A randomized, triple masked, placebo-controlled clinical trial for controlling childhood obesity
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A randomized, triple masked, placebo-controlled clinical trial for controlling childhood obesity Hasan Rezvanian, Mahin Hashemipour, Roya Kelishadi, Naser Tavakoli, Parinaz Poursafa Isfahan, Iran
Methods: This triple-masked randomized clinical trial was conducted among 180 participants aged 10-16 years. They were assigned randomly to 4 groups of equal number to receive metformin, fluoxetine, a combination of the two drugs, or placebo. The trial lasted for 12 weeks and participants were followed up for an additional 12week period. Results: Overall, 91.1% (n=164) of the enrolled participants completed the trial. After the 12-week trial, the body mass index decreased significantly in all groups receiving medications [approximately -1.2 (0.2) kg/m2, P0.5 was considered as abdominal obesity.[26] All measurements were made by the same trained general physician and under the supervision of the same pediatrician. Intervention All participants were advised to increase their physical activity and to follow healthy eating behaviors. In order to increase physical activity, we asked them to reduce their sedentary time, e.g., watching television and playing computer video games to less than two hours a day. In addition, we asked them to have at least 30 minutes of enjoyable, moderate-intensity physical activities every day, which could be provided in one session or divided into at least two 15-minute periods or three 10-minute periods. [27] To be understandable for families, we gave simple explanation about the intensity of physical activity as provided by the US Centers for Disease Prevention and Control: "As a rule of thumb, on a scale of 0 to 10, where sitting is a 0 and the highest level of activity is a 10, moderate-intensity activity is a 5 or 6. When your child does moderateintensity activity, his heart will beat faster than normal and he will breathe harder than normal. Vigorous
World J Pediatr, Vol 6 No 4 . November 15, 2010 . www.wjpch.com
Pharmacologic treatment of childhood obesity hypoglycemia and necessary actions taken to control them. Although hypoglycemia was possible only for those individuals receiving metformin, similar education was provided for all groups considering the blindness of the study. To prevent hypoglycemia, the participants were asked to take drugs during meal eating. A card including clinic's phone numbers and a 24-hour cell phone number was given to the parents to call us in the case of any question, and to inform us about any possible side-effects. The trial was free of charge for the participants. To increase the compliance of the participants during the trial, all participants and their parents were followed up by telephone call monthly. The baseline measurements were repeated after the 12-week trial and 12 weeks after the end of the trial, i.e., 24 weeks after the baseline survey.
Statistical analysis SPSS for Windows (SPSS Inc., Chicago, IL) was used for data analysis. The normality of the distribution of variables with a Kolmogorov-Smirnov test was verified and no significant deviat
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