NCT02034994

Brief Summary

The main objective is to evaluate the effects of a multicomponent, school-based intervention combining change in nutritional behaviors with after school physical activity activities in reducing the excessive weight gain in schoolchildren.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable obesity

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 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2014

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

January 10, 2014

Last Update Submit

September 16, 2019

Conditions

Keywords

school-based interventionafter school physical activitysugar sweetened beveragessedentary behaviorschoolchildren

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

Other Outcomes (5)

  • Sedentary activities

    One year

  • Sugar sweetened beverages intake

    one year

  • cookies intake

    one year

  • +2 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity

Behavioral: Eating behavior and physical activity change

Control group

NO INTERVENTION

No intervention

Interventions

A combination of two prevention school based programs will be addressed to schoolchildren over one year. Primary prevention will be developed monthly in order to reduce cookies and sugar sweetened beverages consumption, reduction of sedentary activities, increase meal consumption frequency and quality etc, in all children from 6th and 7th grades. Overweight and obese children will be invited to participate on a secondary prevention program in which daily physical activity classes will be performed by physical education teachers in school facilities.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Both prevention programs:
  • th and 7th grades students
  • consent form signed by parents / tutors
  • Secondary prevention program:
  • \- overweight and obese children

You may not qualify if:

  • pregnant girls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Schools

Niterói, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

ObesitySedentary Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD. Full Professor of Epidemiology

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

February 15, 2014

Primary Completion

November 15, 2014

Study Completion

December 15, 2014

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations