Contact information
Type
Scientific
Primary contact
Dr Melissa Wake
ORCID ID
Contact details
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AHMAC PDR 2001/15
Study information
Scientific title
Randomised controlled trial of a brief GP intervention to reduce overweight in Victorian primary school children (LEAP)
Acronym
LEAP
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Overweight and mild obesity
Intervention
Arm A: Four consultations with the family doctor, employing a brief family-centred, solution-focussed approach aiming to increase physical activity and reduce fat and sugar intake.
Arm B: Standard identification and care.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy children aged 5.0-9.11 years who are overweight or mildly obese (International Obesity Task Force [IOTF] cutpoints; children with UK Body Mass Index [BMI] z-score ≥3.0 excluded).
Sample drawn from BMI survey of all chidren aged 5.0-9.11 years attending their family doctor in 29 participating practices May-Dec 2002.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Total final enrolment
2112
Participant exclusion criteria
children with UK Body Mass Index [BMI] z-score ≥3.0 excluded
Recruitment start date
01/07/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Community Child Health
Melbourne
3052
Australia
Sponsor information
Organisation
Murdoch Children's Research Institute (Australia)
Sponsor details
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 8341 6200
mcri@mcri.edu.au
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
AHMAC (Australian Health Ministers' Advisory Council) Priority Driven Research Grant 2001/15
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2005 results in: https://www.ncbi.nlm.nih.gov/pubmed/16150065 (added 09/05/2019)
2. 2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17160087 (added 09/05/2019)