The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity

March 4, 2020 updated by: American University of Beirut Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1239

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Schoolchildren Aged 8-12 years

Exclusion Criteria:

  • no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Group of students not receiving any intervention
Experimental: Intervention group
Implementation of Ajyal Salima intervention to promote healthy eating and encourage physical activity in Lebanese school-children.
Other: Ajyal Salima
It comprises in class-activities, meetings with parents and improvement of school foodservice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge score
Time Frame: 3 school years
Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases
3 school years
Change in dietary habits
Time Frame: 3 school years
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)
3 school years
Change in self-efficacy score
Time Frame: 3 school years
Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases
3 school years
Change in Body Mass Index
Time Frame: 3 school years
Change in mean BMIz scores (based on anthropometric measurements during pre- and post- assessment phases
3 school years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUT.NH.16

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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