BackgroundObesity is a widespread problem that not only leads to medical and psychological diseases in adults, but also in children and adolescents at an early stage in life. Because of its global burden on both the individual and society, it is necessary to develop effective evidence-based treatments. Current “Multidisciplinary Obesity Treatments” (MOT) already provide significant weight loss, but still leave room for more long-lasting improvements. In this protocol paper, we outline the research goals of the WELCOME trial, based on a substantial proof of concept.MethodsIn this Randomized Controlled Trial (RCT) – conducted in both an inpatient and two outpatient treatment settings – existing MOT will be supplemented with an Executive Function (EF) training and compare effects on various parameters in an experimental versus an active control group of obese youngsters (8–18 years old). WELCOME aims to (a) train youngsters’ executive functions to facilitate effects on weight loss, psychological and medical comorbidities, (b) to enhance the long-term effects by continuing the training in the daily home context with booster sessions, and (c) to investigate its effects until a 6-month follow-up. In comparison to the active control group, better progress is expected in the experimental group on following variables: weight, psychological comorbidities (unhealthy eating behavior, internalizing symptoms, impaired self-esteem) and medical comorbidities (metabolic syndromes, endothelia dysfunction, tonsillar hypertrophy and sleep obstruction).DiscussionIt is stated that this EF-training for enhancing self-control abilities is necessary for a long-lasting effect of childhood obesity treatment interventions.Trial registrationThe Study Procotol was registered on 10/05/2017 (n° ISRCTN14722584).
Background: Obesity and age influence reliability of dual energy X-ray absorptiometry scanning (DEXA) and bioimpedance spectroscopy (BIS). Both are used in clinical settings, but have not been compared for measurements in obese children. We compared DEXA and BIS for evaluating body composition and inherent changes in obese children before and after a 10-month weight loss program.Methods: DEXA and BIS were used to evaluate 130 patients at baseline and 75 at followup. We tested agreement between the two techniques using Bland-Altman plots and proportional bias using Passing-Bablok regressions. Results:The Bland-Altman plots showed wide agreement limits before and after weight loss when monitoring longitudinal changes. At baseline, the Passing-Bablok regressions revealed a proportional bias for all body compartments. After significant weight loss no proportional bias was found for fat mass and percentage, although BIS systematically underestimated fat mass by 2.9 kg. Longitudinally, no proportional bias was found in the measured changes of absolute fat, fat-free mass and fat-free percentage between both methods, although BIS systematically underestimated fat and fat-free mass by 2.6 kg and 0.7 kg, respectively. Conclusion:While BIS and DEXA are not interchangeable at baseline, the agreement between the two improved after significant weight loss. Proportional changes in fat mass, fatfree mass and fat-free percentage were similar for both techniques. BIS is a viable alternative to DEXA for future paediatric obesity studies measuring treatment effect at group levels, but is not superior to DEXA and cannot be used for monitoring individual changes due to wide limits of agreement.
Background: Currently available treatment programs for children with obesity only have modest long-term results, which is (at least partially) due to the poorer self-control observed within this population. The present trial aimed to determine whether an online self-control training, training inhibition, and redirecting attentional bias, can improve the short- and long-term treatment outcome of (in- or outpatient) child obesity treatment programs.Methods: In this double-blind multi-center randomized controlled trial (RCT), participants aged 8–18 years with obesity were allocated in a 1:1 ratio to receive an online self-control or sham training added to their in- or outpatient multidisciplinary obesity treatment (MOT) program. The primary endpoint was BMI SDS. Data were analyzed by linear mixed models and the main interactions of interest were randomization by time and randomization by number of sessions, as the latter was cumulatively expressed and therefore represents the effect of increasing dose over time.Results: One hundred forty-four inpatient (mean age 14.3 ± 2.2 years, BMI 2.7 ± 0.4 SDS, 42% male) and 115 outpatient children (mean age 11.9 ± 2.1 years, BMI 2.4 ± 0.4 SDS, 45% male) were included. Children's BMI lowered significantly during treatment in both the in- and outpatient treatment centers, p < 0.001. In a mixed model with BMI as dependent variable, randomization by time was non-significant, but the number of self-control trainings (randomization * number of sessions) interacted significantly with setting and with age (p = 0.002 and p = 0.047), indicating a potential effect in younger inpatient residents. Indeed, a subgroup analysis on 22 inpatient children of 8–12 years found a benefit of the number of self-control trainings on BMI (p = 0.026).Conclusions: The present trial found no benefit of the self-control training in the entire study population, however a subgroup of young, inpatient participants potentially benefited.
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