Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000932864
Ethics application status
Approved
Date submitted
17/08/2012
Date registered
3/09/2012
Date last updated
2/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
IMPROVE- Improving Maternal and Progency Obesity Via Exercise: Antenatal exercise in overweight and obese women and its effects on offspring and maternal health
Scientific title
A prospective randomised controlled trial on the effects of antenatal exercise in overweight and obese women on offspring and maternal health
Secondary ID [1] 281052 0
Nil
Universal Trial Number (UTN)
U1111-1133-5895
Trial acronym
IMPROVE- Improving Maternal and Progency Obesity Via Exercise
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity prevention 287193 0
Condition category
Condition code
Reproductive Health and Childbirth 287521 287521 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 287522 287522 0 0
Other metabolic disorders
Diet and Nutrition 287528 287528 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A regular moderate intensity exercise program staring from the 20th week of pregnancy and continuing to the 36 th week of pregnancy consisting of 30- 45 minutes of exercise, 5 times a week. The intervention will consist of stationary cycling at home, supervised/overseen by a trained exercise physiologist. Exercise sessions will be monitored by heart rate monitors and exercise intensity kept at moderate intensity (40-59% VO2 reserve)
Intervention code [1] 285510 0
Prevention
Intervention code [2] 285520 0
Lifestyle
Intervention code [3] 285593 0
Treatment: Other
Comparator / control treatment
Control subjects (ie not undertaking the exercise intervention arm) will be asked to do the physical activities they would normally do.
Control group
Active

Outcomes
Primary outcome [1] 287764 0
Birth weight will be measured on electronic scales within 24 hours of birth.
Timepoint [1] 287764 0
Within 24 hours of term delivery
Primary outcome [2] 287765 0
Neonatal body composition by DEXA scanning
Timepoint [2] 287765 0
at 14 days after delivery
Secondary outcome [1] 298796 0
Maternal weight gain based on weight taken at initial obsteric assessment at 20 weeks and compared to weight at 36 weeks gestation. This will be measured on electronic scales at the Liggins Institute.
Timepoint [1] 298796 0
Change in maternal body weight from 20 weeks (baseline) to 36 weeks of gestation (end of intervention)
Secondary outcome [2] 298797 0
Maternal body composition by DEXA scan
Timepoint [2] 298797 0
At 2 weeks post-partum
Secondary outcome [3] 298798 0
Maternal obstetric complications- gestational diabetes mellitus, pregnancy induced hypertension. Data from obstetric visits (which will be different obstetricians caring for these women) will be collated by the research team and analysed. Oral glucose tolerance tests will be performed as part of the study at 28 weeks and these results will be analysed seperately.
Timepoint [3] 298798 0
From baseline (20 weeks of gestation to time of delivery)

Eligibility
Key inclusion criteria
Pregnant women with a BMI => 25 and a single live fetus confirmed on early pregnancy dating ultrasonography (5-16 weeks of gestation)and a period of gestation < 20 weeks at recruitment
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoking and substance abuse
Significant chronic disease
On long term medication known to affect fetal growth

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 will be performed by an independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed by an independent statistician using a computerised random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
21/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4489 0
New Zealand
State/province [1] 4489 0
Auckland

Funding & Sponsors
Funding source category [1] 285838 0
Government body
Name [1] 285838 0
Gravida
Country [1] 285838 0
New Zealand
Primary sponsor type
University
Name
Liggins Institute, University of Auckland
Address
The Liggins Institute
The University of Auckland
2–6 Park Avenue, Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284736 0
None
Name [1] 284736 0
Address [1] 284736 0
Country [1] 284736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287859 0
Northern B Health and Disabilty Ethics Committee
Ethics committee address [1] 287859 0
Ethics committee country [1] 287859 0
Date submitted for ethics approval [1] 287859 0
24/08/2012
Approval date [1] 287859 0
16/10/2012
Ethics approval number [1] 287859 0

Summary
Brief summary
Obese women who become pregnant have increased pregnancy weight gain, pregnancy complications and their offspring develop obesity. Lifestyle interventions during pregnancy may restrict fetal overnutrition and metabolic programming of offspring disrupting the obesity cycle. The central hypothesis for this project is that increasing maternal physical activity can improve maternal and neonatal outcomes, in particular protecting the offspring from obesity. Furthermore we hypothesise that these interventions will be reflected in altered gene expression in placenta, muscle, fat and liver. This human study will confirm the clinical efficacy of moderate exercise in overweight and obese women during the last half of pregnancy. Outcome measures in will include alterations in auxology and body composition during fetal life, at birth and through childhood (latter stage will be another study), serum biochemistry and hormones. These studies represent translational research targeting the very earliest development of obesity to reduce the health burden of this major health issue.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34591 0
Prof Paul Hofman
Address 34591 0
Liggins institute, The University of Auckland
Building 505
85 Park Road
Grafton, Auckland, 1023
Country 34591 0
New Zealand
Phone 34591 0
+ 64 (0)9 923 6453
Fax 34591 0
Email 34591 0
p.hofman@auckland.ac.nz
Contact person for public queries
Name 17838 0
Prof Paul Hofman
Address 17838 0
Liggins institute, The University of Auckland
Building 505
85 Park Road
Grafton, Auckland, 1023
Country 17838 0
New Zealand
Phone 17838 0
+ 64 (0)9 923 6453
Fax 17838 0
+ 64 (0)9 3738763
Email 17838 0
p.hofman@auckland.ac.nz
Contact person for scientific queries
Name 8766 0
Prof Paul Hofman
Address 8766 0
Liggins institute, The University of Auckland
Building 505
85 Park Road
Grafton, Auckland, 1023
Country 8766 0
New Zealand
Phone 8766 0
+ 64 (0)9 923 6453
Fax 8766 0
+ 64 (0)9 3738763
Email 8766 0
p.hofman@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23238Study protocol   
23239Statistical analysis plan   
23240Informed consent form   
23241Clinical study report   
23242Ethical approval   

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNulliparity is associated with subtle adverse metabolic outcomes in overweight/obese mothers and their offspring.2017https://dx.doi.org/10.1111/cen.13426
N.B. These documents automatically identified may not have been verified by the study sponsor.