date [1]
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24/09/2015
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Ethics approval number [1]
294167
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Summary
Brief summary
Low birth weight is an important risk factor for adult ischemic heart disease. Those born small-for-gestational-age (<10th percentile for gestational age and gender) are at the highest risk for adult cardiovascular disease. Children and adults born small for gestational age have increased arterial intima-media thickness – a noninvasive marker of subclinical atherosclerosis, the underlying disease process responsible for the majority of cardiovascular events. Birth weight is inversely associated with blood pressure – a major cardiovascular risk factor, in both children and adults.
Published data from populations of children and young adults suggest that omega-3 fatty acid supplementation will have beneficial effects in reducing arterial intima-medial thickness and systolic blood pressure in children who were born small for gestational age. This hypothesis has not been tested in a randomized controlled trial.
This study is designed to test the effectiveness of omega-3 fatty acid supplementation from 6 to 18 months of age in reducing aortic intima-media thickness and systolic blood pressure in children born small-for-gestational-age. The study will be conducted as an open label randomized controlled trial over a 1 year intervention (when the infant is 6-18 months old) where aortic intima media thickness and systolic blood pressure will be measured at recruitment, 6, 12 and 18 months of age.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Michael Skilton
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Address
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Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006
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Country
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Australia
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Phone
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+61 2 8627 1916
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jovana Mijatovic
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Address
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Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006
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Country
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Australia
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Phone
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+61 286271341
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Michael Skilton
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Address
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Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006
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Country
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Australia
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Phone
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+61 2 8627 1916
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Fax
41692
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
When the study was initially conceptualised, participants were informed that "only the (listed) researchers....., the research assistants and research midwives working on this study will have access" to participant data.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
2796
Plain language summary
No
Results are not ready as the study is still active...
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Documents added automatically
No additional documents have been identified.
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