Abstract
BackgroundObesity is not only a highly prevalent disease but also poses a considerable burden on children and their families. Evidence is increasing that a lack of self-regulation skills may play a role in the etiology and maintenance of obesity. Our goal with this currently ongoing trial is to examine whether training that focuses on the enhancement of self-regulation skills may increase the sustainability of a complex lifestyle intervention.Methods/DesignIn a multicenter, prospective, parallel group, randomized controlled superiority trial, 226 obese children and adolescents aged 8 to 16 years will be allocated either to a newly developed computer-training program to improve their self-regulation abilities or to a placebo control group. Randomization occurs centrally and blockwise at a 1:1 allocation ratio for each center. This study is performed in pediatric inpatient rehabilitation facilities specialized in the treatment of obesity. Observer-blind assessments of outcome variables take place at four times: at the beginning of the rehabilitation (pre), at the end of the training in the rehabilitation (post), and 6 and 12 months post-rehabilitation intervention. The primary outcome is the course of BMI-SDS over 1 year after the end of the inpatient rehabilitation. Secondary endpoints are the self-regulation skills. In addition, health-related quality of life, and snack intake will be analyzed.DiscussionThe computer-based training programs might be a feasible and attractive tool to increase the sustainability of the weight loss reached during inpatient rehabilitation.Trial registrationThe present study protocol was registered on 13 July 2015 at German Clinical Trials Register: DRKS00007879.
Highlights
Obesity is a highly prevalent disease and poses a considerable burden on children and their families
The computer-based training programs might be a feasible and attractive tool to increase the sustainability of the weight loss reached during inpatient rehabilitation
Obesity is associated with 0.7 to 2.8 % of health-related expenditure linked to society; obese individuals cause 30 % more direct costs compared to normalweight individuals [4]
Summary
In order to reduce one’s overweight in the long term and maintain a healthy weight, a comprehensive lifestyle change is necessary These programs target mainly the change in diet and exercise behavior and require high self-regulation skills from the participants. The authors reported a higher caloric intake during an unrestricted food task for the children in the control group over the course of the experiment, that is, the control group increased their intake from pre- to postintervention This time effect was not observed in the intervention group. Compared to the untrained control group, children of the intervention group were better able to maintain their achieved weight loss at the end of the inpatient treatment This effect was observed only 8 weeks post-intervention but was no longer significant at the 3-month follow-up.
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