Clinical trial NCT00674544: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters
Official title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: childhood
children
obesity
physical activity
nutrition
fitness
family
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2008-05-08
Enrollment: 650
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.

Detailed description: We will assess the effect of this multidisciplinary intervention in a multicenter cluster randomized controlled trial including a total of 40 kindergarten classes in the French (canton Vaud) and in the German (canton St. Gallen) speaking part of Switzerland. Health promoters, trained in physical education, will receive further postgraduate training (in nutrition, education, psychology) and will then in reward teach several kindergarten teachers hands-on. These trained health promoters will intervene on the level of the kindergarten teacher, the parents, the local community and also on the level of the children following a professional pre-specified curriculum in the kindergarten that focuses primarily on physical activity, healthy nutrition, media use and sleep duration. The curriculum also includes information evenings, workshops and fun weekly homework packages. Special attention will be paid to establish a curriculum that reaches also socio-cultural high risk groups living in Switzerland. Measurements will be performed before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy kindergarten children

Exclusion Criteria:

* Children with severe chronic disease (restricting physical activity)

Primary outcomes:
measure: BMI and aerobic fitness
timeFrame: 1 schoolyear
Secondary outcomes:
measure: total and central body fatness
timeFrame: 1 schoolyear
measure: motor abilities
timeFrame: 1 schoolyear
measure: physical activity
timeFrame: 1 schoolyear
measure: Media use
timeFrame: 1 schoolyear
measure: Nutritional behavior and food intake
timeFrame: 1 schoolyear
measure: Cognition tests
timeFrame: 1 schoolyear
measure: Health-related quality of life, presence of hyperactivity
timeFrame: 1 schoolyear
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Service of Endocrinology, Diabetes and Metabolism; University of Lausanne
Study officials:
affiliation: University of Lausanne
name: Jardena J Puder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puder JJ, Marques-Vidal P, Schindler C, Zahner L, Niederer I, Burgi F, Ebenegger V, Nydegger A, Kriemler S. Effect of multidimensional lifestyle intervention on fitness and adiposity in predominantly migrant preschool children (Ballabeina): cluster randomised controlled trial. BMJ. 2011 Oct 13;343:d6195. doi: 10.1136/bmj.d6195.
citation: Niederer I, Kriemler S, Gut J, Hartmann T, Schindler C, Barral J, Puder JJ. Relationship of aerobic fitness and motor skills with memory and attention in preschoolers (Ballabeina): a cross-sectional and longitudinal study. BMC Pediatr. 2011 May 11;11:34. doi: 10.1186/1471-2431-11-34.
citation: Burgi F, Meyer U, Granacher U, Schindler C, Marques-Vidal P, Kriemler S, Puder JJ. Relationship of physical activity with motor skills, aerobic fitness and body fat in preschool children: a cross-sectional and longitudinal study (Ballabeina). Int J Obes (Lond). 2011 Jul;35(7):937-44. doi: 10.1038/ijo.2011.54. Epub 2011 Mar 29.
citation: Burgi F, Meyer U, Niederer I, Ebenegger V, Marques-Vidal P, Granacher U, Kriemler S, Puder JJ. Socio-cultural determinants of adiposity and physical activity in preschool children: a cross-sectional study. BMC Public Health. 2010 Nov 26;10:733. doi: 10.1186/1471-2458-10-733.
citation: Niederer I, Kriemler S, Zahner L, Burgi F, Ebenegger V, Hartmann T, Meyer U, Schindler C, Nydegger A, Marques-Vidal P, Puder JJ. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial. BMC Public Health. 2009 Mar 31;9:94. doi: 10.1186/1471-2458-9-94.