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El ensayo clínico NCT06579963 (REFLECT) para Frecuencia cardíaca, All-day Steps, Distance Walked, Active Minutes, Moderate-intensity Activity Minutes, Vigorous-intensity Activity Duration, Sleep Quantity, Time in Sleep Stages, Awake Duration, Sleep Score está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Assessing the Effect of Cool Roofs on Health Using Smartwatches (REFLECT)

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06579963 (REFLECT) es un ensayo intervencionista para Frecuencia cardíaca, All-day Steps, Distance Walked, Active Minutes, Moderate-intensity Activity Minutes, Vigorous-intensity Activity Duration, Sleep Quantity, Time in Sleep Stages, Awake Duration, Sleep Score. Su estado actual es: reclutando. El ensayo se inició el 4 de septiembre de 2024, con el objetivo de reclutar a 800 participantes. Dirigido por Aditi Bunker, se espera que finalice el 31 de enero de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 10 de diciembre de 2024.
Resumen
Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are susceptible to increased heat exposure.

Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof application may improve heart health, sleep and physical activity in household occupants.

The long-term research goal is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will use smartwatches to measure the effects cool roof application on heart health, sleep and physical activity in four urban climate hotspots: Ouagadougou, Burkina Faso; Hermosillo, Mexico; Ahmedabad, India; and Niue, Oceania.

Descripción detallada
Increasing heat exposure from climate change is causing and exacerbating heat-related illnesses in millions worldwide - particularly in low resource settings. June 2024 was the 13th consecutive hottest month on record globally - shattering previous records. Heat exposure can instigate and worsen numerous health conditions. Adaptation is essential for protecting people from increasing heat exposure. The built environment, especially homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, evidence is currently lacking on a global scale - generated through empirical studies - guiding the uptake of interventions to reduce indoor heat stress in low resource settings.

Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and lower energy use, offering protection to home occupants from extreme heat. Continuous monitoring of health and wellbeing using smartwatches can provide insight into important parameters such as heart rate, sleep and physical activity - which are all affected by heat. Using smartwatches, the investigators will also continuously measure health and wellbeing outcomes during the day and night. The investigators will conduct a global multi-centre study to investigate the effects of cool-roof use on heart rate, sleep and physical activity in four urban climate hotspots - Ouagadougou, Burkina Faso (sub-Saharan Africa), Ahmedabad, India (Asia), Niue (Oceania), and Sonora, Mexico (Latin America). These sites represent hotspots where people experience a triple burden from heat exposure, chronic health issues and vulnerable housing conditions (slums, informal settlements and low socioeconomic housing). They also exhibit diversity in climate profiles, housing typology, level of socioeconomic development, population density and rates of urbanisation.

This trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in four locations. Findings will inform global policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change.

Título oficial

A Randomized Controlled Trial (RCT) Evaluating the Effects of Cool Roofs on Health Outcomes Using Smartwatches: a Global Multi-center Study

Condiciones médicas
Frecuencia cardíacaAll-day StepsDistance WalkedActive MinutesModerate-intensity Activity MinutesVigorous-intensity Activity DurationSleep QuantityTime in Sleep StagesAwake DurationSleep Score
Otros ID del ensayo
  • REFLECT
  • 3728163
  • 226745/Z/22/Z (Otra financiación) (Wellcome Trust UK)
Número del NCT
Inicio del ensayo (real)
2024-09-04
Última actualización
2024-12-10
Fecha de finalización (estimada)
2026-01-31
Inscripción (prevista)
800
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
Hot Temperature
Humidity
Housing
Wearable
Smartwatch
Heart rate
Cardiovascular
Physical activity
Sleep
Cool roof
Heat stress
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalCool roof
Households will receive sunlight reflecting 'cool roof' coating on their roofs.
Cool Roof
Cool roofs are a sunlight reflecting roof coating that can reduce indoor temperature. Cool roofs have high solar reflectance (reflecting the ultraviolet and visible wavelengths of sunlight, reducing heat transfer to the surface of a roof) and high thermal emittance (radiating absorbed solar energy).
Sin intervenciónNo cool roof
No cool roof application. Households will keep their original roofing for the duration of the trial.
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Heart rate
Heart rate in beats per minute measured at 15-second intervals using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
All-day steps
The number of steps measured daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Active minutes
The total number of minutes of active exercise daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Distance walked
The total distance walked daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Moderate-intensity activity minutes
The total number of minutes of moderate-intensity activity daily using Garmin Vivosmart 5 devices.
MeasuSmartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at barements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month.
Vigorous-intensity activity duration
The total number of minutes of vigorous-intensity activity daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep quantity
The number of hours spent asleep each night using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Time in sleep stages
The number of hours spent in sleep stages each night using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Awake duration
The number of hours spent awake during sleep time each night using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep score
The Garmin sleep score (0-100) each night using Garmin Vivosmart 5 devices. A higher score means a better outcome.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
  • Permanent household resident

  • Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.
  • Participant unable to provide written/verbal informed consent. Participants will be excluded if they are not willing or able to wear a smartwatch.
  • In Mexico and Niue, participants will be excluded if they do not have a smartphone with an internet connection that can connect to the smartwatch.
  • Only one participant per household.
Aditi Bunker logoAditi Bunker
  • 🏢Sika Services AG
  • 🏛️SOPREMA
  • 🏢Engineered Polymer Solutions (EPS B.V.)
  • 🏛️Resene
  • 🏛️Pacific Community
  • 🏛️Habitat for Humanity
  • 🧬The Tindall Foundation
  • 🧪Labfront
  • 🏛️Instituto Tecnológico de Hermosillo
  • 🎓University of Ouagadougou, Burkina Faso
  • ⚕️Indian Institute of Public Health, India
  • ⚕️London School of Hygiene and Tropical Medicine
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Parte responsable del ensayo
Aditi Bunker, Investigador-patrocinador, Co-Principal Investigator, University of Auckland, New Zealand
Contactos centrales del ensayo
Contacto: Aditi Bunker, Dr, +49 6221 565344, [email protected]
Contacto: Collin Tukuitonga, Sir. Dr., +6493737599, [email protected]
4 Sitios del ensayo en 4 países

Sanora

Instituto Tecnológico de Hermosillo, Hermosillo, Sanora, Mexico
Jose Antonio Hoyo Montano, Contacto, +526621610612, [email protected]
Jose Antonio Hoyo Montano, Investigador principal
Aún no recluta
University Joseph Ki-Zerbo, Ouagadougou, Burkina Faso
Abdramane Soura, Contacto, +22670026232, [email protected]
Abdramane Soura, Investigador principal
Aún no recluta

Gandhinagar

Indian Institute of Public Health Gandhinagar, Ahmedabad, Gandhinagar, India
Anish Sinha, Contacto, +919377470505, [email protected]
Dileep Mavlankar, Investigador principal
Anish Sinha, Subinvestigador
Reclutando
Niue, Alofi, Niue
Noah Bunkley, Contacto, +640273502516, [email protected]
Collin Tukuitonga, Investigador principal
Noah Bunkley, Subinvestigador
Reclutando