Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial

Abstract

Background Childhood obesity and physical inactivity are increasing dramatically worldwide. Children of low socioeconomic status and/or children of migrant background are especially at risk. In general, the overall effectiveness of school-based programs on health-related outcomes has been disappointing. A special gap exists for younger children and in high risk groups. Methods/Design This paper describes the rationale, design, curriculum, and evaluation of a multicenter preschool randomized intervention study conducted in areas with a high migrant population in two out of 26 Swiss cantons. Twenty preschool classes in the German (canton St. Gallen) and another 20 in the French (canton Vaud) part of Switzerland were separately selected and randomized to an intervention and a control arm by the use of opaque envelopes. The multidisciplinary lifestyle intervention aimed to increase physical activity and sleep duration, to reinforce healthy nutrition and eating behaviour, and to reduce media use. According to the ecological model, it included children, their parents and the teachers. The regular teachers performed the majority of the intervention and were supported by a local health promoter. The intervention included physical activity lessons, adaptation of the built infrastructure; promotion of regional extracurricular physical activity; playful lessons about nutrition, media use and sleep, funny homework cards and information materials for teachers and parents. It lasted one school year. Baseline and post-intervention evaluations were performed in both arms. Primary outcome measures included BMI and aerobic fitness (20 m shuttle run test). Secondary outcomes included total (skinfolds, bioelectrical impedance) and central (waist circumference) body fat, motor abilities (obstacle course, static and dynamic balance), physical activity and sleep duration (accelerometry and questionnaires), nutritional behaviour and food intake, media use, quality of life and signs of hyperactivity (questionnaires), attention and spatial working memory ability (two validated tests). Researchers were blinded to group allocation. Discussion The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration Trial Registration: clinicaltrials.gov NCT00674544

Relationship of physical activity with motor skills, aerobic fitness and body fat in preschool children: a cross-sectional and longitudinal study (Ballabeina)

“…We analyzed data from a randomized controlled trial (Ballabeina-Study, clinicaltrials.gov NCT0067454), 19 in which preschool classes from two separate regions in Switzerland were randomly selected. Children were assessed both at baseline (summer 2008) and 9 months later.…”

Independent contribution of parental migrant status and educational level to adiposity and eating habits in preschool children

“…In the context of a multidisciplinary multilevel lifestyle intervention in Swiss kindergarten children (Ballabeina study/clinicatrials.gov NCT00674544), we randomly selected 40 classes from areas with a high migrant prevalence (that is, X40%) in two Swiss cantons (St. Gallen, SG and Vaud, VD) (Niederer et al, 2009). This study was approved by the cantonal ethical committees of SG and VD, and was performed in the late summer of 2008.…”

“…Using a general questionnaire, maternal and paternal MS were determined by the place of birth and EL as the highest grade of school completed (Niederer et al, 2009). Further questions included media use, defined by the time spent with TV viewing and video games playing (min/day).…”

“…Standing height was determined and body weight was measured using an electronic scale (Seca, Basel, Switzerland; accuracy 0.05 kg) to calculate BMI (Niederer et al, 2009). Then, children weight categories were established from the Swiss national percentiles (Prader et al, 1989), as national percentiles are known to be more sensitive than the international ones (Reilly, 2002).…”

“…Activity was measured with an activity monitor (GT1M, Actigraph, Pensacola, FL, USA), which was initialized to save data in 15-s intervals (epochs) (Niederer et al, 2009). The accelerometers were worn around the hip during 5 consecutive days.…”