Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000271505
Ethics application status
Approved
Date submitted
22/06/2006
Date registered
29/06/2006
Date last updated
29/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial using exercise to reduce gestational diabetes and other adverse maternal and neonatal outcomes in obese pregnant women –The pilot study.
Scientific title
A randomized controlled trial using exercise to reduce gestational diabetes and other adverse maternal and neonatal outcomes in obese pregnant women –The pilot study.
Universal Trial Number (UTN)
Trial acronym
BAMBINO Study-Becoming Active Mothers for Better Infant Outcomes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese Pregnant Women 1247 0
Condition category
Condition code
Diet and Nutrition 1331 1331 0 0
Obesity
Reproductive Health and Childbirth 1332 1332 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 1333 1333 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Flexible exercise program with a goal of 1500 kCal of energy expenditure per week (approximately equivalent to 30 minutes of activity 5 days per week), measured using exercise diary, heart rate monitor and accelerometer data. The flexible individually tailored exercise program will be developed and reviewed weekly by exercise physiologists. Exercise will be commenced prior to 12 weeks gestation and will continue until delivery or development of a contraindication to exercise.
Intervention code [1] 1158 0
Lifestyle
Comparator / control treatment
The control group will be assigned to usual activity.
Control group
Active

Outcomes
Primary outcome [1] 1819 0
Increased physical activity
Timepoint [1] 1819 0
Secondary outcome [1] 3184 0
Fasting glucose, insulin, Fitness, body composition, resting blood pressure, inflammatory markers and
quality of life.
Timepoint [1] 3184 0
Measured at baseline, 20 weeks gestation, 28 weeks gestation, 36 weeks gestation and 6 weeks postpartum.
Secondary outcome [2] 3185 0
Neonatal body composition
Timepoint [2] 3185 0
Assessed at delivery and at 6 weeks post partum.

Eligibility
Key inclusion criteria
Pregnant, less than 12 weeks gestationBMI 30 or greater. Willing and able to be randomized to an exercise intervention. Able to provide informed consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication or inability to exercise.Not able to speak English.Medical or obstetric contraindication to exercise including haemodynamically significant heart disease, restrictive lung disease, incompetent cervix (cerclage), multiple gestation, severe anaemia, chronic bronchitis, type 1 diabetes, orthopaedic limitations, poorly controlled seizure disorder, poorly controlled hyperthyroidism, heavy smoker [ACOG guidelines].

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 involves contacting an independent administrator who holds the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will manage sequence generation, using a computer generated random number sequence. Women will be stratified by 1.BMI 30-40 vs BMI>40 and 2. Children at home vs No children at home. Women within each strata will be randomly allocated to the control vs intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1458 0
Hospital
Name [1] 1458 0
Royal Brisbane and Women's Hospital (RBWH) Foundation Grant
Country [1] 1458 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital (RBWH) Foundation
Address
Country
Australia
Secondary sponsor category [1] 1287 0
None
Name [1] 1287 0
Nil
Address [1] 1287 0
Country [1] 1287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2836 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 2836 0
Ethics committee country [1] 2836 0
Australia
Date submitted for ethics approval [1] 2836 0
Approval date [1] 2836 0
16/06/2006
Ethics approval number [1] 2836 0
2006/076
Ethics committee name [2] 2837 0
University of QLD
Ethics committee address [2] 2837 0
Ethics committee country [2] 2837 0
Australia
Date submitted for ethics approval [2] 2837 0
Approval date [2] 2837 0
Ethics approval number [2] 2837 0
Ethics committee name [3] 2838 0
QLD University of Technology
Ethics committee address [3] 2838 0
Ethics committee country [3] 2838 0
Australia
Date submitted for ethics approval [3] 2838 0
Approval date [3] 2838 0
Ethics approval number [3] 2838 0

Summary
Brief summary
This is a pilot study to look at the feasibility of a target directed flexible exercise program in obese pregnant women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36060 0
Address 36060 0
Country 36060 0
Phone 36060 0
Fax 36060 0
Email 36060 0
Contact person for public queries
Name 10347 0
Katie Foxcroft
Address 10347 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston,Qld 4029
Country 10347 0
Australia
Phone 10347 0
07 36365164
Fax 10347 0
07 36365737
Email 10347 0
[email protected]
Contact person for scientific queries
Name 1275 0
Dr Leonie Callaway
Address 1275 0
E Floor
Clinical Sciences Building
Royal Brisbane and Women’s Hospital
HERSTON QLD 4054
Country 1275 0
Australia
Phone 1275 0
07 3346 4917 or page via RBWH switch (07 3636 8111)
Fax 1275 0
07 3346 4734
Email 1275 0
[email protected]

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.