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Clinical Trial NCT06579950 (REFLECT) for Resting Heart Rate, Blood Glucose Control, Depression, Heat-related Symptoms, Physician Diagnosed Heat-related Illnesses, Food Insecurity, Diet Quality, Health-related Quality of Life, Indoor Thermal Comfort, Coping Ability, Life Satisfaction, Healthcare Provider Utilization, Hospitalization, Systolic Blood Pressure, Diastolic Blood Pressure, Inner Ear Canal Temperature, Dehydration, Sleep Quality, Cognition, Productivity, Aggression, Indoor Air Temperature, Indoor Relative Humidity, Indoor Heat Index, Household Energy Expenditure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Assessing the Effects of Cool Roofs on Indoor Environments and Health (REFLECT)

Recruiting
Clinical Trial NCT06579950 (REFLECT) is an interventional study for Resting Heart Rate, Blood Glucose Control, Depression, Heat-related Symptoms, Physician Diagnosed Heat-related Illnesses, Food Insecurity, Diet Quality, Health-related Quality of Life, Indoor Thermal Comfort, Coping Ability, Life Satisfaction, Healthcare Provider Utilization, Hospitalization, Systolic Blood Pressure, Diastolic Blood Pressure, Inner Ear Canal Temperature, Dehydration, Sleep Quality, Cognition, Productivity, Aggression, Indoor Air Temperature, Indoor Relative Humidity, Indoor Heat Index, Household Energy Expenditure that is recruiting. It started on 4 September 2024 with plans to enroll 3,200 participants. Led by Aditi Bunker, it is expected to complete by 31 January 2026. The latest data from ClinicalTrials.gov was last updated on 10 December 2024.
Brief Summary
Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings 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 especially vulnerable to increased indoor heat exposure.

Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants.

The long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in four urban climate hotspots: Ouagadougou, Burkina Faso; Hermosillo, Mexico; Ahmedabad, India; and Niue, Oceania.

Detailed Description
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 health conditions including cardiovascular, metabolic, endocrine and respiratory disease, heat-related illnesses, pregnancy complications, and mental health conditions. Adaptation is essential for protecting people from increasing heat exposure. The built environment, especially our homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, currently there is a lack of evidence on a global scale - generated through empirical studies - guiding the uptake of interventions to reduce 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. The investigators aim to conduct a global multi-centre cluster-randomized controlled trial investigating the effects of cool-roof use on health, environmental and economic outcomes in four urban climate hotspots - Ouagadougou, Burkina Faso (sub-Saharan Africa), Ahmedabad, India (Asia), Niue (Oceania), and Hermosillo, Mexico (Latin America). The 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.

The 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.

Official Title

The Effects of Cool Roofs on Health, Environmental, and Economic Outcomes: a Global Multi-center Cluster-randomized Controlled Trial

Conditions
Resting Heart RateBlood Glucose ControlDepressionHeat-related SymptomsPhysician Diagnosed Heat-related IllnessesFood InsecurityDiet QualityHealth-related Quality of LifeIndoor Thermal ComfortCoping AbilityLife SatisfactionHealthcare Provider UtilizationHospitalizationSystolic Blood PressureDiastolic Blood PressureInner Ear Canal TemperatureDehydrationSleep QualityCognitionProductivityAggressionIndoor Air TemperatureIndoor Relative HumidityIndoor Heat IndexHousehold Energy Expenditure
Other Study IDs
  • REFLECT
  • 3728162
  • 226745/Z/22/Z (Other Grant/Funding Number) (Wellcome Trust UK)
NCT ID Number
Start Date (Actual)
2024-09-04
Last Update Posted
2024-12-10
Completion Date (Estimated)
2026-01-31
Enrollment (Estimated)
3,200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Hot Temperature
Humidity
Housing
Heart rate
Cardiovascular
Depression
Mental health
Blood glucose
Diabetes
Cool roof
Heat Stress
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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).
No InterventionNo cool roof
No cool roof application. Households will keep their original roofing for the duration of the trial.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Resting heart rate
Resting heart rate in beats per minute measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Blood glucose control
Three month average of blood glucose in mmol/mol measured as glycosylated hemoglobin (HbA1c) using capillary blood and the HemoCue® HbA1c 501 System.
Two measurements will be taken: one at baseline and one in the last month of three consecutive hottest months.
Depression
Self-reported presence and frequency of symptoms of depression assessed using aggregate score of the Patient Health Questionnaire 9 (PHQ-9). Minimum score of 0 and a maximum score of 27 with a higher score meaning a worse outcome.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Heat-related symptoms
Self-reported heat-related symptoms in the past month, assessed using a recall questionnaire.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Physician diagnosed heat-related illnesses
Self-reported new diagnosis from a medical practitioner of a heat-related illness in the last month assessed using a recall questionnaire.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Food insecurity
Self-reported experience based measure of individual food security assessed using the Food Insecurity Experience Scale (FIES).
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Diet quality
Self-reported individual food group consumption in the previous 24 hours assessed using the Diet Quality Questionnaire (DQQ).
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Health-related quality of life
Current self-reported health-related quality of life assessed using the EuroQol EQ-5D-5L quality assessment tool. The minimum and maximum scores for the EuroQol EQ-5D-5L quality assessment tool are -0.59 and 1, respectively. A score of 1 represents the best possible health state, while scores below 0 indicate health states that are considered worse than death.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Indoor thermal comfort
Self-reported household heat, humidity and comfort experience over the last four weeks assessed using a recall questionnaire.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Coping ability
Self-reported coping strategies for high indoor temperatures assessed using a recall questionnaire.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Life satisfaction
Current self-reported life satisfaction assessed using the World Values Survey. Values can range from 1 to 10 with a higher score representing greater life satisfaction.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Healthcare provider utilization
Self-reported healthcare provider utilization in the past four weeks assessed using a recall questionnaire.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Hospitalization
Self-reported overnight hospital stay in the past four weeks assessed using a recall questionnaire.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Systolic Blood Pressure
Maximum blood pressure (mmHg) during systole measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Diastolic Blood Pressure
Minimum blood pressure (mmHg) during diastole measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Cognition
Accuracy and response time to the four-choice Deary-Liewald Test measured using the CogniFit app-based assessment tool.
Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Inner Ear Canal Temperature
Internal body temperature (℃) measured once using Braun digital ear thermometer.
Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Dehydration
Dehydration as indicated by urine specific gravity ≥1.020 measured as urine specific gravity using Siemens Multistix SG dipstick.
Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep quality
Self-reported sleep distrubance assessed using the Athens Insomnia Scale (AIS). Values range from 0 to 24 with a higher score indicating a worse outcome.
Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Aggression
Self-reported personal aggresion assessed using the Buss-Perry Aggression Questionnaire-Ultra Short Form (BPAQ-ML).
Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Productivity
Self-reported job absenteeism and presenteeism assessed using the Health and Work Performance Questionnaire Short Form (HPQ-SF).
Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Indoor air temperature
Indoor air temperature (℃) measured using Hobo MX1101 heat and humidity measurement device.
Measurements at 15 minute intervals for 12 months.
Indoor relative humidity
Ratio of the amount of water vapor present in the air to the greatest amount possible at the same temperature (%) measured using Hobo MX1101 heat and humidity measurement device.
Measurements at 15 minute intervals for 12 months.
Indoor heat index
Index that combines air temperature and relative humidity (℃) based on temperature and humidity measurements from the Hobo MX1101 heat and humidity measurement device calculated using the formulae endorsed by the US National Oceanic and Atmospheric Administration.
Measurements at 15 minute intervals for 12 months.
Household energy expenditure
Self-reported household energy expenditure assessed using a recall questionnaire from the head of the household.
Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Permanent household resident.

  • Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.
  • Participant unable to provide written/verbal informed consent.
Aditi Bunker logoAditi Bunker
  • 🏢Sika Services AG
  • 🏛️SOPREMA
  • 🏢Engineered Polymer Solutions (EPS B.V.)
  • 🏛️Resene
  • 🏛️Pacific Community
  • 🏛️Habitat for Humanity
  • 🧬The Tindall Foundation
  • ⚕️London School of Hygiene and Tropical Medicine
  • Heidelberg University logoHeidelberg University171 active trials to explore
  • 🏛️Instituto Tecnológico de Hermosillo
  • 🎓University of Ouagadougou, Burkina Faso
  • ⚕️Indian Institute...
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Study Responsible Party
Aditi Bunker, Sponsor-Investigator, Co-Principal Investigator, University of Auckland, New Zealand
Study Central Contact
Contact: Aditi Bunker, Dr, +49 6221 565344, [email protected]
Contact: Collin Tukuitonga, Sir. Dr., +6493737599, [email protected]
4 Study Locations in 4 Countries

Gandhinagar

Indian Institute of Public Health Gandhinagar, Ahmedabad, Gandhinagar, India
Anish Sinha, Contact, +919377470505, [email protected]
Dileep Mavlankar, Principal Investigator
Anish Sinha, Sub-Investigator
Recruiting
University Joseph Ki-Zerbo, Ouagadougou, Burkina Faso
Abdramane Soura, Contact, +22670026232, [email protected]
Abdramane Soura, Principal Investigator
Not yet recruiting

Sanora

Instituto Tecnológico de Hermosillo, Hermosillo, Sanora, Mexico
Jose Antonio Hoyo Montano, Contact, +526621610612, [email protected]
Jose Antonio Hoyo Montano, Principal Investigator
Not yet recruiting
Niue, Alofi, Niue
Noah Bunkley, Contact, +640273502516, [email protected]
Collin Tukuitonga, Principal Investigator
Noah Bunkley, Sub-Investigator
Recruiting