Trial Review

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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 information initially 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] 292379 0
Nil known
Universal Trial Number (UTN)
U1111-1198-9607
Trial acronym
Linked study record


Health condition
Health condition(s) or problem(s) studied:
obesity 303955 0
hypertension 304038 0
Condition category
Condition code
Public Health 303296 303296 0 0
Epidemiology
Diet and Nutrition 303309 303309 0 0
Obesity
Cardiovascular 303310 303310 0 0
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] 298557 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302682 0
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] 302682 0
Timepoint 1 (out of 1) - Study is cross-sectional
Primary outcome [2] 302693 0
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] 302693 0
Timepoint 1 (out of 1)
Primary outcome [3] 302694 0
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] 302694 0
Timepoint 1 (out of 1)
Secondary outcome [1] 336744 0
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] 336744 0
Timepoint 1 (out of 1) - study is cross-sectional
Secondary outcome [2] 336745 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 [2] 336745 0
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] 296933 0
Government body
Name [1] 296933 0
Australian Government Department of Education and Training: Australian Postgraduate Award PhD Scholarship
Country [1] 296933 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] 295948 0
None
Name [1] 295948 0
Address [1] 295948 0
Country [1] 295948 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298138 0
Ethics committee address [1] 298138 0
Ethics committee country [1] 298138 0
Date submitted for ethics approval [1] 298138 0
Approval date [1] 298138 0
Ethics approval number [1] 298138 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’ 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 76126 0
Ms Rebecca Leech
Address 76126 0
Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 76126 0
Australia
Phone 76126 0
+61 407846675
Fax 76126 0
Email 76126 0
[email protected]
Contact person for public queries
Name 76127 0
Ms Rebecca Leech
Address 76127 0
Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 76127 0
Australia
Phone 76127 0
+61 0407846675
Fax 76127 0
Email 76127 0
[email protected]
Contact person for scientific queries
Name 76128 0
Ms Rebecca Leech
Address 76128 0
Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 76128 0
Australia
Phone 76128 0
+61 0407846675
Fax 76128 0
Email 76128 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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEating patterns of Australian adults: associations with blood pressure and hypertension prevalence.2019https://dx.doi.org/10.1007/s00394-018-1741-y
EmbaseTemporal eating patterns: Associations with nutrient intakes, diet quality, and measures of adiposity.2017https://dx.doi.org/10.3945/ajcn.117.156588
N.B. These documents automatically identified may not have been verified by the study sponsor.