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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) 3,200 Randomized
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 30 September 2027. The la...Show More
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 exampl...Show More
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...Show More
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 ExpenditureOther 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
2026-02-27
Completion Date (Estimated)
2027-09-30
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
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/Arm | Intervention/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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time 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. |
| Outcome Measure | Measure Description | Time 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. |
Participation Assistant
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- 🏢Sika Services AG
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]
5 Study Locations in 5 Countries
Fiji National University, Suva, Fiji
Donald Wilson, Contact, +6798053931, [email protected]
Recruiting
University Joseph Ki-Zerbo, Ouagadougou, Burkina Faso
Active, not recruiting
Gandhinagar
Indian Institute of Public Health Gandhinagar, Ahmedabad, Gandhinagar, India
Active, not 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
Active, not recruiting