Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention (PAAPAS-DC)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention group
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring school-based intervention, sedentary behavior, physical activity, sugar sweetened beverages
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Combine primary prevention activities at the school level with secondary prevention at the household level
No intervention
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
Body composition
body composition will be estimated by bioelectrical impedance, using the leg=to=leg method with Tanita scales
Full Information
NCT ID
NCT02711488
First Posted
February 15, 2016
Last Updated
September 16, 2019
Sponsor
Rio de Janeiro State University
Collaborators
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT02711488
Brief Title
Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
Acronym
PAAPAS-DC
Official Title
Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
school-based intervention, sedentary behavior, physical activity, sugar sweetened beverages
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Combine primary prevention activities at the school level with secondary prevention at the household level
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
one year
Secondary Outcome Measure Information:
Title
Body composition
Description
body composition will be estimated by bioelectrical impedance, using the leg=to=leg method with Tanita scales
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
adherence to the protocol at household level
Description
will be measured by questionnaire
Time Frame
one year
Title
physical activity
Description
will be measured by questionnaire
Time Frame
one year
Title
physical activity
Description
In a subgroup will be measured by accelerometer (GT3X Actigraph).
Time Frame
one year
Title
food intake
Description
Will be assessed by 24-hour recall
Time Frame
one year
Title
food intake
Description
Will be assessed by a short (23 items) food frequency questionnaire (FFQ), reduced from a validated FFQ for Brazilian adolescents.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
27534742
Citation
Sgambato MR, Cunha DB, Henriques VT, Estima CC, Souza BS, Pereira RA, Yokoo EM, Paravidino VB, Sichieri R. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention. BMC Public Health. 2016 Aug 17;16(1):809. doi: 10.1186/s12889-016-3473-3.
Results Reference
derived
Learn more about this trial
Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
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