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Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health-E-PALS-Pilot
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 School-based intervention

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Schoolchildren
  • Aged 9 to 11 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- Health-E-PALS-Pilot

    Control group

    Arm Description

    Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons.

    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 -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 -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 -post assessment phases

    Secondary Outcome Measures

    Change in body weight status
    Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment.

    Full Information

    First Posted
    January 25, 2017
    Last Updated
    January 31, 2017
    Sponsor
    American University of Beirut Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03040258
    Brief Title
    Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study
    Official Title
    Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity-Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 10, 2008 (Actual)
    Primary Completion Date
    March 10, 2010 (Actual)
    Study Completion Date
    March 10, 2010 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity
    Keywords
    School-based intervention

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group- Health-E-PALS-Pilot
    Arm Type
    Experimental
    Arm Description
    Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Group of students not receiving any intervention
    Intervention Type
    Other
    Intervention Name(s)
    Health-E-PALS-Pilot
    Intervention Description
    Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service
    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 -post assessment phases
    Time Frame
    One school year
    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 -post assessment phases)
    Time Frame
    One school year
    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 -post assessment phases
    Time Frame
    One school year
    Secondary Outcome Measure Information:
    Title
    Change in body weight status
    Description
    Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment.
    Time Frame
    One school year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Schoolchildren Aged 9 to 11 years Exclusion Criteria: - no exclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nahla Houalla, PhD
    Organizational Affiliation
    American University of Beirut Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study

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