Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention

Obesity Clinical Trial

— PAAPAS-DC  

Official title:

Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711488
• Other study ID #: IMS-PAAPAS-project
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 1, 2016

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 objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.

Description:

The study will combine primary prevention activities at the school level with secondary prevention at the household level, both focusing on behavior strategies such as mindfulness, reduction of eating rate; eating with others at a dinning table; healthy eating, increasing physical activity and reducing sedentary lifestyle habits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 1, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

• Both prevention programs

• 5th and 6th grades students

• consent form signed by parents/tutors

• Secondary prevention program

• Overweight and obese children

Exclusion Criteria:

• pregnant girls

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Intervention group
The proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes. The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adherence to the protocol at household level	will be measured by questionnaire	one year
Other	physical activity	will be measured by questionnaire	one year
Other	physical activity	In a subgroup will be measured by accelerometer (GT3X Actigraph).	one year
Other	food intake	Will be assessed by 24-hour recall	one year
Other	food intake	Will be assessed by a short (23 items) food frequency questionnaire (FFQ), reduced from a validated FFQ for Brazilian adolescents.	one year
Primary	Body Mass Index		one year
Secondary	Body composition	body composition will be estimated by bioelectrical impedance, using the leg=to=leg method with Tanita scales	one year