Diseño de un estudio comunitario randomizado controlado multi-componente para prevención de obesidad en niños escolares: Protocolo de investigación

Introduction: the aim was to design a multi-component randomized controlled community study and evaluate its effect in the prevention of obesity in schoolchildren from the department of Caaguazu, Paraguay. Material and methods: Design: randomized controlled community trial. Setting: 16 public and private schools in the urban and rural area of the Department of Caaguazu, Paraguay. Participants and intervention: 16 schools will be randomly assigned to two groups. Intervention group, they will receive a nutritional education and physical activity program in the school environment for 6 months. Control group will receive 3 educational talks in the same period. Main outcome measure: primary (thickness of skin folds), secondary (z body mass index, nutritional knowledge, fruits and vegetables consumption, physical activity level) and demographic variables (sex, age and area). All variables will be measured at baseline and at the end of the study, using calibrated tools, validated questionnaires, and protocols. Analysis: descriptive statistics will be used, in addition to the Student t test and chi2 to establish differences. Crude and adjusted linear regression and logistic models will be run. Ethics and dissemination: the study protocol has been evaluated and approved by the Research Ethics Committee of the National University of Caaguazu. Institutional (schools) and individual (parents) informed consent and children\u0027s assent will be used.