Condition category
Mental and Behavioural Disorders
Date applied
22/12/2010
Date assigned
07/02/2011
Last edited
12/08/2015
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 David Sánchez-Carracedo

ORCID ID

Contact details

Dept. Psicología Clínica y de la Salud
Facultad de Psicología
Universidad Autonoma de Barcelona
Barcelona
08193
Spain
+34 93 581 38 55
david.sanchez@uab.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Reduction of risk factors for eating and weight-related problems in secondary students by means of a prevention programme implemented by community agents previously formed

Acronym

MABIC

Study hypothesis

The effectiveness achieved by the programme when administered by experts (previous study) will be maintained when implemented by community agents previously formed, and the programme will be more effective in reducing the risk factors evaluated than the control group (no intervention) at the follow-up measures.

Ethics approval

Clinical Research Ethical Committee of Parc Taulí Health Corporation, December 2008, ref: 2009-512

Study design

Cluster randomised controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Eating and weight-related disorders

Intervention

The trial will be carried out in twelve schools.

Six intervention schools, fourteen classes, approximately 400 participants (adolescent females and males).

Six control schools, fourteen classes, approximately 400 participants (adolescent females and males).

The prevention programme consists of two components:
1. Nutrition component (Nut): One 60-minute talk and one 60-minute activity session. Topics include: Balanced eating concept, concept and differentiation between eating and nutrition, nutrients, food pyramid and foods, importance of water. Activity consists of analysis of menus.
2. Media Literacy component (ML): Four 60-minute talks and two activity sessions (60-minute duration). The topics of the talks include: "Feminine beauty ideal", "Feminine beauty ideal in the media", and "How to deal with media messages". The activity sessions include analysis of advertising and writing model letters of complaint to the media.

One booster session will be implemented 6 month after the end of the last session. The programme is described in a manual: Raich, Sánchez-Carracedo, and López-Guimerà (2008). Eating, Feminine Beauty Ideal and the Media. How to train critical secondary students (Alimentación, modelo estético femenino y medios de comunicación. Cómo formar alumnos críticos en educación secundaria) (2nd edition) Barcelona: Graó. ISBN: 978-84-7827-644-8: http://www.grao.com/libros/ficha.asp?ID=686.

The intervention is partially based on a previous version informed in a previous trial (López-Guimerà, Sánchez-Carracedo, Fauquet, Portell, and Raich, in press), registered in ISRCTN with unique identifier ISRCTN07896919 (http://www.controlled-trials.com/ISRCTN07896919). In this case, the intervention will be implemented by community agents previously formed.

The training of community agents (teachers, nurses and health technicians from de cities councils), 20 hours duration, was performed in 2010, and is accredited by the Education Department of the Catalan Autonomous Government and the General Council for Continuing Education of Health Professions.

Classes assigned to intervention will received the program approximately one session per week for ten weeks. The control group only receiving classes as normal (not treatment)

Six schools from Sabadell will be allocated to intervention group. Six schools from neighboring towns of similar socio-cultural characteristics will be allocated to control group (no intervention)

Contact details of co-investigators:
Jordi Fauquet Ars (jordi.fauquet@uab.cat)
Gemma López-Guimerà (gemma.lopez@uab.cat)
Juan Ramón Barrada (juanramon.barrada@uab.cat)
Joaquim Puntí (Joaquim.punti@uab.cat)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sociocultural Attitudes Toward Appearance Scale -3
2. Children Eating Attitudes Test
3. Weight Control Behaviours (Inventory designed ad hoc)
4. Perception of Teasing Scale
5. Body Dissatisfaction and Drive for Thinness subscales from Eating Disorders Inventory -6. All the questionnaires in their Spanish adaptation. The primary and secondary outcomes were assessed at baseline, post-test (two weeks after the last activity "Letter of complaint to the media") and nine months follow-up

Secondary outcome measures

The primary outcome measures above were assessed for participants who completed the "analysis of advertising" and the "letters of complaint to the media" activities, and by nutritional status (following International Obesity Task Force criteria).

Overall trial start date

10/01/2011

Overall trial end date

10/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Second-grade (eight-grade in USA; 13 years) male and female students in Spanish secondary education

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Approximately 800 participants (adolescent females and males)

Participant exclusion criteria

No exclusion criteria were used and intact classes participated.

Recruitment start date

10/01/2011

Recruitment end date

10/01/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad Autonoma de Barcelona
Barcelona
08193
Spain

Sponsor information

Organisation

Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)

Sponsor details

C/ Albacete 5
Madrid
28027
Spain
+34 91 603 70 00
informa@micinn.es

Sponsor type

Government

Website

http://www.micinn.es/portal/site/MICINN/

Funders

Funder type

Government

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) - Health Research Fund, Ministry of Science and Innovation (MICINN) (ref: PSI 2009-08956)

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24118981

Publication citations

Additional files

Editorial Notes