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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
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

9 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 15, 2016
    Last Updated
    September 16, 2019
    Sponsor
    Rio de Janeiro State University
    Collaborators
    Universidade Federal do Rio de Janeiro
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    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

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

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