The LEAP Trial was a randomized control trial conducted during 2002–2003 in 29 family medical practices in Melbourne, Australia. Detailed methods and processes of the randomized controlled trial are reported elsewhere. (McCallum Z, Wake M, Gerner B, et al. LEAP (Live, Eat and Play): can Australian general practitioners tackle childhood overweight/obesity? — Methods and processes from the LEAP (Live, Eat and Play) randomised controlled trial (J Paediatr Child Health. 2005; 41:488–494).
This study revealed that the randomized control trials provide effective results with enough options to widen your research. Live, Eat and Play (LEAP) was a randomized controlled trial of a brief secondary prevention intervention delivered by family physicians in 2002–2003. The trial targeted overweight and mildly obese children aged 5 to 9 years. Primary care utilization was prospectively audited via medical records, and parents reported family resource use by written questionnaire.
Outcome measures were BMI (primary) and parent-reported physical activity and dietary habits (secondary) in intervention compared with control children. This research kept both the children and their parents active simultaneously. The study shows how important it is to have the involvement of the parents while addressing such complex issues. The objective of the research was to evaluate the resource use that would be required to repeat the intervention. For this reason, the costs of the initial development of the LEAP intervention, training materials, and all research costs were excluded.
Relevant resource use included both investment of health care resources (such as GP visits) and family resources (such as additional time and money required to meet changed dietary and physical activity practices). Resource use and costs of the LEAP intervention were derived from 3 main sources: the LEAP team records, practice audit, and parent written questionnaires at 9 months. An important aspect of this research is the analysis of the monetary assistance required for such programs.
Evaluation of financial implications must be a part of intervention strategies. When the financial issues are linked to the interventions of the obesity prevention method, the process becomes more self-sufficient as it will give the organizations, institutions or individuals adequate information as to which program to invest in. Pecuniary repercussions are always a matter of extreme importance as the success or failure of a research programme and that of the intervention process largely depend on this aspect.
For example in the 9th month questionnaire of this LEAP trial, parents were reported time and travel costs to LEAP. Later they included the expenses incurred due to the grocery shopping and other sports merchandise shopping for their children and these all monetary issues were meticulously processed and documented by the LEAP team. The end results of this trial are satisfactory and the method can be applied if there is a large scale involvement of government institutions, or private organizations.
The team also found that the higher the involvement of the parents the greater the chance of intervention. Direct association of parents has long lasting positive impacts especially when the parents take time off to ensure that their children are physically active. Even better, the parents will be advised and inspired to set an example by indulging themselves in the physical activities; this could include fixing a day in a week for outdoor plays, another day for swimming or any other physical activity demanding tasks.
On the flip side, this brief intervention resulted in higher costs to families and the health care sector as well. This could have been devoted to other uses that do create benefits to health and/or family well-being. This has implications for countries such as the United States, the United Kingdom, and Australia, whose current guidelines recommend routine surveillance and counselling for high child BMI in the primary care sector.