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

September 6, 2016 updated by: Mauro Fisberg
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • International Life Science Institute (ILSI)
      • Sao Paulo, Brazil
        • Instituto Pensi- Fundação Jose Luiz Setubal - Hospital Infantil Sabara
      • Santiago, Chile
        • Departamento de Nutrición, Diabetes y Metabolismo, Centro de Nutrición Molecular y Enfermedades Crónicas - Pontificia Universidad Católica
      • Bogotá, Colombia
        • Departamento de Nutrición y Bioquímica - Pontificia Universidad Javeriana
      • San José, Costa Rica
        • Departamento de Bioquímica - Escuela de Medicina - Universidad de Costa Rica
      • Quito, Ecuador
        • Universidad San Francisco de Quito
      • Lima, Peru
        • Instituto de Investigacion Nutricional
      • Caracas, Venezuela
        • Centro de Estudios del Desarrollo - Universidade Central da Venezuela (CENDES-UCV)/Fundación Bengoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The sample will include subjects of both sexes, between 15 and 65 years old, considering four age ranges (as see below), that belong to high, middle or low socioeconomic levels (SEL), living in private households in the major cities and other relevant cities in terms of population weight, according to the regions of each of the countries selected for the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overweight/obesity
Time Frame: baseline
overweight/obesity will be assessed via anthropometric evaluation
baseline
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
2 food records will be applied with 7 days apart
energy expenditure
Time Frame: 1 week
accelerometer measurement during 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 food records will be applied with 7 days apart
beverage intake
Time Frame: after 7 days
Beverage intake will be evaluated using a food frequency questionnaire
after 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELANS-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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