ANZCTR - Registration

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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 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]

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

Type 2 Diabetes

Condition category

Condition code

Public Health

Epidemiology

Diet and Nutrition

Obesity

Cardiovascular

Coronary heart disease

Cardiovascular

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Timepoint 1 (out of 1) - Study is cross-sectional

Primary outcome [2]

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]

Timepoint 1 (out of 1) - Study is cross-sectional

Primary outcome [3]

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]

Timepoint 1 (out of 1) - Study is cross-sectional

Secondary outcome [1]

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]

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]

University

Name [1]

Deakin University Faculty of Health Higher Degree by Research Publication Award

Address [1]

221 Burwood Hwy,
Burwood,
Victoria, 3125

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Ms Rebecca Leech

Address

Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125

Country

Australia

Phone

+61 407846675

Fax

rebecca.leech@deakin.edu.au

Contact person for public queries

Name

Rebecca Leech

Address

Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125

Country

Australia

Phone

+61 407846675

Fax

rebecca.leech@deakin.edu.au

Contact person for scientific queries

Name

Rebecca Leech

Address

Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125

Country

Australia

Phone

+61 407846675

Fax

rebecca.leech@deakin.edu.au

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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