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临床试验/NCT01004367
NCT01004367已完成不适用

ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.

University Ghent1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2009年10月1日最近更新:
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
1,400
试验地点
1
主要终点
Behavioural determinants of physical activity and nutrition by determinant questionnaire

研究概览

简要总结

Worldwide, low-income and middle-income countries are undergoing rapid demographic and nutritional changes. Populations tend to move from their traditional food habits towards dietary patterns characterized by a more energy-dense diet, while urbanization and technology (work, transport) play a role in the reduction of their physical activity. This shift towards energy-dense diets and lower levels of physical activity are key determinants of chronic diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public health all in low-income and middle-income countries. Clearly, not properly addressing this health problem will only aggravate the already enormous impact of chronic diseases on the social and economic development of these countries. This study aims to develop a culturally relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old) in Cuenca. The intervention will target behavioural nutrition and physical activity. Intervention strategies will be developed based on theoretical behavioural change models integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and (ii) the Comprehensive Participatory Planning and Evaluation protocol.

The study includes two phases:

  1. A formative research, which will be conducted in order to understand the causality of the school environment and unhealthy eating and low physical activity levels in school-going adolescents, aged 12-13 years old.
  2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster will be randomly assigned to the intervention and the other to the control group.

研究设计

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

入排标准

年龄范围
11 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •11-13 years old
  • •school-going
  • •willing to participate

排除标准

  • •severe medical/physical disorder

研究组 & 干预措施

1

Experimental

Environmental- and individual based components carried out in the school.

干预措施: Experimental (Other)

2

No Intervention

No intervention

结局指标

主要结局

Behavioural determinants of physical activity and nutrition by determinant questionnaire

时间窗: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

Physical activity, physical fitness and sedentarity (questionnaire and accelerometer)

时间窗: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

Food intake by 24h recall

时间窗: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

次要结局

  • Anthropometry(at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
  • Blood pressure(at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
  • Socio-economical questionnaire(at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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