Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000174088
Ethics application status
Approved
Date submitted
15/02/2010
Date registered
25/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
PREGGIO: Pregnancy and Glycaemic Index Outcomes Study
Scientific title
PREGGIO: Pregnancy and Glycaemic Index Outcomes Study Comparing a Low Glycaemic Index (GI) Diet to a Standard Healthy Diet.
Secondary ID [1] 1415 0
none
Universal Trial Number (UTN)
Trial acronym
PREGGIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 256824 0
Gestational Diabetes 256825 0
Obesity 256826 0
Condition category
Condition code
Diet and Nutrition 256973 256973 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effect of Low GI dietary advice from a dietitian in Pregnancy on birth weight, gestational diabetes and child obesity. Participants will see the dietitian a minimum of two one hour visits for dietary assessment. Once at the beginning of their pregnancy and once at the end of their pregnancy.
Intervention code [1] 256029 0
Prevention
Comparator / control treatment
Active control: General healthy eating advice from a dietitian. Participants will see the dietitian a minimum of two one hour visits for dietary assessment. Once at the beginning of their pregnancy and once at the end of their pregnancy.
Control group
Active

Outcomes
Primary outcome [1] 257862 0
birth weight (g) from medical record
Timepoint [1] 257862 0
at birth of baby
Primary outcome [2] 257863 0
development of Gestational Diabetes - as determined from medical record (GTT at 28 weeks gestation)
Timepoint [2] 257863 0
28 weeks gestation
Secondary outcome [1] 263316 0
Child obesity (BMI) calculated by measuring the childs height and weight
Timepoint [1] 263316 0
2 years of age

Eligibility
Key inclusion criteria
-<20 weeks gestation
-Singleton pregnancy
-Age = 18 years
-Ability to read and understand a consent form
-Ability to comply with the visits and advice
-<20 weeks gestation
-Singleton pregnancy
-Age = 18 years
-Ability to read and understand a consent form
-Ability to comply with the visits and advice
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-= 20 weeks gestation
-Multiple pregnancies
-Diabetes or previous gestational diabetes
-Undertaking a fad diet or requiring special dietary needs e.g. coeliac disease
-Inability to comply with visits and advice
-Any serious medical condition, in the opinion of the Investigator
-Medical condition/medications likely to affect body weight
-Non-English speaking background

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)
Sealed opaque containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256529 0
Other Collaborative groups
Name [1] 256529 0
National Health and Medical Research Council (NHMRC) via Sydney University
Country [1] 256529 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Clinical Trials Research Unit
Address
Clinical Trials & Research Unit
South East Sydney & Illawarra Area Health Service
Diabetes Centre Level 2 304 Crown St, Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 255837 0
None
Name [1] 255837 0
Address [1] 255837 0
Country [1] 255837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258576 0
Human Resource Ethics Committee
Ethics committee address [1] 258576 0
Research Services Office
University of Wollongong
Northfields Ave
Gwynneville NSW 2500
Ethics committee country [1] 258576 0
Australia
Date submitted for ethics approval [1] 258576 0
Approval date [1] 258576 0
11/02/2010
Ethics approval number [1] 258576 0
CT09/007

Summary
Brief summary
To study the effects of Low GI diets in pregnancy. We wish to examine the effect of a low Gi diet on birth weight, development of gestational diabetes and child obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30851 0
Address 30851 0
Country 30851 0
Phone 30851 0
Fax 30851 0
Email 30851 0
Contact person for public queries
Name 14098 0
Shelly Charters
Address 14098 0
Antenatal Clinic
Level 2, Block C
Wollongong Hospital
Crown Street
Wollongong
NSW 2500
Country 14098 0
Australia
Phone 14098 0
+61 2 4253 4276
Fax 14098 0
Email 14098 0
[email protected]
Contact person for scientific queries
Name 5026 0
Prof Robert Moses
Address 5026 0
Principal Investigator, Clinical Trials & Research Unit
Diabetes Centre Level 2 304 Crown St, Wollongong NSW 2500
Country 5026 0
Australia
Phone 5026 0
+61 2 4231 1952
Fax 5026 0
Email 5026 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
SourceTitleYear of PublicationDOI
EmbaseDietary micronutrient intake during pregnancy is a function of carbohydrate quality1,2.2015https://dx.doi.org/10.3945/ajcn.114.104836
N.B. These documents automatically identified may not have been verified by the study sponsor.