Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001154291
Ethics application status
Not required
Date submitted
10/07/2018
Date registered
13/07/2018
Date last updated
13/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association of free sugar intake with food and nutrient intake, blood pressure, and obesity measures in Australian adults
Scientific title
Association of free sugar intake with food and nutrient intake, blood pressure, and obesity measures in Australian adults
Secondary ID [1] 295479 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 308739 0
Blood Pressure 308740 0
Condition category
Condition code
Diet and Nutrition 307676 307676 0 0
Obesity
Public Health 307677 307677 0 0
Epidemiology
Cardiovascular 307726 307726 0 0
Hypertension

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 defined 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 eight days apart, using the Automated Multiple-Pass Method (AMPM) developed by the Agricultural Research Service of the United States Department of Agriculture (USDA).

Anthropometric measures were based on Australian Bureau of Statistics, and the height, weight and waist circumference (WC) were measured. Measurements for subjects with WC greater than 200cm or weight greater than 150kg were not recorded and were treated as missing in this analysis. Blood pressure was measured twice, with the latter one usually being used. A third measure was repeated if the previous two readings had a difference exceeding 10mmHg.

The above data were obtained from the National Nutrition and Physical Activity Survey (NNPAS), which was part of the Australian Health Survey 2011-2012 carried out by the Australian Bureau of Statistics (ABS).
Intervention code [1] 301793 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306661 0
Blood pressure.
Subject was categorised as higher category if either of their systolic or diastolic pressure reading met a higher category which was referred to as "elevated blood pressure" and binary variable was used for blood pressure (normal vs. elevated).

The above data was from the NNPAS dataset.
Timepoint [1] 306661 0
Day of 24-hour recall
Primary outcome [2] 306710 0
Obesity.
For obesity measure, Body Mass Index (BMI) scores were used and were calculated as weight (in kg) divided by height (in m) squared. Waist:Height ratio (WHtR), which was calculated as waist (in cm) divided by height (in m) and Wrist Circumference (WC) were also used to indicate subject's potential cardio-metabolic risk.

The above data was from the NNPAS dataset.
Timepoint [2] 306710 0
Day of 24-hour recall
Secondary outcome [1] 349216 0
Food and nutrient intake
Dietary intake assessment was done based on US Department of Agriculture (USDA) Automated Multiple Pass Method (AMPM). Two 24-hour recall were done, and dietary intake was translated into nutrient intake using the AUSNUT 2011-2013 food database and food items were categorised as beverages and non-beverages.

The above data was from the NNPAS dataset.
Timepoint [1] 349216 0
During the first and second 24-hour recall

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 18 years old or above were included in this analysis.
Minimum age
18 Years
Maximum age
No limit
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
13/07/2015
Date of last participant enrolment
Anticipated
Actual
11/11/2015
Date of last data collection
Anticipated
Actual
20/11/2015
Sample size
Target
12366
Accrual to date
Final
12153
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300068 0
Government body
Name [1] 300068 0
Australian Government Department of Health and Ageing
Country [1] 300068 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] 299464 0
None
Name [1] 299464 0
Address [1] 299464 0
Country [1] 299464 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 300915 0
Ethics committee address [1] 300915 0
Ethics committee country [1] 300915 0
Date submitted for ethics approval [1] 300915 0
Approval date [1] 300915 0
Ethics approval number [1] 300915 0

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

Contacts
Principal investigator
Name 85262 0
Dr Jimmy Chun Yu Louie
Address 85262 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road,
Country 85262 0
Hong Kong
Phone 85262 0
+852 2299 0677
Fax 85262 0
Email 85262 0
[email protected]
Contact person for public queries
Name 85263 0
Jimmy Chun Yu Louie
Address 85263 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road,
Country 85263 0
Hong Kong
Phone 85263 0
+852 2299 0677
Fax 85263 0
Email 85263 0
[email protected]
Contact person for scientific queries
Name 85264 0
Jimmy Chun Yu Louie
Address 85264 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road,
Country 85264 0
Hong Kong
Phone 85264 0
+852 2299 0677
Fax 85264 0
Email 85264 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.