Efficacy of a school-based programme implemented by community agents in the prevention of eating and weight-related disorders

ISRCTN	ISRCTN47682626
DOI	https://doi.org/10.1186/ISRCTN47682626
Protocol serial number	N/A
Sponsor	Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)
Funder	Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) - Health Research Fund, Ministry of Science and Innovation (MICINN) (ref: PSI 2009-08956)

Submission date: 22/12/2010
Registration date: 07/02/2011
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Sánchez-Carracedo
Scientific

Dept. Psicología Clínica y de la Salud, Facultad de Psicología
Universidad Autonoma de Barcelona
Barcelona
08193
Spain

Phone	+34 93 581 38 55
Email	david.sanchez@uab.es

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled multi-centre trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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
Study acronym	MABIC
Study objectives	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(s)	Clinical Research Ethical Committee of Parc Taulí Health Corporation, December 2008, ref: 2009-512
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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).
Completion date	10/01/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	13 Years
Sex	All
Target sample size at registration	800
Key inclusion criteria	Second-grade (eight-grade in USA; 13 years) male and female students in Spanish secondary education
Key exclusion criteria	No exclusion criteria were used and intact classes participated.
Date of first enrolment	10/01/2011
Date of final enrolment	10/01/2012

Locations

Countries of recruitment

Spain

Study participating centre

Universidad Autonoma de Barcelona

Barcelona
08193
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	01/02/2016	17/01/2019	Yes	No
Protocol article	protocol	12/10/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/01/2019: Publication reference was added