Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000138381
Ethics application status
Approved
Date submitted
3/03/2008
Date registered
17/03/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Energy Monitor in Metabolic Management of Gestational Diabetes Mellitus
Scientific title
The Effect of the Energy Monitor in Metabolic Management of Gestational Diabetes Mellitus
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes mellitus 2900 0
Condition category
Condition code
Metabolic and Endocrine 3035 3035 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Energy Monitor is a wearable device that is used to estimate the total energy expenditure of normal daily physical activity. It works similar to pedometer. However, instead of measuring the number of footsteps, it measures the three dimensional body acceleration, from which an accurate estimate of energy expenditure can be derived.
Using the provided software, participants will be able to download and view the energy levels data.
Participation in this trial starts after the diagnosis of gestational diabetes mellitus (third trimester) and ends on the day of delivery.
Intervention code [1] 2629 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3918 0
Change in maternal weight
Timepoint [1] 3918 0
At baseline and at immediately before birth takes place.
Secondary outcome [1] 6594 0
Infant weight
Timepoint [1] 6594 0
At birth
Secondary outcome [2] 6595 0
Physical activity using energy monitor
Timepoint [2] 6595 0
At baseline and at immediately before birth takes place.

Eligibility
Key inclusion criteria
Pregnant women in third trimester diagnosed with gestational diabetes mellitus.
Singleton pregnancy (not multiple)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with diabetes before pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 788 0
2031

Funding & Sponsors
Funding source category [1] 3151 0
University
Name [1] 3151 0
University of New South Wales
Country [1] 3151 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Electrical Engineering & Telecommunications
University of NSW
Rear of Quadrangle
Gate 2
High Street
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 2827 0
Hospital
Name [1] 2827 0
Royal Hospital For Women
Address [1] 2827 0
Barker Street
Randwick NSW 2031
Country [1] 2827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5126 0
South Eastern Sydney Area Health Service
Ethics committee address [1] 5126 0
Room G71
Edmund Blanket Building (EBB)
Cnr High & Avoca Street
Randwick NSW 2031
Ethics committee country [1] 5126 0
Australia
Date submitted for ethics approval [1] 5126 0
Approval date [1] 5126 0
27/04/2007
Ethics approval number [1] 5126 0
06/294
Ethics committee name [2] 5127 0
University Of New South Wales
Ethics committee address [2] 5127 0
Level 3 Rupert Myers Building
University of NSW
near Gate 14
Barker Street
Kensingtion NSW 2052
Ethics committee country [2] 5127 0
Australia
Date submitted for ethics approval [2] 5127 0
Approval date [2] 5127 0
03/05/2007
Ethics approval number [2] 5127 0
07125

Summary
Brief summary
Gestational diabetes is a problem in pregnancy that can be diagnosed in up to 10% of pregnant women. The majority of patients are managed with dietary advice and lifestyle measures alone. Dietary advice consists of education and meal planning addressing issues of caloric intake, content (fat & carbohydrate) and timing of meals. Lifestyle measures revolve around suitable exercise and energy expenditure. Gestational diabetics monitor their blood glucose levels (BGL). This project collects data on energy expenditure through daily physical activity from pregnant women wearing a portable Energy Monitor, developed in our research group. There is no radiation associated with this monitor. Together with a record of food intake this study seeks to evaluate whether it is possible to calculate a differential between energy intake and energy expenditure that correlates with measures of glycaemic control (average daily BGLs), infant weight and maternal weight gain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28420 0
Address 28420 0
Country 28420 0
Phone 28420 0
Fax 28420 0
Email 28420 0
Contact person for public queries
Name 11577 0
Rudi Voon
Address 11577 0
Biomedical System Laboratory
Electrical Engineering Building (G17)
University of NSW
Gate 2
High Street
Kensington NSW 2052
Country 11577 0
Australia
Phone 11577 0
+61 2 93856571
Fax 11577 0
Email 11577 0
[email protected]
Contact person for scientific queries
Name 2505 0
Rudi Voon
Address 2505 0
Biomedical System Laboratory
Electrical Engineering Building (G17)
University of NSW
Gate 2
High Street
Kensington NSW 2052
Country 2505 0
Australia
Phone 2505 0
+61 2 93856571
Fax 2505 0
Email 2505 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.