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
Scientific
Centre for Community Child Health
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
| Phone | +61 (0)3 9345 5937 |
|---|---|
| melissa.wake@rch.org.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | Added as of 16/08/2007: 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
3052
Australia
Sponsor information
Murdoch Children's Research Institute (Australia)
Research council
Research council
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
| Phone | +61 (0)3 8341 6200 |
|---|---|
| mcri@mcri.edu.au | |
"ROR" |
https://ror.org/048fyec77 |
Funders
Funder type
Research council
National Health and Medical Research Council (NHMRC) (Australia) (ref: 334309)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
