Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000101482
Ethics application status
Approved
Date submitted
12/01/2016
Date registered
1/02/2016
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Expansion, evaluation and sustainability of a new paediatric weight management service
Scientific title
Expansion, evaluation and sustainability of a new paediatric multidisciplinary weight management service for children and adolescents who are overweight or obese.
Secondary ID [1] 288293 0
None
Universal Trial Number (UTN)
U1111-1178-3418
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 297254 0
Condition category
Condition code
Diet and Nutrition 297457 297457 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention or service is part of routine clinical care for all participants. It is an intensive clinical weight management program in a real-life setting. The child/adolescent and parent/carer attends the clinic for 5 appointments, over an individualised time frame. During this time, for children/adolescents classified as obese, they have access to consultations with a dietitian, psychologist and paediatrician, the combination of which is determined as clinically indicated. For children/adolescents classified as overweight, the same applies, however no paediatrician consultations are included due to a lack of medical co-morbidities and low medical risk for this group of children/adolescents. All consultations are one-on-one sessions with the clinician, child/adolescent and their parent/carer, and run for approximately 1 hour. The paediatrician consultations cover a comprehensive medical evaluation, the dietitian will give guidance and advice on dietary modifications, promotion of an active lifestyle and nutrition counselling, and the psychologist consultations will focus on behaviour modification strategies and supportive parental involvement. The observation period for all children/adolescents involved in the research project is 24 months following baselines assessment.
Intervention code [1] 293648 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297019 0
BMI z-score. BMI or 'body mass index' is calculated from measures of weight (using digital scales) and height (using a stadiometer) by the equation: BMI = weight / height2. It is then transformed into a z-score using the CDC data files.
Timepoint [1] 297019 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [1] 319858 0
Weight (in kg) using digital scales
Timepoint [1] 319858 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [2] 319859 0
Height (in cm) using a stadiometer
Timepoint [2] 319859 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [3] 319860 0
BMI or 'body mass index' is calculated from measures of weight (using digital scales) and height (using a stadiometer) by the equation: BMI = weight / height2.
Timepoint [3] 319860 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [4] 319861 0
Fat mass and fat free mass - assessed via Bod Pod (Registered Trademark) (air displacement plethysmography) or bioelectrical impendance analysis.
Timepoint [4] 319861 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [5] 319862 0
Body cell mass - assessed via total body potassium measurement
Timepoint [5] 319862 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [6] 319863 0
Resting metabolic rate - assessed via the MedGem (Registered Trademark) indirect calorimeter
Timepoint [6] 319863 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [7] 319864 0
Nutritional Intake - assessed via a dietary screening tool designed to assess diet quality, dietary behaviours, habits and meal patterns (called the E-KINDEX: A dietary screening tool to assess children's obesogenic habits). It is a questionnaire completed by children/adolescents or parents/carers depending on the child's age.
Timepoint [7] 319864 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [8] 319865 0
Physical activity - assessed via a physical activity questionnaire completed by children/adolescents or parents/carers depending on the child's age. Also assessed via an Actigraph (accelerometer) for a sub-set of participants (those aged between 6 and 8 years).
Timepoint [8] 319865 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [9] 319866 0
Health-related quality of life - assessed via a validated questionnaire measurement tool, the PedsQL (Trademark)
Timepoint [9] 319866 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [10] 319867 0
Patient satisfaction - assessed via semi-structured interviews with randomly selected participants and their parent/guardian.
Timepoint [10] 319867 0
At the end of the intensive clinic.
Secondary outcome [11] 320316 0
Mid-Upper arm circumference (cm) assessed using a flexible, non-stretch tape measure.
Timepoint [11] 320316 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [12] 320317 0
Waist circumference (cm) measured using a flexible, non-stretch tape measure.
Timepoint [12] 320317 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.
Secondary outcome [13] 331526 0
Hand grip strength - measured using a dynamometer.
Timepoint [13] 331526 0
At the end of the intensive clinic and then 6 months, 12 months and 24 months post clinic discharge.

Eligibility
Key inclusion criteria
To be involved in the study, children and adolescents must meet the following criteria:
* Be referred to the weight management service by a paediatrician, general practitioner or member of the education department
* Be less than 2 years of age, above the 97th%ile on the WHO growth charts and gaining weight rapidly, or less than 2 years of age and assessed by a paediatrician or general practitioner to have weight concerns OR
* Be 2-18 years of age with a BMI equal to or greater than the 85th%ile on the US-CDC charts or greater than or equal to the 85th%ile on the WHO charts.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children or adolescents will be excluded from the project if a parent/guardian is unable or not willing to attend clinic appointments.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2016
Actual
1/06/2016
Date of last participant enrolment
Anticipated
2/04/2018
Actual
15/06/2017
Date of last data collection
Anticipated
Actual
22/11/2018
Sample size
Target
150
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5026 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 12512 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292668 0
Hospital
Name [1] 292668 0
Children's Health Queensland Hospital and Health Service
Country [1] 292668 0
Australia
Primary sponsor type
Individual
Name
Jacqueline Walker
Address
Room 409, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 291390 0
None
Name [1] 291390 0
Address [1] 291390 0
Country [1] 291390 0
Other collaborator category [1] 278768 0
Individual
Name [1] 278768 0
Professor Sandra Capra
Address [1] 278768 0
Room 534, Level 5, School of Human Movement Studies Building (26B, School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, QLD 4072
Country [1] 278768 0
Australia
Other collaborator category [2] 278769 0
Individual
Name [2] 278769 0
Dr Robyn Littlewood
Address [2] 278769 0
Director of Dietetics and Food Services
Children’s Health Queensland Hospital and Health Service
Level 7a, Clinical Directorate
Lady Cilento Children’s Hospital
501 Stanley Street, South Brisbane Qld 4101
Country [2] 278769 0
Australia
Other collaborator category [3] 278770 0
Individual
Name [3] 278770 0
Professor Peter Davies
Address [3] 278770 0
Children's Nutrition Research Centre
Centre for Children's Health Research
Graham St, South Brisbane, Qld, 4101 Australia
Country [3] 278770 0
Australia
Other collaborator category [4] 278796 0
Individual
Name [4] 278796 0
Dr Anne Kynaston
Address [4] 278796 0
Senior Staff Specialist
General Paediatric and Dermatology Department
Level 12, Medical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country [4] 278796 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294140 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 294140 0
Ethics committee country [1] 294140 0
Australia
Date submitted for ethics approval [1] 294140 0
29/02/2016
Approval date [1] 294140 0
18/04/2016
Ethics approval number [1] 294140 0
2016-01-015
Ethics committee name [2] 294141 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [2] 294141 0
Ethics committee country [2] 294141 0
Australia
Date submitted for ethics approval [2] 294141 0
24/02/2016
Approval date [2] 294141 0
03/05/2016
Ethics approval number [2] 294141 0
HREC/16/QRCH/112

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

Contacts
Principal investigator
Name 62666 0
Dr Jacqueline Walker
Address 62666 0
Room 409, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 62666 0
Australia
Phone 62666 0
+61 7 33656116
Fax 62666 0
+61 7 33656877
Email 62666 0
[email protected]
Contact person for public queries
Name 62667 0
Jacqueline Walker
Address 62667 0
Room 409, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 62667 0
Australia
Phone 62667 0
+61 7 33656116
Fax 62667 0
+61 7 33656877
Email 62667 0
[email protected]
Contact person for scientific queries
Name 62668 0
Jacqueline Walker
Address 62668 0
Room 409, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 62668 0
Australia
Phone 62668 0
+61 7 33656116
Fax 62668 0
+61 7 33656877
Email 62668 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
Participants did not give consent for de-identified data to be available to other parties.


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
Dimensions AIThe Need for Early Referral: Characteristics of Children and Adolescents Who Are Overweight and Obese Attending a Multidisciplinary Weight Management Service2017https://doi.org/10.3390/children4110093
N.B. These documents automatically identified may not have been verified by the study sponsor.