Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000366853
Ethics application status
Approved
Date submitted
15/01/2021
Date registered
31/03/2021
Date last updated
7/02/2023
Date data sharing statement initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The mobile food record: A pilot study using images to assess dietary intake in children and adolescents with type 1 diabetes
Scientific title
The mobile food record: A pilot study using images to assess dietary intake in children and adolescents with type 1 diabetes
Secondary ID [1] 303164 0
Nil known
Universal Trial Number (UTN)
U1111-1263-7973
Trial acronym
mFR (Mobile Food Record)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 320317 0
Condition category
Condition code
Metabolic and Endocrine 318231 318231 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cross-sectional pilot study to assess the usability and acceptability of the mobile food record (mFR) to measure dietary intake in children and adolescents with Type 1 diabetes (T1D).
Metadata of before and after images of all consumed foods and beverages captured by the app of 50 participants during four consecutive days will be collected. The data will allow assessment of eating frequency (number of eating occasions) and enable researchers to view the time of images alongside continuous glucose monitoring (CGM) traces. Micro- and macronutrient intakes will be assessed against clinical measures, diabetes nutrition guidelines, Australian Dietary Guidelines and Nutrient Reference Values. At completion, participants will be asked to complete an online usability questionnaire and provided with feedback on their average daily food group intake.
A trained Research Assistant will be trained in the set up and usage of the Mobile Food Record App and will email a link to participants to download the App onto their personal mobile devices.
Participants will take photos of all consumed foods and beverages during 4 consecutive days. The App use is anticipated to take approximately 30 seconds to capture one food image. Participant will upload their CGM traces to the appropriate and secure diasend or carelink online-based cloud which will be accessible by a member of the research team to download trace date for assessment.
Intervention code [1] 319490 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326215 0
1) Usability of images captured using the mFR App by children and adolescents with Type 1. The usability will be assessed by reseachers using an online usability questionnaire. This questionnaire has been previously developed and tested in young and healthy adults participating in a similar study design. The answers provided by all participants will be a measure of usability that may lead to modifications to improve its features for future use.
Timepoint [1] 326215 0
Post completion of the 4 day mFR
Primary outcome [2] 326558 0
2) Acceptability of the using the mFR App by children and adolescents with Type 1.
The acceptability will be assessed by reseachers using an online acceptability questionnaire which will be completed by all participants. This questionnaire has been previously developed and tested in young and healthy adults participating in a similar study design.
Timepoint [2] 326558 0
Completion of the usability questionnaires after the study
Secondary outcome [1] 390548 0
1) Measure the micronutrient intakes of children and adolescents with T1D by entering contents of the completed 4-day mFRs into the nutrient analysis program FoodWorks to compare participant data to paediatric Nutrient Reference Values (NHMRC, 2019).
Timepoint [1] 390548 0
Post completion of the 4 day mFR.
Secondary outcome [2] 390549 0
2) Assessment of eating frequency by correlating CGM data with the mFR data.
Timepoint [2] 390549 0
Post completion of the 4 day mFR and correlated CGM data.
Secondary outcome [3] 391863 0
3) Measuring the food group serves of children and adolescents with T1D by entering contents of the completed 4-day mFRs into the nutrient analysis program FoodWorks to compare participant data to Australian Dietary Guidelines food group recommendations.
Timepoint [3] 391863 0
Post completion of the 4 day mFR.
Secondary outcome [4] 393188 0
4) Measure the macronutrient intakes of children and adolescents with T1D by entering contents of the completed 4-day mFRs into the nutrient analysis program FoodWorks to compare participant data to paediatric Nutrient Reference Values (NHMRC, 2019).
Timepoint [4] 393188 0
Post completion of the 4 day mFR.

Eligibility
Key inclusion criteria
1) Aged 9 to 18 years
2) Using a continuous glucose monitor >75% of the time
3) Diagnosed with Type 1 Diabetes for more than 1 year prior
Minimum age
9 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Participants who do not own a mobile device
2) No access to the internet

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)
This is a pilot study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Cross-sectional pilot study of community dwelling children and adolescents
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given the resources and time available for this cross-sectional pilot study, a sample size of 50 has been identified as feasible.
Food and nutrient intake will be estimated and compared to National Reference Values (NHMRC, 2019), Australian Dietary Guidelines food serve recommendations (NHMRC, 2013) and current paediatric diabetes nutrition guidelines. Associations between dietary intake, age, gender, diabetes duration, BMI z-score and HbA1c will be explored.
P values of < 0.05 will be used to determine statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2021
Actual
14/04/2021
Date of last participant enrolment
Anticipated
19/08/2022
Actual
21/07/2022
Date of last data collection
Anticipated
1/09/2022
Actual
16/08/2022
Sample size
Target
50
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18424 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 32531 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 307571 0
Other Collaborative groups
Name [1] 307571 0
Telethon Kids Institute
Country [1] 307571 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Telethon Kids Institute
Children's Diabetes Centre
15 Hospital Avenue
Nedlands 6009 WA Perth
Country
Australia
Secondary sponsor category [1] 308257 0
None
Name [1] 308257 0
Address [1] 308257 0
Country [1] 308257 0
Other collaborator category [1] 281588 0
University
Name [1] 281588 0
Curtin University
Address [1] 281588 0

School of Public Health, Building 400, Hayman Road
Bentley WA 6102
Country [1] 281588 0
Australia
Other collaborator category [2] 281589 0
University
Name [2] 281589 0
University of Hawaii Cancer Center
Address [2] 281589 0
701 Ilalo Street,
Honolulu HI 96813
USA
Country [2] 281589 0
United States of America
Other collaborator category [3] 281590 0
University
Name [3] 281590 0
Purdue University
Address [3] 281590 0
465 Northwestern Avenue
West Lafayette Indiana 47907
USA
Country [3] 281590 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307630 0
WA Child and Adolescent Health Service Human research Ethics Committee
Ethics committee address [1] 307630 0
Ethics committee country [1] 307630 0
Australia
Date submitted for ethics approval [1] 307630 0
21/04/2020
Approval date [1] 307630 0
28/07/2020
Ethics approval number [1] 307630 0
RGS0000003855

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

Contacts
Principal investigator
Name 107926 0
Prof Elizabeth Davis
Address 107926 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6009 WA
Country 107926 0
Australia
Phone 107926 0
+61 08 6456 5031
Fax 107926 0
Email 107926 0
[email protected]
Contact person for public queries
Name 107927 0
Amelia Harray
Address 107927 0
Telethon Kids Institute
Children's Diabetes Centre
15 Hospital Avenue
Nedlands 6009 WA
Country 107927 0
Australia
Phone 107927 0
+61 08 6456 5882
Fax 107927 0
Email 107927 0
[email protected]
Contact person for scientific queries
Name 107928 0
Amelia Harray
Address 107928 0
Telethon Kids Institute
Children's Diabetes Centre
15 Hospital Avenue
Nedlands 6009 WA
Country 107928 0
Australia
Phone 107928 0
+61 08 6456 5882
Fax 107928 0
Email 107928 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
At this stage there is no ethics approval for data sharing in place.


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.