NCT03040258

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

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

March 10, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2010

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

January 25, 2017

Last Update Submit

January 31, 2017

Conditions

Childhood Obesity

Keywords

School-based intervention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Change in body weight status

    One school year

Study Arms (2)

Intervention group- Health-E-PALS-Pilot

EXPERIMENTAL

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

Control group

NO INTERVENTION

Group of students not receiving any intervention

Interventions

Health-E-PALS-PilotOTHER

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

Intervention group- Health-E-PALS-Pilot

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schoolchildren
  • Aged 9 to 11 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 Officials

  • Nahla Houalla, PhD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

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

January 25, 2017

First Posted

February 2, 2017

Study Start

March 10, 2008

Primary Completion

March 10, 2010

Study Completion

March 10, 2010

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share