Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
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| ClinicalTrials.gov Identifier: NCT00674544 |
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Recruitment Status :
Completed
First Posted : May 8, 2008
Last Update Posted : January 28, 2011
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Sponsor:
University of Lausanne Hospitals
Collaborator:
University of Basel
Information provided by:
University of Lausanne Hospitals
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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 |
|---|---|---|
| Obesity | Behavioral: Lifestyle intervention | Not Applicable |
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 (Clinical Trial) |
| Estimated 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 2008 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Toddler Health
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control group
No intervention, regular kindergarten program
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Experimental: Intervention group
Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings
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Behavioral: Lifestyle intervention
Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings |
Primary Outcome Measures :
- BMI and aerobic fitness [ Time Frame: 1 schoolyear ]
Secondary Outcome Measures :
- total and central body fatness [ Time Frame: 1 schoolyear ]
- motor abilities [ Time Frame: 1 schoolyear ]
- physical activity [ Time Frame: 1 schoolyear ]
- Media use [ Time Frame: 1 schoolyear ]
- Nutritional behavior and food intake [ Time Frame: 1 schoolyear ]
- Cognition tests [ Time Frame: 1 schoolyear ]
- Health-related quality of life, presence of hyperactivity [ Time Frame: 1 schoolyear ]
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| Ages Eligible for Study: | 3 Years to 7 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy kindergarten children
Exclusion Criteria:
- Children with severe chronic disease (restricting physical activity)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674544
Locations
| Switzerland | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Jardena Puder, University of Lausanne |
| ClinicalTrials.gov Identifier: | NCT00674544 |
| Other Study ID Numbers: |
3200BO-116837 |
| First Posted: | May 8, 2008 Key Record Dates |
| Last Update Posted: | January 28, 2011 |
| Last Verified: | April 2009 |
Keywords provided by University of Lausanne Hospitals:
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childhood children obesity physical activity |
nutrition fitness family |
Additional relevant MeSH terms:
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Obesity Overweight Overnutrition Nutrition Disorders Body Weight |