Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000443897
Ethics application status
Approved
Date submitted
15/01/2021
Date registered
16/04/2021
Date last updated
28/02/2023
Date data sharing statement initially provided
16/04/2021
Date results information initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Quality or Quantity: The Role of Carbohydrate in the Health of Children with Diabetes.
Scientific title
Quality or Quantity: The Role of Carbohydrate in the Health of Children with Diabetes.
Secondary ID [1] 303173 0
Nil
Universal Trial Number (UTN)
U1111-1263-8061
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 320295 0
Condition category
Condition code
Metabolic and Endocrine 318219 318219 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational quantitative cross sectional study assessing the association between carbohydrate (CHO) restriction and a multitude of health outcomes including nutritional status, cardiovascular disease, glycaemic control, bone density and psychosocial functioning in children 10 years and younger with Type 1 Diabetes (T1D) in Western Australia (WA).
A population–based sample of 100 children will be invited on one occasion to measure: non-fasting bloods (to assess biomarkers for malnutrition, cardiovascular disease, kidney and liver function); height; weight; blood pressure; bone density and body composition (using dual energy X-ray absorptiometry) and; study specific questionnaires to assess physical activity, psychosocial functioning and socio demographic background. The participants will be asked to complete each of the questionnaires and assessments described above during the initial visit. It is anticipated that the questionnaire will take no longer than 40 minutes to complete. The questionnaires will be conducted by research nurse or research dietitian. Participating families will complete a 4-day food diary to assess dietary intake.
Intervention code [1] 319482 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326208 0
1) Determine the proportion of children with T1D who are meeting nutrition recommendations as per Paediatric Clinical Diabetes Guidelines, the Australian Dietary Guidelines food group serve recommendations and Nutrient Reference Values.
Timepoint [1] 326208 0
Post baseline after completion of the 4 day food diary
Primary outcome [2] 326555 0
2) Assess biomarkers of overall nutritional status in young children with T1D in Western Australia.
A blood samples will be collected to assess iron stores, Vitamin B12 and D, zinc, blood lipids, and magnesium.
Timepoint [2] 326555 0
At the time of the observation
Secondary outcome [1] 390517 0
1) Systematic characterisation of the dietary intake of children living with T1D in WA.
- Participants will completed 4-day food diary recording all foods, beverages and dietary supplements to estimate distribution of dietary intake using nutrient analysing program FoodWorks 10.
Timepoint [1] 390517 0
Assessed over 4 consecutive days after attendance at the observation session
Secondary outcome [2] 390521 0
2) Assessing diet quality using Australian Child and Adolescent Recommended Food Score
Timepoint [2] 390521 0
At the time of the observation
Secondary outcome [3] 390525 0
3) Cardiovascular disease risk factors assessed by blood markers (low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides and total cholesterol). This is a composite secondary outcome.
Timepoint [3] 390525 0
At the time of the observation
Secondary outcome [4] 393192 0
4) Proportion of energy from CHO assessed using a food diary.
Timepoint [4] 393192 0
At the time of the observation

Eligibility
Key inclusion criteria
1) Type 1 diabetes for at least 1 year
2) Aged between 2 and 10 years
3) Able to attend Perth Children’s Hospital for one visit
Minimum age
2 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The parent/caregiver is unable to read and complete questionnaires in English.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study has been powered to medium to large effects of predictors in the linear regression models (partial R-squared = 0.09). To allow this, 100 participants will be recruited.
Appropriate descriptive statistics (frequencies (%), mean (SD), median (IQR)) will be presented for all sociodemographic and clinical characteristics of the sample. Measures of central tendency and dispersion will be presented for food group serves, and micro- and macronutrient intakes. One-sample t-tests or Wilcoxon signed-tests will be used to compare sample values to the Australian Guide to Healthy Eating for Children and Adolescents and the Nutrient Reference Values, respectively. The proportion of daily energy intake resulting from CHO will be calculated based on total energy obtained from CHO over the study period divided by total energy intake and a categorical measure created (very low, low, recommended (45%-55%), high). These categories will be determined based on guidance from the literature and distribution of the measure. The sample proportion (along with simultaneously calculated 95% confidence intervals) consuming each diet type will be presented.

A binomial logistic regression using a binary indicator of ‘very low CHO diet’ (Y/N) will be used to determine the sociodemographic and clinical predictors of consuming a CHO-restricted diet. Exploration of bivariate associations between the diet quality score and each health biomarker will be achieved through Pearson product-moment correlation or Spearman rank-correlation. To explore the relative contribution of ‘diet type’ and ‘diet quality’ in predicting individual nutrition markers a series of linear regressions or logistic regressions will be employed. Models will include terms for ‘CHO intake’ (non-linear term of CHO intake or categorical measure) and ‘diet quality’, and will adjust for energy intake and sociodemographic and clinical confounders (e.g. education, psychosocial functioning).

To further examine the relationship between ‘dietary intake’ and ‘nutritional status’ a canonical correlation analysis will be employed. This type of analysis is used in situations where regression would be appropriate, but there are multiple outcome measures. This exploratory exercise will use nutritional status indicators with an appropriate distribution (e.g. iron, lipids, vitamin D) as the dependent variables and nutrient intakes (micro- and macronutrient intake and diet quality index score) as the independent variables. Canonical correlation analysis identifies the linear combination of the two sets of variables that best explain the correlation between the two sets. The linear composites are ‘canonical’ variables (a kind of latent variable) and the resultant correlation between these canonical variables will provide an indication of the strength of the relationship between food intake and nutrition. Further exploration into the relative contribution of the specific importance of the original predictors in the observed relationship.
P values of < 0.05 will be used to determine statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/04/2021
Actual
5/08/2021
Date of last participant enrolment
Anticipated
9/12/2022
Actual
22/02/2023
Date of last data collection
Anticipated
15/12/2022
Actual
22/02/2023
Sample size
Target
100
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18423 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 32530 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 307580 0
Government body
Name [1] 307580 0
Future Health Research Innovation Fund-WA Research fund
Country [1] 307580 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 308269 0
None
Name [1] 308269 0
Address [1] 308269 0
Country [1] 308269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307639 0
WA Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 307639 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 307639 0
Australia
Date submitted for ethics approval [1] 307639 0
18/08/2020
Approval date [1] 307639 0
29/09/2020
Ethics approval number [1] 307639 0
RGS0000004230

Summary
Brief summary
There are an increasing number of families attending the Diabetes Clinic at Perth Children’s Hospital (PCH) who are using low carbohydrate (CHO) diets in an attempt to control blood glucose levels. However, little is known about what these children are eating and their overall nutritional status. The use of these diets is often promoted for weight loss in adults; however, there is minimal evidence on the short and long-term impacts on the use in children. As such, they are not promoted in clinical guidelines or in the clinical setting and families are seeking advice elsewhere such as non-evidence based online forums.

This study aims to determine if children with T1D on low CHO diets are at greater risk of poor nutritional status, cardiovascular disease, osteoporosis and poor psychosocial functioning, compared to those who meet the daily recommended CHO targets for children. The findings will directly inform future studies and clinical practice to benefit children with T1D.

All children aged 10 years and younger with T1D for more than 1 year will be invited to participate in the study. A population–based sample of 100 children will attend PCH on one occasion to measure: non-fasting bloods (to assess biomarkers for malnutrition, cardiovascular disease, kidney and liver function); height; weight; blood pressure; bone density and body composition (using dual energy X-ray absorptiometry (DXA)) and; questionnaires to assess physical activity and psychosocial functioning. Participating families will complete a 4-day food diary to assess dietary intake, which will be entered into a nutrient analysis program. Statistical analyses will determine associations between proportion of energy from CHO, types of CHO-containing foods, nutritional status and risk factors for co-morbidities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107962 0
Prof Elizabeth Davis
Address 107962 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 107962 0
Australia
Phone 107962 0
+61 8 6456 5031
Fax 107962 0
Email 107962 0
[email protected]
Contact person for public queries
Name 107963 0
Dr Amelia Harray
Address 107963 0
Telethon Kids Institute
Perth Children's Hospital
Northern Entrance
15 Hospital Avenue
Nedlands WA 6009
Country 107963 0
Australia
Phone 107963 0
+61 08 6456 5882
Fax 107963 0
Email 107963 0
[email protected]
Contact person for scientific queries
Name 107964 0
Dr Amelia Harray
Address 107964 0
Telethon Kids Institute
Perth Children's Hospital
Northern Entrance
15 Hospital Avenue
Nedlands WA 6009
Country 107964 0
Australia
Phone 107964 0
+61 08 6456 5882
Fax 107964 0
Email 107964 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 ethics approval for data sharing is not in place for this study.


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.