Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000443493
Ethics application status
Approved
Date submitted
24/08/2007
Date registered
31/08/2007
Date last updated
10/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Live, Eat and Play (LEAP2) project
Scientific title
Randomised controlled trial of a brief general practitioner (GP) intervention to reduce overweight in Victorian primary school children
Secondary ID [1] 463 0
ISRCTN 52511065
Universal Trial Number (UTN)
Trial acronym
LEAP2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight
Obesity 2293 0
Condition category
Condition code
Public Health 2389 2389 0 0
Health service research
Public Health 2390 2390 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief solution-focussed approach to reducing overweight in 5-9 year olds delivered by GPs. GPs were trained in family healthy lifestyle counselling and families were provided with a set of purpose-designed family materials. The participants were 258 families with children aged 5-9 at entry who were found to be overweight/mildly obese in a height and weight survey conducted in general practice. Families randomised to the ‘intervention’ group receive four GP consultations over a three month period to discuss healthy lifestyle changes. The families randomised to the ‘usual care’ group do not receive these consultations. Both groups are followed up by the research team six and twelve months after joining the project. They complete study questionnaires, are reweighed and measured, and record 7 full days of physical activity by accelerometry. Both groups were followed up again 3-4 years after joining the project, and again completed these measures.
Intervention code [1] 2007 0
Behaviour
Comparator / control treatment
No treatment/usual care
Control group
Active

Outcomes
Primary outcome [1] 3290 0
Body mass index (BMI) at 6 and 12 months, adjusted for baseline BMI
Timepoint [1] 3290 0
At baseline, 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [1] 5470 0
Measured child waist circumference
Timepoint [1] 5470 0
At 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [2] 5471 0
Parent-reported child nutrition
Timepoint [2] 5471 0
At baseline, 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [3] 5472 0
Parent-reported child physical activity
Timepoint [3] 5472 0
At baseline, 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [4] 5473 0
Parent-reported functional health status
Timepoint [4] 5473 0
At baseline, 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [5] 5474 0
Child-reported functional health status
Timepoint [5] 5474 0
At 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [6] 5475 0
Child-reported body satisfaction and appearance/self-worth
Timepoint [6] 5475 0
At 6 months, 12 months and 3-4 years after randomisation.
Secondary outcome [7] 5476 0
Accelerometry
Timepoint [7] 5476 0
At 6 months, 12 months and 3-4 years after randomisation.

Eligibility
Key inclusion criteria
Children are aged between 5 and 9 years at baseline and are either overweight or mildly obese at the initial measuring session (International Obesity TaskForce (IOTF) cut-off points, Cole et al, 2000). Informed parental consent is required.
Minimum age
5 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded if they a) are in the ‘very obese’ weight category (BMI z-score >=3.0), b) have any chromosomal, endocrine or medical condition/disability/medication which, in the judgement of the investigators, could impact on their weight or growth, or c) are currently receiving ongoing weight management in a secondary or tertiary care program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Families were allocated by a staff member not otherwise involved in the project. Researchers conducting follow up visits remained blinded throughout data collection. Intervention status was recorded in a password-protected database concealed to all staff involved in follow up
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-generated computerised sequence, created by a third–party biostatistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2548 0
Government body
Name [1] 2548 0
National Health & Medical Research Council (NHMRC)
Country [1] 2548 0
Australia
Primary sponsor type
Other
Name
Centre for Community Child Health at the Murdoch Childrens Research Institute, Royal Children’s Hospital
Address
Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 2307 0
Individual
Name [1] 2307 0
Associate Professor Melissa Wake
Address [1] 2307 0
Centre for Community Child Health,
The Royal Children's Hospital,
Flemington Road
Parkville Victoria 3052
Country [1] 2307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4474 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 4474 0
Ethics committee country [1] 4474 0
Australia
Date submitted for ethics approval [1] 4474 0
Approval date [1] 4474 0
23/03/2005
Ethics approval number [1] 4474 0
25006 A

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

Contacts
Principal investigator
Name 28003 0
Address 28003 0
Country 28003 0
Phone 28003 0
Fax 28003 0
Email 28003 0
Contact person for public queries
Name 11160 0
Ms Bibi Gerner
Address 11160 0
Centre for Community Child Health
The Royal Children’s Hospital
Flemington Road
Parkville Victoria 3052
Country 11160 0
Australia
Phone 11160 0
+61 3 9345 7025
Fax 11160 0
+61 3 9345 5900
Email 11160 0
bibi.gerner@mcri.edu.au
Contact person for scientific queries
Name 2088 0
Associate Professor Melissa Wake
Address 2088 0
Centre for Community Child Health
The Royal Children’s Hospital
Flemington Road
Parkville Victoria 3052
Country 2088 0
Australia
Phone 2088 0
+61 3 9345 5937
Fax 2088 0
+61 3 9345 5900
Email 2088 0
melissa.wake@mcri.edu.au

No information has been provided regarding IPD availability


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.