Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001300369
Ethics application status
Not required
Date submitted
5/09/2017
Date registered
11/09/2017
Date last updated
11/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Associations of usual free sugar intake on the body mass index z-score of Australian children and adolescents
Scientific title
The direct and indirect associations of usual free sugar intake on BMI z-score of Australian children and adolescents
Secondary ID [1] 292816 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 304636 0
Condition category
Condition code
Diet and Nutrition 303956 303956 0 0
Obesity
Public Health 303957 303957 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The independent variable is the intake of free sugar, which is definned by the WHO as all monosaccharides and disaccharides added to foods by the manufacturer, cook, or consumer, plus sugars naturally present in honey, syrups, and fruit juices.

Each participant completed two 24-hr recall, with at least seven days apart, using the Automated Multiple-Pass Method (AMPM) developed by the Agricultural Research Service of the United States Department of Agriculture (USDA). Informed consent was obtained from the primary caregiver or a responsible adult for children aged less than 14 years, while adolescents aged 14 years or above provided their own consent in the presence of a parent or responsible adult
Intervention code [1] 299065 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303301 0
BMI z-score. Height and weight were measured at the time of the first visit. BMI were calculated as weight (in kg) divided by height (in m) squared. The z-score was calculated by comparing the BMI with the age-and-sex specific population curves.
Timepoint [1] 303301 0
at the time of the first 24-hr recall
Secondary outcome [1] 338560 0
Energy intake. Data were translated from the dietary intake data collected from two 24-hr recalls using the 2007 AUSNUT food composition database.
Timepoint [1] 338560 0
at the time of the 2 24-hr recall periods

Eligibility
Key inclusion criteria
Usual residents of private dwellings in urban and rural areas of Australia, covering about 97% of the people living in Australia. Dietary data from those whose age was between 9-16 years old were included in this analysis.
Minimum age
9 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-usual residents of Australia

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/02/2007
Date of last participant enrolment
Anticipated
Actual
21/08/2007
Date of last data collection
Anticipated
Actual
30/08/2007
Sample size
Target
4400
Accrual to date
Final
4487
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297445 0
Government body
Name [1] 297445 0
The Commonwealth Scientific and Industrial Research Organisation
Country [1] 297445 0
Australia
Primary sponsor type
Individual
Name
Dr. Jimmy 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] 296442 0
None
Name [1] 296442 0
Address [1] 296442 0
Country [1] 296442 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298554 0
Ethics committee address [1] 298554 0
Ethics committee country [1] 298554 0
Date submitted for ethics approval [1] 298554 0
Approval date [1] 298554 0
Ethics approval number [1] 298554 0

Summary
Brief summary
Previous studies suggested dietary sugar consumption as one of the main factors of obesity, yet the findings on children were inconsistent. Notably, although the consumption of sugar-sweetened beverages (SSB) was found to be positively associated with body weight gain in children, the association between the consumption of free sugar, as defined by the World Health Organization (WHO), and weight gain on children remained inconclusive. Hence, the current analysis aimed to assess the effects of consuming free sugar on the BMI z-score of a group of Australian children and adolescents.
Trial website
https://www.health.gov.au/internet/main/publishing.nsf/Content/8F4516D5FAC0700ACA257BF0001E0109/$File/childrens-nut-phys-survey.pdf
Trial related presentations / publications
Commonwealth Scientific and Industrial Research Organisation (Australia), Preventative Health National Research Flagship, & The University of South Australia. (2008). 2007 Australian National Children's Nutrition and Physical Activity Surveys - Main Findings. Canberra, Australia: Department of Health and Ageing (Australia) Retrieved from http://www.health.gov.au/internet/main/publishing.nsf/Content/66596E8FC68FD1A3CA2574D50027DB86/$File/childrens-nut-phys-survey.pdf
Public notes
Ethics approval was not needed for this study as this is a secondary analysis on a pre-existing dataset.

Contacts
Principal investigator
Name 77446 0
Dr Jimmy Chun Yu Louie
Address 77446 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road, Pokfulam, HKSAR
Country 77446 0
Hong Kong
Phone 77446 0
+852 2299 0677
Fax 77446 0
Email 77446 0
jimmyl@hku.hk
Contact person for public queries
Name 77447 0
Dr Jimmy Chun Yu Louie
Address 77447 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road, Pokfulam, HKSAR
Country 77447 0
Hong Kong
Phone 77447 0
+852 2299 0677
Fax 77447 0
Email 77447 0
jimmyl@hku.hk
Contact person for scientific queries
Name 77448 0
Dr Jimmy Chun Yu Louie
Address 77448 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road, Pokfulam, HKSAR
Country 77448 0
Hong Kong
Phone 77448 0
+852 2299 0677
Fax 77448 0
Email 77448 0
jimmyl@hku.hk

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

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