Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2
EDAL2
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
1 other identifier
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedOctober 6, 2021
September 1, 2021
2 years
May 23, 2011
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
control
NO INTERVENTIONControl pupils follow their usual activities
lifestyle counseling
EXPERIMENTALIn 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No adequate age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Rovira i Virgililead
- Diputació de Tarragonacollaborator
Study Sites (1)
Spain
Amposta, Tarragona, Terres de l'Ebre Catalunya, Spain
Related Publications (1)
Llaurado E, Tarro L, Morina D, Queral R, Giralt M, Sola R. EdAl-2 (Educacio en Alimentacio) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. BMJ Open. 2014 Nov 20;4(11):e005496. doi: 10.1136/bmjopen-2014-005496.
PMID: 25412862DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Montse Giralt, Md, PhD
Universitat Rovira i Virgili, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 27, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 6, 2021
Record last verified: 2021-09