NCT04297059

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

March 4, 2020

Last Update Submit

March 4, 2020

Conditions

Childhood Obesity

Keywords

BMIHealth policiesSchool health promotionIntervention

Outcome Measures

Primary Outcomes (4)

  • Change in knowledge score

    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

    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

    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

    Change in mean BMIz scores (based on anthropometric measurements during pre- and post- assessment phases

    3 school years

Study Arms (2)

Intervention group

EXPERIMENTAL

Implementation of Ajyal Salima intervention to promote healthy eating and encourage physical activity in Lebanese school-children.

Other: Ajyal Salima

Control group

NO INTERVENTION

Group of students not receiving any intervention

Interventions

Ajyal SalimaOTHER

It comprises in class-activities, meetings with parents and improvement of school foodservice

Intervention group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schoolchildren Aged 8-12 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 5, 2020

Study Start

September 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share