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Lo studio clinico NCT06579963 (REFLECT) per Frequenza cardiaca, 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 è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Assessing the Effect of Cool Roofs on Health Using Smartwatches (REFLECT)

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06579963 (REFLECT) è uno studio interventistico per Frequenza cardiaca, 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, attualmente in arruolamento. Avviato il 4 settembre 2024, prevede di arruolare 800 partecipanti. Sotto la guida di Aditi Bunker, dovrebbe concludersi entro il 31 gennaio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 10 dicembre 2024.
Sommario breve
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.

Descrizione dettagliata
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.

Titolo ufficiale

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

Condizioni
Frequenza cardiacaAll-day StepsDistance WalkedActive MinutesModerate-intensity Activity MinutesVigorous-intensity Activity DurationSleep QuantityTime in Sleep StagesAwake DurationSleep Score
Altri ID dello studio
  • REFLECT
  • 3728163
  • 226745/Z/22/Z (Altro numero di finanziamento) (Wellcome Trust UK)
Numero NCT
Data di inizio (effettiva)
2024-09-04
Ultimo aggiornamento pubblicato
2024-12-10
Data di completamento (stimata)
2026-01-31
Arruolamento (previsto)
800
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Hot Temperature
Humidity
Housing
Wearable
Smartwatch
Heart rate
Cardiovascular
Physical activity
Sleep
Cool roof
Heat stress
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleCool 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).
Nessun interventoNo cool roof
No cool roof application. Households will keep their original roofing for the duration of the trial.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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.
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
  • 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 responsabile dello studio
Aditi Bunker, Promotore-investigatore, Co-Principal Investigator, University of Auckland, New Zealand
Contatti principali dello studio
Contatto: Aditi Bunker, Dr, +49 6221 565344, [email protected]
Contatto: Collin Tukuitonga, Sir. Dr., +6493737599, [email protected]
4 Centri dello studio in 4 paesi
University Joseph Ki-Zerbo, Ouagadougou, Burkina Faso
Abdramane Soura, Contatto, +22670026232, [email protected]
Abdramane Soura, Investigatore principale
Non ancora in arruolamento

Gandhinagar

Indian Institute of Public Health Gandhinagar, Ahmedabad, Gandhinagar, India
Anish Sinha, Contatto, +919377470505, [email protected]
Dileep Mavlankar, Investigatore principale
Anish Sinha, Sub-investigatore
In arruolamento

Sanora

Instituto Tecnológico de Hermosillo, Hermosillo, Sanora, Mexico
Jose Antonio Hoyo Montano, Contatto, +526621610612, [email protected]
Jose Antonio Hoyo Montano, Investigatore principale
Non ancora in arruolamento
Niue, Alofi, Niue
Noah Bunkley, Contatto, +640273502516, [email protected]
Collin Tukuitonga, Investigatore principale
Noah Bunkley, Sub-investigatore
In arruolamento