Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000992303
Ethics application status
Not required
Date submitted
23/06/2017
Date registered
10/07/2017
Date last updated
10/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A secondary analysis examining the changes in dietary glycaemic index and glycaemic load in Australian children between 1995 - 2012
Scientific title
A secondary analysis examining the changes in dietary glycaemic index and glycaemic load in Australian children between 1995 - 2012
Secondary ID [1] 292272 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dietary glycaemic index 303793 0
dietary glycaemic load 303794 0
Condition category
Condition code
Public Health 303162 303162 0 0
Epidemiology
Diet and Nutrition 303163 303163 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Dietary glycaemic index and dietary glycaemic load, as well as the major sources of dietary glycaemic load in 3 Australian population-based nutrition surveys, namely 1995 Australian National Nutrition Survey (1995NS), 2007 Australian National Children's Nutrition and Physical Activity Survey (2007NS) and 2011-12 National Nutrition and Physical Activity Survey (2012NS), were described.

The 1995NS was conducted by the Australian Bureau of Statistics (ABS) and the Department of Health together with the 1995 National Health Survey. Data were collected between February 1995 and March 1996. Information about food and beverage intake, usual frequency of intake, eating habit, attitudes and physical measurements of Australians population aged 2 year-old or above was collected (n = 13,858) with a 61.4% response rate. Participants were selected randomly from dwellings in different State and Territories. Dietary intake was assessed using a single 24-hour recall, and a subset of the sample (76.2% of those aged 12 and over) also completed a food frequency questionnaire (FFQ). Children aged 15 to 16 years provided their own dietary recall while parents, guardians or close relatives were responsible for providing the information for children aged 14 years or below. Among all the participants in 1995NS, 2,729 (19.7%) were aged between 2 and 16 inclusively.

For 2007NS, information on dietary intake, physical activities and demographic characteristics of randomly selected children and adolescents aged 2 to 16 years (n = 4,837) from all Australian states and territories were collected with a response rate of 40%. Data collection occurred between February 2007 and August 2007. Dietary data were collected using a 24-hour recall during face to face home visit, and the majority of the sample (n = 4,658) also completed a second 24-hour recall during a telephone interview conducted 7-21 days after the home visit. Care-givers provided dietary recall information for children aged 2 to 8 years while children of 9 years or above provided their own dietary recall.

For 2012NS, respondents were randomly selected from 9,500 private dwellings across Australia except for very remote area and some non-private dwellings, e.g., hotels and hospitals. Dietary and physical activity information of the Australian population aged 2 years or above (n = 12,153) were collected from May 2011 to June 2012 from 12,366 dwellings with a 77% response rate. Dietary data were collected using a 24-hour recall during face to face home visit, and a second 24-hour recall during a telephone interview was collected in ~60% of subjects at least 8 days after the home visit. Adults were responsible for providing full food recall and physical activity question for children aged 2 to 5 years, while children aged 6 to 8 years can assist in the recall. Children aged 9 to 11 years were interviewed directly with adult assisting and children aged 12 to 14 years answered the questions themselves with adults in the same room. Those aged 15 – 17 years were interviewed personally with parental consent. Among all the participants in 2012NS, 2,548 (20.9%) were aged between 2 and 16 years inclusively.

A published systematic method was used to assign glycemic index values to foods reported in the surveys. Dietary glycemic load is defined as the sum of the products of glycemic index (as %) and the amount of available carbohydrate in the reported serving of the foods, and dietary glycemic index is calculated as dietary GL divided by total amount of available carbohydrate in the diet.
Intervention code [1] 298449 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302532 0
Changes in dietary glycaemic index
Timepoint [1] 302532 0
1995 vs 2007 vs 2012
Primary outcome [2] 302533 0
Changes in dietary glycaemic load
Timepoint [2] 302533 0
1995 vs 2007 vs 2012
Primary outcome [3] 302534 0
Changes in major sources of dietary glycaemic load
Timepoint [3] 302534 0
1995 vs 2007 vs 2012
Secondary outcome [1] 336326 0
Changes in inter-individual variations in dietary glycaemic index explained by major contributors to dietary glycaemic load
Timepoint [1] 336326 0
1995 vs 2007 vs 2012
Secondary outcome [2] 336574 0
Changes in inter-individual variations in dietary glycaemic load explained by major contributors to dietary glycaemic load
Timepoint [2] 336574 0
1995 vs 2007 vs 2012

Eligibility
Key inclusion criteria
Participants aged 2-16 years of the 3 national nutrition surveys (1995 National Nutrition Survey, 2007 Australian National Children's Nutrition and Physical Activity Survey and 2011-2012 Australian Health Survey) who provided plausible dietary intake data (as assessed by a published method).
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Implausible dietary intake, as determined by the Goldberg cut-off method

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
30/10/2015
Date of last data collection
Anticipated
Actual
30/10/2015
Sample size
Target
8500
Accrual to date
Final
8539
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296811 0
University
Name [1] 296811 0
The University of Sydney
Country [1] 296811 0
Australia
Funding source category [2] 296894 0
University
Name [2] 296894 0
The University of Hong Kong
Country [2] 296894 0
Hong Kong
Funding source category [3] 296897 0
Government body
Name [3] 296897 0
The Australian Bureau of Statistics
Country [3] 296897 0
Australia
Funding source category [4] 296898 0
Government body
Name [4] 296898 0
The Commonwealth Scientific and Industrial Research Organization
Country [4] 296898 0
Australia
Primary sponsor type
Individual
Name
Dr Jimmy Chun Yu Louie
Address
5S-14, Kadoorie Biological Sciences Bldg,
The University of Hong Kong,
1 Pokfulam Road,
Pokfulam, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 295799 0
None
Name [1] 295799 0
Address [1] 295799 0
Country [1] 295799 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298045 0
Ethics committee address [1] 298045 0
Ethics committee country [1] 298045 0
Date submitted for ethics approval [1] 298045 0
Approval date [1] 298045 0
Ethics approval number [1] 298045 0

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

Contacts
Principal investigator
Name 75806 0
Dr Jimmy Chun Yu Louie
Address 75806 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road
Country 75806 0
Hong Kong
Phone 75806 0
+85222990677
Fax 75806 0
+85225599114
Email 75806 0
[email protected]
Contact person for public queries
Name 75807 0
Jimmy Chun Yu Louie
Address 75807 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road
Country 75807 0
Hong Kong
Phone 75807 0
+85222990677
Fax 75807 0
+85225599114
Email 75807 0
[email protected]
Contact person for scientific queries
Name 75808 0
Jimmy Chun Yu Louie
Address 75808 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road
Country 75808 0
Hong Kong
Phone 75808 0
+85222990677
Fax 75808 0
+85225599114
Email 75808 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
EmbaseThe decreasing trend in dietary glycaemic index and glycaemic load in Australian children and adolescents between 1995 and 2012.2018https://dx.doi.org/10.3390/nu10091312
N.B. These documents automatically identified may not have been verified by the study sponsor.