Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters

NCT ID: NCT00674544

Last Updated: 2011-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

No intervention, regular kindergarten program

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy kindergarten children

Exclusion Criteria

* Children with severe chronic disease (restricting physical activity)
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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University of Lausanne

Principal Investigators

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Jardena J Puder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Locations

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Service of Endocrinology, Diabetes and Metabolism; University of Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 21998346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21569343 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21448128 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21110865 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19335890 (View on PubMed)

Other Identifiers

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3200BO-116837

Identifier Type: -

Identifier Source: org_study_id

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