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NCT Number: NCT07643571

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

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.

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Key information

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

School inclusion criteria

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

Participant inclusion criteria

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

Participant exclusion criteria

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

Treatment and study plan

WeChat Mini-program Based Heat Health Risk Early Warning Intervention

Other

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.

Primary outcomes

  1. The primary outcome is the comprehensive total score of children's executive function constructed based on the Wisconsin Card Sorting Test (WCST)

    Time frame: 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.

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: at 2.5 months of intervention

    Systolic Blood Pressure measured in mmHg

  2. Diastolic Blood Pressure

    Time frame: at 2.5 months of intervention

    Diastolic blood pressure measured in mmHg

  3. Heart Rate

    Time frame: at 2.5 months of intervention

    Resting heart rate measured in beats per minute (bpm)

  4. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: at 2.5 months of intervention

    Pulmonary function indicator measured in liters (L)

  5. Forced Vital Capacity (FVC)

    Time frame: at 2.5 months of intervention

    Pulmonary function indicator measured in liters (L)

  6. Peak Expiratory Flow (PEF)

    Time frame: at 2.5 months of intervention

    Pulmonary function indicator measured in liters per second (L/s)

  7. Forced Expiratory Flow 25-75% (FEF25-75%)

    Time frame: at 2.5 months of intervention

    Mid-expiratory flow measured in liters per second (L/s)

  8. Fractional Exhaled Nitric Oxide (FeNO50)

    Time frame: at 2.5 months of intervention

    Exhaled nitric oxide level at 50 mL/s flow rate, measured in parts per billion (ppb)

  9. Fractional Exhaled Nitric Oxide (FeNO200)

    Time frame: at 2.5 months of intervention

    Exhaled nitric oxide level at 200 mL/s flow rate, measured in parts per billion (ppb)

  10. Calcium Nitric Oxide (CaNO)

    Time frame: at 2.5 months of intervention

    Airway nitric oxide parameter measured in ppb

  11. Fractional Expiratory Carbon Monoxide (FeCO)

    Time frame: at 2.5 months of intervention

    Exhaled carbon monoxide level measured in parts per million (ppm)

  12. Body Fat Percentage

    Time frame: at 2.5 months of intervention

    Body fat percentage measured by bioelectrical impedance analysis

  13. Total Body Water

    Time frame: at 2.5 months of intervention

    Total body water measured in liters (L)

  14. Inorganic Salts

    Time frame: at 2.5 months of intervention

    Inorganic salt content measured in kilograms (kg)

  15. Basal Metabolic Rate (BMR)

    Time frame: at 2.5 months of intervention

    Basal metabolic rate measured in kilocalories per day (kcal/day)

  16. Body Weight

    Time frame: at 2.5 months of intervention

    Body weight measured in kilograms (kg)

  17. High-Temperature Health KAP Score

    Time frame: at 2.5 months of intervention

    Knowledge, Attitude, and Practice (KAP) score on high-temperature health

  18. High-Temperature Health Cognition and Protection Behavior Drawing Score

    Time frame: at 2.5 months of intervention

    Drawing-based score of children's cognition and protective behaviors for high-temperature health

  19. Short-Term Behavioral Pattern Score

    Time frame: at 2.5 months of intervention

    Score of children's short-term behavioral patterns related to heat health

  20. SAS Anxiety Scale Score

    Time frame: at 2.5 months of intervention

    Self-rating Anxiety Scale (SAS) score for children's anxiety symptoms

  21. CDI Children's Depression Scale Score

    Time frame: at 2.5 months of intervention

    Children's Depression Inventory (CDI) score for depressive symptoms

  22. SGRQ Respiratory Symptom Scale Score

    Time frame: at 2.5 months of intervention

    St. George's Respiratory Questionnaire (SGRQ) score for respiratory symptoms

  23. School Absenteeism Days

    Time frame: at 2.5 months of intervention

    Number of school absenteeism days during the study period

  24. Academic Performance

    Time frame: at 2.5 months of intervention

    Scores of children's academic examinations

  25. Heat-Related Illness Incidence

    Time frame: at 2.5 months of intervention

    Occurrence frequency of heat-related illnesses in children

  26. Gastrointestinal Diseases Incidence

    Time frame: at 2.5 months of intervention

    Occurrence frequency of gastrointestinal diseases in children

  27. Respiratory Diseases Incidence

    Time frame: at 2.5 months of intervention

    Occurrence frequency of respiratory diseases in children

  28. Allergies Incidence

    Time frame: at 2.5 months of intervention

    Occurrence frequency of allergies in children

  29. Accidental Injuries Incidence

    Time frame: at 2.5 months of intervention

    Occurrence frequency of accidental injuries in children

  30. Early Warning Information Check-in Rate

    Time frame: at 2.5 months of intervention

    Check-in rate of early warning information received by the intervention group

Study contacts

Contact information is provided by the study sponsor or research team.

TianTian LI, Study Director

CONTACT

[email protected]

010-50930213

Tiantian Li, PhD

CONTACT

[email protected]

010-50930213

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention, China

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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