NCT00674544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 28, 2011

Status Verified

April 1, 2009

Enrollment Period

1.1 years

First QC Date

May 6, 2008

Last Update Submit

January 27, 2011

Conditions

Obesity

Keywords

childhoodchildrenobesityphysical activitynutritionfitnessfamily

Outcome Measures

Primary Outcomes (1)

  • BMI and aerobic fitness

    1 schoolyear

Secondary Outcomes (7)

  • total and central body fatness

    1 schoolyear

  • motor abilities

    1 schoolyear

  • physical activity

    1 schoolyear

  • Media use

    1 schoolyear

  • Nutritional behavior and food intake

    1 schoolyear

  • +2 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

No intervention, regular kindergarten program

Intervention group

EXPERIMENTAL

Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings

Behavioral: Lifestyle intervention

Interventions

Lifestyle interventionBEHAVIORAL

Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings

Intervention group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy kindergarten children

You may not qualify if:

  • Children with severe chronic disease (restricting physical activity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service of Endocrinology, Diabetes and Metabolism; University of Lausanne

Lausanne, 1010, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 21998346DERIVED

  • 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.

    PMID: 21569343DERIVED

  • 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.

    PMID: 21448128DERIVED

  • 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.

    PMID: 21110865DERIVED

  • 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.

    PMID: 19335890DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jardena J Puder, MD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 28, 2011

Record last verified: 2009-04

Locations

CH(1)