search
Back to results

Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2 (EDAL2)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
lifestyle counseling
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

7 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In the intervention group, all children of the selected classroom are exposed to the intervention.
  • The data a will collected on all the children, but only the data from individuals (and their parents) who provided informed consent are included in the final analyses.
  • Name, gender, date and place of birth are recorded at the start of the program, while weight, height, body mass index (BMI) and waist circumference variables (identified set of anthropometric measures) are recorded in each of the 3 academic years of the study.

Exclusion Criteria:

  • No adequate age
  • Lack of inclusion criteria

Sites / Locations

  • Spain

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

lifestyle counseling

Arm Description

Control pupils follow their usual activities

In 3 academic years, the intervention program consisted of three components: Classroom practice by HPA to highlight healthy lifestyle habits Teaching practice by HPA using books designed to include the nutritional objectives Parental activities included with their children In each of 12 activities (1 h/activity), the classroom practice consisted of three components: Experimental development of activities regarding each healthy lifestyle habit Assessment of activity performed in classroom An activity developed for use at home

Outcomes

Primary Outcome Measures

Reduction in prevalence of obesity
Primary outcomes include obesity (BMI ≥95th percentile) and overweight (BMI ≥85th percentile) We will analyzed obesity and overweight and a measure of thinness according to the Cole criteria as well as other measures of adiposity such as BMI z score and waist circumference. The numbers of subjects having a particular dietary habit are expressed as percentages of the total number of individuals being evaluated

Secondary Outcome Measures

Full Information

First Posted
May 23, 2011
Last Updated
September 28, 2021
Sponsor
University Rovira i Virgili
Collaborators
Diputació de Tarragona
search

1. Study Identification

Unique Protocol Identification Number
NCT01362023
Brief Title
Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2
Acronym
EDAL2
Official Title
A Primary-school-based Study to Reduce Prevalence of Childhood Obesity in Terres de l'Ebre (Catalunya (Spain) - EDAL-Educació en Estils Saludables de Vida alimentació-2: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili
Collaborators
Diputació de Tarragona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university students acting as "health promoting agents" (HPA) on the prevalence of obesity.
Detailed Description
Initial pupil enrollment and continued for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Control pupils follow their usual activities
Arm Title
lifestyle counseling
Arm Type
Experimental
Arm Description
In 3 academic years, the intervention program consisted of three components: Classroom practice by HPA to highlight healthy lifestyle habits Teaching practice by HPA using books designed to include the nutritional objectives Parental activities included with their children In each of 12 activities (1 h/activity), the classroom practice consisted of three components: Experimental development of activities regarding each healthy lifestyle habit Assessment of activity performed in classroom An activity developed for use at home
Intervention Type
Behavioral
Intervention Name(s)
lifestyle counseling
Other Intervention Name(s)
Childhood obesity
Intervention Description
In 3 academic years, the intervention program consisted of three components: Classroom practice by HPA to highlight healthy lifestyle habits Teaching practice by HPA using books designed to include the nutritional objectives Parental activities included with their children In each of 12 activities (1 h/activity), the classroom practice consisted of three components: Experimental development of activities regarding each healthy lifestyle habit Assessment of activity performed in classroom An activity developed for use at home
Primary Outcome Measure Information:
Title
Reduction in prevalence of obesity
Description
Primary outcomes include obesity (BMI ≥95th percentile) and overweight (BMI ≥85th percentile) We will analyzed obesity and overweight and a measure of thinness according to the Cole criteria as well as other measures of adiposity such as BMI z score and waist circumference. The numbers of subjects having a particular dietary habit are expressed as percentages of the total number of individuals being evaluated
Time Frame
Changes from baseline in prevalence of obesity at 3 academic years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In the intervention group, all children of the selected classroom are exposed to the intervention. The data a will collected on all the children, but only the data from individuals (and their parents) who provided informed consent are included in the final analyses. Name, gender, date and place of birth are recorded at the start of the program, while weight, height, body mass index (BMI) and waist circumference variables (identified set of anthropometric measures) are recorded in each of the 3 academic years of the study. Exclusion Criteria: No adequate age Lack of inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montse Giralt, Md, PhD
Organizational Affiliation
Universitat Rovira i Virgili, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spain
City
Amposta
State/Province
Tarragona
ZIP/Postal Code
Terres de l'Ebre Catalunya
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25412862
Citation
Llaurado E, Tarro L, Morina D, Queral R, Giralt M, Sola R. EdAl-2 (Educacio en Alimentacio) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. BMJ Open. 2014 Nov 20;4(11):e005496. doi: 10.1136/bmjopen-2014-005496.
Results Reference
derived

Learn more about this trial

Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2

We'll reach out to this number within 24 hrs