Randomised controlled trial of a brief GP intervention to reduce overweight in Victorian primary school children (LEAP)
| ISRCTN | ISRCTN45068927 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45068927 |
| Protocol serial number | AHMAC PDR 2001/15 |
| Sponsor | Murdoch Children's Research Institute (Australia) |
| Funder | AHMAC (Australian Health Ministers' Advisory Council) Priority Driven Research Grant 2001/15 |
- Submission date
- 09/01/2004
- Registration date
- 26/04/2004
- Last edited
- 09/05/2019
- 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 Road
Parkville
Melbourne
3052
Australia
| Phone | +61 (0)3 9345 5761 |
|---|---|
| melissa.wake@rch.org.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial of a brief GP intervention to reduce overweight in Victorian primary school children (LEAP) |
| Study acronym | LEAP |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 9 Years |
| Sex | Not Specified |
| Total final enrolment | 2112 |
| Key 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. |
| Key exclusion criteria | children with UK Body Mass Index [BMI] z-score ≥3.0 excluded |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
Centre for Community Child Health
Melbourne
3052
Australia
3052
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2005 | 09/05/2019 | Yes | No |
| Results article | results | 01/04/2007 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
