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OpenTrials
Completed

NCT Number: NCT02226627

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

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Life Science Institute (ILSI), Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males and females
  • 15 to 65 years old

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. overweight/obesity

    Time frame: baseline

    overweight/obesity will be assessed via anthropometric evaluation

  2. energy intake

    Time frame: 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

  3. energy expenditure

    Time frame: 1 week

    accelerometer measurement during 1 week

Secondary outcomes

  1. snack intake

    Time frame: 2 food records will be applied with 7 days apart

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

  2. beverage intake

    Time frame: after 7 days

    Beverage intake will be evaluated using a food frequency questionnaire

Sponsors and collaborators

Lead sponsor

Mauro Fisberg

Other

Collaborators

  • Instituto de Investigacion Nutricional, Peru
  • International Life Sciences Institute, Argentina
  • Pontificia Universidad Catolica de Chile
  • Pontificia Universidad Javeriana
  • Universidad Central de Venezuela
  • Universidad San Francisco de Quito
  • Universidad de Costa Rica

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2014
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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