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

Physical Activity Clinical Trial

— PAPAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046474
• Other study ID #: IMS-PAPAS-project
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2010
• Last updated: July 19, 2011
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

• 5th grades

Exclusion Criteria:

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Beans Intake
• Beverage Intake
• Fruit Intake
• Physical Activity
• Sugar Intake

Intervention

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.

Locations

Country	Name	City	State
Brazil	20 Schools of Metropolitan Area	Duque de Caxias	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index		one year	No
Secondary	Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean		one year	No