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School-Based Intervention Program to Promote Healthy Eating and Physical Activity

Primary Purpose

Obesity, Childhood, Health Behavior, Physical Activity

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring School-Based Intervention, Ecological Model, Participatory Approach, Palestinian Female Schoolchildren

Eligibility Criteria

4 Years - 65 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • East Jerusalem Female Schoolchildren

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model.

    Regular school curriculum

    Outcomes

    Primary Outcome Measures

    Change in percent of schoolchildren eating breakfast daily
    Change in percent of schoolchildren eating breakfast will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
    Change in percent of schoolchildren performing physical activity for ≥ 5 days per week
    Change in percent of schoolchildren performing physical activity for ≥ 5 days per week will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
    Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables
    Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
    Change in teachers' engagement
    Change in teachers' engagement will be assessed through a self report questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2017
    Last Updated
    April 23, 2023
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03205293
    Brief Title
    School-Based Intervention Program to Promote Healthy Eating and Physical Activity
    Official Title
    School-Based Intervention Program to Promote Healthy Eating and Physical Activity Using Participatory Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    December 1, 2021 (Actual)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this research is to develop, apply, and evaluate a school-based intervention program in East Jerusalem schools, designed to increase knowledge and to improve the attitudes and healthy behavior of schoolchildren, their teachers and their mothers' with regard to healthy eating and physical activity habits. The study tested the hypothesis that the impact of the entire school intervention program on students' lifestyles is mediated by their teachers' engagement in health promotion and by their mothers' involvement in school activity.
    Detailed Description
    A randomized controlled intervention program trial was carried out in 14 females' schools in East Jerusalem, selected randomly by a stratified sampling of four groups of schools. The primary target population was the students, while the secondary target populations were the mothers and the teachers at these schools. From the schools operating in East Jerusalem (Palestinian Authority, Jerusalem Municipality, private, and United Nations Relief and Works Agency) grades 4 and 5 were considered eligible to participate in the pre- and post-intervention studies. The study process was designed, using the ecological model, in three stages; Stage one: Need assessment stage (pre-intervention, March-Jun 2011): A semi-structured interview was used with all 14 school principals, and a structured self-administered questionnaire was used with all teachers. A random sample of a 4th and 5th grade classes was selected, in which all mothers and their daughters were eligible to answer a self-administered questionnaire. The height and weight of the children were measured during this stage. These measurements were the baseline for assessing the current situation. In addition to school inspection tours was done to assess the school's health environment. Stage two: Action stage (intervention, September 2011-June 2013): A random allocation of schools into intervention and control groups was done, followed by participatory planning and administration of the intervention in each of the 7 schools based on their needs assessments and assets. The program was implemented and administered by a steering committee in each of the schools, consisting of teachers, mothers, and children. Teachers underwent trainings in nutrition and physical activity. The program activities were monitored by regular visits twice a month. The implementation team met every four to six weeks to review the progress. Stage three: Evaluation (post intervention, February-April 2013): Evaluation of the program was done after eighteen months of intervention using the same assessment questionnaires for both intervention and control schools among a different sample of children from grades 4 and 5, their mothers, and all of the teachers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood, Health Behavior, Physical Activity, Dietary Habits
    Keywords
    School-Based Intervention, Ecological Model, Participatory Approach, Palestinian Female Schoolchildren

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomized control program trial, pre-post study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Regular school curriculum
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
    Primary Outcome Measure Information:
    Title
    Change in percent of schoolchildren eating breakfast daily
    Description
    Change in percent of schoolchildren eating breakfast will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
    Time Frame
    At Baseline and 18 months after intervention
    Title
    Change in percent of schoolchildren performing physical activity for ≥ 5 days per week
    Description
    Change in percent of schoolchildren performing physical activity for ≥ 5 days per week will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
    Time Frame
    At Baseline and 18 months after intervention
    Title
    Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables
    Description
    Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
    Time Frame
    At Baseline and 18 months after intervention
    Title
    Change in teachers' engagement
    Description
    Change in teachers' engagement will be assessed through a self report questionnaire
    Time Frame
    At Baseline and 18 months after intervention

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female Schoolchildren, their mothers and teachers
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: East Jerusalem Female Schoolchildren Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donna Zwas, MD, MPH
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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