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

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ClinicalTrials.gov Identifier: NCT02226627
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : September 8, 2016
Sponsor:
Collaborators:
International Life Sciences Institute, Argentina
Pontificia Universidad Catolica de Chile
Pontificia Universidad Javeriana
Universidad de Costa Rica
Universidad San Francisco de Quito
Instituto de Investigacion Nutricional, Peru
Universidad Central de Venezuela
Information provided by (Responsible Party):
Mauro Fisberg, Hospital Infantil Sabará

Brief Summary:
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.

Condition or disease
Dietary Habits Physical Activity Overweight and Obesity

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Study Type : Observational
Actual Enrollment : 9000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Latin American Survey of Nutrition and Health / Estudio Latinoamericano de Nutrición y Salud
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226627


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mauro Fisberg, MD, PhD, Hospital Infantil Sabará
ClinicalTrials.gov Identifier: NCT02226627     History of Changes
Other Study ID Numbers: ELANS-2014
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms