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The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ajyal Salima
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring BMI, Health policies, School health promotion, Intervention

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Schoolchildren Aged 8-12 years

Exclusion Criteria:

  • no exclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Implementation of Ajyal Salima intervention to promote healthy eating and encourage physical activity in Lebanese school-children.

    Group of students not receiving any intervention

    Outcomes

    Primary Outcome Measures

    Change in knowledge score
    Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases
    Change in dietary habits
    Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and all post- assessment phases)
    Change in self-efficacy score
    Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases
    Change in Body Mass Index
    Change in mean BMIz scores (based on anthropometric measurements during pre- and post- assessment phases

    Secondary Outcome Measures

    Full Information

    First Posted
    March 4, 2020
    Last Updated
    March 4, 2020
    Sponsor
    American University of Beirut Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04297059
    Brief Title
    The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity
    Official Title
    2-year Intervention and 1-year Follow-up of a School-based Programme to Promote Healthy Behaviours and Prevent Childhood Obesity in Lebanese Children: the Healthier Kids - Ajyal Salima Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    American University of Beirut Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study was carried out to determine the long-term effectiveness of a school-based intervention programme when implemented over 2 years and its sustained effect one year later.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity
    Keywords
    BMI, Health policies, School health promotion, Intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1239 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Implementation of Ajyal Salima intervention to promote healthy eating and encourage physical activity in Lebanese school-children.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Group of students not receiving any intervention
    Intervention Type
    Other
    Intervention Name(s)
    Ajyal Salima
    Intervention Description
    It comprises in class-activities, meetings with parents and improvement of school foodservice
    Primary Outcome Measure Information:
    Title
    Change in knowledge score
    Description
    Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases
    Time Frame
    3 school years
    Title
    Change in dietary habits
    Description
    Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and all post- assessment phases)
    Time Frame
    3 school years
    Title
    Change in self-efficacy score
    Description
    Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases
    Time Frame
    3 school years
    Title
    Change in Body Mass Index
    Description
    Change in mean BMIz scores (based on anthropometric measurements during pre- and post- assessment phases
    Time Frame
    3 school years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Schoolchildren Aged 8-12 years Exclusion Criteria: no exclusion criteria

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity

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