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

Study Overview
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Brief Summary
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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.

Detailed Description
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Initial pupil enrollment and continued for 3 years.

Official Title
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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

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Control pupils follow their usual activities | |
| Experimental: lifestyle counseling<br>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<br>* 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<br>* Other names: Childhood obesity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |