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

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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Other: Health-E-PALS-Pilot

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Schoolchildren
• Aged 9 to 11 years

Exclusion Criteria:

- no exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Group of students not receiving any intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One school year
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)	One school year
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	One school year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight status	Change in Body Mass Index - BMI (in kg/m^2) at pre- and post-assesment.	One school year

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Nahla Houalla, PhD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2008
• Primary Completion (Actual): March 10, 2010
• Study Completion (Actual): March 10, 2010

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: School-based intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: NUT.NH.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No