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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy kindergarten children Exclusion Criteria: Children with severe chronic disease (restricting physical activity)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention, regular kindergarten program | |
| Experimental: Intervention group<br>Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings | Behavioral: Lifestyle intervention<br>* Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI and aerobic fitness |  | 1 schoolyear | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood, children, obesity, physical activity, nutrition, fitness, family