Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/05/2005
Date assigned
16/09/2005
Last edited
10/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes