Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001601325
Ethics application status
Not required
Date submitted
24/11/2017
Date registered
6/12/2017
Date last updated
14/11/2019
Date data sharing statement initially provided
14/11/2019
Date results information initially provided
14/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding Australian adults' eating patterns: relationships of frequency and timing of meals and snacks with cardiometabolic risk factors
Scientific title
Understanding Australian adults’ eating patterns: associations of eating patterns (e.g. frequency and/or temporal distribution of eating occasions) with cardiometabolic risk factors
Secondary ID [1] 293439 0
Nil known
Universal Trial Number (UTN)
U1111-1205-6584
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular diseases
 305613 0
Type 2 Diabetes 305614 0
Condition category
Condition code
Public Health 304834 304834 0 0
Epidemiology
Diet and Nutrition 304835 304835 0 0
Obesity
Cardiovascular 304836 304836 0 0
Coronary heart disease
Cardiovascular 304837 304837 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As this study is a secondary analysis of the National Health Measures Survey data that was collected as part of the Australian Health Survey, 2011-2013 (http://www.abs.gov.au/australianhealthsurvey), no participants will be enrolled.
The independent variables examined from this data includes: The temporal distribution (e.g. timing across the day) and frequency of eating occasions, including meals and snacks were examined.
Dietary intake information was collected during two 24-hour dietary recalls (~9 days apart) conducted by a trained interviewer from the Australian Bureau of Statistics. The methodology used in the 24-h recall was based on the USDA, 5-step Automated Multiple Pass Method. The participants identified the type of eating occasion and the time when each eating occasion began as well as all foods and beverages consumed at these eating occasions.
Intervention code [1] 299682 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304038 0
Chronic disease blood biomarkers including: Total cholesterol (C, mmol/L), fasting LDL-C (mmol/L), HDL-C (mmol/L), fasting plasma triglycerides (mmol/L), fasting plasma glucose (mmol/L), glycated hemoglobin (Hb1AC) concentrations (mmol/mol). Collections of participant blood samples were organised by Australian Bureau of Statistics staff and most blood samples were collected at Sonic Healthcare collection clinics or via a home visit using standard operating procedures for phlebotomy collection. In some cases, other pathology service providers were used, mostly in regional areas.
Timepoint [1] 304038 0
Timepoint 1 (out of 1) - Study is cross-sectional
Primary outcome [2] 304039 0
Dependent variables: systolic and diastolic blood pressure (mmHg)
These variables were calculated from blood pressure measurements that were taken during the household survey by the trained Australian Bureau of Statistics interviewer.
Timepoint [2] 304039 0
Timepoint 1 (out of 1) - Study is cross-sectional
Primary outcome [3] 304040 0
adiposity measures including: waist circumference (cm) and BMI (weight [kg]/height (m)^2)
Calculated from measurements that were taken during the household survey by the trained Australian Bureau of Statistics interviewer.
Timepoint [3] 304040 0
Timepoint 1 (out of 1) - Study is cross-sectional
Secondary outcome [1] 340779 0
variables: Level of adherence to the Australian Dietary Guidelines, including: food variety, intakes of food groups (e.g. discretionary foods, fruit, vegetables, grain foods,, lean meats and alternatives and dairy and alternatives); intakes of added sugars, saturated fat, unsaturated fat, alcohol, fluids; salt and total diet quality score (Dietary Guidelines Index)

These variable were determined from dietary information collected during the 2 x 24h recalls.
Timepoint [1] 340779 0
Timepoint 1 (out of 1) - study is cross-sectional

Eligibility
Key inclusion criteria
All persons aged 19 years and over who participated in both the National Nutrition and Physical Activity Survey (NNPAS) and the National Health Measures Survey (NHMS) components of the Australian Health Survey; completed two 24 hour recalls; not currently pregnant or breastfeeding; did not undertake shiftwork in the past four months
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who: did not report any dietary intakes during one of the 24 hour dietary recalls; did not report the time at which an eating occasion commenced, or were missing data for outcomes measures or covariates

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
This study involves secondary analyses of dietary and health data from the 2011-12 Australian National Health Measures Survey (NHMS). All participants aged 5 years and over who participated in the National Nutrition and Physical Activity Survey (NNPAS; n=11,478 selected using a multistage, probability sample design) were invited to participate in the NHMS. The analyses draws on data from adult NNPAS participants who also proceeded to participate in the NHMS, with two days of dietary recall data, who were not pregnant, breastfeeding or undertook shift work in past four weeks (n=2537) ), The frequency of all eating occasions, meals and snacks were calculated after applying previously published definitions of an eating occasion. Latent class analysis was used to assess the timing and frequency of eating occasions, or temporal eating patterns, across the day in men and women.. Person weights and replicate weights were applied to compute point estimates and standard errors to account for the probability of selection in the NHMS, The F test (for continuous data) and the adjusted Pearson Chi-2 test (for categorical data), were used to examine the sociodemographics and diet quality and health outcomes characteristics of different eating patterns. The Bonferroni correction was applied where >3 categories were compared. Linear regression and logistic regression (for binary outcomes) were used to examine associations between eating patterns (temporal eating patterns, frequency of all eating occasions, meals and snacks) and blood biomarkers of chronic disease risk, measures of adiposity and blood pressure. Models were statistically adjusted for potential covariates and energy misreporting. Sensitivity analyses that excluded energy misreporters was also undertaken.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/12/2017
Date of last participant enrolment
Anticipated
15/01/2018
Actual
15/01/2018
Date of last data collection
Anticipated
15/01/2018
Actual
20/01/2018
Sample size
Target
2537
Accrual to date
Final
4482
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298068 0
University
Name [1] 298068 0
Deakin University Faculty of Health Higher Degree by Research Publication Award
Country [1] 298068 0
Australia
Primary sponsor type
Individual
Name
Ms Rebecca M Leech
Address
Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125
Country
Australia
Secondary sponsor category [1] 297144 0
None
Name [1] 297144 0
Address [1] 297144 0
Country [1] 297144 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 299084 0
Ethics committee address [1] 299084 0
Ethics committee country [1] 299084 0
Date submitted for ethics approval [1] 299084 0
Approval date [1] 299084 0
Ethics approval number [1] 299084 0

Summary
Brief summary
Little is known about dietary intake at the level of an “eating occasion (EO)”, which includes meals and snacks. Current dietary advice is framed around the amount and types of food populations should consume, rather than a consideration of eating patterns. Eating patterns describe the frequency and temporal distribution of meals and snacks. Eating patterns are likely to be important determinants of adults’ health; however, the cardiometabolic health impacts of EO, meal and snack frequency and temporal eating patterns are inconclusive.

The aim of this secondary analyses was to investigate associations of different eating patterns (e.g. frequency of all EOs, meals and snacks; temporal eating patterns) with risk factors for cardiometabolic diseases.

The Census and Statistics Act 1905 provides ethics approval for the Australian Bureau of Statistics to conduct household interview components of national surveys, including the National Nutrition and Physical Activity Survey (NNPAS). Participants from the NNPAS were invited to participate in the National Health Measures Survey (NHMS) and were required to give their informed consent to participate in the collection of biomedical blood samples for which ethics approval was granted in February 2011 by the Department of Health and Ageing’s Departmental Ethics Committee. As part of the ethics approval, participants were ensured that they (or their nominated doctor) would be notified of any critical or clinically significant blood test results. As this is a secondary analysis of the NHMS data which is de-identified, an exemption for ethics approval was granted by the Deakin University Human Research Ethics Committee on April 16, 2015. (Project number: 2015-073).
Trial website
Trial related presentations / publications
Public notes
As this is a secondary analysis of the NHMS data which is de-identified, an exemption for ethics approval was granted by the Deakin University Human Research Ethics Committee on April 16, 2015. (Project number: 2015-073).

Details of the ethics approval for the collection of data in the NHMS conducted in 2011-2013 by the Australian Bureau of Statistics are also provided in the brief summary above.

Contacts
Principal investigator
Name 79246 0
Ms Rebecca Leech
Address 79246 0
Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 79246 0
Australia
Phone 79246 0
+61 407846675
Fax 79246 0
Email 79246 0
[email protected]
Contact person for public queries
Name 79247 0
Ms Rebecca Leech
Address 79247 0
Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 79247 0
Australia
Phone 79247 0
+61 407846675
Fax 79247 0
Email 79247 0
[email protected]
Contact person for scientific queries
Name 79248 0
Ms Rebecca Leech
Address 79248 0
Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 79248 0
Australia
Phone 79248 0
+61 407846675
Fax 79248 0
Email 79248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Leech RM, Timperio A, Worsley A, McNaughton SA. Ea... [More Details]

Documents added automatically
No additional documents have been identified.