- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00554294
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial (trinkfit)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- All children in 2nd and 3rd grade of selected elementary schools
Exclusion Criteria:
- parental consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control group
Control schools had school curriculum as usual and did not receive environmental intervention.
|
|
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Experimental: Intervention group
Intervention schools received water dispensers, drinking bottles and lessons as intervention.
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overweight
Prazo: one school year
|
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
|
one school year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Intake of Drinks
Prazo: one school year
|
one school year
|
|
Physical Activity and Inactivity
Prazo: one school year
|
one school year
|
|
Water Flow of the Water Dispensers
Prazo: one school year
|
one school year
|
|
Parameters of Process Evaluation (Acceptance, Feasibility)
Prazo: 1,5 years
|
1,5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mathilde Kersting, PhD, Research Insitute of Child Nutrition
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 05HS026
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