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

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ClinicalTrials.gov Identifier: NCT01362023
Recruitment Status : Unknown
Verified May 2011 by University Rovira i Virgili.
Recruitment status was:  Enrolling by invitation
First Posted : May 27, 2011
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Diputació de Tarragona
Information provided by:
University Rovira i Virgili

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
Childhood Obesity Behavioral: lifestyle counseling

Detailed Description:
Initial pupil enrollment and continued for 3 years.

Study Type : Interventional  (Clinical Trial)
Estimated 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 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

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 Name: Childhood obesity



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   7 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362023


Locations
Spain
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: URoviraiVirgili
ClinicalTrials.gov Identifier: NCT01362023     History of Changes
Other Study ID Numbers: YES
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms