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

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT00674544
Collaborator
University of Basel (Other)
650
1
2
13
50

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
650 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. BMI and aerobic fitness [1 schoolyear]

Secondary Outcome Measures

  1. total and central body fatness [1 schoolyear]

  2. motor abilities [1 schoolyear]

  3. physical activity [1 schoolyear]

  4. Media use [1 schoolyear]

  5. Nutritional behavior and food intake [1 schoolyear]

  6. Cognition tests [1 schoolyear]

  7. Health-related quality of life, presence of hyperactivity [1 schoolyear]

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy kindergarten children
Exclusion Criteria:
  • Children with severe chronic disease (restricting physical activity)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service of Endocrinology, Diabetes and Metabolism; University of Lausanne Lausanne Switzerland 1010

Sponsors and Collaborators

  • University of Lausanne Hospitals
  • University of Basel

Investigators

  • Principal Investigator: Jardena J Puder, MD, University of Lausanne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00674544
Other Study ID Numbers:
  • 3200BO-116837
First Posted:
May 8, 2008
Last Update Posted:
Jan 28, 2011
Last Verified:
Apr 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2011