- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01291238
School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.
Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Youth with an intellectual disability are reported more sedentary and more often overweight than non intellectual disability youth. Cardio metabolic risk factors are observed more frequent and at an earlier age among young people with intellectual disability. The school reaches all students and they spend the main part of their day in the school milieu hence examples of healthy lifestyle can be provided there.
This intervention increased physical activity with daily scheduled physical activity. At least one lesson each week was at the gym. Food provided in the school environment was considered from content of sugar and fat and ónly healthy food choices was available at school. This included all school activities, both in the school area and on school activities out in the community. It included home economic lessons as well as the school cafeterias supply and school lunch content.
To increase vegetable intake a special designed plate was used for lunch according the "plate model". In addition, the plate model was one theme during art class.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Stockholm, Suécia, SE-141 86
- Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- mild/moderate intellectual disability
- students at the upper secondary schools for intellectual disability students
Exclusion Criteria:
- severe intellectual disability
- obesity related syndromes
- major physical disabilities
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Healthy lifestyle habits
Increased physical activity and healthy food with decreased sugar and fat content
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Increased physical activity and decreased sugar and fat intake during school hours
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Decrease in cardio metabolic risk factors
Prazo: 2 years
|
At baseline and after 2 years of intervention; height, weight, waist circumference, blood pressure was measured. In addition fasting blood samples of total cholesterol, triglycerides, fasting glucose and insulin. Absorptiometry photos (DXA) for body composition. Postintervention measures in addition compared to a controlgroup. Cross sectional data on all school students of all above mentioned variables and also cholesterol as HDL and LDL compared to a control group. |
2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Increase in physical fitness
Prazo: 2 years
|
At baseline and after 2 years of intervention a submaximal ergometer bicycle test. Postintervention measures in addition compared to a controlgroup. Cross sectional data on all school students from accelerometer, actiwatch, for frequency, intensity and level of physical activity compared to a control group. |
2 years
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Increased vegetable intake
Prazo: at least 1 year
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To measure if the special plate made students take 37,5% vegetables or more as is the vegetable field on the plate.Effect of the specially designed plate according the plate-model evaluates in an observational study with videorecording and photos of a self served lunchportion on an ordinary plate in an experimental situation.
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at least 1 year
|
Colaboradores e Investigadores
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
- 2009/772-32
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