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

January 27, 2011 updated by: University of Lausanne Hospitals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1010
        • Service of Endocrinology, Diabetes and Metabolism; University of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy kindergarten children

Exclusion Criteria:

  • Children with severe chronic disease (restricting physical activity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI and aerobic fitness
Time Frame: 1 schoolyear
1 schoolyear

Secondary Outcome Measures

Outcome Measure
Time Frame
total and central body fatness
Time Frame: 1 schoolyear
1 schoolyear
motor abilities
Time Frame: 1 schoolyear
1 schoolyear
physical activity
Time Frame: 1 schoolyear
1 schoolyear
Media use
Time Frame: 1 schoolyear
1 schoolyear
Nutritional behavior and food intake
Time Frame: 1 schoolyear
1 schoolyear
Cognition tests
Time Frame: 1 schoolyear
1 schoolyear
Health-related quality of life, presence of hyperactivity
Time Frame: 1 schoolyear
1 schoolyear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Collaborators

University of Basel

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200BO-116837

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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