Randomised controlled trial of a brief GP intervention to reduce overweight in Victorian primary school children - Live, Eat and Play (LEAP 2)

ISRCTN ISRCTN52511065
DOI https://doi.org/10.1186/ISRCTN52511065
Secondary identifying numbers 334309; ACTRN12607000443493
Submission date
06/05/2005
Registration date
16/09/2005
Last edited
10/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melissa Wake
Scientific

Centre for Community Child Health
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Phone +61 (0)3 9345 5937
Email melissa.wake@rch.org.au

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study acronymLEAP 2
Study objectivesAdded 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(s)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)
Health condition(s) or problem(s) studiedOverweight and mild obesity
InterventionFour 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 typeOther
Primary outcome measureAdded as of 16/08/2007:
BMI at 6 and 12 months, adjusted for baseline BMI.
Secondary outcome measuresAdded 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 study start date01/07/2005
Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit5 Years
Upper age limit9 Years
SexBoth
Target number of participantsAdded as of 16/08/2007: 420
Key inclusion criteriaHealthy 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.
Key exclusion criteriaAdded 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
Date of first enrolment01/07/2005
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • Australia

Study participating centre

Centre for Community Child Health
Parkville
3052
Australia

Sponsor information

Murdoch Children's Research Institute (Australia)
Research council

Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Phone +61 (0)3 8341 6200
Email mcri@mcri.edu.au
ROR logo "ROR" https://ror.org/048fyec77

Funders

Funder type

Research council

National Health and Medical Research Council (NHMRC) (Australia) (ref: 334309)
Government organisation / National government
Alternative name(s)
NHMRC
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 03/09/2009 Yes No