Trial Review

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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
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
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.