ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001029381

Ethics application status

Not required

Date submitted

9/07/2017

Date registered

17/07/2017

Date last updated

19/11/2019

Date data sharing statement initially provided

19/11/2019

Date results provided

19/11/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Understanding Australian adults' eating patterns: relationships of frequency and/or timing of eating occasions, including meals and snacks, with dietary intakes, obesity and blood pressure

Scientific title

Understanding Australian adults’ eating patterns: associations of eating patterns (e.g. frequency and/or temporal distribution of eating occasions) with nutrient intakes, diet quality and measures of adiposity and blood pressure.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1198-9607

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

hypertension

Condition category

Condition code

Public Health

Epidemiology

Diet and Nutrition

Obesity

Cardiovascular

Hypertension

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 Nutrition and Physical Activity 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

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Dependent variables: BMI; obesity status (healthy weight./overweight and obese)
These variables were calculated from height and weight measurements that were taken using digital scales and a portable stadiometer during the household survey by the trained Australian Bureau of Statistics interviewer.

Timepoint [1]

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

Primary outcome [2]

Dependent variables: waist circumference (cm), central adiposity status (health/centrally overweight/obese)
These variables were calculated from waist circumference measurements that were taken during the household survey by the trained Australian Bureau of Statistics interviewer.

Timepoint [2]

Timepoint 1 (out of 1)

Primary outcome [3]

Dependent variables: blood pressure status (normal/hypertensive), 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 [3]

Timepoint 1 (out of 1)

Secondary outcome [1]

variables: energy and nutrient intakes (e.g. carbohydrates, total sugars, protein, total fat, saturated fat, monounsaturated fat, polyunsaturated fat, fibre, folate, vitamin C, beta-carotene, calcium, iron, iodine, sodium and potassium).

These variable were determined from dietary information collected during the 2 x 24h recalls. Estimates were averaged over the two days of intake.

Timepoint [1]

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

Secondary outcome [2]

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 [2]

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

Eligibility

Key inclusion criteria

Resides in a private dwelling in a non-remote area (e.g. urban or rural) of Australia; adult aged 19 years or older; 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 Nutrition and Physical Activity Survey (NNPAS). The NNPAS used a multistage, probability sample design to select a nationally representative sample of 12,153 persons aged 2 years and older. The analyses draws on data from adult participants with two days of dietary recall data (n=6053) who were not pregnant, breastfeeding or undertook shift work in past four weeks (n=5366), 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 and the clustered survey design of the NNPAS, The F test (for continuous data) and the adjusted Pearson Chi-2 test (for categorical data), were used to examine the sociodemographics and dietary and health behaviour 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), nutrient intakes, diet quality indicators and 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

16/07/2014

Date of last participant enrolment

Anticipated

Actual

21/12/2016

Date of last data collection

Anticipated

Actual

21/12/2016

Sample size

Target

5366

Accrual to date

Final

5366

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Education and Training: Australian Postgraduate Award PhD Scholarship

Address [1]

Department of Education and Training
GPO Box 9880
Canberra ACT 2601

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’ dietary intakes and health; however, the nutritional and health impacts of EO, meal and snack frequency and temporal eating patterns are inconclusive. Further, inconsistent evidence for eating patterns and health may be partly attributed to the lack of consensus on approaches for defining an EO or for assessing temporal eating patterns. 

The aims of these secondary analyses were to: 1) explore the influence of different definitions of EOs on the characterisation of eating patterns, 2) to examine temporal eating patterns using a novel data-driven analytic approach, and 3) to investigate associations of different eating patterns (e.g. frequency of all EOs, meals and snacks; temporal eating patterns) with nutrient intakes, overall diet quality and measures of adiposity and blood pressure.

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).  At this is a secondary analysis of the NNPAS 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

Leech RM, Worsley A, Timperio A, McNaughton SA. Characterizing eating patterns: a comparison of eating occasion definitions. American Journal of Clinical Nutrition. 2015;102(5):1229-37.

Leech RM, Worsley A, Timperio A, McNaughton SA. Temporal eating patterns: a latent class analysis approach. International Journal of Behavioral Nutrition and Physical Activity. 2017;14(1):3. 

Leech RM, Livingstone KM, Worsley A, Timperio A, McNaughton SA. Meal Frequency but Not Snack Frequency Is Associated with Micronutrient Intakes and Overall Diet Quality in Australian Men and Women. Journal of Nutrition. 2016;146(10):2027-34. 

Leech RM, Worsley A, Timperio A, McNaughton SA. The role of energy intake and energy misreporting in the associations between eating patterns and adiposity. European Journal of Clinical Nutrition. 2017; doi: 10.1038/ejcn.2017.90.

Public notes

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 0407846675

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 0407846675

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

Source	Title	Year of Publication	DOI
Embase	Temporal eating patterns: Associations with nutrient intakes, diet quality, and measures of adiposity.	2017	https://dx.doi.org/10.3945/ajcn.117.156588
Embase	Eating patterns of Australian adults: associations with blood pressure and hypertension prevalence.	2019	https://dx.doi.org/10.1007/s00394-018-1741-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically