- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00554294
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial (trinkfit)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.
To analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All children in 2nd and 3rd grade of selected elementary schools
Exclusion Criteria:
- parental consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control group
Control schools had school curriculum as usual and did not receive environmental intervention.
|
|
|
Eksperimentel: Intervention group
Intervention schools received water dispensers, drinking bottles and lessons as intervention.
|
In intervention schools a water dispenser was installed and children received water bottles as environmental intervention.
Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overweight
Tidsramme: one school year
|
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
|
one school year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Intake of Drinks
Tidsramme: one school year
|
one school year
|
|
Physical Activity and Inactivity
Tidsramme: one school year
|
one school year
|
|
Water Flow of the Water Dispensers
Tidsramme: one school year
|
one school year
|
|
Parameters of Process Evaluation (Acceptance, Feasibility)
Tidsramme: 1,5 years
|
1,5 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Mathilde Kersting, PhD, Research Insitute of Child Nutrition
Publikationer og nyttige links
Generelle publikationer
- Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics. 2009 Apr;123(4):e661-7. doi: 10.1542/peds.2008-2186.
- Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Immigrational background affects the effectiveness of a school-based overweight prevention program promoting water consumption. Obesity (Silver Spring). 2010 Mar;18(3):528-34. doi: 10.1038/oby.2009.270. Epub 2009 Aug 27.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 05HS026
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