Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001214325
Ethics application status
Approved
Date submitted
10/08/2017
Date registered
21/08/2017
Date last updated
27/09/2019
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of lifestyle patterns in children with/without Attention Deficit Hyperactivity Disorder
Scientific title
A comparison of lifestyle patterns in children with/without Attention Deficit Hyperactivity Disorder
Secondary ID [1] 292592 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 304265 0
Condition category
Condition code
Mental Health 303615 303615 0 0
Other mental health disorders
Mental Health 303616 303616 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Once the participants (parents/caregivers) sign the consent form, a series of questionnaires that investigate their demographic data: gender, date of birth, height, weight, past medical history, taking medication daily or not to all children. Their caregiver will also be given a questionnaire to retrieve their relationship status, age, education level, annual income, and pressure scale. Children with ADHD will be diagnosed within DSM-V or previous version by experienced paediatric psychiatrists in Australia. On-line survey link will be given to parents/caregivers of children to report lifestyle pattern which will consist: children diet quality with food frequency questionnaire; levels of physical activity in weekly with Children's Leisure Activities Study Survey-Parent Questionnaire (CLASS); sleep quality that will complete by their caregivers with Children’s Sleep Habits Questionnaire, CSHQ; children self-reported weekly screening time (smart phone, tablets, laptop, television, e-Reader) and how much they will spend on these devices before one-hour bedtime. And children with ADHD will use Child Behaviour Checklist to assess the disease severity in children with ADHD.
Intervention code [1] 298855 0
Not applicable
Comparator / control treatment
Parents/Caregivers of typically developing children in 8-12 years old will as the comparison group
Control group
Active

Outcomes
Primary outcome [1] 303044 0
Child Behavior Checklist 6-18, CBCL 6/18. Assessing follow behaviour problems in children:
Aggressive Behavior
Anxious/Depressed
Attention Problems
Rule-Breaking Behavior
Somatic Complaints
Social Problems
Thought Problems
Withdrawn/Depressed.
Timepoint [1] 303044 0
completion the questionnaire
Secondary outcome [1] 337761 0
We use Food Frequency Questionnaire (EPIC-Norfolk) then calculates for diet quality index-international precisely.
Timepoint [1] 337761 0
completion the questionnaire
Secondary outcome [2] 337762 0
Level of weekly physical activity with Children's Leisure Activities Study Survey-Parent Questionnaire, CLASS (Telford, 2004)
Timepoint [2] 337762 0
completion the questionnaire
Secondary outcome [3] 337763 0
Sleep quality with Children’s Sleep Habits Questionnaire
Timepoint [3] 337763 0
completion the questionnaire
Secondary outcome [4] 337764 0
Screen time of past week (self-report with type of devices, days)
Timepoint [4] 337764 0
completion the questionnaire
Secondary outcome [5] 337765 0
Parental Stress with Kessler Psychological Distress Scale 10-item
Timepoint [5] 337765 0
completion the questionnaire
Secondary outcome [6] 337766 0
Height and weight of children
Timepoint [6] 337766 0
completion the questionnaire
Secondary outcome [7] 337767 0
Caregivers educational level by using a questionnaire specifically designed for this study
Timepoint [7] 337767 0
completion the questionnaire
Secondary outcome [8] 337814 0
Screen time one-hour before bedtime (self-report with type of devices, days in past week)
Timepoint [8] 337814 0
completion of questionnaire
Secondary outcome [9] 337815 0
Annual income of caregivers by using a questionnaire specifically designed for this study
Timepoint [9] 337815 0
completion the questionnaire

Eligibility
Key inclusion criteria
1. Parents/caregivers of children 8-12 years old
2. Children with ADHD will have had a diagnosis of ADHD made by a health professional by parents/caregivers reported.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children with a current history of intellectual disability which means their intelligence quotient belows 70, that will cause significantly differences in their behaviours. This will be determined by self-report with the screening question at the beginning of online survey: "Has your child been formally diagnosed by a mental health practitioner (e.g., psychologist or psychiatrist) as having an intellectual disability?"
2. Children with a past history of seizure which will cause significantly differences in their behaviours. This will be determined by self-report with the screening question at the beginning of online survey: "Has your child experienced the seizure in past year?"
This change is under full discussion.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
The Mann-Whitney U test will be used to compare the differences between children with ADHD and children without ADHD on nonparametric variables (gender, levels of physical activity, and number of comorbidities, education level of caregivers, annual income of caregivers). ANOVA will be used to examine lifestyle patterns (dietary, physical activity, sleep quality, screening time), demographic (height, weight, age) differences in children with ADHD and typically developing children. ANOVA will also be used to compare intercultural differences in parametric outcome variables as lifestyle patterns (dietary, physical activity, sleep quality, screening time), demographic (height, weight, age). Structural equation modelling (SEM) or pathway analysis (PA) will be performed to determine the most significant factors among the lifestyle pattern investigations (dietary, levels of physical activity, screening time, sleep quality, education level of caregivers, annual income of caregivers, and pressure of caregivers) that could influence the disease severity and discover interactions between lifestyle pattern in children with ADHD.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2018
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
1/07/2019
Date of last data collection
Anticipated
Actual
1/07/2019
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21033 0
New Zealand
State/province [1] 21033 0
All states
Country [2] 21034 0
United States of America
State/province [2] 21034 0
All states
Country [3] 21035 0
Canada
State/province [3] 21035 0
All states
Country [4] 21036 0
United Kingdom
State/province [4] 21036 0
All states

Funding & Sponsors
Funding source category [1] 297171 0
University
Name [1] 297171 0
RMIT University
Country [1] 297171 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Rd, Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 296232 0
None
Name [1] 296232 0
N/A
Address [1] 296232 0
N/A
Country [1] 296232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298339 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 298339 0
Ethics committee country [1] 298339 0
Australia
Date submitted for ethics approval [1] 298339 0
23/08/2017
Approval date [1] 298339 0
09/05/2018
Ethics approval number [1] 298339 0

Summary
Brief summary
Background and purpose: Attention deficit hyperactivity disorder (ADHD), a neurodevelopmental disorder, which has relatively high prevalence and incidence of comorbidity among children. Medication is usually the first-line treatment for ADHD; however, the adverse effects of medication may cause other medical issues. Healthy lifestyle pattern (diet, physical activities, reducing screening time) may ameliorate disease severity. To discover suitable interventions, comprehensive investigations of lifestyle patterns will be conducted in both western and eastern countries among primary school children with or without ADHD. The aims of present studies are: to compare the lifestyle patterns in children with ADHD and typically developing children, to determine cultural differences of children with ADHD in western and eastern countries, and to develop a suitable lifestyle modification program for children with ADHD.
Methods: The first phase of this study will investigate the lifestyle patterns in Australian and Taiwanese children with or without ADHD. All participants and their parents will be given a series of questionnaires to examine: dietary pattern, physical activity, sleep quality, screening time, demographic data, disease severity, and pressure of their caregiver. These data will be using multiple regression methods to determine the best predictors of the symptoms of ADHD.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2750 2750 0 0
/AnzctrAttachments/373426-Investigation-21068 Di Benedetto - Notice of approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 76762 0
Dr Eunro Lee
Address 76762 0
School of Health and Biomedical Science, RMIT Bundoora West Campus, 201.03.14B, Plenty Rd, Bundoora, VIC, 3083
Country 76762 0
Australia
Phone 76762 0
+61 3 9925 7610
Fax 76762 0
Email 76762 0
[email protected]
Contact person for public queries
Name 76763 0
Mr Chao Chi Hong
Address 76763 0
PhD student in School of Health and Biomedical Science, RMIT Bundoora West Campus, Plenty Rd, Bundoora, VIC, 3083
Country 76763 0
Australia
Phone 76763 0
+61 3 9925 7612
Fax 76763 0
Email 76763 0
[email protected]
Contact person for scientific queries
Name 76764 0
Dr Eunro Lee
Address 76764 0
School of Health and Biomedical Science, RMIT Bundoora West Campus, 201,3,14B, Plenty Rd, Bundoora VIC 3083
Country 76764 0
Australia
Phone 76764 0
+61 3 9925 7610
Fax 76764 0
Email 76764 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
We will not to share any information with all the participants to publicly available since they are vulnerable, mental disorder patients. Highly confidential to their any information is necessary.


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.