Skip to main content
OpenTrials
Completed

NCT Number: NCT00674544

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service of Endocrinology, Diabetes and Metabolism; University of Lausanne

Lausanne, 1010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy kindergarten children

Exclusion criteria

  • Children with severe chronic disease (restricting physical activity)

Treatment and study plan

Lifestyle Intervention

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • University of Basel

Registry information

Official study title

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

Acronym: Ballabeina

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 8, 2008
Registry last updated
Jan 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.