Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001617257
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
2/10/2018
Date last updated
13/04/2021
Date data sharing statement initially provided
20/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The EverydayLife Study: Understanding eating patterns, physical activity, sleep and mood in Australian adults.
Scientific title
Eating patterns: How do they interact with activity, sleep and mood in Australian adults?
Secondary ID [1] 292675 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic diseases 304422 0
Obesity 304423 0
Condition category
Condition code
Diet and Nutrition 303753 303753 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study has two components (Part A and Part B). In Part A, participants will be asked to complete a Smartphone food diary and an online questionnaire. The Smartphone diary will be used over seven days to record food and beverage intake at each eating occasion (defined as any occasion when a food or beverage is consumed). For each eating occasion, participants record the foods and beverages consumed by providing an image and/or written message describing food types and the amounts of each food consumed. For each eating occasion, the diary will incorporate questions about the context of the eating occasion such as where they ate, who they ate with, what they were doing when eating (e.g. watching television). Food and beverage data from the Smartphone diary will be downloaded to a purpose-designed database and coded using Australian food composition databases. Food and nutrient intake will be calculated. Dietary data will be analysed in relation to eating patterns including patterning (frequency, timing and spacing of eating occasions) and the nutritional content of eating occasions. Levels of adherence to the Australian Dietary Guidelines will also be assessed.

The Smartphone diary incorporates questions which provides a measure of current mood and additional visual analogue scales to differentiate mental and physical facets of fatigue. These mood measures will be completed at each eating occasion on two of the seven days. Additionally, the Smartphone diary incorporates sleep diary measures by including questions on sleep and wake times for each day.

In Part B, a subgroup of participants (50%) will be invited to attend a clinic visit approximately 3 months later where a trained Research Assistant will collect measures of anthropometry, blood pressure and body composition. Participants will also be asked to complete a cognitive test and short online questionnaire. Following the visit, participants will wear a SenseWear armband and complete a second Smartphone food diary for seven days. The SenseWear armband will provide a measure of physical activity, energy expenditure and sleep.
Intervention code [1] 298910 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307311 0
Sleep assessed at baseline using an online questionnaire (Pittsburgh Sleep Quality Index (PSQI) and Munich ChronoType Questionnaire (MCTQ)) and Smartphone food diary. Sleep assessed at 3 months using an online questionnaire (Epworth Sleepiness Scale and Light Exposure History), SenseWear armband and Smartphone food diary.
Timepoint [1] 307311 0
3 months
Primary outcome [2] 307312 0
Mood assessed at baseline using an online questionnaire (NEO FFI Personality Inventory) and Smartphone food diary. Mood assessed at 3 months using Smartphone food diary.
Timepoint [2] 307312 0
3 months
Primary outcome [3] 307313 0
Body composition assessed at 3 months using Dual Energy X-ray Absorptiometry (DXA).
Timepoint [3] 307313 0
3 months
Secondary outcome [1] 351437 0
Physical Activity assessed at baseline using an online questionnaire (questions from the Australian National Health Survey 2011-12) and at 3 months using a SenseWear armband.
Timepoint [1] 351437 0
3 months
Secondary outcome [2] 351438 0
BMI assessed at baseline using self-reported height and weight from an online questionnaire (standard questions designed and used in previous studies) and at 3 months using height and weight measures assessed at clinic visit. Height (cm) assessed using a stadiometer and weight (kg) assessed using digital scales.
Timepoint [2] 351438 0
3 months
Secondary outcome [3] 351439 0
Blood Pressure assessed at clinic visit using an automatic blood pressure machine.
Timepoint [3] 351439 0
3 months
Secondary outcome [4] 351441 0
Cognition assessed using the Trail Making Test App.
Timepoint [4] 351441 0
3 months
Secondary outcome [5] 351553 0
Waist circumference assessed at clinic visit using an anthropometric tape measure.
Timepoint [5] 351553 0
3 months

Eligibility
Key inclusion criteria
The key inclusion criteria for this study are as follows:
• Living in Victoria, Australia
• Own a Smartphone that was purchased in Australia
• English is the primary language spoken at home
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The key exclusion criteria for this study are as follows:
• Pregnant or breastfeeding women
• Have a medical condition that is adversely affected by exposure to ionising radiation
• Have a history of high levels of ionising radiation exposure (e.g. medical treatment, chest x-ray) in the past 12 months

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
While there is limited data on which to base sample size estimations, previous research on early eaters, late eaters and grazers suggests that that the prevalence in Australia of the three temporal eating patterns is 42%, 34% and 24%, with a mean (SD) number of daily eating occasions of 4.6 (1.1), 4.8 (1.2) and 5.2 (1.3), respectively. Therefore, a sample of 154 per eating occasion group will allow us to detect differences in the number of eating occasions between temporal eating pattern types at the level previously reported. Therefore, we will recruit 924 participants for Part A, which allows for a participation rate of 50% from Part A to B to result in 154 participants for each eating type for the detailed assessment in Part B. With a sample size of n=462 (in Part B), in linear regression models, with two-tailed a=0.05 and nine covariates, we will have 80% power to detect an effect size corresponding to a correlation of r=0.14 or greater.

Statistical analyses will be carried out using Stata Version 12 and MPlus. Data will initially be analysed using univariate statistics to examine the distribution of key variables. Initial descriptive analysis will involve examining three eating pattern groups (early eaters, late eaters and grazers) for variations in patterns of physical activity and sleep and in relation to measures of mood. We will examine these relationships taking into consideration potential confounding variables. Multilevel structural equation modelling using MPlus will be used to examine relationships between eating, physical activity and sleep patterns and mood. We will examine the time-lagged effects of each lifestyle behaviours and mood on subsequent days, and examine the bidirectional relationships between the lifestyle behaviours on mood by assessing the temporal sequencing.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2018
Date of last participant enrolment
Anticipated
30/01/2020
Actual
13/01/2020
Date of last data collection
Anticipated
30/04/2020
Actual
23/03/2020
Sample size
Target
924
Accrual to date
Final
867
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297268 0
Government body
Name [1] 297268 0
Australian Research Council
Country [1] 297268 0
Australia
Primary sponsor type
University
Name
Institute for Physical Activity and Nutrition, Deakin University
Address
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 296286 0
None
Name [1] 296286 0
Address [1] 296286 0
Country [1] 296286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298386 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 298386 0
Ethics committee country [1] 298386 0
Australia
Date submitted for ethics approval [1] 298386 0
07/07/2017
Approval date [1] 298386 0
09/08/2017
Ethics approval number [1] 298386 0
2017-211

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

Contacts
Principal investigator
Name 76914 0
Prof Sarah McNaughton
Address 76914 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy
Burwood VIC 3125
Country 76914 0
Australia
Phone 76914 0
+61 3 9251 7842
Fax 76914 0
Email 76914 0
[email protected]
Contact person for public queries
Name 76915 0
Sarah McNaughton
Address 76915 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy
Burwood VIC 3125
Country 76915 0
Australia
Phone 76915 0
+61 3 9251 7842
Fax 76915 0
Email 76915 0
[email protected]
Contact person for scientific queries
Name 76916 0
Sarah McNaughton
Address 76916 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy
Burwood VIC 3125
Country 76916 0
Australia
Phone 76916 0
+61 3 9251 7842
Fax 76916 0
Email 76916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.