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Trial registered on ANZCTR


Registration number
ACTRN12619001729112
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results information initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a nutrition education website for young people with Type 1 Diabetes
Scientific title
Evaluating a nutrition education website for young people with Type 1 Diabetes
Secondary ID [1] 299951 0
Nil known
Universal Trial Number (UTN)
U1111-1244-6899
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 315401 0
Condition category
Condition code
Human Genetics and Inherited Disorders 313697 313697 0 0
Other human genetics and inherited disorders
Diet and Nutrition 313698 313698 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 313801 313801 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to website access will have access to the pilot website for a period of 3 months. Access will be staggered according to randomisation date. They will be given an individual, user-specific log-in and instructions for use, including selecting which type of user they are when logging in - parent, child, or both. The user specific log-in will be linked to their participant code in order to link website access to clinical data and endpoint data. Participants will attend planned visits to Endocrinologist, DNE and/or Dietitian as usual during the study period. The website contains information, resources, games/quizzes, a frequently asked questions section, and a 'ask a dietitian' feature. Information and quizzes cover many aspects, such as carb counting, label reading, glycemic index, making healthy choices, and 'whats in our food'. There are no requirements for usage of the website, and no reminders are sent to participants to use the website. Usage is measured through website analytics - through each participants ID login, how many times they have logged in, what type of user they are (parent, child, parent-child dyad) and if/how many quizzes have been completed.
Intervention code [1] 316218 0
Treatment: Other
Comparator / control treatment
Participants randomised to standard care will continue to receive usual standard care, attending planned visits to the Endocrinologist, DNE and/or Dietitian as usual during the study period. They will be asked to complete the final assessment questionnaires 3 months from randomisation.
Control group
Active

Outcomes
Primary outcome [1] 322126 0
Change in nutrition knowledge questionnaire score - The Electronic Nutrition and Carbohydrate Counting Quiz (eNCQ) (modified with authors permission for Australian setting). Validated questionnaire.
Timepoint [1] 322126 0
Startpoint - At enrolment
Endpoint - Three months post-enrolment
Secondary outcome [1] 377432 0
Change in HbA1C
Timepoint [1] 377432 0
Startpoint - At enrolment
Endpoint -Collected via case notes, from a clinic visit within 3 months after the end of the participant’s pilot period (ie. between 3-6 months of the randomisation date).
Secondary outcome [2] 377433 0
Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs). Validated questionnaire.
Timepoint [2] 377433 0
Startpoint - At enrolment
Endpoint - Three months post-enrolment
Secondary outcome [3] 377710 0
Change in BMI-Z score (collected from height and weight)
Timepoint [3] 377710 0
Startpoint - At enrolment
Endpoint -Collected via case notes, from a clinic visit within 3 months after the end of the participant’s pilot period (ie. between 3-6 months of the randomisation date).
Secondary outcome [4] 377718 0
,Change in Children’s Dietary Questionnaire Score (CDQ). Validated questionnaire,
Timepoint [4] 377718 0
Startpoint - At enrolment
Endpoint - Three months post-enrolment
Secondary outcome [5] 377719 0
Change in 'Evaluating a nutrition education website for Type 1 Diabetes Questionnaire' score - (developed by WCH for the purpose of this study).
Timepoint [5] 377719 0
Startpoint - At enrolment
Endpoint - Three months post-enrolment

Eligibility
Key inclusion criteria
Inclusion criteria:
• Diagnosed with Type 1 Diabetes
• Seen by an Endocrinologist at WCH
• <19 years of age
• Diabetes duration, greater or equal to 12 months
o Rationale: the website is targeted at improving dietitian/nutrition information access for patients with longer diabetes duration
• English speaking
• Living in an area with internet and cellular phone coverage and has access to computer with internet, smart phone or tablet through which to access website
Minimum age
1 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 2 Diabetes, Cystic Fibrosis related Diabetes, Maturity Onset Diabetes of the Young

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Due to being the pilot study, no samples size or power calculations were completed. Statistical analyses performed using IBM Corp. Released 2010. IBM SPSS Statistics for Mac, Version 25.0. Armonk, NY: IBM Corp. Normality of data was assessed using the Kolmogorov-Smirnov test.
Statistical analysis:
Within-group: Parametric - Paired Samples T-test. Non-parametric - Wilcoxon Signed Rank Test
Between-group: Parametric - Independent Sample T-test. Non-parametric - Mann Whitney U Test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15357 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 28673 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 304417 0
Government body
Name [1] 304417 0
SA Health Allied Health Seed Funding Grant
Address [1] 304417 0
Citi Centre Building 11 Hindmarsh Square Adelaide South Australia 5000
Country [1] 304417 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Rd, North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 304672 0
None
Name [1] 304672 0
Address [1] 304672 0
Country [1] 304672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304852 0
WCHN Human Research Ethics Committee
Ethics committee address [1] 304852 0
Citi Centre Building 11 Hindmarsh Square Adelaide South Australia 5000
Ethics committee country [1] 304852 0
Australia
Date submitted for ethics approval [1] 304852 0
10/10/2018
Approval date [1] 304852 0
11/02/2019
Ethics approval number [1] 304852 0

Summary
Brief summary
The purpose of this study was to create a nutrition education website to improve accessibility and immediacy of trustworthy nutrition information targeted at young people with T1D and their families. The website also aims to improve engagement of patients with longer diabetes duration, thereby improving their nutritional management of T1D. The primary aim of this study was to determine the effect of this online nutrition education website on nutrition knowledge (primary outcome), clinical outcomes, and treatment satisfaction, compared to standard care, on patients with T1D and their carers attending the WCH diabetes clinic. It was hypothesised that those who had access to the pilot website would have a higher nutrition knowledge score than those receiving standard care alone.
Trial website
https://learn.digitalmedia.sahealth.sa.gov.au/diabetes/site/run/diabetes/home
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98406 0
Ms Stephanie Savio
Address 98406 0
Women's and Children's Hospital
72 King William Rd, North Adelaide SA 5006
Country 98406 0
Australia
Phone 98406 0
+61 408 889 005
Fax 98406 0
Email 98406 0
stephanie.savio@sa.gov.au
Contact person for public queries
Name 98407 0
Ms Stephanie Savio
Address 98407 0
Women's and Children's Hospital
72 King William Rd, North Adelaide SA 5006
Country 98407 0
Australia
Phone 98407 0
+61 408 889 005
Fax 98407 0
Email 98407 0
stephanie.savio@sa.gov.au
Contact person for scientific queries
Name 98408 0
Dr Jacqueline Miller
Address 98408 0
Women's and Children's Hospital
72 King William Rd, North Adelaide SA 5006
Country 98408 0
Australia
Phone 98408 0
+61 08 8128 4676
Fax 98408 0
Email 98408 0
jacqueline.miller@sahmri.com

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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5957 0
Ethical approval
Citation [1] 5957 0
Link [1] 5957 0
Email [1] 5957 0
Other [1] 5957 0
Type [2] 5958 0
Informed consent form
Citation [2] 5958 0
Link [2] 5958 0
Email [2] 5958 0
Other [2] 5958 0
Type [3] 5959 0
Study protocol
Citation [3] 5959 0
Link [3] 5959 0
Email [3] 5959 0
Other [3] 5959 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
In total, 211 participants were approached. Of these, five participants did not consent, and thus 206 were sent an email with the survey link to the baseline assessment. 116 were excluded from the study due to not completing the baseline study, and thus 88 participants were randomised to either the control (n=44) or intervention group (n=44). Of the 88, 41 participants (control=25, intervention n=15) completed the endpoint surveys.
There was no significant difference in baseline (n=44) and endpoint (n=15) score for the intervention group, with a median baseline of 30, out of 36, and median endpoint of 30. The control group also did not have a statistically significant change in score, with a baseline (n=44) and endpoint (n=25) of 29 and 30, respectively.
In total, 20 of the 44 participants did not use the website at all during the study period. Of the 24 that did, 17 logged in once, five participants logged in twice, one logged in three times, and one logged in four times. Furthermore, 33 participants did not complete any quizzes. Three participants completed one quiz, three completed two, two did three, and one participant did five, six, and nine quizzes. Of the 22 that logged into the website, 11 logged in as a parent user, seven logged in a child user, four logged in as combination of the dyads over two or more logins, and 2 participants logged in a parent-child user. The “ask a dietitian” feature of the website was not used at all during the study period.