Journal des soins pharmaceutiques et des systèmes de santé
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Transition of Intervention of Clinical Trials for Obesity

Fujii H, Yukawa K and Sato H

Objectives: Earlier studies have revealed that modification of lifestyle habits from the aspects of nutrition and exercise is the most effective measure to control metabolic syndrome, and this finding may be reflected in the number of registered clinical trials. This paper aims to test this assumption and conduct exploratory analysis of the recent trends in clinical trials related to obesity.
Design and methods: Of the clinical trial data registered with the International Clinical Trial Registry Platform (ICTRP), we used 1,478 data sets of obese patients for analysis (available as of August 2016).

This study is exploratory analysis, aiming to test some hypotheses and identify the overall tendency. The target hypotheses are as follows. Among clinical trials targeting obese patients, the number of those intended to verify the effect of lifestyle modification has been increasing year by year.
Results: The percentage of clinical trials targeting obesity has been increasing year by year. We clearly found that the number of clinical trials using lifestyle intervention has been increasing (p<0.05). We conducted a chisquared test to examine whether there is any difference in terms of interventions among countries, and found that while clinical trials targeting obese patients were relatively more frequently conducted in the United States, France, and the Netherlands, these clinical trials were relatively less frequent in Japan, China, India, and Australia/New Zealand. The coefficient of correlation between the ratio of people with BMI 25 or higher and the percentage of clinical trials targeting obese patients is 0.55, suggesting a moderate correlation.
Conclusion: In this study, we found that clinical trials conducted targeting obesity have led to the accumulation on a yearly basis of study results showing that lifestyle modification is the most effective way to control obesity, and that these clinical trials have been relatively more frequently conducted than other clinical trials. In the future, once a more effective method is discovered, it will be more frequently used in other clinical trials as well. According to the analysis results by country, we found that countries where obesity exists as a more serious health problem tend to conduct more clinical trials targeting obesity.