ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Chronic diseases

Cardiovascular disease

Obesity

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Diet and Nutrition

Obesity

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

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]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Blood Pressure assessed at clinic visit using an automated blood pressure machine

Timepoint [1]

Day 1 of the 7-day observation period

Primary outcome [2]

Waist circumference (assessed using anthropometric tape measure) during the clinic visit.

Timepoint [2]

Day 1 of the 7-day observation period

Primary outcome [3]

Body mass index (BMI) calculated from height (cm) using a stadiometer and weight (kg) assessed using digital scales during the clinic visit

Timepoint [3]

Day 1 of the 7-day observation period

Secondary outcome [1]

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]