The Ethics of Childhood Obesity Treatment - from the Childhood Obesity Task Force (COTF) of European Association for the Study of Obesity (EASO)

Abstract

With the American Medical Association's recent declaration that obesity is a serious disease [1], a critical consideration of the ethics of treating childhood obesity is especially timely. Although data suggest that the childhood obesity epidemic has stabilized in some countries [2], the levels remain too high; 18-49% of European children are overweight [3]. Consequently there is an immense and urgent need for the effective treatment of this complex disease. Unfortunately, the most recent Cochrane review concludes that, although family-based interventions can reduce excess weight in children and adolescents, long-term, effective and sustainable interventions for childhood obesity have yet to be identified [4]. Childhood obesity is a complex disease caused by a multitude of factors and it is associated with a wide range of co-morbidities. This complexity makes it challenging to design interventions and test the treatment approaches - particularly with regard to which outcome(s) should be used as the criteria for success. Most childhood obesity treatments occur in healthcare settings. As such, the randomized controlled trial (RCT), which is the ‘gold standard' of the medical/clinical research tradition, has been used to evaluate whether a given obesity treatment protocol is safe and effective. It is questionable however, if the RCT is the optimal study design to address this complex issue.Researchers investigating childhood obesity treatments face difficulties in deciding which outcomes best reflect the impact of treatment and, if a RCT is conducted, what type of treatment should it be randomized against. In light of the widespread childhood obesity epidemic, this paper will explore the ethical implications of these issues. Pediatric obesity research is conducted in a vulnerable group of patients and families. Many children who are obese suffer from significant psychological problems including anxiety, depression, attention-deficit hyperactivity as well as emotional and eating disorders [5,6]. Added to this, obesity carries a social stigma that adversely affects children as well as their families. There has been - and still is - considerable debate as to who bears the responsibility for the development of excess weight in the child and who bears the responsibility for alleviating the condition at the individual and the societal levels [7,8]. In recognition of these issues, there are discussions surrounding the ethics of community-based approaches of treating childhood obesity [9] and about mechanistic clinical studies aimed at understanding the pathophysiology of morbid obesity in children without a direct aim of reducing weight or the degree of obesity [10]. Less attention, however, has been given to the ethics of studying the individual treatment of the condition.The vast majority of childhood obesity therapy research is conducted at hospitals and their associated clinics or at universities. In this framework, treatment protocols are examined and approved by ethical review committees; thus it can be assumed that the basic premises of these studies are ethically acceptable. Nonetheless, investigators are obliged to ensure that their research fulfils the four basic principles of ethical research: respect for autonomy, beneficence, non-maleficence, and justice [11]. In the context of childhood obesity research, this can be challenging. Children who are obese and their families are often desperate for treatment because existing programs can have long waiting lists or be out of reach due to cost, time, and transportation factors.Given these circumstances, investigators must carefully consider if their protocol provides a situation in which they can scientifically test their hypotheses and balance this with creating a situation in which children and families freely make the choice to enter the study (autonomy), that the child receives a net benefit through participation in a timely manner (beneficence and non-maleficence), and that the exclusion criteria for participation are reasonable (justice). With these principles in mind, it becomes apparent that the development of treatment protocols must recognize the need for effective treatment along with consideration for the well-being of the child and his or her parent(s). The majority of childhood obesity treatments use the reduction of weight, BMI (kg/m2), waist circumference, and/or body composition as the primary outcome. These studies usually evaluate the change over a period of a few months to a maximum of a couple of years. Although weight loss or stabilization represents a reasonable target, it may be overly simplistic since childhood obesity is a complex phenotype that is associated with multiple concurrent co-morbidities. Clinical studies suggest that almost 50% of children who are obese exhibit pre- or grade 1 or 2 hypertension [12,13], another 29% have dyslipidemia [14], 44% have more than 5% fat in their livers [15], and 74% exhibit more than 5% fat in t