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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mauro Fisberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pontificia Universidad Catolica de Chile
Pontificia Universidad Javeriana
Universidad de Costa Rica
Universidad Central de Venezuela
International Life Sciences Institute, Argentina
Universidad San Francisco de Quito
Instituto de Investigacion Nutricional, Peru

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mauro Fisberg, MD PhD, Instituto Pensi- Fundação Jose Luiz Setubal - Hospital Infantil Sabara

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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