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CompletedNCT00674544BallabeinaUpdated Jan 28, 2011

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

An interventional study of Lifestyle intervention in Obesity, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-28.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
3 Years to 7 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Obesity

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Keywords

  • childhood
  • children
  • obesity
  • physical activity
  • nutrition
  • fitness
  • family
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 650 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy kindergarten children

Exclusion criteria

Exclusion Criteria:

  • Children with severe chronic disease (restricting physical activity)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
650 participants (estimated)

Study arms

  • No intervention
    Control group

    No intervention, regular kindergarten program

  • Experimental
    Intervention group

    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

  • BehavioralLifestyle intervention

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

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What researchers measure

Primary outcomes

  1. BMI and aerobic fitness

    Time frame: 1 schoolyear

Secondary outcomes

  1. total and central body fatness

    Time frame: 1 schoolyear

  2. motor abilities

    Time frame: 1 schoolyear

  3. physical activity

    Time frame: 1 schoolyear

  4. Media use

    Time frame: 1 schoolyear

  5. Nutritional behavior and food intake

    Time frame: 1 schoolyear

  6. Cognition tests

    Time frame: 1 schoolyear

  7. Health-related quality of life, presence of hyperactivity

    Time frame: 1 schoolyear

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Study locations

1 site
  • Service of Endocrinology, Diabetes and Metabolism; University of Lausanne
    Lausanne, 1010, Switzerland
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References and documents

Publications

  • 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. PubMed 21998346 ↗
  • 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. PubMed 21569343 ↗
  • 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. PubMed 21448128 ↗
  • 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. PubMed 21110865 ↗
  • 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. PubMed 19335890 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00674544
Lead sponsor
University of Lausanne Hospitals
Collaborators
University of Basel
First posted
May 8, 2008
Start date
May 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Jan 28, 2011

Study contacts

Jardena J Puder, MD
principal investigator · University of Lausanne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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