Reducing Beverages and Sugar and Increasing Physical Activity in Public School Adolescents From Brazil (PAPAS)

This study has been completed.
Sponsor:
Collaborator:
Universidade Federal do Rio de Janeiro
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01046474
First received: January 11, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.


Condition Intervention Phase
Sugar Intake
Beverage Intake
Fruit Intake
Beans Intake
Physical Activity
Behavioral: lifestyle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro

Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • Body mass index [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: reducing beverages and sugar and increase physical activity
reduction of beverages and sugar and increasing physical activity
Behavioral: lifestyle

Based on beliefs and behaviors of children sections of education will be delivered via classroom activities.

Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.

Children will also be stimulated to increase everyday activities such as walking and playing games at home and school. Also, activities with parents and family members such as walking around the neighborhood on weekends will be promoted.

No Intervention: control -no intervention

Detailed Description:

Specific objectives are:

  1. To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program.
  2. To compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools.
  3. To evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias.
  4. To compare change in family expenditures with sweetened beverages and sugar.
  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 5th grades

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046474

Locations
Brazil
20 Schools of Metropolitan Area
Duque de Caxias, Rio de Janeiro, Brazil
Sponsors and Collaborators
Rio de Janeiro State University
Universidade Federal do Rio de Janeiro
  More Information

Additional Information:
No publications provided by Rio de Janeiro State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rosely Sichieri, State University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01046474     History of Changes
Other Study ID Numbers: IMS-PAPAS-project
Study First Received: January 11, 2010
Last Updated: July 19, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Rio de Janeiro State University:
school children
body mass index
sugar intake
beverage intake

ClinicalTrials.gov processed this record on April 15, 2014