- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07643571
Study on Intervention Effect of Heat-related Health Risk Early Warning Digital Technology for School-age Children
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tiantian Li, PhD
- Número de teléfono: 010-50930213
- Correo electrónico: litiantian@nieh.chinacdc.cn
Copia de seguridad de contactos de estudio
- Nombre: TianTian LI, Study Director
- Número de teléfono: 010-50930213
- Correo electrónico: litiantian@nieh.chinacdc.cn
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿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 |
|---|---|
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Sin intervención: Control Group
The control group does not receive the mini-program-based high-temperature health risk early warning intervention.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
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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.
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at 2.5 months of intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systolic Blood Pressure
Periodo de tiempo: at 2.5 months of intervention
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Systolic Blood Pressure measured in mmHg
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at 2.5 months of intervention
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Diastolic Blood Pressure
Periodo de tiempo: at 2.5 months of intervention
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Diastolic blood pressure measured in mmHg
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at 2.5 months of intervention
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Heart Rate
Periodo de tiempo: at 2.5 months of intervention
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Resting heart rate measured in beats per minute (bpm)
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at 2.5 months of intervention
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Forced Expiratory Volume in 1 second (FEV1)
Periodo de tiempo: at 2.5 months of intervention
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Pulmonary function indicator measured in liters (L)
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at 2.5 months of intervention
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Forced Vital Capacity (FVC)
Periodo de tiempo: at 2.5 months of intervention
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Pulmonary function indicator measured in liters (L)
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at 2.5 months of intervention
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Peak Expiratory Flow (PEF)
Periodo de tiempo: at 2.5 months of intervention
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Pulmonary function indicator measured in liters per second (L/s)
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at 2.5 months of intervention
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Forced Expiratory Flow 25-75% (FEF25-75%)
Periodo de tiempo: at 2.5 months of intervention
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Mid-expiratory flow measured in liters per second (L/s)
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at 2.5 months of intervention
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Fractional Exhaled Nitric Oxide (FeNO50)
Periodo de tiempo: at 2.5 months of intervention
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Exhaled nitric oxide level at 50 mL/s flow rate, measured in parts per billion (ppb)
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at 2.5 months of intervention
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Fractional Exhaled Nitric Oxide (FeNO200)
Periodo de tiempo: at 2.5 months of intervention
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Exhaled nitric oxide level at 200 mL/s flow rate, measured in parts per billion (ppb)
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at 2.5 months of intervention
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Calcium Nitric Oxide (CaNO)
Periodo de tiempo: at 2.5 months of intervention
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Airway nitric oxide parameter measured in ppb
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at 2.5 months of intervention
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Fractional Expiratory Carbon Monoxide (FeCO)
Periodo de tiempo: at 2.5 months of intervention
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Exhaled carbon monoxide level measured in parts per million (ppm)
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at 2.5 months of intervention
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Body Fat Percentage
Periodo de tiempo: at 2.5 months of intervention
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Body fat percentage measured by bioelectrical impedance analysis
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at 2.5 months of intervention
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Total Body Water
Periodo de tiempo: at 2.5 months of intervention
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Total body water measured in liters (L)
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at 2.5 months of intervention
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Inorganic Salts
Periodo de tiempo: at 2.5 months of intervention
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Inorganic salt content measured in kilograms (kg)
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at 2.5 months of intervention
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Basal Metabolic Rate (BMR)
Periodo de tiempo: at 2.5 months of intervention
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Basal metabolic rate measured in kilocalories per day (kcal/day)
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at 2.5 months of intervention
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Body Weight
Periodo de tiempo: at 2.5 months of intervention
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Body weight measured in kilograms (kg)
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at 2.5 months of intervention
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High-Temperature Health KAP Score
Periodo de tiempo: at 2.5 months of intervention
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Knowledge, Attitude, and Practice (KAP) score on high-temperature health
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at 2.5 months of intervention
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High-Temperature Health Cognition and Protection Behavior Drawing Score
Periodo de tiempo: at 2.5 months of intervention
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Drawing-based score of children's cognition and protective behaviors for high-temperature health
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at 2.5 months of intervention
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Short-Term Behavioral Pattern Score
Periodo de tiempo: at 2.5 months of intervention
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Score of children's short-term behavioral patterns related to heat health
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at 2.5 months of intervention
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SAS Anxiety Scale Score
Periodo de tiempo: at 2.5 months of intervention
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Self-rating Anxiety Scale (SAS) score for children's anxiety symptoms
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at 2.5 months of intervention
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CDI Children's Depression Scale Score
Periodo de tiempo: at 2.5 months of intervention
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Children's Depression Inventory (CDI) score for depressive symptoms
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at 2.5 months of intervention
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SGRQ Respiratory Symptom Scale Score
Periodo de tiempo: at 2.5 months of intervention
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St. George's Respiratory Questionnaire (SGRQ) score for respiratory symptoms
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at 2.5 months of intervention
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School Absenteeism Days
Periodo de tiempo: at 2.5 months of intervention
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Number of school absenteeism days during the study period
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at 2.5 months of intervention
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Academic Performance
Periodo de tiempo: at 2.5 months of intervention
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Scores of children's academic examinations
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at 2.5 months of intervention
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Heat-Related Illness Incidence
Periodo de tiempo: at 2.5 months of intervention
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Occurrence frequency of heat-related illnesses in children
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at 2.5 months of intervention
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Gastrointestinal Diseases Incidence
Periodo de tiempo: at 2.5 months of intervention
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Occurrence frequency of gastrointestinal diseases in children
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at 2.5 months of intervention
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Respiratory Diseases Incidence
Periodo de tiempo: at 2.5 months of intervention
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Occurrence frequency of respiratory diseases in children
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at 2.5 months of intervention
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Allergies Incidence
Periodo de tiempo: at 2.5 months of intervention
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Occurrence frequency of allergies in children
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at 2.5 months of intervention
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Accidental Injuries Incidence
Periodo de tiempo: at 2.5 months of intervention
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Occurrence frequency of accidental injuries in children
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at 2.5 months of intervention
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Early Warning Information Check-in Rate
Periodo de tiempo: at 2.5 months of intervention
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Check-in rate of early warning information received by the intervention group
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at 2.5 months of intervention
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803.
- Lei J, Sun Q, Chen R, Zhu Y, Zhou L, Xue X, Fang J, Du Y, Wang Y, Li T, Kan H. Respiratory Benefits of Multisetting Air Purification in Children: A Cluster Randomized Crossover Trial. JAMA Pediatr. 2025 Feb 1;179(2):122-128. doi: 10.1001/jamapediatrics.2024.5049.
- Wang Y, Sun Y, Ban J, Fang J, Sun Q, Du Y, Liu Y, Dong H, Wang Q, Chen C, Zhang Y, Ma R, Chen R, Kan H, Li T. Cognitive benefits of air purification among schoolchildren: A randomized, double-blind, crossover trial. Innovation (Camb). 2026 Feb 5;7(5):101304. doi: 10.1016/j.xinn.2026.101304. eCollection 2026 May 4.
- Pan CY, Tsai CL, Chu CH, Sung MC, Huang CY, Ma WY. Effects of Physical Exercise Intervention on Motor Skills and Executive Functions in Children With ADHD: A Pilot Study. J Atten Disord. 2019 Feb;23(4):384-397. doi: 10.1177/1087054715569282. Epub 2015 Feb 2.
- Assari S, Zare H. Extreme Heat Exposure is Associated with Lower Learning, General Cognitive Ability, and Memory among US Children. Open J Neurosci. 2025;3(1):10-22. doi: 10.31586/ojn.2025.1277. Epub 2025 Jan 10.
- Perera F, Nadeau K. Climate Change, Fossil-Fuel Pollution, and Children's Health. N Engl J Med. 2022 Jun 16;386(24):2303-2314. doi: 10.1056/NEJMra2117706. No abstract available.
- Romanello M, Napoli CD, Green C, Kennard H, Lampard P, Scamman D, Walawender M, Ali Z, Ameli N, Ayeb-Karlsson S, Beggs PJ, Belesova K, Berrang Ford L, Bowen K, Cai W, Callaghan M, Campbell-Lendrum D, Chambers J, Cross TJ, van Daalen KR, Dalin C, Dasandi N, Dasgupta S, Davies M, Dominguez-Salas P, Dubrow R, Ebi KL, Eckelman M, Ekins P, Freyberg C, Gasparyan O, Gordon-Strachan G, Graham H, Gunther SH, Hamilton I, Hang Y, Hanninen R, Hartinger S, He K, Heidecke J, Hess JJ, Hsu SC, Jamart L, Jankin S, Jay O, Kelman I, Kiesewetter G, Kinney P, Kniveton D, Kouznetsov R, Larosa F, Lee JKW, Lemke B, Liu Y, Liu Z, Lott M, Lotto Batista M, Lowe R, Odhiambo Sewe M, Martinez-Urtaza J, Maslin M, McAllister L, McMichael C, Mi Z, Milner J, Minor K, Minx JC, Mohajeri N, Momen NC, Moradi-Lakeh M, Morrissey K, Munzert S, Murray KA, Neville T, Nilsson M, Obradovich N, O'Hare MB, Oliveira C, Oreszczyn T, Otto M, Owfi F, Pearman O, Pega F, Pershing A, Rabbaniha M, Rickman J, Robinson EJZ, Rocklov J, Salas RN, Semenza JC, Sherman JD, Shumake-Guillemot J, Silbert G, Sofiev M, Springmann M, Stowell JD, Tabatabaei M, Taylor J, Thompson R, Tonne C, Treskova M, Trinanes JA, Wagner F, Warnecke L, Whitcombe H, Winning M, Wyns A, Yglesias-Gonzalez M, Zhang S, Zhang Y, Zhu Q, Gong P, Montgomery H, Costello A. The 2023 report of the Lancet Countdown on health and climate change: the imperative for a health-centred response in a world facing irreversible harms. Lancet. 2023 Dec 16;402(10419):2346-2394. doi: 10.1016/S0140-6736(23)01859-7. Epub 2023 Nov 14.
- Ebi KL, Capon A, Berry P, Broderick C, de Dear R, Havenith G, Honda Y, Kovats RS, Ma W, Malik A, Morris NB, Nybo L, Seneviratne SI, Vanos J, Jay O. Hot weather and heat extremes: health risks. Lancet. 2021 Aug 21;398(10301):698-708. doi: 10.1016/S0140-6736(21)01208-3.
- Liu Z, Gao P, Gao AY, Lin Y, Feng XX, Zhang F, Xu LQ, Niu WY, Fang H, Zhou S, Li WH, Yuan JH, Xu CX, Wu N, Li HJ, Wen LM, Patton GC, Wang HJ, Wu YF. Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):e214375. doi: 10.1001/jamapediatrics.2021.4375. Epub 2022 Jan 4.
- Shinde S, Weiss HA, Varghese B, Khandeparkar P, Pereira B, Sharma A, Gupta R, Ross DA, Patton G, Patel V. Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial. Lancet. 2018 Dec 8;392(10163):2465-2477. doi: 10.1016/S0140-6736(18)31615-5. Epub 2018 Nov 22.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NIEH202643
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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