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

9 июня 2026 г. обновлено: 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.

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

200

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

  • Имя: TianTian LI, Study Director
  • Номер телефона: 010-50930213
  • Электронная почта: litiantian@nieh.chinacdc.cn

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Да

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Без вмешательства: Control Group
The control group does not receive the mini-program-based high-temperature health risk early warning intervention.
Экспериментальный: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The primary outcome is the comprehensive total score of children's executive function constructed based on the Wisconsin Card Sorting Test (WCST)
Временное ограничение: 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.

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 сентября 2026 г.

Завершение исследования (Оцененный)

1 сентября 2026 г.

Даты регистрации исследования

Первый отправленный

3 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

9 июня 2026 г.

Первый опубликованный (Действительный)

11 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

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НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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