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

9 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control Group
The control group does not receive the mini-program-based high-temperature health risk early warning intervention.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The primary outcome is the comprehensive total score of children's executive function constructed based on the Wisconsin Card Sorting Test (WCST)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Systolic Blood Pressure
Lasso di tempo: at 2.5 months of intervention
Systolic Blood Pressure measured in mmHg
at 2.5 months of intervention
Diastolic Blood Pressure
Lasso di tempo: at 2.5 months of intervention
Diastolic blood pressure measured in mmHg
at 2.5 months of intervention
Heart Rate
Lasso di tempo: 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)
Lasso di tempo: at 2.5 months of intervention
Pulmonary function indicator measured in liters (L)
at 2.5 months of intervention
Forced Vital Capacity (FVC)
Lasso di tempo: at 2.5 months of intervention
Pulmonary function indicator measured in liters (L)
at 2.5 months of intervention
Peak Expiratory Flow (PEF)
Lasso di tempo: 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%)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: at 2.5 months of intervention
Airway nitric oxide parameter measured in ppb
at 2.5 months of intervention
Fractional Expiratory Carbon Monoxide (FeCO)
Lasso di tempo: 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
Lasso di tempo: at 2.5 months of intervention
Body fat percentage measured by bioelectrical impedance analysis
at 2.5 months of intervention
Total Body Water
Lasso di tempo: at 2.5 months of intervention
Total body water measured in liters (L)
at 2.5 months of intervention
Inorganic Salts
Lasso di tempo: at 2.5 months of intervention
Inorganic salt content measured in kilograms (kg)
at 2.5 months of intervention
Basal Metabolic Rate (BMR)
Lasso di tempo: at 2.5 months of intervention
Basal metabolic rate measured in kilocalories per day (kcal/day)
at 2.5 months of intervention
Body Weight
Lasso di tempo: at 2.5 months of intervention
Body weight measured in kilograms (kg)
at 2.5 months of intervention
High-Temperature Health KAP Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: at 2.5 months of intervention
Number of school absenteeism days during the study period
at 2.5 months of intervention
Academic Performance
Lasso di tempo: at 2.5 months of intervention
Scores of children's academic examinations
at 2.5 months of intervention
Heat-Related Illness Incidence
Lasso di tempo: at 2.5 months of intervention
Occurrence frequency of heat-related illnesses in children
at 2.5 months of intervention
Gastrointestinal Diseases Incidence
Lasso di tempo: at 2.5 months of intervention
Occurrence frequency of gastrointestinal diseases in children
at 2.5 months of intervention
Respiratory Diseases Incidence
Lasso di tempo: at 2.5 months of intervention
Occurrence frequency of respiratory diseases in children
at 2.5 months of intervention
Allergies Incidence
Lasso di tempo: at 2.5 months of intervention
Occurrence frequency of allergies in children
at 2.5 months of intervention
Accidental Injuries Incidence
Lasso di tempo: 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
Lasso di tempo: at 2.5 months of intervention
Check-in rate of early warning information received by the intervention group
at 2.5 months of intervention

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

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Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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