Protocol of a Randomized Cluster Trial to Assess the Effectiveness of the MOVI-2 Program on Overweight Prevention in Schoolchildren

Introduction and objectivesThe MOVI physical activity program has been shown to reduce adiposity and to improve serum lipid profiles in schoolchildren. However, MOVI may have not achieved its maximum potential effectiveness, as increased physical activity on weekdays may have been offset by more sedentary behavior at weekends. We therefore developed the MOVI-2 program, which includes physical activity at weekends as well. This paper reports the rationale and methods of a trial to assess the effectiveness of MOVI-2 in preventing overweight and reducing cardiovascular risk in 1200 4th- and 5th-grade primary schoolchildren in Cuenca, Spain.MethodsTen schools were randomly assigned to MOVI-2 and 10 schools to the control group. MOVI-2 consisted of recreational physical activity in after-school time, including two 90-min sessions on weekdays and one 150-min session on Saturdays, during each week of one academic year. The control group was expected to follow their usual patterns of physical activity. The primary end points, which were assessed at the start and the end of the MOVI-2 program, were weight and height, waist circumference, skinfold thickness, percentage of body fat, blood pressure, lipid profile, and insulin resistance. Secondary end points were physical activity, fitness, health-related quality of life, sleep quality, academic performance, enjoyment with physical activity, and physical self-concept.ConclusionsThis study will assess whether MOVI-2 overcomes some potential limitations of physical activity interventions in children (Clinicaltrials.gov number NCT01277224).

ResumenIntroducción y objetivosSe ha demostrado que el programa MOVI de actividad física recreativa durante los días lectivos reduce la adiposidad y mejora el perfil lipídico en escolares. Sin embargo, puede que la mayor actividad física durante la semana se compensara con mayor sedentarismo en el fin de semana, de forma que MOVI no alcanzara toda su efectividad potencial. Por ello diseñamos el programa MOVI-2, que también incluye actividad física durante el fin de semana. Se comunican la justificación y los métodos de un ensayo sobre la efectividad de MOVI-2 en la prevención del sobrepeso y la reducción del riesgo cardiovascular en 1.200 escolares de cuarto y quinto curso de primaria en Cuenca.MétodosSe asigna aleatoriamente a 10 colegios al programa MOVI-2 y 10 colegios al grupo de control. MOVI-2 consiste en actividad física recreativa en horario extraescolar, con dos sesiones de 90 min en días lectivos y una sesión de 150 min los sábados, durante cada semana de un curso académico. Se espera que el grupo control mantenga la actividad física habitual. Las variables principales, que se miden en cada niño al inicio y final de MOVI-2, son: peso y talla, perímetro de cintura, pliegue cutáneo tricipital, porcentaje de grasa corporal, presión arterial, perfil lipídico y resistencia a la insulina. Las variables secundarias son: actividad física realizada, condición física, calidad de vida y del sueño, rendimiento académico, disfrute con la actividad física y autoconcepto físico.ConclusionesEste estudio informará de si MOVI-2 supera algunas limitaciones potenciales de las intervenciones de actividad física en escolares (número Clinicaltrials.gov, NCT01277224).