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
Protocol serial number	334309; ACTRN12607000443493
Sponsor	Murdoch Children's Research Institute (Australia)
Funder	National Health and Medical Research Council (NHMRC) (Australia) (ref: 334309)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LEAP 2
Study objectives	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(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) studied	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
Primary outcome measure(s)	Added as of 16/08/2007: BMI at 6 and 12 months, adjusted for baseline BMI.
Key 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
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	9 Years
Sex	All
Target sample size at registration	420
Key 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.
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

Australia

Study participating centre

Centre for Community Child Health

Parkville
3052
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

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