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Monitoring and reporting of adverse effects in weight loss trials in children
Catja Alcoat1, Rasmus Køster-Rasmussen1
1Center for General Practice, Department of Public Health, University of Copenhagen, Denmark.
Abstract:
We investigated if the studies included in a Cochrane Review had examined and reported adverse effects of lifestyle intervention for weight loss in children. We evaluated each of the 70 RCTs included. A total of 67 trials (96%) did not report a method for monitoring adverse effects. Six trials (9%) reported physical adverse events. One trial reported a "negative effect on children's feelings". None of the 70 studies examined for or reported social adverse effects. In conclusion, only a few studies of lifestyle intervention for weight loss in children examined for potential harm, and 96% did not meet the present-day standard for reporting trials as described in the CONSORT statement.
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