Randomised controlled trial of a brief GP intervention to reduce overweight in Victorian primary school children - Live, Eat and Play (LEAP 2)
- Conditions
- Overweight and mild obesityNutritional, Metabolic, EndocrineObesity
- Registration Number
- ISRCTN52511065
- Lead Sponsor
- Murdoch Children's Research Institute (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 420
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Added as of 16/08/2007: <br>BMI at 6 and 12 months, adjusted for baseline BMI.
- Secondary Outcome Measures
Name Time Method Added as of 16/08/2007: <br>1. Accelerometry<br>2. Measured child waist circumference<br>3. Parent-reported child nutrition<br>4. Parent-reported physical activity<br>5. Parent-reported child functional health status (the Pediatric Quality of Life Inventory™ [PedsQL™])<br>6. Child-reported functional health status (PedsQL™)<br>7. Child-reported body satisfaction<br>8. Child-reported appearance/self-worth