Study Protocol: The Feeding Exercise Randomized Trial among Overweight and Obese Adolescents in Greece

Background: This paper describes the study protocol used in the Feeding Exercise Clinical Trial in Adolescents in the region of Larissa in Greece, a randomized controlled clinical trial, among overweight/obese adolescents. Methods: The main aim of the study was to comparatively evaluate the effectiveness of 2 different clinical interventions among 12 to 18-year-old overweight and obese adolescents. The first group participated in an exercise program and the second group in a combined dietary and exercise program. The third group was the control group. The study was conducted between 2014 and 2015. All adolescents aged 12 to 18 years old from public schools of Larisa and also their parents asked to participate. The effects of the intervention program will be analyzed by repeated-measures analysis of variance or the Friedman test. Changes in lifestyle behaviors from the baseline to the end of the intervention will be assessed using a chi-square test for categorical variables. A Pearson or a Spearman correlation coefficient and a linear regression analysis will be performed to explore any associations between quantitative variables. The following parameters were measured among adolescents: height, weight, body mass index, waist circumference, systolic and diastolic pressure, pulse rate, dietary and exercise habits of the adolescents and their parents. Conclusion: This is the first clinical trial in Greece investigating the impact of clinical interventions on obesity among adolescents. It is expected that the results will provide useful insights into the effectiveness of clinical interventions among overweight and obese adolescents in Greece.