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Trial registered on ANZCTR


Registration number
ACTRN12621001654842
Ethics application status
Approved
Date submitted
20/10/2021
Date registered
1/12/2021
Date last updated
18/11/2022
Date data sharing statement initially provided
1/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Eating in Context Study: understanding the ways through which individual and everyday factors affect food choices at different eating occasions, and how this impacts health in adults aged 18 to 64 years.
Scientific title
Eating in context: Understanding the pathways through which everyday contextual factors influence food choices and cardiometabolic health in adults aged 18 to 64 years.
Secondary ID [1] 305367 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic diseases 323709 0
Cardiovascular disease 323710 0
Obesity 323711 0
Condition category
Condition code
Diet and Nutrition 321245 321245 0 0
Other diet and nutrition disorders
Diet and Nutrition 321765 321765 0 0
Obesity
Cardiovascular 321766 321766 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
The exposures being assessed in this study are predictors of food intakes and subsequent cardiometabolic health, and include: 1) individual factors and 2) eating occasion contextual factors. These exposures are described below.
1) Individual factors will be assessed using an online survey. The survey will include questions on age, gender, education, occupation, income, country of birth, medical history and medication use, and activity behaviors. The survey will take approximately 20 minutes to complete. Participants will complete the online survey in their own time shortly after they have registered for the study, read the plain language statement and provided their informed consent.
2) Data on eating occasion contextual factors will be collected via an Automated Self-Administered 24-Hour Dietary Recall (ASA24-Australia) and the Narrative Clip 2. The ASA24 is a free online tool that can capture information about eating occasion contextual factors (eating location, who was present, tv/computer use, where food was sourced). Participants will be asked to complete three online food recalls (ASA-24) on non-consecutive days (including one weekend day) over a seven-day data collection period. Each recall will take approximately 30-40 minutes to complete and will be completed on days 3, 5 & 7 of the observation period. The Narrative Clip is a small, hands-free wearable camera that automatically takes person point-of-view images. Wearable cameras capture objective and rich data on environmental or social contexts of eating, including location, advertising, purchasing habits, screen behaviors, social interactions and physical positioning. Participants will be asked to use the wearable camera for four days over the 7-day observation period (e.g. Days 1, 2, 4 & 6).

The outcomes being assessed in this study include 1) markers of cardiometabolic health (primary outcomes) and 2) overall diet quality and food group intakes (secondary outcomes). Once participants have completed the online survey they will be scheduled in to attend a single 45-minute face-to-face session at the Deakin University Burwood Clinic on Day 1 of the observation period only. At this visit participants blood pressure, waist circumference, height, and weight will be measured, with each component taking approximately 5 minutes to complete. A trained study researcher will take all measurements and record the observations. During this session, participants will also receive instructions on how to use the wearable camera and complete the online 24 hour recalls using the ASA-24 tool. They will also receive instructions regarding the Melbourne Pathology visit and be fitted with a Sensewear Armband. This instructive component will take approximately 25-minutes. The Sensewear Armband will be worn for all 7-days of the observation period and will provide an objective measure of energy expenditure and time spent in different activity intensities. This data will be used to assess important covariates and includes: energy misreporting (e.g. under- or over-reporting of dietary intake in the ASA-24) and individual physical activity levels.

Blood markers of cardiometabolic health will be collected during a visit to a Melbourne Pathology Clinic. Participants can choose which collection center to visit (there are >300 collection centers in Victoria). Participants are required to attend the clinic in a fasting state at any point during the 7-day observation period or in the two-week period after the 7-day observation period.

Information on diet quality and food group intakes will be collected using three Automated Self-Administered 24-Hour Dietary Recall (ASA24-Australia). This information is collected at the same time as the information on eating occasion contextual factors and involves no additional time commitment by the participant (as described earlier, one recall takes 30-40 minutes).

The total time commitment for this study is as follows: 1) Online survey (occurring after study registration and before the 7-day observation period): 20 minutes; 2) 7-days of observation (free living environment) during which participants will wear the Sensewear armband on all 7-days and the wearable camera on days 1, 2, 4 and 6 only; 3) a 45-minute face-to-face clinic visit on day 1 of the observation period; 4) Three online 24-hour dietary recalls completed by participants at home using the ASA-24 tool: each recall takes 30-40 minutes and will be completed on days 3, 5 and 7 of the observation period; and 4) a visit to a Melbourne Pathology center: approximately one hour of time required, either during the 7-day observation period or up to two weeks thereafter.
Intervention code [1] 321857 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329240 0
Blood Pressure assessed at clinic visit using an automated blood pressure machine
Timepoint [1] 329240 0
Day 1 of the 7-day observation period
Primary outcome [2] 329241 0
Waist circumference (assessed using anthropometric tape measure) during the clinic visit.
Timepoint [2] 329241 0
Day 1 of the 7-day observation period
Primary outcome [3] 329242 0
Body mass index (BMI) calculated from height (cm) using a stadiometer and weight (kg) assessed using digital scales during the clinic visit
Timepoint [3] 329242 0
Day 1 of the 7-day observation period
Secondary outcome [1] 401861 0
Overall diet quality, defined as level of compliance with current Australian Dietary Guidelines, will be calculated using the established Dietary Guidelines Index (DGI). The DGI score will be calculated from the data on dietary intake collected during multiple 24-hour dietary recalls using the online automated ASA-24 tool. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only.
Timepoint [1] 401861 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [2] 401862 0
Intakes of vegetables will be assessed at all eating occasions recorded in the ASA-24. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only.
Timepoint [2] 401862 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [3] 402811 0
Intakes of fruit will be assessed at all eating occasions recorded in the ASA-24. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only.
Timepoint [3] 402811 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [4] 402812 0
Intakes of cereals/grains will be assessed at all eating occasions recorded in the ASA-24. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only.
Timepoint [4] 402812 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [5] 402813 0
Intakes of meat/meat alternatives will be assessed at all eating occasions recorded in the ASA-24. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only..
Timepoint [5] 402813 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [6] 402814 0
Intakes of dairy foods/dairy alternatives will be assessed at all eating occasions recorded in the ASA-24. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only.
Timepoint [6] 402814 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [7] 402815 0
Intakes of discretionary foods will be assessed at all eating occasions recorded in the ASA-24. This secondary outcome will be assessed using dietary information provided by the ASA-24 tool only.
Timepoint [7] 402815 0
Days 2, 4 and 6 of the 7 day observation period
Secondary outcome [8] 402816 0
Primary outcome: fasting blood glucose will be collected during a visit to a Melbourne Pathology clinic.
Timepoint [8] 402816 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.
Secondary outcome [9] 402817 0
Primary outcome: highly sensitive c-reactive protein will be collected in a fasting state during a visit to a Melbourne Pathology clinic.
Timepoint [9] 402817 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.
Secondary outcome [10] 402818 0
Primary outcome: blood insulin will be collected in a fasting state during a visit to a Melbourne Pathology clinic.
Timepoint [10] 402818 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.
Secondary outcome [11] 402819 0
Primary outcome: blood glycosylated hemoglobin (HBA1C) will be collected in a fasting state during a visit to a Melbourne Pathology clinic.
Timepoint [11] 402819 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.
Secondary outcome [12] 402820 0
Primary outcome: blood low density lipoprotein (LDL) cholesterol will be collected in a fasting state during a visit to a Melbourne Pathology clinic.
Timepoint [12] 402820 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.
Secondary outcome [13] 402821 0
Primary outcome: blood high density lipoprotein (HDL) cholesterol will be collected in a fasting state during a visit to a Melbourne Pathology clinic.
Timepoint [13] 402821 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.
Secondary outcome [14] 402822 0
Primary outcome: blood total cholesterol will be collected in a fasting state during a visit to a Melbourne Pathology clinic.
Timepoint [14] 402822 0
Any day during 7-day observation period, or in the period up to 2 weeks thereafter.

Eligibility
Key inclusion criteria
- Living in Victoria, Australia
- Own a smartphone, desktop computer, laptop, or tablet with internet access
- Can communicate confidently in English, e.g., speak, read, and write English confidently
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or breastfeeding women

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The sample size of 150 adult participants is based on simulation studies for calculating unbiased regression coefficients and variances according to cluster number and size in multilevel models. Further, previous studies using wearable cameras have shown that sample sizes of 40 and 53 adults were sufficient to detect significant (alpha = 0.05) associations between environmental and social contextual factors at eating occasions (exposures) and dietary intakes (outcomes).

Deep learning artificial intelligence (AI) technology (e.g. convolutional neural networks) will be used to identify images captured by the wearable camera that contain food or drink. AI technology can detect food images with good accuracy, reduce the burden of data processing and address privacy concerns. Statistical analyses will be carried out using Stata Version 16 and MPlus Version 8.6. We will triangulate the food image data with the ASA24 contextual factors data to classify the context of each eating occasion. Multilevel regression analyses will be used to examine eating occasion contextual factors ([exposures] e.g., social interactions, purchasing habits, food advertising, screen behaviours) and individual factors (exposures) in relation to food group intakes and overall diet quality (secondary outcomes), and cardiometabolic health indicators (primary outcomes). Only group level associations will be analyzed, and for aggregate data, a threshold value of 5 will be applied to cells the data tables in order to maintain participant confidentiality.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/12/2021
Actual
6/12/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
29/07/2023
Actual
Sample size
Target
150
Accrual to date
64
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309737 0
Government body
Name [1] 309737 0
National Health and Medical Research Council
Country [1] 309737 0
Australia
Primary sponsor type
University
Name
Institute for Physical Activity and Nutrition (IPAN), Deakin University
Address
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences. Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 310758 0
None
Name [1] 310758 0
Address [1] 310758 0
Country [1] 310758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309494 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309494 0
Ethics committee country [1] 309494 0
Australia
Date submitted for ethics approval [1] 309494 0
27/07/2021
Approval date [1] 309494 0
20/09/2021
Ethics approval number [1] 309494 0
2021-267

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

Contacts
Principal investigator
Name 114346 0
Dr Rebecca Leech
Address 114346 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences, Faculty of Health
Deakin University
75 Pigdons Rd
Waurn Ponds VIC 3216
Country 114346 0
Australia
Phone 114346 0
+61 3 5227 8768
Fax 114346 0
Email 114346 0
rebecca.leech@deakin.edu.au
Contact person for public queries
Name 114347 0
Rebecca Leech
Address 114347 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences, Faculty of Health
Deakin University
75 Pigdons Rd
Waurn Ponds VIC 3216
Country 114347 0
Australia
Phone 114347 0
+61 3 5227 8768
Fax 114347 0
Email 114347 0
rebecca.leech@deakin.edu.au
Contact person for scientific queries
Name 114348 0
Rebecca Leech
Address 114348 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
75 Pigdons Rd
Waurn Ponds VIC 3216
Country 114348 0
Australia
Phone 114348 0
+61 3 5227 8768
Fax 114348 0
Email 114348 0
rebecca.leech@deakin.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13298Ethical approval    382822-(Uploaded-04-10-2021-14-10-10)-Study-related document.pdf



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.