Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000497606
Ethics application status
Approved
Date submitted
17/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of exercise during pregnancy on maternal and neonatal outcomes.
Scientific title
Randomised controlled study of the effects of exercise during pregnancy on maternal insulin sensitivity and neonatal outcomes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 621 0
Condition category
Condition code
Reproductive Health and Childbirth 694 694 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise group: A programme of moderate-intensity aerobic (cycling) exercise performed for 40 minutes, 5 times per week, from 20 weeks gestation to term.
Intervention code [1] 645 0
Lifestyle
Comparator / control treatment
Control group: Asked to maintain their current level of habitual physical activity
Control group
Active

Outcomes
Primary outcome [1] 846 0
Maternal insulin sensitivity
Timepoint [1] 846 0
Assessed at 20 weeks and 35 weeks gestation
Secondary outcome [1] 1682 0
Neonatal auxology.
Timepoint [1] 1682 0
Secondary outcome [2] 1683 0
Neonatal and maternal body composition.
Timepoint [2] 1683 0
Assessed two weeks postpartum.

Eligibility
Key inclusion criteria
Healthy non-smoking nulliparous women, with a confirmed singleton pregnancy of less than 20 weeks at enrolment. BMI greater than 18 kg/m2.
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
A previous pregnancy of greater than 20 weeks; a first-degree relative with diabetes mellitus; the presence of any chronic illness that may affect either the pregnancy or the ability to participate in an exercise programme; the presence of any other medical condition known to be associated with reduced insulin sensitivity and the development of any absolute contraindication for exercise during pregnancy (as defined by ACOG).

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)
Allocation to study groups is performed by an independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is performed by an independent statistician using a computerised random number generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 232 0
New Zealand
State/province [1] 232 0

Funding & Sponsors
Funding source category [1] 769 0
Government body
Name [1] 769 0
National Research Centre for Growth and Development (NZ)
Country [1] 769 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 630 0
None
Name [1] 630 0
Nil
Address [1] 630 0
Country [1] 630 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35441 0
Address 35441 0
Country 35441 0
Phone 35441 0
Fax 35441 0
Email 35441 0
Contact person for public queries
Name 9834 0
Sarah Hopkins
Address 9834 0
Liggins Institute
University of Auckland
Private Bag 92019
Auckland
Country 9834 0
New Zealand
Phone 9834 0
+64 3737599
Fax 9834 0
Email 9834 0
s.hopkins@auckland.ac.nz
Contact person for scientific queries
Name 762 0
Dr Paul Hofman
Address 762 0
Liggins Institute
University of Auckland
Private Bag 92019
Auckland
Country 762 0
New Zealand
Phone 762 0
+64 3737599
Fax 762 0
Email 762 0
p.hofman@auckland.ac.nz

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.