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

Childhood Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362023
• Other study ID #: YES
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2021
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Initial pupil enrollment and continued for 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Spain	Spain	Amposta	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
University Rovira i Virgili	Diputació de Tarragona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline in prevalence of obesity at 3 academic years