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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 among disadvantaged communities

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10335633
Enrollment
4760
Registered
2025-03-19
Start date
2020-12-01
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric obesity Nutritional, Metabolic, Endocrine

Interventions

Current interventions as of 13/03/2026: The SEISMO school-based intervention was conceptualized to positively impact healthy lifestyles, psychological resilience, weight stigma, academic performance,
2) SEÍSMO multicomponent, comprehensive, and multilevel (MCM) stage expected from 2024 to 2041. 1. 1. The SEÍSMO first-stage intervention (I+D) The original intervention was implemented over four edi
2nd – 2021/2022
3rd – 2022/2023
4th – 2023/2024) lasting 12 months each. The periods between each academic year were dedicated to creating new intervention modules that have progressively been incorporated into the method and pilote

Sponsors

Gasol Foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 13/03/2026: 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 (14.804€) 2. Informed consent signed by parents/legal guardians Previous 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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Current secondary outcomes as of 13/03/2026: 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 12. Perinatal information, including child's birth weight, pregnancy duration, and breastfeeding duration, reported by the parents/legal guardians using a self-reported questionnaire about the

Countries

Spain

Contacts

Public ContactSantiago Felipe Gómez Santos
sgomez@gasolfoundation.org+34 (0)938346600

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026