Design and methods of a cluster randomised controlled trial addressed to investigate the effects of a school-based intervention on pediatric obesity and other associated outcomes

ISRCTN ISRCTN10335633
DOI https://doi.org/10.1186/ISRCTN10335633
Secondary identifying numbers C.I. PIC-255-20
Submission date
14/03/2025
Registration date
19/03/2025
Last edited
18/03/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Paediatric obesity, a multi-factorial issue, significantly impacts children's biopsychosocial and economic status, particularly those from lower socio-economic backgrounds, thereby exacerbating social health inequalities in Spain.
Obesity preventive interventions should be multilevel, multicomponent, led by a multidisciplinary team, integrated, equitable, person-centred, sensitive to social inequalities, and grounded in a strong psychosocial theoretical basis.
The SEISMO study aims to evaluate the effectiveness of a Multicomponent, Comprehensive, and Multilevel (MCM) school-based intervention, with follow-up for children until adulthood.

Who can participate?
The SEÍSMO study is a school-based intervention aimed at obesity prevention, involving two stages: innovation and development (I+D) and a multicomponent, comprehensive, multilevel intervention (MCM). The SEÍSMO I+D stage includes children aged 6-12 years and the SEÍSMO MCM stage will recruit children aged 3–12 years.

What does the study involve?
The SEISMO school-based intervention aims to improve healthy lifestyles, resilience, academic performance, and reduce obesity among children. It has two stages:
SEÍSMO I+D Stage (2020-2024): This stage involved creating and testing various modules like physical education, family involvement, healthy spaces, water promotion, and healthy eating in schools.
SEÍSMO MCM Stage (2024-2034): This stage will implement the tested modules over 6 years, focusing on promoting healthy habits, engaging the educational community, and improving school policies and environments.
The intervention uses a metaphor called the Healthy Galaxy to motivate children and families to adopt healthy lifestyles.

What are the possible benefits and risks of participating?
Potential benefits are associated with improved participant lifestyle, adoption of health-promoting schools to facilitate lifestyle, improved academic performance, individual resilience, and reduced incidence of paediatric obesity following the MCM SEISMO intervention. There is a risk from weight-based assessment that evidence suggests may exacerbate obesity numbers, so we aim to incorporate the variable of weight bias internationalization to study and minimise weight stigma through the intervention and incorporate other variables of interest into the assessment protocol to robustly assess the evolution of obesity away from weight-centrism.

Where is the study run from?
SEÍSMO I+D stage addressed 120 Spanish schools prioritizing these are located in disadvantaged communities.
SEÍSMO MCM stage will address 56 Catalan (Spain) schools located in disadvantaged communities.

When is the study starting and how long is it expected to run for?
The I+D stage baseline was conducted in 2021-2024 and the SEÍSMO MCM enrolled all the schools in three waves (2024-2025, 2025-2026, and 2026-2027). In both stages, it will be followed up at 18 years old. The final assessment of the last participant who reaches the age of 18 years old will be in December 2042.

Who is funding the study?
The SEÍSMO study is financially supported by Barça Foundation, BNP Paribas Cardiff, Aigües de Barcelona & Agbar, Ajuntament de Barcelona, Agència de Salut Pública de Barcelona (ASPB), Ajuntament de Pineda de Mar, Ajuntament de Balaguer, and Ajuntament de Lleida.

Who is the main contact?
PhD Santiago Felipe Gómez Santos, sgomez@gasolfoundation.org

Study website

Contact information

Dr Santiago Felipe Gómez Santos
Public, Principal Investigator

Jaume I Street 26-28 Local first floor
Sant Boi de Llobregat, Barcelona
08830
Spain

ORCiD logoORCID ID 0000-0003-3352-2510
Phone +34 (0)938346600
Email sgomez@gasolfoundation.org
Mr Genís Según Mercader
Scientific

Jaume I Street 26-28 Local first floor
Sant Boi de Llobregat, Barcelona
08830
Spain

ORCiD logoORCID ID 0000-0003-3035-1744
Phone +34 (0)938346600
Email gsegun@gasolfoundation.org

Study information

Study designSchool-based cluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention, Quality of life, Efficacy
Participant information sheet 47003_PIS_V6_01Nov23.pdf
Scientific titleA cluster randomised controlled trial of a School-based Educational Intervention to Stimulate Motivation towards pediatric Obesity prevention among children 3 to 12 years old: the SEÍSMO study
Study acronymSEÍSMO
Study hypothesisIt is hypothesised that multi-component, comprehensive, multi-level school-based interventions with collaborative approaches that empower the target community towards becoming healthy-promoting schools will have a greater impact on psychological resilience, psychosocial determinants, weight stigma, healthy lifestyles, quality of life, incidence of obesity, academic performance, and weight status (body mass index z-score [zBMI] and waist-to-height ratio [WHtR]).
Ethics approval(s)

Approved 22/10/2020, CEIm Fundació Sant Joan de Déu (Edifici Docent Sant Joan de Déu - c. Santa Rosa, 39-57, 3ª planta, Esplugues de Llobregat, Barcelona, 08950, Spain; +34 (0)93 600 97 51; info@fsjd.org), ref: C.I. PIC-255-20

ConditionPediatric obesity
InterventionThe SEISMO school-based intervention was conceptualized to positively impact healthy lifestyles, psychological resilience, weight stigma, academic performance, quality of life, the incidence of obesity, zBMI and WHtR.

The creation of the SEÍSMO intervention methodology has been organized in two stages: 1) SEISMO innovation and development (I+D) stage from 2020 to 2024; 2) SEÍSMO multicomponent, comprehensive, and multilevel (MCM) stage expected from 2024 to 2034.

1. The SEISMO I+D
The I+D intervention were carried out along four editions (1st – 2020/2021; 2nd – 2021/2022; 3rd – 2022/2023; 4th – 2023/2024) of 12 months each. The periods between each academic year were dedicated to creating new intervention modules that progressively have been incorporated into the methodology and piloted for reaching the entire educational community: children, teaching staff, parents or caregivers, non-teaching staff, and school managers.
The 1st edition served to pilot the physical education module. The 2nd edition included also the family module. During the 3rd edition, the healthy spaces module was additionally added to the intervention methodology, which finally was rounded with the incorporation of the water promotion module, and the healthy eating and sustainable schools’ canteens module, during the 4th edition.

2. The SEÍSMO MCM intervention
The SEÍSMO MCM intervention was conceptualized using the SHE pillars approach for the promotion of the children’s healthy lifestyles, equity, resilience, and quality of life. All the original intervention modules piloted on the SEÍSMO I+D have been integrated into the SEÍSMO MCM. The new intervention is structured for a minimum of 6 consecutive academic years, and it will be coordinated by the multidisciplinary GF team that will promote the implementation of 50 specific groups of actions structured in three pillars:
A) Competencies pillar: to promote healthy habits as a comprehensive part of primary school’s curricular project that is aligned with the most updated Spanish educational law.
It includes eight specific actions organized in: i) five types of activities directly addressed to children and their families, and ii) three types of resources to reinforce these activities.
B) Educational community pillar: to engage the entire educational community towards adopting the health-promoting schools’ approach.
It includes 20 specific actions organized in three action types: i) the activities and resources to consolidate a motor group, ii) the formation and training plan addressed at the entire teaching staff to ensure awareness and skills towards the promotion of a healthy lifestyle, and iii) the communication plan to engage and inform the entire educational community about the achievements in the creation of a health-promoting school.
C) Policy, environment, and cultural pillar: to lead and innovate the healthy governance of schools by enhancing and strengthening school policies, environment, and culture.
It includes 22 specific actions organized into three types: i) the activities and resources to complete a comprehensive diagnosis, ii) the activities and resources to co-create, prioritize, and define the long-term health-promoting school action plan, and iii) the resources to implement and evaluate this action plan.

The full intervention will be progressively offered to the intervention schools. A total range of 1326 - 2178 actions and 289.75 - 363.75 implementation hours will be promoted. Specifically, nine specific groups of actions are directly addressed to children and 41 are indirect.

All the activities and resources addressed for children are adapted according to the child's developmental stage and the curricular standards in three age ranges: i) initial grades (6-7 years); ii) medium grades: 8-9 years; and iii) upper grades: 10-12 years.

The four theoretical bases of SEÍSMO MCM intervention are: i) the IChange model; ii) the Healthy Galaxy metaphor; iii) the Resiliency Theory, operationalized by the Search Institute through the 40 developmental assets, and iv) the motivation interviewing tool.

The Healthy Galaxy is a pedagogical metaphor for the determinants of pediatric obesity. It is based on a fantastic recent story of humanity, where healthy lifestyles decided to take off from planet Earth towards the Healthy Galaxy to create four planets: sleep duration, healthy eating, psychological well-being, and physical activity. This story motivates children and their families to become astronauts and visit each planet. The goal is discovering and reaching the Healthy Galaxy balance to return the healthy lifestyles to Earth. Back on Earth, they will have another mission: to spread everything they have learned. This metaphor guides all interventions and serves as a motivation and gamification strategy to involve the entire educational community.

The intervention will be coordinated by the multidisciplinary GF team and led by school managers and teaching staff. The main initial responsibility of the GF team is to motivate the engagement of the entire educational community to then facilitate and guide the transition towards becoming health-promoting schools.

Control group schools’ implication
The following actions will be conducted by each control school: a) an evaluation plan; b) an annual health-related event; c) a comprehensive school diagnosis during the 1st academic year; d) a total of three follow-up meetings are planned for the 1st and 2nd academic years, and four for the subsequent academic years to ensure adherence and define the actions that will be progressively implemented after the baseline; e) a set of national and regional public resources, including training, guidelines, advisory services, health-related materials, and other initiatives, will be promoted equally in the intervention and control group.




Intervention typeBehavioural
Primary outcome measureWeight status measured using Body Mass Index (BMI) and Waist Height to Ratio (WHtR) at baseline, 12, 24, 36 and 48 months, and at the 18-year-old age group.
Secondary outcome measures1. Hours of sleep measured using the Sleep-Habits Survey for Adolescents (SHSA) questionnaire at baseline, 12, 24, 36, and 48 months, and at the 18-year-old age group
2. Screen time measured using the Screen-Time-based Sedentary Behaviour Questionnaire (SSBQ) at baseline, 12, 24, 36, and 48 months, and at the 18-year-old age group
3. Diet quality measured using the KIDMED index questionnaire at baseline, 12, 24, 36, and 48 months, and at the 18-year-old age group
4. Physical activity measured using the Physical Activity Unified-7 item Screener (PAU-7S) questionnaire at baseline, 12, 24, 36, and 48 months, and at the 18-year-old age group
5. Physical fitness measured using the International Fitness Scale (IFIS) self-rating questionnaire at baseline, 12, 24, 36, and 48 months, and at the 18-year-old age group
6. Quality of life measured using the EUROQOL questionnaire (EQ-5D-5L) at baseline, 12, 24, 36, 48 months, and at the 18-year-old age group
7. Academic performance measured using the school curricular ratings at baseline, 12, 24, 36, and 48 months. At the age of 18 years the academic level will be self-reported
8. Psychosocial determinants measured with an ad hoc questionnaire based on the ASE model through a Likert scale at baseline, 12, and 24 months
9. Psychological resilience measured with the Developmental Asset Profile (DAP) questionnaire at baseline, 12, 24 months, and at the 18-year-old age group
10. Weight stigma measured with the Weight Bias Internalization Scale (WBIS-M) questionnaire at baseline, 12, 24 months, and at the 18-year-old age group
11. Socioeconomic status measured using a self-reported questionnaire about sociodemographic characteristics, academic level, labour market status, and home address at baseline
Overall study start date22/10/2020
Overall study end date31/12/2042

Eligibility

Participant type(s)Population
Age groupChild
Lower age limit3 Years
Upper age limit18 Years
SexBoth
Target number of participantsA total of 56 clusters and 4760 participants (85 per cluster). A ratio 1:1 will be followed allocating 28 clusters to each group.
Participant inclusion criteria1. Children aged 3–12 years and their families who will be enrolled in a participating school located in a census section with an average income per person under the mean in Spain (14.787€)
2. Informed consent signed by parents/legal guardians
Participant exclusion criteriaChildren or parents/legal guardians with a psychological or physical limitation that make it impossible to participate in some or all the evaluation procedures. Each case will be considered individually, and the GF team offer different evaluation options to include all the children and families.
Recruitment start date01/12/2020
Recruitment end date31/12/2026

Locations

Countries of recruitment

  • Spain

Study participating centres

Escola Pau Romeva
C/ del Pisuerga, 1
Barcelona
08028
Spain
Centre d'Estudis Montseny
C/ de Pallars, 410
Barcelona
08019
Spain
Col·legi Paideia
C/ del Montnegre, 36
Barcelona
08029
Spain
Escola el Turó
C/ de Peñalara, 19-55
Barcelona
08031
Spain
Escola Baloo
C/ Harmonia 37
Barcelona
08035
Spain
Escola Piaget
C/del Llobregós, 194
Barcelona
08032
Spain
Escola Pare Poveda
Av. de Vallcarca, 220
Barcelona
08023
Spain
Escola Padre Damián
Av. de Vallvidrera, 10
Barcelona
08017
Spain
Escola Lluís Vives
C/ de Canalejas, 107
Barcelona
08028
Spain
Escola Ferran Sunyer
C/ de Viladomat, 2
Barcelona
08015
Spain
Escola Mercè Rodoreda
C/ del Vesuvi, 35
Barcelona
08016
Spain
Col·legi Amor de Dios
C/del Teide, 27
Barcelona
08031
Spain
Escola Ferrer i Guàrdia
C/ del Pedraforca, 3
Barcelona
08033
Spain
Escola Ciutat Comtal
C/ Pujalt, 6
Barcelona
08033
Spain
Escola Pia Sant Antoni
Rda. de Sant Pau, 72
Barcelona
08001
Spain
Escola La Pau
C/ d'Extremadura, 15
Barcelona
08020
Spain
Escola Alfonsa Cavin
Av. dels Rasos de Peguera, 57
Barcelona
08033
Spain
Escola Princeps
C/ de l'Artesania, 38
Barcelona
08042
Spain
Escola Eduard Marquina
C/Jaume Huguet, 22
Barcelona
08019
Spain
Escola Sant Lluís
C/Arítjols, 12
Barcelona
08016
Spain
Escola Prim
C/ Bernat Metge, 20
Barcelona
08019
Spain
Escola Cal Maiol
C/Sagunt, 92
Barcelona
08014
Spain
Escola Tibidabo
C/ de Joaquim Valls, 10
Barcelona
08016
Spain
Escola Sant Gervasi
C/ Bòbiles, 37
L'Hospitalet de Llobregat, Barcelona
08905
Spain
Escola Charlie Rivel
C/ de Llançà, 20
L'Hospitalet de Llobregat, Barcelona
08904
Spain
Escola Pep Ventura
Plaça Guernica, s/n
L'Hospitalet de Llobregat, Barcelona
08903
Spain
Col·legi Alegre
C/ d'Andorra, 23, 25
L'Hospitalet de Llobregat, Barcelona
08906
Spain
Escola Pau Casals
C/ Almería, 1
L'Hospitalet de Llobregat, Barcelona
08905
Spain
Escola Pau Vila
C/ Menorca, 1
L'Hospitalet de Llobregat, Barcelona
08905
Spain
Escola Josep Maria Folch i Torres
Av. d'Isabel la Catòlica, 61
L'Hospitalet de Llobregat, Barcelona
08906
Spain
Escola Sant Josep Obrer
C/Covadonga, 2
L'Hospitalet de Llobregat, Barcelona, España
08906
Spain
Escola Ernest Lluch
Passatge Colom, 19
L'Hospitalet de Llobregat, Barcelona
08904
Spain
Escola Utmar Hospitalet
C/ Mina, 24
L'Hospitalet de Llobregat, Barcelona
08906
Spain
Escola Lola Anglada:
Av. d'Isabel la Catòlica, 41
L'Hospitalet de Llobregat, Barcelona
08906
Spain
Escola Pablo Neruda
C/ Cornellà, 37
L'Hospitalet de Llobregat, Barcelona
08906
Spain
Escola Utmar Esplugues
C/ del Molí, 48
Esplugues de Llobregat, Barcelona
08950
Spain
Escola El Gornal
Av. Carmen Amaya, 44
L'Hospitalet de Llobregat, Barcelona
08902
Spain
Escola Sant Miquel
C/ Lluís Domènech i Montaner, 1
Cornellà de Llobregat, Barcelona
08940
Spain
Escola Alexandre Gali
C/Cirerer, 1-7
Cornellà de Llobregat, Barcelona
08940
Spain
Escola Jacint Verdaguer
C/ Muralla, 8
Castelldefels, Barcelona
08860
Spain
Escola Jacint Verdaguer
Av. de Salvador Allende, 14, 16
Cornellà de Llobregat, Barcelona
08940
Spain
Escola Sant Antoni Maria Claret
C/Manuel Mariné, 11
Cornellà de Llobregat, Barcelona
08940
Spain
Escola Tanit
C/ Pirineus, 5
Santa Coloma de Gramenet, Barcelona
08923
Spain
Escola Beethoven
C/ Wagner, 16
Sta Coloma de Gramanet, Barcelona
08923
Spain
Escola Rosello Porcel
Rambla de Sant Sebastià, 92
Sta Coloma de Gramenet, Barcelona
08922
Spain
Escola Les Neus
Rambla del Fondo, 50
Santa Coloma de Gramenet, Barcelona
08922
Spain
Escola FEDAC Santa Coloma
C/Sant Ramon, 2
Santa Coloma de Gramenet, Barcelona
08922
Spain
Escola Folch i Torres
C/Wagner, 68-84
Badalona, Barcelona
08917
Spain
Escola Baldomer Sola
Av. del Marquès de Mont-Roig, 178
Badalona, Barcelona
08918
Spain
Escola Mare de Deu Salut
Passeig de la Salut, 36
Badalona, Barcelona
08914
Spain
Escola Joan Llongueras
C/ Sant Fermí, 3
Badalona, Barcelona
08917
Spain
Escola Baldiri Reixac
C/Juan Valera, 159
Badalona, Barcelona
08914
Spain
Escola Maria Ward
C/Gravina, 1
Badalona, Barcelona
08913
Spain
Escola Santísisma Trinidad
C/ de Santiago, 57
Badalona, Barcelona
08918
Spain
Escola Arrels
C/ Provença, 7
Badalona, Barcelona
08914
Spain
Escola Joan Coret
Plaça Voluntaris Olímpics, 3
Badalona, Barcelona
08917
Spain
Escola Antoni Botey
Av. del Doctor Bassols, 77
Badalona, Barcelona
08914
Spain
Escola Ramiro de Maeztu
C/ Ramiro de Maeztu, s/n
Badalona, Barcelona
08913
Spain
Escola Les Ciències
C/ de la Ciència, 19
Badalona, Barcelona
08917
Spain
Escola Ginesta
C/ de la Circumval·lació, S/N
Montcada i Reixac, Barcelona
08110
Spain
Escola Amat Verdú
C/ Marcelino Menéndez y Pelayo
Sant Boi de Llobregat, Barcelona
08830
Spain
Escola Casablanca
Plaça dels Gegants, 2
Sant Boi de Llobregat, Barcelona, España
08830
Spain
Escola Barrufet
Plaza Agricultura, 6
Sant Boi de Llobregat, Barcelona
08830
Spain
Escola Antoni Gaudí
C/Pablo Picasso
Sant Boi de Llobregat, Barcelona
08830
Spain
Escola Ciurana
C/Manuel de Falla, 2
Sant Boi de Llobregat, Barcelona
08830
Spain
Escola Angel Tobies
Av. Riera de la Bisbal, 79
El Vendrell, Tarragona
43700
Spain
Escola Gaspar Portolà
C/Escoles, 0
Balaguer, Lleida
25600
Spain
Escola Montroig
C/Marta Mata, 48
Balaguer, Lleida
25600
Spain
Escola Pia Balaguer
C/Barcelona, 73
Balaguer, Lleida
25600
Spain
Escola La Noguera
C/Joan Miró, 2
Balaguer, Lleida
25600
Spain
Escola Angel Guimerà
C/Àngel Guimerà, s/n
Balaguer, Lleida
25600
Spain
Escola Vedruna Balaguer
C/ Pare Sanahüja, 39
Balaguer, Lleida
25600
Spain
Escola SAFA
C/ Nicolás Longaron, 6
La Llagosta, Barcelona
08120
Spain
Escola Joan Maragall
Passeig del Pintor Sert, 1-9
La Llagosta, Barcelona
08120
Spain
Escola Les Planes
C/de la Constitució, 2
La Llagosta, Barcelona
08120
Spain
Escola Gilpe
Av. Primer de Maig, 6, 8
La Llagosta, Barcelona
08120
Spain
Institut Escola La Mina
Rambla de la Mina 36
Sant Adrià de Besòs, Barcelona
08930
Spain
Escola Catalunya
Plaça de Marie Curie, C. de Lleida, s/n
Sant Adrià de Besòs, Barcelona
08930
Spain
Escola Cascavell
C/d'Argentina, sn
Sant Adrià de Besòs, Barcelona
08930
Spain
Escola Sant Jordi
C/Verdaguer, 15
Pineda de Mar, Barcelona
08397
Spain
Escola Antoni Doltra
C/ Narcis Monturiol, 55
Pineda de Mar, Barcelona
08397
Spain
Escola Jaume I
C/Lluís Vives, 5, 7
Pineda de Mar, Barcelona
08397
Spain
Escola Montpalau
Av. Generalitat, s/n
Pineda de Mar, Barcelona
08397
Spain
Escola Mediterrania
Plaza Pau Casals, 0 S N ( Urb Can Cornet )
Pineda de Mar, Barcelona
08397
Spain
Escola Pràctiques I
C/Ballester, 21
Lleida
25002
Spain
Escola Santa Maria de Gardeny
C/Rossinyol, 2
Lleida
25003
Spain
Escola Gassó i Vidal
C/Rocabruna, 1
Ripollet, Barcelona
08291
Spain
Escola Francesc Escursell i Bartalot
Ctra. de l'Estació, 9
Ripollet, Barcelona
08291
Spain
Escola Miquel Martí i Pol
Av. dels Jocs Olímpics, 7
Viladecans, Barcelona
08840
Spain
Escola Sant Josep
Travessera de Barcelona, 78, 82
Sant Vicenç dels Horts, Barcelona
08620
Spain
Escola Mare de Déu del Carme
C/ del Dr. Robert, 5, 9
El Prat de Llobregat, Barcelona
08820
Spain
Escola Auró
C/ del Germà Joaquim, 128
Terrassa, Barcelona
08223
Spain
Escola Joan XXIII
C/Joan XXIII, 27
Terrassa, Barcelona
08227
Spain
Escola Marcel·li Moragas
C/ Joan I, 5
Gavà, Barcelona
08850
Spain
Escola Sant Andreu de la Barca
C/Josep Tarradellas, 30-38
Sant Andreu de la Barca
08740
Spain
Escola Pintor Sorolla
Av. de Ronda, 116
Elda, Alicante
03600
Spain
Escola Ballester Fandos
Avinguda de la Malva-Rosa, 57
Valencia
46011
Spain
Escola San Juan de Ribera
C/ de la Noria, 19
Alfara del Patriarca, Valencia
46115
Spain
Escola Gaspar Gil Polo
C/Miquel Paredes, s/n
Valencia
46018
Spain
Escola Profesor Sanchis Guarner
C/Pere Patrici Mey, 44
València, Valencia
46019
Spain
Escola Tomás de Villaroya
Av. del Doctor Tomás Sala, s/n
Valencia
46017
Spain
Escola Santa Joaquina de Vedruna
C/de la Iutera, 40
Vinalesa, Valencia
46114
Spain
Escola San Blas
Av. de les Cortes Valencianes, 34
Albal, Valencia
46470
Spain
Escola Lluis Guarner
C/del Doctor Nicasi Benlloch, 128
València, Valencia
46015
Spain
Escola Ausias March
C/Parque de Nazaret, 3
Valencia
46024
Spain
Colegio Luis Feito
C/Luis Feito 19
Madrid
28047
Spain
Colegio Nile
C/de Castilla la Vieja, 18
Fuenlabrada, Madrid
28941
Spain
Colegio La Dehesa de Humanes
Av. de los Deportes, 8
Humanes de Madrid (España)
28970
Spain
Colegio Manuel Azaña
Av. del Ejército, 5
Alcalá de Henares, Madrid
28802
Spain
Colegio San José
C/Francisco Laguna, 21
Madrid
28053
Spain
Colegio Salesianos Carabanchel
Rda. Don Bosco, 32
Madrid
8044
Spain
Colegio San José de Valdemoro
Pl. del Conde,sn.
Valdemoro, Madrid
28340
Spain
Colegio María Reina
Av. Orcasur, 42B
Madrid
28041
Spain
Colegio Alonso Cano
C/Alonso Cano, 1
Móstoles, Madrid
28933
Spain
Colegio Campohermoso
C/Valdehondillo, 1
Humanes de Madrid, Madrid
28970
Spain
Colegio Juan Ocaña
Av. Iker Casillas, 25
Móstoles, Madrid
28935
Spain
Colegio Pequeño Principe
C/ de Aragón, 21
Leganés, Madrid
28914
Spain
Colegio San Miguel
C/Miralcampo
Navalagamella, Madrid
28212
Spain
Colegio Carmen Cabezuelo
C/ Cangas de Onís, 7
Madrid
28037
Spain
Colegio Santo Angel De La Guardia
C/Rodetas, 17
Chapinería, Madrid
28694
Spain
Colegio República del Uruguay
Av. de Ntra. Sra. de Valvanera, 120
Madrid
28047
Spain
Colegio Velazquez
Av. de Nuevo Versalles, 16
Fuenlabrada, Madrid
28942
Spain
Colegio Doctor Severo Ochoa
C/Ezcaray, 3
Madrid.
28032
Spain
Colegio Nuestra Señora De Montserrat
C/Trevélez, 5
Madrid
28041
Spain
Colegio Doctora de Alcalá
C/Pedro Sarmiento de Gamboa, 11
Alcalá de Henares, Madrid
28805
Spain

Sponsor information

Gasol Foundation
Research organisation

Jaume I Street 26-28 Local first floor
Sant Boi de Llobregat
08830
Spain

Phone +34 (0)938346600
Email contact@gasolfoundation.org
Website https://www.gasolfoundation.org/
ROR logo "ROR" https://ror.org/00jb67179

Funders

Funder type

Industry

BNP Paribas Cardif
Private sector organisation / For-profit companies (industry)
Alternative name(s)
BNP Paribas
Location
France
Barça Foundation

No information available

Aigües de Barcelona

No information available

Agbar

No information available

Agència de Salut Pública de Barcelona
Government organisation / National government
Alternative name(s)
Barcelona Public Health Agency, ASPB
Location
Spain
Ajuntament de Barcelona

No information available

Ajuntament de Pineda de Mar

No information available

Ajuntament de Lleida

No information available

Ajuntament de Balaguer

No information available

Results and Publications

Intention to publish date31/12/2043
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan1. Study protocol
2. Comparative between the weight status results of SEISMO with PASOS 2019, a national and representative Spain Study
3. Comparative between the healthy lifestyles results of SEISMO with PASOS 2019, a national and representative Spain Study
4. Results about the first pilot edition. Effects of intervention group vs control group
5. Results comparing first edition and second edition. Effects of intervention between both modules and separately
6. Results comparing first edition, second, and third edition. Effects of intervention between all modules and separately
7. Environment, weight status and healthy lifestyles
8. Planned publication in a high-impact peer-reviewed journal
IPD sharing planData sharing will be considered after request to sgomez@gasolfoundation or to gsegun@gasolfoundation.org. SEISMO webpage: https://gasolfoundation.org/es/seismo/

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version 6 01/11/2023 18/03/2025 No Yes
Protocol file version 6 01/11/2023 18/03/2025 No No

Additional files

47003_PIS_V6_01Nov23.pdf
47003_PROTOCOL_V6_01Nov23.pdf

Editorial Notes

18/03/2025: Study's existence confirmed by CEIm Fundació Sant Joan de Déu.