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Eating Habits and Obesity in First and Second Grade School Children

11 de junho de 2018 atualizado por: Hadassah Medical Organization

The Influence of the Family as Agents of Change on Eating Habits and Obesity in First and Second Grade School Children in Israel.

Purpose: In the framework of a randomized concurrent controlled trial, to assess the effectiveness of a feasible educational mechanism based on the principles of Alfred Adler, that focuses on the family, to improve the dietary habits of schoolchildren, to induce them to increase their physical activity, and to prevent obesity and diseases related to obesity. Primary Objectives for Children: 1.To increase intake of fruits and vegetables, to reduce intake of sweets and unhealthy snacks at home and in school, to increase exercise and to reduce sedentary activities. Primary Objective for the Parents: Increase the involvement of parents in the education of their children regarding nutrition.

Description: Study population: Approximately 600 students and 600 parents from 24 first grade classes in 4 schools. Schools are randomized into intervention and control groups. The intervention comprises a 5-session parental workshop and 5 joint parent-child school-based activities. The control group will be offered the intervention after conclusion of the trial.

Participants are recruited in first grade, anthropometrics are measured, and pupils and parents are interviewed on eating habits and exercise. Snacks are observed. The intervention takes place in the second grade, and outcome assessment is done at the end of the 2nd grade and beginning of the 3rd grade. In-depth interviews will be conducted with parents of obese children.

Significance: Most interventions geared to prevention of childhood obesity have failed dismally. A new approach that focuses on the parent-child interaction may be contributory.

Visão geral do estudo

Descrição detalhada

Of the 743 children in 23 2nd grade classes in 4 schools, parents provided informed consent for 508 (68%), and again for 432 (58%) at the 3rd grade follow-up.

First stage of Recruiting 2007-2008: 3 first grade in each of 4 schools participating in the study. Total 12 classes. After the recruitment, initial data collection was conducted.

2008-2009: Allocation of students in 2nd grade from cycle 1 to intervention and control groups. Intervention in the experimental group. Data collection at the beginning and end of second grade. Recruiting new first grade classes (cycle 2), Primary data collection was conducted.

2009-2010: Completion of the follow-up cycle I. Last data collection at the beginning of the third grade. Allocation students 2nd grade from cycle 2 for intervention or control groups. Intervention in the experimental group of cycle 2. Data collection at the beginning and end of the second grade.

2010-2011: End of follow-up cycle 2. Collect data at the beginning of the third grade.

Description of the Intervention:

  1. 5 joint parent-child classroom activities on the subject of nutrition, undertaken separately in the 12 intervention classes of the 4 clusters (ie. 60 sessions).
  2. 5 workshops based on the approach of Adler that were restricted to parents, undertaken separately in the evenings for the 12 intervention classes (ie 60 sessions).

The control group (11 classes) had no intervention, but was identically monitored from first through third grade.

Tipo de estudo

Intervencional

Inscrição (Real)

508

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

      • Jerusalem, Israel, 91120
        • Hadassah University Hospital

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

6 anos a 9 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • All children in regular first grade classes in 4 schools whose parents provided informed consent

Exclusion Criteria:

  • Schools with separate classes for boys and girls, and schools/classes for children with special needs

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: braço de controle
Experimental: behavioral intervention
Behavioral intervention arm comprises 5 joint parent-child school-based nutritional activities in which nutritional information was combined with Adler's behavioral concepts. and a 5-session parental workshop.

Description of the Intervention:

5 joint classroom activities (parents and children together, involving children in food choices/food preparation-sense of belonging/decision making): 1. Healthy breakfasts and 10 o'clock snacks 2. Fats and oils in the diet, cooking methods, setting limits to oily food intake. 3. Fruit and vegetables in the daily diet, adults as role models. 4. Learning about food categories & pyramid, healthy eating and growth. 5. Limiting consumption of sweets and snacks.

Workshop for Parents: Explaining nutritional needs of children; how to encourage good eating habits, how to deal with children's manipulations, providing tools to elicit change; use of food to attract parental attention; practical tools to deal with their children's eating habits/obesity/refusal to eat/chronic health problems/failure to grow; ways to prevent use of food as an answer to childhood frustrations.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks
Prazo: first grade to third grade
first grade to third grade

Medidas de resultados secundários

Medida de resultado
Prazo
change in BMI and waist circumference
Prazo: first grade to third grade
first grade to third grade

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Tori Goldstein, MSC, Hebew University Faculty of Medicine
  • Investigador principal: Jeremy D Kark, MD PhD, Hadassah Medical Organization

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

1 de março de 2008

Conclusão Primária (Real)

1 de dezembro de 2010

Conclusão do estudo (Real)

1 de fevereiro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

14 de outubro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de outubro de 2009

Primeira postagem (Estimativa)

15 de outubro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de junho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de junho de 2018

Última verificação

1 de outubro de 2009

Mais Informações

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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