Italian Journal of Pediatrics

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Open Access Commentary

"Mi voglio bene": a pediatrician-based randomized controlled trial for the prevention of obesity in Italian preschool children

Paolo Brambilla1, Giorgio Bedogni2*, Carmen Buongiovanni3, Guido Brusoni4, Giuseppe Di Mauro5, Mario Di Pietro6, Marco Giussani7, Manuel Gnecchi8, Lorenzo Iughetti9, Paola Manzoni10, Maura Sticco3 and Sergio Bernasconi11

Author Affiliations

1 Family pediatrician, Milano, and Department of Continuing Medical Education, Federazione Italiana Medici Pediatri, Milano, Italy

2 Clinical Epidemiology Unit, Liver Research Center, Basovizza, Trieste, Italy and Department of Maternal and Pediatric Sciences, University of Milan, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy

3 Department of Pediatrics, University Federico II, Napoli, Italy

4 Family pediatrician, La Spezia, Italy

5 Family pediatrician, Caserta, and Direction of Società Italiana Pediatra Preventiva e Sociale, Italy

6 Center of Auxology and Pediatric Nutrition, Teramo, Italy

7 Department of Continuing Medical Education, Federazione Italiana Medici Pediatri, Milano, Italy

8 Family pediatrician, Gazzaniga, Italy

9 Mother and Child Department, University of Modena e Reggio Emilia, Modena, Italy

10 Family pediatrician, Robbiate, Italy

11 Department of Pediatrics, Università di Parma, Parma, Italy

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Italian Journal of Pediatrics 2010, 36:55 doi:10.1186/1824-7288-36-55

Published: 17 August 2010

Abstract

Background

The first years of life are crucial to start preventive interventions that can have an impact on lifestyle and later overweight and obesity. Under the Italian National Health System (INHS), children are cared for by family pediatricians who perform health balances at regular intervals. The Italian Society of Preventive and Social Pediatrics (SIPPS) has designed a randomized controlled trial (RCT) to evaluate the effectiveness of family pediatricians for the prevention of childhood obesity in preschool children. We report the rationale and protocol of such trial, named the "Mi voglio bene" ("I love myself") study.

Methods

"Mi voglio bene" is a parallel-arm RCT. Family pediatricians willing to participate to the trial will be randomly assigned to a control group and to an experimental group. The control group will provide the usual standard of care while the experimental group will implement 10 preventive actions (promotion of breastfeeding, avoidance of solid foods, control of protein intake, avoidance of sugar-sweetened beverages, avoidance of bottle, active means of transportation, identification of early adiposity rebound, limitation of television viewing, promotion of movement, and teaching portion size) at 10 time points during a 6-yr follow-up. The main outcome measures is the prevalence of overweight and obesity at 6 years of age. The experimental intervention is expected to reduce the prevalence of overweight and obesity from 25% to 20% and the study requires a total of 3610 children. Each pediatrician will enroll 30 consecutive newborns into the study so that a total of 120 pediatricians will participate to the study.

Discussion

"Mi voglio bene" is expected to provide important information for the INHS and possibly other institutional child care settings about the effectiveness of a pediatrician-based approach to the prevention of childhood obesity. We published this study protocol with the aim of opening a discussion with all people interested in fighting childhood obesity and to receive useful criticisms.