Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School

Obesity Clinical Trial

Official title:

Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034994
• Other study ID #: IMS-PAPPAS2-project
• Status: Completed
• Phase: N/A
• Start date: February 15, 2014
• Est. completion date: December 15, 2014

Study information

• Verified date: September 2019
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Specific objectives are:

• evaluate the effect of the program on: change in nutritional behaviors, such as reducing sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities gains in school performance and cognition outcomes the amount of daily physical activity on the percentage of body fat, changes in biochemical markers and blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 15, 2014
• Est. primary completion date: November 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

Both prevention programs:

• 6th and 7th grades students

• consent form signed by parents / tutors

Secondary prevention program:

• overweight and obese children

Exclusion Criteria:

• pregnant girls

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

Behavioral:
• Eating behavior and physical activity change
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.

Locations

Country	Name	City	State
Brazil	Public Schools	Niterói	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
Other	Sedentary activities		One year
Other	Sugar sweetened beverages intake		one year
Other	cookies intake		one year
Other	fruits intake		one year
Other	physical activity		one year
Primary	Body Mass Index		One Year
Secondary	Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean		One year