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

NCT ID: NCT01362023

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Initial pupil enrollment and continued for 3 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

Control pupils follow their usual activities

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

lifestyle counseling

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Childhood obesity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diputació de Tarragona

UNKNOWN

Sponsor Role collaborator

University Rovira i Virgili

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rosa Sola

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Montse Giralt, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Rovira i Virgili, Spain

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Spain

Amposta, Tarragona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25412862 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

YES

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Overweight and Obesity in Preschoolers
NCT03800823 ACTIVE_NOT_RECRUITING NA
Lille Study for Childhood Health Promotion
NCT05121090 NOT_YET_RECRUITING