Obesity clinical trials in youth: concepts and challenges.

The impact of obesity related morbidity is receiving increased attention in the pediatric population with the emergence of type 2 diabetes mellitus, as well as an increase in the prevalence of hypertension.1 The Centers for Disease Control and Prevention released preliminary data from the 1999 National Health and Nutrition Examination Survey, indicating a rise in the prevalence of overweight children (body mass index 95th percentile), from 11% to 13– 14%.2 Despite recognizing this as a major health issue, little success has been made to arrest the trend. Research in the area of obesity is broad and multi-factorial, encompassing genetic, biological, social, and behavioral components in an attempt to delineate the determinants for the development of obesity. Several clinical trials on obesity in children examine interventions for either obesity prevention or treatment. This paper will summarize the essential components of the studies pertaining to youth and obesity prevention and treatment, as well as give direction to future areas of research.