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

Sponsor

University Rovira i Virgili (Other)

Overall Status

Completed

CT.gov ID

NCT01362023

Collaborator

Diputació de Tarragona (Other)

800

Enrollment

Location

Arms

Duration (Months)

33.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity	Behavioral: lifestyle counseling	N/A

Detailed Description

Initial pupil enrollment and continued for 3 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

May 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control Control pupils follow their usual activities
Experimental: lifestyle counseling 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	Behavioral: lifestyle counseling 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 Other Names: Childhood obesity

Arm

Intervention/Treatment

No Intervention: control

Control pupils follow their usual activities

Experimental: lifestyle counseling

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

Behavioral: lifestyle counseling

Other Names:

Childhood obesity

Outcome Measures

Primary Outcome Measures

Reduction in prevalence of obesity [Changes from baseline in prevalence of obesity at 3 academic years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spain	Amposta	Tarragona	Spain	Terres de l'Ebre Catalunya

Sponsors and Collaborators

University Rovira i Virgili
Diputació de Tarragona

Investigators

Principal Investigator: Montse Giralt, Md, PhD, Universitat Rovira i Virgili, Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rosa Sola, MD, PhD, University Rovira i Virgili

ClinicalTrials.gov Identifier:

NCT01362023

Other Study ID Numbers:

First Posted:

May 27, 2011

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Oct 6, 2021