Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000002785
Ethics application status
Approved
Date submitted
10/11/2021
Date registered
10/01/2022
Date last updated
10/01/2022
Date data sharing statement initially provided
10/01/2022
Date results information initially provided
10/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary intakes and patterns of children and adolescents with type 1 diabetes
Scientific title
How does dietary intake and meal routines impact HbA1c and Body Mass Index (BMI) in children and adolescents with type 1 diabetes
Secondary ID [1] 305719 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 324188 0
Condition category
Condition code
Metabolic and Endocrine 321670 321670 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be recruited when attending routine clinic appointments and written consent will be obtained. Participants will be asked to fill in a 3 day weighed/measured food record and complete a dietary behavior questionnaire for one time only.
Baseline data will be collected from the John Hunter Children's Hospital paediatric endocrine database including participant age, gender, duration of diabetes, body mass index (BMI) z score, insulin therapy, total cholesterol and triglycerides.
Intervention code [1] 322108 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329443 0
Identify the mean quantities (g) of fat consumed in meals and snacks, as collected from the 3 day food record.
Timepoint [1] 329443 0
Baseline
Primary outcome [2] 329769 0
Identify the mean quantities (g) consumed in meals and snacks, as collected from the 3 day food record.
Timepoint [2] 329769 0
baseline
Primary outcome [3] 329770 0
Identify the mean quantities (g) of carbohydrate consumed in meals and snacks, as collected from the 3 day food record.
Timepoint [3] 329770 0
Baseline
Secondary outcome [1] 402642 0
range of protein intake at meals, determined by 3 day food record.
Timepoint [1] 402642 0
Baseline
Secondary outcome [2] 403716 0
range of fat intake at meals, determined by 3 day food record.
Timepoint [2] 403716 0
Baseline
Secondary outcome [3] 403717 0
range of carbohydrate intake at meals, determined by 3 day food record.
Timepoint [3] 403717 0
Baseline
Secondary outcome [4] 404352 0
HbA1c, determined by blood sample at clinic visit
Timepoint [4] 404352 0
baseline
Secondary outcome [5] 404353 0
BMI Z score, calculated from height and weight as measured at clinic visit.
Timepoint [5] 404353 0
baseline

Eligibility
Key inclusion criteria
children attended John Hunter Children's Hospital paediatric outpatient clinic
type 1 diabetes diagnosed more than 3 months
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undertaking treatment for diagnosed eating disorder

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Descriptive characteristics reported as means and standard deviations
3 day food records analysed in Australian FoodWorks®, Xyris Software, Version 9
Macronutrient distribution compared to ISPAD guidelines. Pearsons’s correlation coefficient used to test for correlations between meal macronutrient ranges and HbA1c.
P-value =0.05 considered significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/07/2019
Date of last participant enrolment
Anticipated
Actual
28/10/2021
Date of last data collection
Anticipated
Actual
5/11/2021
Sample size
Target
50
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21012 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 35847 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 310076 0
Hospital
Name [1] 310076 0
John Hunter Hospital
Country [1] 310076 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Rd. New Lambton, 2305. NSW
Country
Australia
Secondary sponsor category [1] 311131 0
None
Name [1] 311131 0
Address [1] 311131 0
Country [1] 311131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309767 0
Hunter New England Research Ethics and Governance Information System
Ethics committee address [1] 309767 0
Hunter Medical Research Institute (HMRI)
Lot 1 Kookaburra Circuit
New Lambton Heights, NSW, Australia, 2305
Ethics committee country [1] 309767 0
Australia
Date submitted for ethics approval [1] 309767 0
17/06/2018
Approval date [1] 309767 0
23/11/2018
Ethics approval number [1] 309767 0
2018/ETH00263

Summary
Brief summary
Study Aim is to identify the mean quantities and ranges of fat, protein and carbohydrate consumed in meals and snacks times in a small sample of children aged 6-18 years with type 1 diabetes attending John Hunter Children's Hospital and to then explore any possible associations between macro nutrient variability and HbA1c or BMI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115318 0
Mrs Emma Fisher
Address 115318 0
John Hunter CHildren's Hospital
Lookout Rd
New Lambton,
NSW 2305
Country 115318 0
Australia
Phone 115318 0
+61 432145805
Fax 115318 0
Email 115318 0
Emma.Fisher@health.nsw.gov.au
Contact person for public queries
Name 115319 0
Mrs Emma Fisher
Address 115319 0
John Hunter CHildren's Hospital
Lookout Rd
New Lambton,
NSW, 2305
Country 115319 0
Australia
Phone 115319 0
+61 432145805
Fax 115319 0
Email 115319 0
Emma.Fisher@health.nsw.gov.au
Contact person for scientific queries
Name 115320 0
Mrs Emma Fisher
Address 115320 0
John Hunter CHildren's Hospital
Lookout Rd
New Lambton
NSW, 2305
Country 115320 0
Australia
Phone 115320 0
+61 432145805
Fax 115320 0
Email 115320 0
Emma.Fisher@health.nsw.gov.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?

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
SourceTitleYear of PublicationDOI
EmbaseMacronutrient Intake in Children and Adolescents with Type 1 Diabetes and Its Association with Glycemic Outcomes.2023https://dx.doi.org/10.1155/2023/7102890
N.B. These documents automatically identified may not have been verified by the study sponsor.