Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000280303
Ethics application status
Approved
Date submitted
30/05/2008
Date registered
2/06/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Feasibility and Efficacy of an Individualised Approach to increase Physical Activity among Women with Previous Gestational Diabetes Mellitus
Scientific title
A randomised controlled open clinical trial of the Feasibility and Efficacy of an Individualised Approach to increase Physical Activity among Women with Previous Gestational Diabetes Mellitus
Secondary ID [1] 253264 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 3215 0
Condition category
Condition code
Metabolic and Endocrine 3379 3379 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supported intervention (initial face to face assessment and counselling followed by weekly telephone support for a period of three months) to promote physical activity
Intervention code [1] 2956 0
Behaviour
Comparator / control treatment
Routine post natal care with some written information promoting physical activity
Control group
Active

Outcomes
Primary outcome [1] 4269 0
Change in physical activity, measured using Australian Women's Activity Scale (AWAS)
Timepoint [1] 4269 0
Starting 6 weeks post partum. Final assessment 4.5 months post partum
Secondary outcome [1] 7205 0
Insulin resistance using homeostasis model assessment (HOMA)
Timepoint [1] 7205 0
Starting 6 weeks post partum. Final assessment 4.5 months post partum

Eligibility
Key inclusion criteria
Adult females
Recent pregnancy complicated by gestational diabetes
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with Type 2 diabetes at 6 weeks post partum
Unable to communicate in English
Planning further pregnancy within 12 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random number table used by investigator not involved in study treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Stratification by baseline physical activity and delivery type. (Cesarean section or traumatic vaginal delivery vs Normal delivery)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
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] 3441 0
Charities/Societies/Foundations
Name [1] 3441 0
Diabetes Australia Research Trust
Country [1] 3441 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Services
Address
Raymond Tce
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 3083 0
University
Name [1] 3083 0
University of Queensland
Address [1] 3083 0
Mater Clinical School
Mater Health Services
Raymond Tce
South Brisbane QLD 4101
Country [1] 3083 0
Australia
Other collaborator category [1] 298 0
University
Name [1] 298 0
University of Queensland
Address [1] 298 0
Mater Clinical School
Raymond Terrace
South Brisbane
Country [1] 298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5465 0
Mater Health Services HREC
Ethics committee address [1] 5465 0
Ethics committee country [1] 5465 0
Australia
Date submitted for ethics approval [1] 5465 0
Approval date [1] 5465 0
10/03/2008
Ethics approval number [1] 5465 0
1178M

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

Contacts
Principal investigator
Name 28634 0
Address 28634 0
Country 28634 0
Phone 28634 0
Fax 28634 0
Email 28634 0
Contact person for public queries
Name 11791 0
Professor H D McIntyre
Address 11791 0
Mater Health Services
Raymond Tce
South Brisbane QLD 4101
Country 11791 0
Australia
Phone 11791 0
07 3163 8601
Fax 11791 0
07 3163 2510
Email 11791 0
david.mcintyre@mater.org.au
Contact person for scientific queries
Name 2719 0
Professor H D McIntyre
Address 2719 0
Mater Health Services
Raymond Tce
South Brisbane QLD 4101
Country 2719 0
Australia
Phone 2719 0
07 3163 8601
Fax 2719 0
Email 2719 0
david.mcintyre@mater.org.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.