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Study on Intervention Effect of Heat-related Health Risk Early Warning Digital Technology for School-age Children

9 de junio de 2026 actualizado por: Tiantian Li, Centers for Disease Control and Prevention, China
This cluster randomized trial is conducted in Beijing primary schools to evaluate the efficacy of a WeChat mini-program-based high-temperature early warning intervention on the physical and cognitive health of school-age children. Six participating schools are randomly assigned to two parallel groups. The intervention group receives tiered heat alerts and guided self-health monitoring via the mini-program. The control group follows standard daily school and family routines, with no dedicated digital high-temperature early-warning intervention. The primary outcome is children's executive function after a 2.5-month follow-up. A range of secondary indicators related to physical status, mental health and health behaviors are assessed concurrently to quantify the intervention's benefits in mitigating adverse health outcomes caused by high temperatures.

Descripción general del estudio

Descripción detallada

This pilot study is conducted in Beijing, with 6 primary schools selected as research sites. A stratified cluster randomized controlled design is adopted, with schools as the unit of randomization. Eligible primary schools are randomly assigned to the intervention group and the control group, with 3 schools in each group.

A total of 5 Wisconsin Card Sorting Tests (WCST), 2 health examinations, 2 children's high-temperature protection themed drawing activities, and 5 mini-program questionnaire surveys will be conducted in this study.

The intervention group receives a digital intervention of high-temperature health risk early warning. The research team uses a WeChat mini-program to release corresponding high-temperature health risk level information, health tips, protection science popularization information and other early warning content when the high-temperature health risk level reaches yellow, orange or red, and simultaneously pushes them to head teachers and parents.

The monitoring and survey schedule for the intervention group during the study period is as follows: at baseline and endpoint, unified offline WCST and health examinations will be conducted for children once each, accompanied by one online mini-program questionnaire survey each time. One children's high-temperature protection themed drawing activity will be organized at baseline and at the end of the 3rd month after the intervention, and the works will be uploaded to the mini-program for check-in. At the end of the 1st, 2nd and 3rd months after the intervention, one online follow-up questionnaire and WCST will be completed each month, together with check-in. Meanwhile, blood pressure will be monitored once a week, and daily blood pressure monitoring and check-in will be carried out after each high-temperature health risk early warning release. In addition, after the release of high-temperature health risk early warnings, the intervention group is required to complete check-in for reading and transmitting early warning information, health tips and protection science popularization content, as well as online mini-program surveys on children's awareness of high-temperature health risk early warning information and short-term behavioral patterns. The above WCST and questionnaire surveys will be completed by children with parental assistance; blood pressure monitoring and check-in are the responsibility of head teachers during non-summer vacations and parents during summer vacations.

The control group does not receive the high-temperature health risk early warning intervention and will only complete the corresponding WCST, health examinations, questionnaire surveys and blood pressure monitoring.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Descripción

School inclusion criteria

  1. Willing to participate in the study.
  2. Possess adequate facilities and qualified teaching staff.
  3. The school and teachers maintain good cooperation.
  4. Class size is no less than 35 students.
  5. All participating classrooms are equipped with air conditioners.

Participant inclusion criteria

  1. Fourth-grade primary school students aged 9 to 11, of all genders.
  2. Voluntary participation by students and their parents, good compliance, and signed informed consent.
  3. At least one adult family member has an internet-enabled mobile device.
  4. Good general health with no history of severe physical or mental disorders.
  5. Local permanent residents with a residency of no less than 6 months.

Participant exclusion criteria

  1. Participants who are unable or refuse to complete required examinations.
  2. Students receiving psychological or psychiatric treatment that may confound the study results.
  3. Those currently enrolled in other interventional clinical studies that may affect outcome assessment.
  4. Any other conditions deemed ineligible by the research team. Any participant meeting any of the above exclusion criteria will be excluded from the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control Group
The control group does not receive the mini-program-based high-temperature health risk early warning intervention.
Experimental: WeChat Mini-program Heat Health Early Warning Intervention Group
Participants receive tiered yellow, orange and red heat risk alerts and heat protection guidance via the WeChat Mini Program once alerts are issued due to high temperatures. Teachers and parents share health promotion tips with enrolled children. Mandatory mini-program check-ins and routine health monitoring are implemented throughout the 2.5-month intervention.
This study implements a digital early warning intervention targeting children's high-temperature health risks. During the intervention period, when the high-temperature health risk level reaches yellow, orange or red, relevant risk information, health tips and heat protection education materials are released to parents and head teachers via the WeChat mini-program. Parents or teachers pass on the warning information to participating children. During non-summer periods, Beijing's high-temperature early warning information is pushed to head teachers and parents via the WeChat mini-program; during summer vacation, location-specific early warning information is sent to parents. All recipients are required to pass on the information to children promptly upon receipt.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The primary outcome is the comprehensive total score of children's executive function constructed based on the Wisconsin Card Sorting Test (WCST)
Periodo de tiempo: at 2.5 months of intervention.
The only primary outcome of this study is the composite score of cognitive executive function derived from the Wisconsin Card Sorting Test (WCST) via the TOPSIS method. All WCST absolute indicators and sub-dimensions are sub-indicators instead of independent outcomes. The WCST indicators are grouped into three sub-dimensions: conceptual thinking (Total Correct, Total Errors, Nonperseverative Errors, Conceptual Level Responses, Categories Completed), perseveration (Perseverative Responses, Perseverative Errors), and set maintenance (Failure to Maintain Set). Negative indicators are converted using the formula (x' = Max(x) - x). After Z-score normalization, the decision matrix is established, positive and negative ideal solutions are identified, and Euclidean distances and relative closeness are computed. The resulting relative closeness value is taken as the final composite score of cognitive executive function, the single primary outcome of this study.
at 2.5 months of intervention.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systolic Blood Pressure
Periodo de tiempo: at 2.5 months of intervention
Systolic Blood Pressure measured in mmHg
at 2.5 months of intervention
Diastolic Blood Pressure
Periodo de tiempo: at 2.5 months of intervention
Diastolic blood pressure measured in mmHg
at 2.5 months of intervention
Heart Rate
Periodo de tiempo: at 2.5 months of intervention
Resting heart rate measured in beats per minute (bpm)
at 2.5 months of intervention
Forced Expiratory Volume in 1 second (FEV1)
Periodo de tiempo: at 2.5 months of intervention
Pulmonary function indicator measured in liters (L)
at 2.5 months of intervention
Forced Vital Capacity (FVC)
Periodo de tiempo: at 2.5 months of intervention
Pulmonary function indicator measured in liters (L)
at 2.5 months of intervention
Peak Expiratory Flow (PEF)
Periodo de tiempo: at 2.5 months of intervention
Pulmonary function indicator measured in liters per second (L/s)
at 2.5 months of intervention
Forced Expiratory Flow 25-75% (FEF25-75%)
Periodo de tiempo: at 2.5 months of intervention
Mid-expiratory flow measured in liters per second (L/s)
at 2.5 months of intervention
Fractional Exhaled Nitric Oxide (FeNO50)
Periodo de tiempo: at 2.5 months of intervention
Exhaled nitric oxide level at 50 mL/s flow rate, measured in parts per billion (ppb)
at 2.5 months of intervention
Fractional Exhaled Nitric Oxide (FeNO200)
Periodo de tiempo: at 2.5 months of intervention
Exhaled nitric oxide level at 200 mL/s flow rate, measured in parts per billion (ppb)
at 2.5 months of intervention
Calcium Nitric Oxide (CaNO)
Periodo de tiempo: at 2.5 months of intervention
Airway nitric oxide parameter measured in ppb
at 2.5 months of intervention
Fractional Expiratory Carbon Monoxide (FeCO)
Periodo de tiempo: at 2.5 months of intervention
Exhaled carbon monoxide level measured in parts per million (ppm)
at 2.5 months of intervention
Body Fat Percentage
Periodo de tiempo: at 2.5 months of intervention
Body fat percentage measured by bioelectrical impedance analysis
at 2.5 months of intervention
Total Body Water
Periodo de tiempo: at 2.5 months of intervention
Total body water measured in liters (L)
at 2.5 months of intervention
Inorganic Salts
Periodo de tiempo: at 2.5 months of intervention
Inorganic salt content measured in kilograms (kg)
at 2.5 months of intervention
Basal Metabolic Rate (BMR)
Periodo de tiempo: at 2.5 months of intervention
Basal metabolic rate measured in kilocalories per day (kcal/day)
at 2.5 months of intervention
Body Weight
Periodo de tiempo: at 2.5 months of intervention
Body weight measured in kilograms (kg)
at 2.5 months of intervention
High-Temperature Health KAP Score
Periodo de tiempo: at 2.5 months of intervention
Knowledge, Attitude, and Practice (KAP) score on high-temperature health
at 2.5 months of intervention
High-Temperature Health Cognition and Protection Behavior Drawing Score
Periodo de tiempo: at 2.5 months of intervention
Drawing-based score of children's cognition and protective behaviors for high-temperature health
at 2.5 months of intervention
Short-Term Behavioral Pattern Score
Periodo de tiempo: at 2.5 months of intervention
Score of children's short-term behavioral patterns related to heat health
at 2.5 months of intervention
SAS Anxiety Scale Score
Periodo de tiempo: at 2.5 months of intervention
Self-rating Anxiety Scale (SAS) score for children's anxiety symptoms
at 2.5 months of intervention
CDI Children's Depression Scale Score
Periodo de tiempo: at 2.5 months of intervention
Children's Depression Inventory (CDI) score for depressive symptoms
at 2.5 months of intervention
SGRQ Respiratory Symptom Scale Score
Periodo de tiempo: at 2.5 months of intervention
St. George's Respiratory Questionnaire (SGRQ) score for respiratory symptoms
at 2.5 months of intervention
School Absenteeism Days
Periodo de tiempo: at 2.5 months of intervention
Number of school absenteeism days during the study period
at 2.5 months of intervention
Academic Performance
Periodo de tiempo: at 2.5 months of intervention
Scores of children's academic examinations
at 2.5 months of intervention
Heat-Related Illness Incidence
Periodo de tiempo: at 2.5 months of intervention
Occurrence frequency of heat-related illnesses in children
at 2.5 months of intervention
Gastrointestinal Diseases Incidence
Periodo de tiempo: at 2.5 months of intervention
Occurrence frequency of gastrointestinal diseases in children
at 2.5 months of intervention
Respiratory Diseases Incidence
Periodo de tiempo: at 2.5 months of intervention
Occurrence frequency of respiratory diseases in children
at 2.5 months of intervention
Allergies Incidence
Periodo de tiempo: at 2.5 months of intervention
Occurrence frequency of allergies in children
at 2.5 months of intervention
Accidental Injuries Incidence
Periodo de tiempo: at 2.5 months of intervention
Occurrence frequency of accidental injuries in children
at 2.5 months of intervention
Early Warning Information Check-in Rate
Periodo de tiempo: at 2.5 months of intervention
Check-in rate of early warning information received by the intervention group
at 2.5 months of intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

1 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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