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
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
Contact information
Public, Principal Investigator
Jaume I Street 26-28 Local first floor
Sant Boi de Llobregat, Barcelona
08830
Spain
0000-0003-3352-2510 | |
Phone | +34 (0)938346600 |
sgomez@gasolfoundation.org |
Scientific
Jaume I Street 26-28 Local first floor
Sant Boi de Llobregat, Barcelona
08830
Spain
0000-0003-3035-1744 | |
Phone | +34 (0)938346600 |
gsegun@gasolfoundation.org |
Study information
Study design | School-based cluster randomized controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Cluster randomised trial |
Study setting(s) | School |
Study type | Prevention, Quality of life, Efficacy |
Participant information sheet | 47003_PIS_V6_01Nov23.pdf |
Scientific title | A 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 acronym | SEÍSMO |
Study hypothesis | It 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 |
Condition | Pediatric obesity |
Intervention | The 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 type | Behavioural |
Primary outcome measure | Weight 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 measures | 1. 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 date | 22/10/2020 |
Overall study end date | 31/12/2042 |
Eligibility
Participant type(s) | Population |
---|---|
Age group | Child |
Lower age limit | 3 Years |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | A 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 criteria | 1. 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 criteria | Children 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 date | 01/12/2020 |
Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- Spain
Study participating centres
Barcelona
08028
Spain
Barcelona
08019
Spain
Barcelona
08029
Spain
Barcelona
08031
Spain
Barcelona
08035
Spain
Barcelona
08032
Spain
Barcelona
08023
Spain
Barcelona
08017
Spain
Barcelona
08028
Spain
Barcelona
08015
Spain
Barcelona
08016
Spain
Barcelona
08031
Spain
Barcelona
08033
Spain
Barcelona
08033
Spain
Barcelona
08001
Spain
Barcelona
08020
Spain
Barcelona
08033
Spain
Barcelona
08042
Spain
Barcelona
08019
Spain
Barcelona
08016
Spain
Barcelona
08019
Spain
Barcelona
08014
Spain
Barcelona
08016
Spain
L'Hospitalet de Llobregat, Barcelona
08905
Spain
L'Hospitalet de Llobregat, Barcelona
08904
Spain
L'Hospitalet de Llobregat, Barcelona
08903
Spain
L'Hospitalet de Llobregat, Barcelona
08906
Spain
L'Hospitalet de Llobregat, Barcelona
08905
Spain
L'Hospitalet de Llobregat, Barcelona
08905
Spain
L'Hospitalet de Llobregat, Barcelona
08906
Spain
L'Hospitalet de Llobregat, Barcelona, España
08906
Spain
L'Hospitalet de Llobregat, Barcelona
08904
Spain
L'Hospitalet de Llobregat, Barcelona
08906
Spain
L'Hospitalet de Llobregat, Barcelona
08906
Spain
L'Hospitalet de Llobregat, Barcelona
08906
Spain
Esplugues de Llobregat, Barcelona
08950
Spain
L'Hospitalet de Llobregat, Barcelona
08902
Spain
Cornellà de Llobregat, Barcelona
08940
Spain
Cornellà de Llobregat, Barcelona
08940
Spain
Castelldefels, Barcelona
08860
Spain
Cornellà de Llobregat, Barcelona
08940
Spain
Cornellà de Llobregat, Barcelona
08940
Spain
Santa Coloma de Gramenet, Barcelona
08923
Spain
Sta Coloma de Gramanet, Barcelona
08923
Spain
Sta Coloma de Gramenet, Barcelona
08922
Spain
Santa Coloma de Gramenet, Barcelona
08922
Spain
Santa Coloma de Gramenet, Barcelona
08922
Spain
Badalona, Barcelona
08917
Spain
Badalona, Barcelona
08918
Spain
Badalona, Barcelona
08914
Spain
Badalona, Barcelona
08917
Spain
Badalona, Barcelona
08914
Spain
Badalona, Barcelona
08913
Spain
Badalona, Barcelona
08918
Spain
Badalona, Barcelona
08914
Spain
Badalona, Barcelona
08917
Spain
Badalona, Barcelona
08914
Spain
Badalona, Barcelona
08913
Spain
Badalona, Barcelona
08917
Spain
Montcada i Reixac, Barcelona
08110
Spain
Sant Boi de Llobregat, Barcelona
08830
Spain
Sant Boi de Llobregat, Barcelona, España
08830
Spain
Sant Boi de Llobregat, Barcelona
08830
Spain
Sant Boi de Llobregat, Barcelona
08830
Spain
Sant Boi de Llobregat, Barcelona
08830
Spain
El Vendrell, Tarragona
43700
Spain
Balaguer, Lleida
25600
Spain
Balaguer, Lleida
25600
Spain
Balaguer, Lleida
25600
Spain
Balaguer, Lleida
25600
Spain
Balaguer, Lleida
25600
Spain
Balaguer, Lleida
25600
Spain
La Llagosta, Barcelona
08120
Spain
La Llagosta, Barcelona
08120
Spain
La Llagosta, Barcelona
08120
Spain
La Llagosta, Barcelona
08120
Spain
Sant Adrià de Besòs, Barcelona
08930
Spain
Sant Adrià de Besòs, Barcelona
08930
Spain
Sant Adrià de Besòs, Barcelona
08930
Spain
Pineda de Mar, Barcelona
08397
Spain
Pineda de Mar, Barcelona
08397
Spain
Pineda de Mar, Barcelona
08397
Spain
Pineda de Mar, Barcelona
08397
Spain
Pineda de Mar, Barcelona
08397
Spain
Lleida
25002
Spain
Lleida
25003
Spain
Ripollet, Barcelona
08291
Spain
Ripollet, Barcelona
08291
Spain
Viladecans, Barcelona
08840
Spain
Sant Vicenç dels Horts, Barcelona
08620
Spain
El Prat de Llobregat, Barcelona
08820
Spain
Terrassa, Barcelona
08223
Spain
Terrassa, Barcelona
08227
Spain
Gavà, Barcelona
08850
Spain
Sant Andreu de la Barca
08740
Spain
Elda, Alicante
03600
Spain
Valencia
46011
Spain
Alfara del Patriarca, Valencia
46115
Spain
Valencia
46018
Spain
València, Valencia
46019
Spain
Valencia
46017
Spain
Vinalesa, Valencia
46114
Spain
Albal, Valencia
46470
Spain
València, Valencia
46015
Spain
Valencia
46024
Spain
Madrid
28047
Spain
Fuenlabrada, Madrid
28941
Spain
Humanes de Madrid (España)
28970
Spain
Alcalá de Henares, Madrid
28802
Spain
Madrid
28053
Spain
Madrid
8044
Spain
Valdemoro, Madrid
28340
Spain
Madrid
28041
Spain
Móstoles, Madrid
28933
Spain
Humanes de Madrid, Madrid
28970
Spain
Móstoles, Madrid
28935
Spain
Leganés, Madrid
28914
Spain
Navalagamella, Madrid
28212
Spain
Madrid
28037
Spain
Chapinería, Madrid
28694
Spain
Madrid
28047
Spain
Fuenlabrada, Madrid
28942
Spain
Madrid.
28032
Spain
Madrid
28041
Spain
Alcalá de Henares, Madrid
28805
Spain
Sponsor information
Research organisation
Jaume I Street 26-28 Local first floor
Sant Boi de Llobregat
08830
Spain
Phone | +34 (0)938346600 |
---|---|
contact@gasolfoundation.org | |
Website | https://www.gasolfoundation.org/ |
https://ror.org/00jb67179 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- BNP Paribas
- Location
- France
No information available
No information available
No information available
Government organisation / National government
- Alternative name(s)
- Barcelona Public Health Agency, ASPB
- Location
- Spain
No information available
No information available
No information available
No information available
Results and Publications
Intention to publish date | 31/12/2043 |
---|---|
Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | 1. 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 plan | Data 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
Editorial Notes
18/03/2025: Study's existence confirmed by CEIm Fundació Sant Joan de Déu.