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

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.

Pediatric sentinel surveillance of vaccine-preventable diseases in Italy.

BACKGROUND: Planning and evaluating vaccination programs depend on reliable systems of monitoring disease incidence in the community. In Italy vaccine-preventable diseases are subject to statutory notification, but they are often unreported. In January, 2000, a pediatric sentinel network was launched, with the aim of monitoring in a timely and accurate way the geographic and temporal trends of vaccine-preventable diseases. METHODS: The network consists of National Health System primary care pediatricians; participation is voluntary. The diseases under surveillance include measles, mumps, rubella, pertussis and varicella. Case definitions are based on specific clinical criteria, and pediatricians report cases on a monthly basis. Incidence rates are estimated and compared with those obtained by statutory notifications. The proportion of vaccinated cases is also computed. RESULTS: In 2000 an average of 468 pediatricians participated each month of a total of 7276 pediatricians under contract for primary care by the National Health System. The population under surveillance consisted of 371 670 children younger than 15 years (of a national total of 8.347.804 children of the same age). The annual national incidence per 100.000 children was estimated at 5345 for varicella, 1972 for mumps, 279 for pertussis, 108 for rubella and 62 for measles, although wide variations were observed among geographic areas. The national estimates are 3 to 7 times higher than those obtained through statutory notifications. For all of the diseases the ratio between the two sources of data was significantly higher in southern Italy, compared with the rest of the country. The proportion of vaccinated cases was similar for measles and rubella (21 and 17%) but was approximately 3 times higher for mumps (59%). Most (74%) of the vaccinated mumps cases had received the Rubini vaccine strain. CONCLUSIONS: The sentinel surveillance system is considerably more sensitive than statutory notifications, particularly in southern Italy. The high percentage of mumps cases vaccinated with the Rubini strain indicates a reduced effectiveness of this vaccine. Although further improvements are needed, pediatrician-based sentinel surveillance is a useful tool for evaluating vaccine-preventable disease trends.