|
ISRCTN
|
ISRCTN52511065
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Randomised controlled trial of a brief GP intervention to reduce overweight in Victorian primary school children - Live, Eat and Play (LEAP 2)
|
|
Scientific title
|
|
|
Acronym
|
LEAP 2
|
|
Serial number at source
|
334309; ACTRN12607000443493
|
|
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
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
Australia
|
|
Disease/condition/study domain
|
Overweight and mild obesity
|
|
Participants - 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.
|
|
Participants - 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
|
|
Anticipated start date
|
01/07/2005
|
|
Anticipated end date
|
30/09/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Added as of 16/08/2007: 420
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Added as of 16/08/2007:
BMI at 6 and 12 months, adjusted for baseline BMI.
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
National Health and Medical Research Council (NHMRC) (Australia) (ref: 334309)
|
|
Trial website
|
|
|
Publications
|
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19729418
|
|
Contact name
|
Dr
Melissa
Wake
|
|
Address
|
Centre for Community Child Health
Royal Children's Hospital
Flemington Rd
|
|
City/town
|
Parkville
|
|
Zip/Postcode
|
3052
|
|
Country
|
Australia
|
|
Tel
|
+61 (0)3 9345 5937
|
|
Fax
|
+61 (0)3 9345 5900
|
|
Email
|
melissa.wake@rch.org.au
|
|
Sponsor
|
Murdoch Children's Research Institute (Australia)
|
|
Address
|
Royal Children's Hospital
Flemington Rd
|
|
City/town
|
Parkville
|
|
Zip/Postcode
|
3052
|
|
Country
|
Australia
|
|
Tel
|
+61 (0)3 8341 6200
|
|
Fax
|
+61 (0)3 9348 1391
|
|
Email
|
mcri@mcri.edu.au
|
|
Date applied
|
06/05/2005
|
|
Last edited
|
10/09/2009
|
|
Date ISRCTN assigned
|
16/09/2005
|
