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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040258
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Other: Health-E-PALS-Pilot Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity-Pilot Study
Actual Study Start Date : March 10, 2008
Actual Primary Completion Date : March 10, 2010
Actual Study Completion Date : March 10, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Intervention group- Health-E-PALS-Pilot
Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons.
Other: Health-E-PALS-Pilot
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

No Intervention: Control group
Group of students not receiving any intervention



Primary Outcome Measures :
  1. Change in knowledge score [ Time Frame: One school year ]
    Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases

  2. Change in dietary habits [ Time Frame: One school year ]
    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)

  3. Change in self-efficacy score [ Time Frame: One school year ]
    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 :
  1. Change in body weight status [ Time Frame: One school year ]
    Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment.



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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Schoolchildren
  • Aged 9 to 11 years

Exclusion Criteria:

- no exclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040258


Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Nahla Houalla, PhD American University of Beirut Medical Center
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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03040258    
Other Study ID Numbers: NUT.NH.12
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American University of Beirut Medical Center:
School-based intervention
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight