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Sleep, Nutrition and Psychological Functioning in Kindergarten Children

10 de março de 2020 atualizado por: Michal Kahn, Tel Aviv University

Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study

The proposed study has the following aims: (a) to assess the concomitant and longitudinal links between sleep and cognitive, behavioral and emotional functioning in kindergarten children; (b) to assess the immediate and the long-term effects of an intervention to promote healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on related cognitive, behavioral and health domains; (c) to assess the immediate and the long-term effects of an intervention deigned to promote healthy nutrition (HNI) on the eating habits of children, their weight and BMI measures (the comparison/control group) and (d) to assess the links between eating habits and sleep in kindergarten children.

The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be concomitantly and longitudinally associated with compromised cognitive, emotional and behavioral functioning in kindergarten children; (b) In comparison to the HNI group, children in the HSI group will extend their total sleep time, improve their sleep quality and their sleep schedule will be more stable following the intervention; (c) improvement in sleep habits will be associated with improvement in cognitive, emotional and behavioral functioning; (d) in comparison to the HIS group, children in the HNI group will improve their eating habits, engage in more physical activities and better manage to achieve and maintain an age-appropriate body weight.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

140

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Israel
      • Tel Aviv, Israel, 69978
        • Tel Aviv University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

3 anos a 6 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Preschool children (aged 3-6 years) and their parents

Exclusion Criteria:

  • (a) significant health or neurological-developmental problems; (b) severe psychological problems, psychiatric diagnosis or treatment; (c) concurrent psychotherapy or similar interventions; (d) medical sleep problems (e.g., sleep apnea); (e) lack of mastery in Hebrew.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
Experimental: Healthy Nutrition Intervention
Healthy Nutrition Intervention (HNI)
Comportamental: Healthy Nutrition intervention
Healthy Nutrition Intervention (HNI)- This online system will include information for parents on the following issues: (a) increasing awareness and making healthy food choices; (b) increasing appeal of healthy food by games, rewards, and child involvement in preparation and cooking; (c) setting rules regarding proper eating environment, family meals and schedules; (d) limiting the presence of unhealthy food and beverage temptations at home; (e) limiting TV and other screen time and increasing physical activities; (f) encouraging parents to be positive role models for all these principles.
Experimental: Healthy Sleep Intervention
Healthy Sleep Intervention (HSI)
Comportamental: Healthy Sleep intervention
Healthy Sleep Intervention (HSI)- This online interactive e-learning system will include information for parents on the following topics: (a) establishing appropriate bedtime, including how to assess the sleep needs of their child, how to establish regular bedtime and overall sleep schedule, how to deal with daytime naps; (b) establishing a regular and enjoyable bedtime routine (e.g. bedtime stories); (c) coping with bedtime resistance, setting limits to excessive demands, rewarding appropriate sleep related behaviors; (d) coping with bedtime and nighttime fears, strategies to deal with separation anxieties, fears of darkness, scary imaginative creatures etc; (e) coping with excessive night-wakings and eliminating potential reinforcing consequences; (f) coping with nightmares, night terrors and other parasomnias (e.g., night-walking).
Sem intervenção: Waiting list control
Waiting list control group

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Prazo: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Prazo: Baseline, 6-month follow up
Baseline, 6-month follow up
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Prazo: 1 week post-intervention, 6 month follow up
1 week post-intervention, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Prazo: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in parent reported sleep problems (BCSQ)
Prazo: baseline, 6 month follow up
baseline, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child reported sleep and eating problems
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child reported sleep and eating problems
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child reported sleep and eating problems
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in parent reported nutrition habits of the child and family
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in parent reported nutrition habits of the child and family
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in parent reported nutrition habits of the child and family
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up

Medidas de resultados secundários

Medida de resultado
Prazo
Change in child psychopathological symptoms (SDQ)
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child psychopathological symptoms (SDQ)
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child psychopathological symptoms (SDQ)
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child attention control abilities (computerized tests)
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child attention control abilities (computerized tests)
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child attention control abilities (computerized tests)
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child anthropometric measures (height, weight, blood pressure)
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in reported parental Authority (PAQ-R)
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in reported parental Authority (PAQ-R)
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in reported parental Authority (PAQ-R)
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in cry tolerance and limit setting abilities
Prazo: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in cry tolerance and limit setting abilities
Prazo: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in cry tolerance and limit setting abilities
Prazo: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tel Aviv University

Colaboradores

Israel Science Foundation

Investigadores

  • Investigador principal: Avi Sadeh, Ds.c., Tel Aviv University
  • Investigador principal: Geila Rozen, PhD, Rambam Health Care Campus
  • Investigador principal: Ron Shaoul, M.D., Rambam Health Care Campus

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2014

Conclusão Primária (Real)

1 de novembro de 2018

Conclusão do estudo (Real)

1 de dezembro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

16 de fevereiro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de fevereiro de 2014

Primeira postagem (Estimativa)

24 de fevereiro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • RMB-0425-13

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 .

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