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临床试验/NCT00995267
NCT00995267已完成不适用

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

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 508 人开始时间: 2008年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
508
试验地点
2
主要终点
Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

behavioral intervention

Experimental

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.

干预措施: parent-child interaction/activities based on Adler's methods (Behavioral)

control arm

No Intervention

结局指标

主要结局

Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks

时间窗: first grade to third grade

次要结局

  • change in BMI and waist circumference(first grade to third grade)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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