Contact information
Type
Scientific
Primary contact
Dr Melissa Wake
ORCID ID
Contact details
Centre for Community Child Health
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
+61 (0)3 9345 5937
melissa.wake@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
334309; ACTRN12607000443493
Study information
Scientific title
Acronym
LEAP 2
Study hypothesis
Added as of 16/08/2007:
1. A brief parent-focused behavioural intervention delivered by General Practitioners (GPs) to overweight/obese 5 - 9 year olds will halve the body mass index (BMI) gain (the primary outcome) at 6 and 12 months in the intervention group relative to the non-intervention group
2. A brief parent-focused behavioural intervention delivered by GPs will lead to a range of secondary outcomes at 6 and 12 months for children and their families in the intervention compared to the non-intervention group, including:
2.1. Smaller measured child waist circumference
2.2. Greater measured child physical activity
2.3. Parent-reported increases in child physical activity, reductions in sedentary activity, changes in child eating patterns
3. The intervention will be acceptable, feasible and cost-effective within Australian GP settings
Ethics approval
Added as of 16/08/2007:
Approved by the Royal Children's Hospital Ethics in Human Research Committee (EHRC) on 23rd March 2005 (ref: 25006 A)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Overweight and mild obesity
Intervention
Four consultations with the family doctor, employing a brief family-centred, solution-focused approach aiming to increase physical activity and reduce fat and sugar intake.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Added as of 16/08/2007:
BMI at 6 and 12 months, adjusted for baseline BMI.
Secondary outcome measures
Added as of 16/08/2007:
1. Accelerometry
2. Measured child waist circumference
3. Parent-reported child nutrition
4. Parent-reported physical activity
5. Parent-reported child functional health status (the Pediatric Quality of Life Inventory™ [PedsQL™])
6. Child-reported functional health status (PedsQL™)
7. Child-reported body satisfaction
8. Child-reported appearance/self-worth
Overall trial start date
01/07/2005
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy children aged 5.0 - 9.0 years inclusive who are overweight or mildly obese (International Obesity Task Force [IOTF] cutpoints; children with UK BMI z-score greater than or equal to 3.0 excluded). Sample drawn from BMI survey of all children aged 5.0 - 9.0 years attending their family doctor in 50 participating practices Jul 2005 - Feb 2006.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Added as of 16/08/2007: 420
Participant exclusion criteria
Added as of 16/08/2007:
1. Very obese children (UK BMI z-score more than or equal to 3.0)
2. Children who are currently receiving ongoing weight management in a secondary or tertiary care program
3. Children who have a known endocrine or chromosomal cause for their overweight
4. Children who have major disabilities or health conditions as judged by the investigators prior to randomisation
Recruitment start date
01/07/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Community Child Health
Parkville
3052
Australia
Sponsor information
Organisation
Murdoch Children's Research Institute (Australia)
Sponsor details
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
+61 (0)3 8341 6200
mcri@mcri.edu.au
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia) (ref: 334309)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19729418
Publication citations
-
Results
Wake M, Baur LA, Gerner B, Gibbons K, Gold L, Gunn J, Levickis P, McCallum Z, Naughton G, Sanci L, Ukoumunne OC, Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial., BMJ, 2009, 339, b3308.