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临床试验 NCT06579963 (REFLECT) 针对心率,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目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Assessing the Effect of Cool Roofs on Health Using Smartwatches (REFLECT)

招募中
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临床试验NCT06579963 (REFLECT)是一项针对心率,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干预性研究试验,目前试验状态为招募中。试验始于2024年9月4日,计划招募800名患者。该研究由Aditi Bunker主导,预计于2026年1月31日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2024年12月10日
简要概括
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.

详细描述
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.

官方标题

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

疾病
心率All-day StepsDistance WalkedActive MinutesModerate-intensity Activity MinutesVigorous-intensity Activity DurationSleep QuantityTime in Sleep StagesAwake DurationSleep Score
其他研究标识符
  • REFLECT
  • 3728163
  • 226745/Z/22/Z (其他拨款/资助编号) (Wellcome Trust UK)
NCT编号
实际开始日期
2024-09-04
最近更新发布
2024-12-10
预计完成日期
2026-01-31
计划入组人数
800
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Hot Temperature
Humidity
Housing
Wearable
Smartwatch
Heart rate
Cardiovascular
Physical activity
Sleep
Cool roof
Heat stress
主要目的
预防
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Cool 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).
无干预No cool roof
No cool roof application. Households will keep their original roofing for the duration of the trial.
不适用
主要终点
结果指标度量标准描述时间框架
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.
次要终点
结果指标度量标准描述时间框架
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.
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
  • 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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研究责任方
Aditi Bunker, 申办者-研究者, Co-Principal Investigator, University of Auckland, New Zealand
研究中心联系人
联系人: Aditi Bunker, Dr, +49 6221 565344, [email protected]
联系人: Collin Tukuitonga, Sir. Dr., +6493737599, [email protected]
4 位于 4 个国家/地区的研究中心
University Joseph Ki-Zerbo, Ouagadougou, Burkina Faso
Abdramane Soura, 联系人, +22670026232, [email protected]
Abdramane Soura, 主要研究者
尚未招募

Gandhinagar

Indian Institute of Public Health Gandhinagar, Ahmedabad, Gandhinagar, India
Anish Sinha, 联系人, +919377470505, [email protected]
Dileep Mavlankar, 主要研究者
Anish Sinha, 子研究者
招募中

Sanora

Instituto Tecnológico de Hermosillo, Hermosillo, Sanora, Mexico
Jose Antonio Hoyo Montano, 联系人, +526621610612, [email protected]
Jose Antonio Hoyo Montano, 主要研究者
尚未招募
Niue, Alofi, Niue
Noah Bunkley, 联系人, +640273502516, [email protected]
联系人, [email protected]
Collin Tukuitonga, 主要研究者
Noah Bunkley, 子研究者
招募中