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Anti-obesity medications (AOMs) have emerged as one element of comprehensive obesity clinical care intended to improve long-term health outcomes for children and adolescents. The number of pediatric AOM clinical trials has burgeoned in recent years as new pharmacotherapeutics have been developed. Factors related to growth and development in children and adolescents can present unique challenges in terms of designing and conducting clinical trials investigating the safety and efficacy of AOMs. These barriers can delay the AOM development and evaluation process, increase the cost of performing trials, create challenges in the interpretation of results, influence the generalizability of the findings and present ethical dilemmas. In an effort to address these issues and provide guidance to streamline the process of designing and conducting pediatric AOM clinical trials, relevant key stakeholders convened a series of roundtable meetings to discuss, debate and achieve harmonization on design features. Stakeholder participants included a multidisciplinary group of international pediatric obesity experts, patient (parent) representatives and representatives from academic medicine, key regulatory agencies and industry. Topics of discussion included primary efficacy end-points, secondary end-points, eligibility criteria, trial run-in and follow-up phases, use of active comparators and guidelines for down-titration and/or stopping rules for excessive weight reduction. Consensus recommendations were agreed upon. Regarding end-points, emphasis was placed on moving away from BMI z-score as a primary outcome, incorporating multiple alternative BMI-related outcomes and measuring adiposity/body fat as a prominent secondary end-point. Trial eligibility criteria were carefully considered to maximize generalizability while maintaining safety. The limited value of trial run-in phases was discussed. It was also underscored that designing trials with extended follow-up periods after AOM withdrawal should be avoided owing to ethical issues (including possible psychological harm) related to weight regain without providing the opportunity to access other treatments. The panel emphasized the value of the randomized, placebo-controlled trial but recommended the thoughtful consideration of the use of active comparators in addition to, or instead of, placebo to achieve clinical equipoise when appropriate. Finally, the panel recommended that clinical trial protocols should include clear guidance regarding AOM down-titration to avoid excessive weight reduction when applicable., (© 2024 The Author(s). Pediatric Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

Background: Given children's low levels of physical activity and high prevalence of obesity, there is an urgent need to identify innovative physical activity options., Objective: This study aims to test the effectiveness of exergaming (video gaming that involves physical activity) to reduce children's adiposity and improve cardiometabolic health., Methods: This randomized controlled trial assigned 46 children with overweight/obesity to a 24-week exergaming or control condition. Intervention participants were provided a gaming console with exergames, a gameplay curriculum (1 h per session, three times a week) and video chat sessions with a fitness coach (telehealth coaching). Control participants were provided the exergames following final clinic visit. The primary outcome was body mass index (BMI) z-score. Secondary outcomes were fat mass by dual energy X-ray absorptiometry and cardiometabolic health metrics., Results: Half of the participants were girls, and 57% were African-American. Intervention adherence was 94.4%, and children's ratings of acceptability and enjoyment were high. The intervention group significantly reduced BMI z-score excluding one control outlier (intervention [standard error] vs. control [standard error]: -0.06 [0.03] vs. 0.03 [0.03], p = 0.016) with a marginal difference in intent-to-treat analysis (-0.06 [0.03] vs. 0.02 [0.03], p = 0.065). Compared with control, the intervention group improved systolic blood pressure, diastolic blood pressure, total cholesterol, low-density lipoprotein-cholesterol and moderate-to-vigorous physical activity (all p values <0.05)., Conclusions: Exergaming at home elicited high adherence and improved children's BMI z-score, cardiometabolic health and physical activity levels. Exergaming with social support may be promoted as an exercise option for children., (© 2018 World Obesity Federation.)

Background: Structured exergaming with prescribed moderate intensity physical activity has reduced adiposity among adolescents. The extent to which adolescents reduce adiposity when allowed to self-select intensity level is not known., Objective: The objective of the study was to examine the influence of exergaming on adolescent girls' body composition and cardiovascular risk factors., Methods: This randomized controlled trial assigned 41 overweight and obese girls aged 14 to 18 years to group-based dance exergaming (36 h over 3 months) or to a self-directed care control condition. Body size and composition were measured by anthropometry, dual-energy X-ray absorptiometry [%fat and bone mineral density {BMD}] and magnetic resonance imaging. Cardiovascular risk factors included blood pressure, cholesterol, triglycerides, glucose and insulin., Results: Attrition was 5%. Using analysis of covariance controlling for baseline value, age and race, there were no significant condition differences. Per protocol (attended >75%), the intervention group significantly decreased abdominal subcutaneous adiposity and increased trunk and spine BMD (ps < 0.05). Per protocol (>2600 steps/session), the intervention group significantly decreased leg %fat and decreased abdominal subcutaneous and total adiposity (ps < 0.05)., Conclusion: Exergaming reduced body fat and increased BMD among those adolescent girls who adhered. Further research is required before exergaming is recommended in clinical settings., (© 2016 World Obesity Federation.)