{"title":"Monitoring and reporting of adverse effects in weight loss trials in children.","authors":"Catja Alcoat, Rasmus Køster-Rasmussen","doi":"10.61409/A05240327","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11119,"journal":{"name":"Danish medical journal","volume":"72 3","pages":""},"PeriodicalIF":1.0000,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Danish medical journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.61409/A05240327","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍:
The Danish Medical Journal (DMJ) is a general medical journal. The journal publish original research in English – conducted in or in relation to the Danish health-care system. When writing for the Danish Medical Journal please remember target audience which is the general reader. This means that the research area should be relevant to many readers and the paper should be presented in a way that most readers will understand the content.
DMJ will publish the following articles:
• Original articles
• Protocol articles from large randomized clinical trials
• Systematic reviews and meta-analyses
• PhD theses from Danish faculties of health sciences
• DMSc theses from Danish faculties of health sciences.