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

September 28, 2021 updated by: Rosa Sola, University Rovira i Virgili

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Initial pupil enrollment and continued for 3 years.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Amposta, Tarragona, Spain, Terres de l'Ebre Catalunya
        • Spain

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

7 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Control pupils follow their usual activities
Experimental: lifestyle counseling

In 3 academic years, the intervention program consisted of three components:

  1. Classroom practice by HPA to highlight healthy lifestyle habits
  2. Teaching practice by HPA using books designed to include the nutritional objectives
  3. Parental activities included with their children

In each of 12 activities (1 h/activity), the classroom practice consisted of three components:

  1. Experimental development of activities regarding each healthy lifestyle habit
  2. Assessment of activity performed in classroom
  3. An activity developed for use at home
Behavioral: lifestyle counseling

In 3 academic years, the intervention program consisted of three components:

  1. Classroom practice by HPA to highlight healthy lifestyle habits
  2. Teaching practice by HPA using books designed to include the nutritional objectives
  3. Parental activities included with their children

In each of 12 activities (1 h/activity), the classroom practice consisted of three components:

  1. Experimental development of activities regarding each healthy lifestyle habit
  2. Assessment of activity performed in classroom
  3. An activity developed for use at home
Other Names:
  • Childhood obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in prevalence of obesity
Time Frame: 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
Changes from baseline in prevalence of obesity at 3 academic years

Collaborators and Investigators

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

Sponsor

University Rovira i Virgili

Collaborators

Diputació de Tarragona

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (Estimate)

May 27, 2011

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yes (OTHER: Beijing 302 Hospital)

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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