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

Obesity Clinical Trial

— Ballabeina  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674544
• Other study ID #: 3200BO-116837
• Status: Completed
• Phase: N/A
• First received: May 6, 2008
• Last updated: January 27, 2011
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2009
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Healthy kindergarten children

Exclusion Criteria:

• Children with severe chronic disease (restricting physical activity)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Switzerland	Service of Endocrinology, Diabetes and Metabolism; University of Lausanne	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI and aerobic fitness		1 schoolyear	No
Secondary	total and central body fatness		1 schoolyear	No
Secondary	motor abilities		1 schoolyear	No
Secondary	physical activity		1 schoolyear	No
Secondary	Media use		1 schoolyear	No
Secondary	Nutritional behavior and food intake		1 schoolyear	No
Secondary	Cognition tests		1 schoolyear	No
Secondary	Health-related quality of life, presence of hyperactivity		1 schoolyear	No