Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/05/2010
Date assigned
28/05/2010
Last edited
18/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Montserrat Giralt

ORCID ID

Contact details

C/Sant Llorenç
nº 21
Reus
43201
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled clinical trial to assess the efficacy of an educational school-based intervention to reduce prevalence of obesity in childhood in Catalonia

Acronym

EdAl

Study hypothesis

A regular systematic educational intervention in primary school improves lifestyle and reduces obesity.

Ethics approval

Comite etic d'investigacio clinica de l'Hospital Universitari Sant Joan de Reus approved on the 29th July 2008 (ref: 08-07-24/07aclproj1)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

Intervention:
Four educational activities/year for 3 years (a total of 12 activities), of 8 nutritional objectives and physical activity performed by health agents in primary schools. Weight, height, body mass index (BMI) and waist circumference measures will be taken at each year by 3 years. A questionnaire about eating and physical activity habits questionnaire will be filled by the parents each year, 3 times.

Control:
Scholars will follow usual activities in primary schools. Weight, height, BMI and waist circumference measures will be taken at each year by 3 years. A questionnaire about eating and physical activity habits questionnaire will be filled by the parents at the inclusion and final visits.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To reduce prevalence of obesity.

All measures have taken in May of 2006, 2007, 2008, 2009, 2010.

Secondary outcome measures

1. To improve dietary and physical activity habits
2. To measure weight, height, BMI, waist circumference measures will be taken at each visit

All measures have taken in May of 2006, 2007, 2008, 2009, 2010.

Overall trial start date

01/04/2006

Overall trial end date

30/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary scholars aged 6 to 9 years from Cambrils, Reus, Salou and Vilaseca
2. Public and private schools

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

700 participants in control and 700 participants in intervention groups

Participant exclusion criteria

Not adequate age

Recruitment start date

01/04/2006

Recruitment end date

30/12/2010

Locations

Countries of recruitment

Spain

Trial participating centre

C/Sant Llorenç, nº 21
Reus
43201
Spain

Sponsor information

Organisation

University of Rovira i Virgili (Universitat Rovira i Virgili) (Spain)

Sponsor details

Facultat de Medicina i Ciències de la Salut
C/Sant LLorenç
nº 21
Reus
43201
Spain

Sponsor type

University/education

Website

http://www.urv.cat

Funders

Funder type

Government

Funder name

Reddis Private Foundation (Fundació Privada Reddis) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Municipality of Reus (Ajuntament de Reus) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Health (Conselleria de Salut) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Government of Catalonia (Generalitat de Catalunya) (Spain)

Alternative name(s)

Government of Catalonia

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Funder name

Central Markey of Reus (Mercat Central de Reus) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Protected Designation of Origin Siurana (DOP Siurana) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

La Morella Nuts (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Technological Centre of Nutritional Health CT09-1-0019 (Centre Tecnològic de Nutrició i Salut) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21352597
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24529258

Publication citations

  1. Protocol

    Giralt M, Albaladejo R, Tarro L, Moriña D, Arija V, Solà R, A primary-school-based study to reduce prevalence of childhood obesity in Catalunya (Spain)--EDAL-Educació en alimentació: study protocol for a randomised controlled trial., Trials, 2011, 12, 54, doi: 10.1186/1745-6215-12-54.

  2. Results

    Tarro L, Llauradó E, Albaladejo R, Moriña D, Arija V, Solà R, Giralt M, A primary-school-based study to reduce the prevalence of childhood obesity--the EdAl (Educació en Alimentació) study: a randomized controlled trial., Trials, 2014, 15, 58, doi: 10.1186/1745-6215-15-58.

Additional files

Editorial Notes