Arenaza, LideMedrano, MaríaAmasene, MaríaRodríguez-Vigil, BeatrizDíez, IgnacioGraña, ManuelTobalina, IgnacioMaiz, EdurneArteche, EdurneLarrarte, EiderHuybrechts, IngeDavis, Catherine L.Ruiz, Jonatan R.Ortega, Francisco B.Margareto, JavierLabayen, Idoia2017-08-10Arenaza , L , Medrano , M , Amasene , M , Rodríguez-Vigil , B , Díez , I , Graña , M , Tobalina , I , Maiz , E , Arteche , E , Larrarte , E , Huybrechts , I , Davis , C L , Ruiz , J R , Ortega , F B , Margareto , J & Labayen , I 2017 , ' Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial : Study protocol for a randomized controlled trial ' , Trials , vol. 18 , no. 1 , 372 . https://doi.org/10.1186/s13063-017-2117-y1745-6215researchoutputwizard: 11556/456Publisher Copyright: © 2017 The Author(s).Background: The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise. Methods: A total of 84 children, aged 8-12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry). Discussion: Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity.799211enginfo:eu-repo/semantics/openAccessjournal article10.1186/s13063-017-2117-yType-2 diabetesChildrenExerciseFamily based lifestyle intervention programmiRNAEctopic fatType-2 diabetesChildrenExerciseFamily based lifestyle intervention programmiRNAEctopic fatMedicine (miscellaneous)Pharmacology (medical)SDG 3 - Good Health and Well-beingFunding InfoThe Spanish Ministry of Industry and_x000D_ Competitiveness (DEP2016-78377-R), by “Fondos Estructurales de la Unión_x000D_ Europea (FEDER), Una manera de hacer Europa.” and by the University of the_x000D_ Basque Country (GIU14/21). This work was also supported by grants from_x000D_ Spanish Ministry of Economy and Competitiveness (RYC-2010-05957; RYC-_x000D_ 2011-09011), Spanish Ministry of Education, Culture and Sports (FPU14/_x000D_ 03329) and by the Education, Linguistic Policy and Culture Department of_x000D_ the Government of the Basque Country (PRE_2016_1_0057).The Spanish Ministry of Industry and_x000D_ Competitiveness (DEP2016-78377-R), by “Fondos Estructurales de la Unión_x000D_ Europea (FEDER), Una manera de hacer Europa.” and by the University of the_x000D_ Basque Country (GIU14/21). This work was also supported by grants from_x000D_ Spanish Ministry of Economy and Competitiveness (RYC-2010-05957; RYC-_x000D_ 2011-09011), Spanish Ministry of Education, Culture and Sports (FPU14/_x000D_ 03329) and by the Education, Linguistic Policy and Culture Department of_x000D_ the Government of the Basque Country (PRE_2016_1_0057).http://www.scopus.com/inward/record.url?scp=85027098526&partnerID=8YFLogxK