Efficacy of an educational school-based intervention to reduce prevalence of obesity in childhood in Catalonia

ISRCTN	ISRCTN29247645
DOI	https://doi.org/10.1186/ISRCTN29247645
Protocol serial number	N/A
Sponsor	University of Rovira i Virgili (Universitat Rovira i Virgili) (Spain)
Funders	Reddis Private Foundation (Fundació Privada Reddis) (Spain), Municipality of Reus (Ajuntament de Reus) (Spain), Ministry of Health (Conselleria de Salut) (Spain), Government of Catalonia (Generalitat de Catalunya) (Spain), Central Markey of Reus (Mercat Central de Reus) (Spain), Protected Designation of Origin Siurana (DOP Siurana) (Spain), La Morella Nuts (Spain), Technological Centre of Nutritional Health CT09-1-0019 (Centre Tecnològic de Nutrició i Salut) (Spain)

Submission date: 24/05/2010
Registration date: 28/05/2010
Last edited: 24/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Montserrat Giralt
Scientific

C/Sant Llorenç, nº 21
Reus
43201
Spain

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	EdAl
Study objectives	A regular systematic educational intervention in primary school improves lifestyle and reduces obesity.
Ethics approval(s)	Comite etic d'investigacio clinica de l'Hospital Universitari Sant Joan de Reus approved on the 29th July 2008 (ref: 08-07-24/07aclproj1)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	To reduce prevalence of obesity. All measures have taken in May of 2006, 2007, 2008, 2009, 2010.
Key secondary outcome measure(s)	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.
Completion date	30/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	9 Years
Sex	All
Target sample size at registration	1400
Key inclusion criteria	1. Primary scholars aged 6 to 9 years from Cambrils, Reus, Salou and Vilaseca 2. Public and private schools
Key exclusion criteria	Not adequate age
Date of first enrolment	01/04/2006
Date of final enrolment	30/12/2010

Locations

Countries of recruitment

Spain

Study participating centre

C/Sant Llorenç, nº 21

Reus
43201
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/02/2014		Yes	No
Results article	4-year follow-up results	05/01/2018		Yes	No
Protocol article	protocol	27/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/05/2018: Publication reference added.