- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00063544
Physical Activity and Childhood Obesity
Visão geral do estudo
Status
Descrição detalhada
BACKGROUND:
Childhood obesity is rapidly increasing in many countries and environmental factors are the main cause. The onset of puberty may be a critical period. Diet and physical activity are likely to be prime causative factors, although the relative role of each may vary between children of differing age, gender and ethnicity. There are also likely to be many psychosocial and social-demographic factors that can confound these relationships, and these confounders may vary between sub-groups. There continues to be uncertainty regarding the role of these factors and their differential effects in subgroups of the population. It is crucial to develop a better understanding of how dietary and physical activity patterns affect energy balance, and how these characteristics interact with other factors.
Measures of physical activity will be added to ongoing assessments of boys and girls (n=10,000) participating in the Avon Longitudinal Study of Parents and Children (ALSPAC). This comprehensive study has been following children and their parents for about 9-10 years. The study has an extensive database including maternal and paternal social background, lifestyle and habits (including diet and physical activity), medical history and medications during pregnancy and thereafter. ALSPAC has also collected and retained biological samples including maternal blood, urine, cord blood, umbilical cord, placenta, hair and nail clippings, deciduous teeth, child's blood and DNA. Data on the mothers also include details of her own parent's lifestyle, her childhood, lifestyle, occupation history and diet, and access to mother's biological samples. Over 71% of the cohort (>10,000 of 14,541 participants) have been retained.
DESIGN NARRATIVE:
Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity. Physical activity will be measured objectively for 5 days. The data, together with other data collected during pregnancy, infancy and childhood will be used to investigate relationships between modes, intensities, quantities and patterns of physical activity and the development of obesity at this critical stage of life. The strengths of this prospective study are its size, high retention rates and the extensive set of whole-of-life measures already taken on the children. With over 10,000 children expected to attend annually for health checks throughout adolescence, the study will be adequately powered to quantify associations between physical activity and obesity. The study of physical activity in children has to date been seriously restricted because of high levels of measurement error inherent in all self-report measures of physical activity. In this study, physical activity will be measured using a single-plane accelerometer (CSA model 7164) - a small, lightweight electronic motion sensor attached to the child's belt for a period of 5 days. This instrument gives the capacity to to characterize children's physical activity, and inactivity, more accurately than ever before. Comprehensive measurements of diet and body composition (principally Dual-emission X-ray Absorptiometry - DXA) will also be taken at ages 11 and 13 under separate funding.
Tipo de estudo
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Plano de estudo
Como o estudo é projetado?
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity.
Prazo: 5 days
|
In this study, physical activity will be measured using a single-plane accelerometer (CSA model 7164) - a small, lightweight electronic motion sensor attached to the child's belt for a period of 5 days.
This instrument gives the capacity to to characterize children's physical activity, and inactivity, more accurately than ever before.
|
5 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chris Riddoch, Bristol University
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1219
- R01HL071248 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .