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临床试验/NCT02226627
NCT02226627已完成不适用

Latin American Survey of Nutrition and Health / Estudio Latinoamericano de Nutrición y Salud

Mauro Fisberg8 个研究点 分布在 8 个国家目标入组 9,000 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9,000
试验地点
8
主要终点
overweight/obesity

研究概览

简要总结

This study aims to make a proper scientific assessment on the dietary intake and physical activity levels of a representative sample of the urban population of 8 Latin American countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The study was based on complex, multistage sample design, stratified by conglomerates, being all regions of each country represented, and random selection of main cities within each region according to probability proportional to size method. Sample will be stratified by gender, age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and divided in three strata (high, medium and low) based on national indexes used in each country. All the study sites are university-based and will adhere to a common study protocol for training, implementation of fieldwork, data collection and management, and quality control procedures to be performed simultaneously. All participants will be required to provide a written informed consent. A pilot study at small scale will be performed in each country in order to test procedures and tools involved in ELANS. Anthropometric variables, including body weight, height, waist, hip and neck circumferences will be measured according to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire. Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota University) after a harmonization process between local foods and NDSR database. Physical activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day accelerometry.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • males and females
  • 15 to 65 years old

排除标准

  • Adolescents without assent and parent´s or legal guardian´s permission will be excluded
  • Any adolescent or adult with mental and/or physical disability will be excluded.
  • Any adolescent or adult with a chronic or acute illness that may affect normal eating behavior or energy expenditure will be excluded.
  • Pregnant and nursing women of a child younger than 6 months will be excluded.
  • Any adolescent or adult who is not able to read will be excluded.
  • Any adolescent or adult who is not present at or refuses to accept the second visit will be excluded.
  • Any adolescent or adult living in any residential settings different from a household (hospitals, regiments, homes, such as old-age homes, etc.) and mobile homes or trailers are excluded.

结局指标

主要结局

overweight/obesity

时间窗: baseline

overweight/obesity will be assessed via anthropometric evaluation

energy intake

时间窗: 2 food records will be applied with 7 days apart

Nutritional intake will be performed using two 24-hour dietary recalls, with 'multiple pass' procedure

energy expenditure

时间窗: 1 week

accelerometer measurement during 1 week

次要结局

  • snack intake(2 food records will be applied with 7 days apart)
  • beverage intake(after 7 days)

研究者

发起方
Mauro Fisberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mauro Fisberg

MD, PhD

Hospital Infantil Sabará

研究点 (8)

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