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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Diputació de Tarragona
Information provided by:
University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT01362023
First received: May 23, 2011
Last updated: June 9, 2011
Last verified: May 2011
  Purpose

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 Intervention
Childhood Obesity
Behavioral: lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • Reduction in prevalence of obesity [ Time Frame: Changes from baseline in prevalence of obesity at 3 academic years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 800
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Initial pupil enrollment and continued for 3 years.

  Eligibility

Ages Eligible for Study:   7 Years to 8 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: URoviraiVirgili
ClinicalTrials.gov Identifier: NCT01362023     History of Changes
Other Study ID Numbers: YES
Study First Received: May 23, 2011
Last Updated: June 9, 2011
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on July 08, 2014