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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226627
• Other study ID #: ELANS-2014
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: September 6, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Hospital Infantil Sabará
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dietary Habits
• Overweight
• Overweight and Obesity
• Physical Activity

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
Mauro Fisberg	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, University of Costa Rica

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Costa Rica,  Ecuador,  Peru,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overweight/obesity	overweight/obesity will be assessed via anthropometric evaluation	baseline	No
Primary	energy intake	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	No
Primary	energy expenditure	accelerometer measurement during 1 week	1 week	No
Secondary	snack intake	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	No
Secondary	beverage intake	Beverage intake will be evaluated using a food frequency questionnaire	after 7 days	No