Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000209897
Ethics application status
Approved
Date submitted
5/01/2021
Date registered
26/02/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
26/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy and cost-effectiveness of technology-assisted dietary assessment in healthy adults
Scientific title
Accuracy and cost-effectiveness of technology-assisted dietary assessment in healthy adults
Secondary ID [1] 303095 0
AUSTRALIAN RESEARCH COUNCIL PROJECT ID: DP190101723
Universal Trial Number (UTN)
Trial acronym
ACE-TADA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 320181 0
Condition category
Condition code
Diet and Nutrition 318127 318127 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design:
The study design will use a controlled feeding study cross-over design to compare the accuracy of three technology-assisted methods of assessing dietary intake:
Arm 1: Automated Self-Administered 24-hour dietary recall (ASA24);
Arm 2: Self-administered online 24-hour recall (Intake24); and
Arm 3: Image-assisted mobile food record (mFR24).

The study is a 3-period cross-over study, in which the sequence of the three groups, will be randomised for each participant. This study will obtain three (3) non-consecutive 24-hour recalls (24HR) from each of participants attending a face-to-face session. Each participant will therefore be exposed to each of the three techniques at different time periods. The crossover design, a repeated measurements design, will allow both between group and within group method comparisons. This is also the design of choice in dietary assessments, as both the errors between groups and errors within groups are important to examine. The wash-out period between each feeding day will be 7 days.

24 Hour Dietary Recall:
The 24-hour Dietary Recall (24HR) is the current standard method used in population surveillance studies to assess usual intakes (kilojoules, nutrients and food and beverages) both in Australia and internationally. The 24HR, conducted as a structured interview, is designed to capture detailed information of foods and beverages consumed in the previous 24 hours. The 5-step multiple-pass method provides a structured interview format with specific probes and involves five structured sets of probing. ASA24 and Intake24 are automated self-administered web versions of the 24HR recall. Participants will undertake these self-administered methods on the day following the controlled feeding study through a web link emailed to their device. The ASA24 and Intake24 will be completed using the dedicated software on a computer without assistance. ASA24 and Intake24 take between 30-45 minutes to complete. The participant is guided through questions on food and beverages consumed at each meal, and includes a meal-based quick list, detail pass, final review and forgotten foods review. The mFR24 method will use images of meals and snacks captured by the participant in the previous 24-hour period. The images and related metadata are automatically uploaded to a secure cloud based server, thus viewing of the images and the metadata by the participant can be controlled so that the images are only available for viewing after midnight. On the day after the face-to-face feeding day, participants will review their eating occasion images on their mobile device using the “review” module of the mFR app and label the food and beverage items. This software allows the user to zoom in and show the time and date stamp that may assist with remembering the items consumed. A trained interviewer will conduct a 30 minute video interview where the participant will use a food model booklet that contains drawings and photographs to assist people with portion size estimation. All participants will be followed up by video/telephone to ensure they have completed the 24HR recall and to conduct a short survey on the method acceptability.

Procedures:
Prior to attending a face-to-face session, eligible participants will be randomised using a random number generator. The order the participant completes the recall will be allocated to ensure there is no order effect.

Participants will be invited to attend a University study centre where they will have their height, weight and waist circumference measured, complete a demographic questionnaire and additional questionnaires to assess response, memory and cognitive biases. They will consume three meals (breakfast, lunch and dinner) of true intake (composition and amounts). The mFR24 group will be instructed on how to use the mFR App to take a before and after image of their meals and any food or beverage consumed outside of the meal times. Participants will select from a menu and will be blinded to the weight of the foods selected. The menu items will consist of commonly eaten food and beverage items taken from the Australian Health Survey data. All food items will be weighed pre- and post to determine the plated weight of each food and beverage item selected. Once the participant has finished eating, the tray is collected so that plate waste can be recorded by the research staff. The true weight of each food and beverage item will be recorded. Research staff will take a before and after image of participant’s food tray to be used for improving automated image analysis methods.

Participants will return in weeks 2 and 3 to undertake the second and third feeding days and undertake their allocated 24HR the following day.
At the end of the third feeding day, participants will complete an additional online questionnaire to evaluate method preference and their perceptions on each dietary assessment method using closed and open-ended questions.

Focus groups – A qualitative methodological approach using focus groups will explore and describe perceptions and beliefs regarding the dietary assessment methods. Approximately 10% of the recruited sample (approximately 20-30 participants stratified by age group and gender) will be invited to attend a 1 hour focus group (5-8 participants) or a 30 minute in-depth telephone interview conducted by a trained researcher assistant. The focus group script with prompts will be developed by the research team and will cover questions on what would motivate them to take part in studies assessing diet, barriers and enablers to participation and retention and incentives most favoured. Discussions will be audio-recorded and transcribed verbatim for efficacy and accuracy by a professional transcription service. Analysis of the transcripts will commence immediately at the end of the first year, so that findings of earlier focus groups can be used to inform the discussions of subsequent focus group during Year 2. Transcripts will be managed using NVivo software. Sampling and analysis will continue until saturation.


Mode of delivery:
Participants will be required to attend face-to-face sessions for breakfast, lunch and dinner on the same day. A follow-up interview the day after the feeding study will be conducted either in-person or via a video interview.

Location:
The face-to-face sessions will take place in a University study centre and food laboratory.

Intervention code [1] 319394 0
Treatment: Other
Intervention code [2] 319395 0
Behaviour
Comparator / control treatment
No control group - participants own control.
Arm 1: Automated Self-Administered 24-hour dietary recall (ASA24) is considered the control method.
Control group
Active

Outcomes
Primary outcome [1] 326114 0
Participant estimated portion weights by dietary recall method (ASA24, Intake24 and mFR24) compared with true portion weights (weighed food and beverages) for three meals.
Timepoint [1] 326114 0
Timepoint: Baseline, 1 week and 2 weeks, immediately after each controlled feeding day and dietary recall session (1 day after).
Primary outcome [2] 326659 0
Participant estimated energy intake by dietary recall method (ASA24, Intake24 and mFR24) compared with true energy intake (weighed food and beverages) for three meals.
Timepoint [2] 326659 0
Timepoint: Baseline, 1 week and 2 weeks, immediately after each controlled feeding day and dietary recall session (1 day after).
Secondary outcome [1] 390175 0
Recall method acceptability and preference on each dietary assessment method (ASA24, Intake24 and mFR24) conducted by focus group and in-depth interviews.
Timepoint [1] 390175 0
Timepoint: at week 3 after final study site visit
Secondary outcome [2] 390176 0
Economic evaluation assessed by ED-5D and resource use (staff costs, provision of ASA24, Intake24 and mobile food record costs as measured by audit of study records).
Timepoint [2] 390176 0
Timepoint: at week 3 after final study site visit

Eligibility
Key inclusion criteria
aged between 18 -70 years,
able to attend all sessions,
mobile telephone with internet access
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Serious illness,
medical conditions,
pregnant,
currently dieting to lose weight,
special dietary requirements or dietary restrictions due to food allergies or intolerances

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be conducted by a biostatistician not involved in the implementation of the trial on site (therefore not in contact with the study participants) using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 150 participants will allow for 90% power at a 5% significance level when the true difference between any two mean differences between estimated and known energy intake is zero. Dietary data for the true intake and the 24HRs will be analysed using the AUSNUT 2011-13 database and analysed for total food weight, total energy, macronutrients and food groups. Known foods and weights are obtained for all foods and beverages selected, data A comparison of the accuracy of estimated intakes of energy and selected nutrients and food groups by recall mode will be conducted based on reported compared with true intake. Linear regression models will be used to assess whether the differences between true and reported intakes were significant within each group and also to examine whether there were differences in the accuracy of estimated energy, nutrient, and food group intakes by recall mode. Bland-Altman plots, will be used to test for agreement between the estimated values and known measures. The association between the error and estimation and the size of the know value will be assessed using Pearson correlations.

Cost-effectiveness and acceptability of methods:
The project will evaluate both the financial cost and time cost to participants in each of the modalities (i.e., Arm 1:ASA24, Arm 2: Intake24 and Arm 3: mFR24). This will provide evidence when placed alongside the predictive ability of each modality, will provide data to guide which of the 24HR methods may be the most cost-effective. For financial costs, time spent training individuals to take the mFR images, time spent completing the 24HR, and any time spent to support individuals to complete their dietary recall will be recorded. This will then be multiplied by standard staff costs (including on-costs) to estimate the financial cost of using each method on a per-person basis. For participant time costs, the time taken to complete each method will be recorded. By comparing both costs and outcomes associated with different method to a common problem, data can be provided to government on which approaches represent a good use of scarce resources, and which do not.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2021
Actual
11/03/2021
Date of last participant enrolment
Anticipated
7/03/2022
Actual
2/12/2021
Date of last data collection
Anticipated
28/03/2022
Actual
28/01/2022
Sample size
Target
150
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 32344 0
6102 - Bentley
Recruitment postcode(s) [2] 32345 0
6107 - Cannington
Recruitment postcode(s) [3] 32346 0
6101 - East Victoria Park
Recruitment postcode(s) [4] 32347 0
6152 - Como
Recruitment postcode(s) [5] 32348 0
6148 - Riverton
Recruitment postcode(s) [6] 32349 0
6151 - South Perth
Recruitment postcode(s) [7] 32350 0
6105 - Kewdale
Recruitment postcode(s) [8] 32351 0
6100 - Victoria Park
Recruitment postcode(s) [9] 32352 0
6147 - Parkwood
Recruitment postcode(s) [10] 32353 0
6103 - Rivervale

Funding & Sponsors
Funding source category [1] 307500 0
Government body
Name [1] 307500 0
Australian Research Council
Country [1] 307500 0
Australia
Primary sponsor type
Individual
Name
Deborah Kerr
Address
School of Population Health, Curtin University
GPO Box U1987, Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 308185 0
None
Name [1] 308185 0
Address [1] 308185 0
Country [1] 308185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307571 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 307571 0
Ethics committee country [1] 307571 0
Australia
Date submitted for ethics approval [1] 307571 0
12/03/2019
Approval date [1] 307571 0
30/04/2019
Ethics approval number [1] 307571 0
HRE2019-0222
Ethics committee name [2] 307578 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [2] 307578 0
Ethics committee country [2] 307578 0
Australia
Date submitted for ethics approval [2] 307578 0
20/09/2019
Approval date [2] 307578 0
30/11/2020
Ethics approval number [2] 307578 0
RGS0000003674

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

Contacts
Principal investigator
Name 107718 0
Prof Deborah Kerr
Address 107718 0
School of Population Health, Curtin University, GPO Box U1987, Perth WA 6845
Country 107718 0
Australia
Phone 107718 0
+61 892664122
Fax 107718 0
+61 892662958
Email 107718 0
[email protected]
Contact person for public queries
Name 107719 0
Deborah Kerr
Address 107719 0
Curtin School of Population Health, Curtin University, GPO Box U1987, Perth WA 6845
Country 107719 0
Australia
Phone 107719 0
+61 892664122
Fax 107719 0
+61 892662958
Email 107719 0
[email protected]
Contact person for scientific queries
Name 107720 0
Deborah Kerr
Address 107720 0
Curtin School of Population Health, Curtin University, GPO Box U1987, Perth WA 6845
Country 107720 0
Australia
Phone 107720 0
+61 892664122
Fax 107720 0
+61 892662958
Email 107720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 12 months and ending 5 years following main results publication
Available to whom?
bona fide research groups with a qualified statistician
Available for what types of analyses?
only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator. Data will be made available by emailing the Principal Investigator [email protected]


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.