Taffy Makaya, Rebecca Poole and Kavitha Rozario
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weight management interventions. This has been widely used and has been
considered a mandatory requirement by some commissioners.
The aim is to improve the evaluation of both physical activity and dietary
interventions, through the development of two specific SEFs that could be
used to help evaluators collect standardised data to allow comparison between
similar programmes. The SEFs for diet and physical activity were developed
in conjunction with leading academics and public health practitioners, to
ensure that the document was evidence-based and suitable for practical
application by public health practitioners.
MEDICAL MANAGEMENT
Introduction
Where conservative measures such as lifestyle changes and weight loss
programmes have failed, clinicians can consider drug therapy. However,
choices of drug therapy for paediatric obesity are considerably limited, and
drugs may have significant side effects. This section will cover indications for
medical management of obesity, current drug therapy options, advantages and
limitations of specific medications, and possible future avenues for
development.
The Food and Drug Administration (FDA) published obesity drug
guidance in 2007 [42] which outlined requirements for clinically significant
results of obesity medications. For a drug’s result to be clinically significant,
the difference in mean weight loss between active-treated and placebo-treated
groups needs to be at least 5%, or the proportion of subjects who lose at least
5% baseline body weight in the active-treated group needs to be at least 35%
and approximately double the proportion who lost at least 5% in the placebo-
treated group. The FDA also states that the drug should show an improvement
in metabolic biomarkers, for example, blood pressure and lipids.
The 2007 Draft Obesity Guidance also made several recommendations
regarding obesity drug therapy for children and adolescents specifically [42].
Before being investigated in the paediatric population, all obesity medications
must first be studied in adults. Initial studies of a drug’s pharmacokinetics in
paediatric subjects should also be considered prior to full trials, enabling
correct drug doses to be established. Ideally trials should be randomized
controlled double-blinded trials, of one-year duration. Before trials in children