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临床试验/NCT02082080
NCT02082080Unknown4 期

Prevention and Control of Obesity in Primary School Children in Tehran

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
360
试验地点
1
主要终点
Change from baseline in pain on the 11-point Short Pain Scale (SPS-11) at week 24 Change from baseline BMI (Body Mass Index) at 6 months

研究概览

简要总结

This study evaluates the effect of an interventional model for preventing and controlling overweight and obesity in male and female fifth-graders. First, based on WHO (World Health Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be screened. Then from the screened students 30 students with the following inclusion criteria will be recruited: not metabolically ill, not on a weight losing diet and not professionally athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic data, as well as data on waist and hip circumference, triceps skin-fold thickness, food intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be collected at the beginning and at end of the 6-month intervention. The approach of the study will be Health Promoting Schools. The intervention includes three components, i.e., nutrition education (students and parents), increased physical activity, and changing environment (food items offered in schools' canteens). Nutrition education will be imparted (a 30-minute session per week) by health instructors; physical activity will be done under the supervision of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session) will be monthly. Finally the efficacy of the intervention will be determined and reported.

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
None

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •BMI-Z-Score> or =1 (WHO)
  • •Students in the fifth or sixth grades

排除标准

  • •Metabolic disorders (hypo or hyperthyroidism)
  • •Any disease which interfere with adherence to the intervention
  • •Intake of any appetite-reducing drug
  • •Doing professional sports
  • •Being on a weight reduction diet

研究组 & 干预措施

Obese and overweight children, education

Active Comparator

Overweight and obese school children in grades 5 and 6

干预措施: Social support (Other)

Obese and overweight children

No Intervention

Obese and overweight children, education

Active Comparator

Overweight and obese school children in grades 5 and 6

干预措施: Education (Other)

结局指标

主要结局

Change from baseline in pain on the 11-point Short Pain Scale (SPS-11) at week 24 Change from baseline BMI (Body Mass Index) at 6 months

时间窗: Baseline, month 6

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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