NCT01046474

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

January 11, 2010

Last Update Submit

July 19, 2011

Conditions

Keywords

school childrenbody mass indexsugar intakebeverage intake

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    one year

Secondary Outcomes (1)

  • Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean

    one year

Study Arms (2)

reducing beverages and sugar and increase physical activity

EXPERIMENTAL

reduction of beverages and sugar and increasing physical activity

Behavioral: lifestyle

control -no intervention

NO INTERVENTION

Interventions

lifestyleBEHAVIORAL

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.

reducing beverages and sugar and increase physical activity

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • th grades

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

20 Schools of Metropolitan Area

Duque de Caxias, Rio de Janeiro, Brazil

Location

Related Publications (2)

  • Munoz-Espinosa LE, Torre A, Cisneros L, Montalvo I, Male R, Mejia S, Aguilar JR, Lizardi J, Zuniga-Noriega J, Eugenia Icaza M, Gasca-Diaz F, Hernandez-Hernandez L, Cordero-Perez P, Chi L, Torres L, Rodriguez-Alvarez F, Tapia G, Poo JL. Noninvasive Evaluation of Prolonged-Release Pirfenidone in Compensated Liver Cirrhosis. ODISEA Study, a Randomised Trial. Liver Int. 2025 Jun;45(6):e70131. doi: 10.1111/liv.70131.

  • Cunha DB, de Souza Bda S, Pereira RA, Sichieri R. Effectiveness of a randomized school-based intervention involving families and teachers to prevent excessive weight gain among adolescents in Brazil. PLoS One. 2013;8(2):e57498. doi: 10.1371/journal.pone.0057498. Epub 2013 Feb 25.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations