Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001355268
Ethics application status
Approved
Date submitted
8/08/2018
Date registered
10/08/2018
Date last updated
2/11/2022
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity in the prevention and management of gestational diabetes
Scientific title
Timing physical activity to prevent and manage gestational diabetes
Secondary ID [1] 295762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 309165 0
Condition category
Condition code
Metabolic and Endocrine 308043 308043 0 0
Other endocrine disorders
Reproductive Health and Childbirth 308064 308064 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women between 12-30 wks of pregnancy will be advised to perform 10-minutes of light-moderate intensity walking after each main meal. They will also receive standard-care from the Diabetes Service (as below control). The intervention will be from 12-35 wks of pregnancy until brith. Accelerometers will objectively measure physical activity.
Intervention code [1] 312094 0
Lifestyle
Comparator / control treatment
Women between 12-30 wks of pregnancy will receive standard-care (Control, usual antenatal or GDM care) as well as advice to perform 30-min of physical activity.
Control group
Active

Outcomes
Primary outcome [1] 307036 0
Postprandial hyperglycemia assessed from continuous glucose monitoring.
Timepoint [1] 307036 0
Baseline and in the final week of the intervention
Secondary outcome [1] 350450 0
Fasting blood glucose finger prick monitor
Timepoint [1] 350450 0
Mean fasting blood glucose across the intervention. Fasting blood glucose is taken daily.
Secondary outcome [2] 350451 0
Mean 24-h Blood glucose assessed from continuous blood glucose monitoring
Timepoint [2] 350451 0
Baseline and in the final week of the intervention
Secondary outcome [3] 350452 0
Physical activity assessed from accelerometry
Timepoint [3] 350452 0
Assessed for 7-days at Baseline, 32 weeks of pregnancy, and final week of intervention.
Secondary outcome [4] 350453 0
24-h blood pressure assessed by an Ambulatory blood pressure monitor.
Timepoint [4] 350453 0
At 32 weeks of pregnancy
Secondary outcome [5] 350508 0
Sedentary time assessed from accelerometers
Timepoint [5] 350508 0
Assessed for 7-days at baseline, 32 weeks of pregnancy and in the final week of the intervention.

Eligibility
Key inclusion criteria
Between 12-30 weeks of pregnancy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
•<18 years of age
•Contraindications to performing exercise (i.e., restrictive lung disease, Multiple gestation at risk for premature labour8)
•High-risk pregnancy (i.e., twins, drug or alcohol abuse, chronic health problems, or pregnancy complications)
•Women on any medication for preexisting hypertension, cardiac disease, renal disease, thyroid disease, or psychosis; and women who were currently being treated with metformin or corticosteroids.

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)
Simple randomisation computer program and concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple stratified (GDM and non-GDM) randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will first be assessed for normality using Q-Q plots, histograms and the shapiro-wilk test. A Linear mixed model (with intervention duration as a covariate) will compare the changes in study outcomes between the PMW and Control groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2018
Actual
4/09/2018
Date of last participant enrolment
Anticipated
Actual
20/01/2022
Date of last data collection
Anticipated
Actual
6/06/2022
Sample size
Target
80
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23669 0
2522 - University Of Wollongong

Funding & Sponsors
Funding source category [1] 300350 0
University
Name [1] 300350 0
University of Wollongong
Country [1] 300350 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave
University of Wollongong,
Keiraville, 2522
NSW
Country
Australia
Secondary sponsor category [1] 299819 0
None
Name [1] 299819 0
Address [1] 299819 0
Country [1] 299819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301166 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 301166 0
Ethics committee country [1] 301166 0
Australia
Date submitted for ethics approval [1] 301166 0
25/06/2018
Approval date [1] 301166 0
08/08/2018
Ethics approval number [1] 301166 0
2018/318

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

Contacts
Principal investigator
Name 86070 0
Dr Monique Francois
Address 86070 0
University of Wollongong
Northfields Ave,
Keiraville, 2522
NSW
Country 86070 0
Australia
Phone 86070 0
61 02 42215136
Fax 86070 0
Email 86070 0
[email protected]
Contact person for public queries
Name 86071 0
Monique Francois
Address 86071 0
University of Wollongong
Northfields Ave,
Keiraville, 2522
NSW
Country 86071 0
Australia
Phone 86071 0
61 02 42215136
Fax 86071 0
Email 86071 0
[email protected]
Contact person for scientific queries
Name 86072 0
Monique Francois
Address 86072 0
University of Wollongong
Northfields Ave,
Keiraville, 2522
NSW
Country 86072 0
Australia
Phone 86072 0
61 02 42215136
Fax 86072 0
Email 86072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.