Article type
Year
Abstract
Background: The validity of randomised controlled trials (RCTs) of treatment interventions in childhood obesity have been described as questionable (Summerbell 2003). Problems include small sample size, the measurement of short to medium term outcomes only using unreliable outcome measures, and inability to generalise to primary care or community settings. As a result, the Cochrane review of this topic was unable to draw any conclusions on the effectiveness of interventions. Prospective meta-analysis (PMA) may make it possible to overcome some of the inherent difficulties in conducting RCTs in this area.
Objectives:
1. To obtain valid answers to important questions in childhood overweight and obesity by creating a register of trials, and an associated register of prospective meta-analyses, of treatment interventions for the management of childhood obesity.
2. To improve trial quality through measures such as standardisation of data format across trials. For example, outcome definition and measurement.
3. To facilitate collaboration.
Methods: To be eligible for inclusion in the register, trials will be randomised, involve children aged four to twelve years and/or one or more parents/guardians. Interventions should include a behavioural-based program plus the use of at least one standard method of weight management such as increased physical activity, decreased sedentary behaviour and dietary modification. A detailed protocol will need to be made available to register each trial. Trials may be planned or current (with results as yet unpublished) with follow-up of participants at least two years duration. Management and advisory committees with international representation will be established and will oversee the register. Expressions of interest for these committees are sought.
Conclusion: Currently three trials based in Australia are included, with an invitation to international researchers with eligible trials to enrol. Prospective meta-analysis methodology will allow the simultaneous collection of standardised international data on the various range of interventions for childhood weight management. This will hopefully lead to an improvement in the quality and comparability of clinical trials research in an area which has become a significant public health problem across the globe.
Objectives:
1. To obtain valid answers to important questions in childhood overweight and obesity by creating a register of trials, and an associated register of prospective meta-analyses, of treatment interventions for the management of childhood obesity.
2. To improve trial quality through measures such as standardisation of data format across trials. For example, outcome definition and measurement.
3. To facilitate collaboration.
Methods: To be eligible for inclusion in the register, trials will be randomised, involve children aged four to twelve years and/or one or more parents/guardians. Interventions should include a behavioural-based program plus the use of at least one standard method of weight management such as increased physical activity, decreased sedentary behaviour and dietary modification. A detailed protocol will need to be made available to register each trial. Trials may be planned or current (with results as yet unpublished) with follow-up of participants at least two years duration. Management and advisory committees with international representation will be established and will oversee the register. Expressions of interest for these committees are sought.
Conclusion: Currently three trials based in Australia are included, with an invitation to international researchers with eligible trials to enrol. Prospective meta-analysis methodology will allow the simultaneous collection of standardised international data on the various range of interventions for childhood weight management. This will hopefully lead to an improvement in the quality and comparability of clinical trials research in an area which has become a significant public health problem across the globe.