Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-01 @ 10:21 AM
Study NCT ID:
NCT06834893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effects of Cool Roofs on Indoor Environments and Health in Hermosillo, Mexico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D003681', 'term': 'Dehydration'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D000374', 'term': 'Aggression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Trial participants will be aware of the intervention to which they have been allocated, and the research fieldworkers will be aware of the intervention allocation. The trial steering committee members and trial statistician will remain blinded until the end of trial period and data collection.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting heart rate', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Resting heart rate in beats per minute measured as the average of three readings in the left arm over one hour using portable automated sphygmomanometers.'}, {'measure': 'Blood glucose control', 'timeFrame': 'Two measurements will be taken: one at baseline and one in the last month of three consecutive hottest months.', 'description': 'Three month average of blood glucose in mmol/mol measured as glycosylated hemoglobin (HbA1c) using capillary blood and the HemoCue® HbA1c 501 System.'}, {'measure': 'Depression', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Heat-related symptoms', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported heat-related symptoms in the past month, assessed using a recall questionnaire.'}, {'measure': 'Physician diagnosed heat-related illnesses', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported new diagnosis from a medical practitioner of a heat-related illness in the last month assessed using a recall questionnaire.'}, {'measure': 'Food insecurity', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported experience based measure of individual food security assessed using the Food Insecurity Experience Scale (FIES).'}, {'measure': 'Diet quality', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported individual food group consumption in the previous 24 hours assessed using the Diet Quality Questionnaire (DQQ).'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': '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.'}, {'measure': 'Indoor thermal comfort', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported household heat, humidity and comfort experience over the last four weeks assessed using a recall questionnaire.'}, {'measure': 'Coping ability', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported coping strategies for high indoor temperatures assessed using a recall questionnaire.'}, {'measure': 'Life satisfaction', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': '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.'}, {'measure': 'Healthcare provider utilization', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported healthcare provider utilization in the past four weeks assessed using a recall questionnaire.'}, {'measure': 'Hospitalization', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported overnight hospital stay in the past four weeks assessed using a recall questionnaire.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.', 'description': '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.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.', 'description': '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.'}, {'measure': 'Cognition', 'timeFrame': 'Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Accuracy and response time to the four-choice Deary-Liewald Test measured using the CogniFit app-based assessment tool.'}, {'measure': 'Inner Ear Canal Temperature', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.', 'description': 'Internal body temperature (℃) measured once using Braun digital ear thermometer.'}, {'measure': 'Dehydration', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Dehydration as indicated by urine specific gravity ≥1.020 measured as urine specific gravity using Siemens Multistix SG dipstick.'}, {'measure': 'Sleep quality', 'timeFrame': 'Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': '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.'}, {'measure': 'Aggression', 'timeFrame': 'Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.', 'description': 'Self-reported personal aggresion assessed using the Buss-Perry Aggression Questionnaire-Ultra Short Form (BPAQ-ML).'}, {'measure': 'Productivity', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.', 'description': 'Self-reported job absenteeism and presenteeism assessed using the Health and Work Performance Questionnaire Short Form (HPQ-SF).'}, {'measure': 'Indoor air temperature', 'timeFrame': 'Measurements at 15 minute intervals for 12 months.', 'description': 'Indoor air temperature (℃) measured using Hobo MX1101 heat and humidity measurement device.'}, {'measure': 'Indoor relative humidity', 'timeFrame': 'Measurements at 15 minute intervals for 12 months.', 'description': '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.'}, {'measure': 'Indoor heat index', 'timeFrame': 'Measurements at 15 minute intervals for 12 months.', 'description': '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.'}, {'measure': 'Household energy expenditure', 'timeFrame': 'Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.', 'description': 'Self-reported household energy expenditure assessed using a recall questionnaire from the head of the household.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hot Temperature', 'Humidity', 'Housing', 'Heart rate', 'Cardiovascular', 'Depression', 'Mental health', 'Blood glucose', 'Diabetes', 'Cool roof', 'Heat Stress'], 'conditions': ['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']}, 'descriptionModule': {'briefSummary': 'Ambient air temperatures in Mexico have broken record highs in 2024 with Hermosillo reaching the highest maximum temperature recorded in Mexico at 51.9 C. 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 in the northern zone of Mexico are susceptible to increased heat exposure.\n\nHeat 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 use can promote physical, mental and social wellbeing in household occupants.\n\nThe long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in northern zone of Mexico. 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 Hermosillo, Mexico.', 'detailedDescription': "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 homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, there currently 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.\n\nCities and towns of LMIC are among the most vulnerable to the adverse impacts of climate change and are likely to experience increases in ambient air temperature over the coming decades. People in Hermosillo (located in the State of Sonora, Mexico) are exposed to heat and low humidity year-round. The State of Sonora has a large burden of non-communicable diseases (NCDs), with nearly 28% of deaths due to NCDs, such as heart diseases and diabetes mellitus. The combined burden of heat and NCDs places Sonora's, especially Hermosillo's, populations at greater risk of adverse health effects from heat extremes.\n\nSunlight-reflecting cool roof coatings passively reduce indoor temperatures and lower energy use, offering protection to home occupants from extreme heat. The investigators therefore aim to conduct a cluster-randomized controlled trial investigating the effects of cool-roof use on health, environmental and economic outcomes in Hermosillo.\n\nThe trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in Hermosillo. Findings will inform regional policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent household resident.\n\nExclusion Criteria:\n\n* Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.\n* Participant unable to provide written/verbal informed consent.'}, 'identificationModule': {'nctId': 'NCT06834893', 'acronym': 'REFLECT', 'briefTitle': 'Assessing the Effects of Cool Roofs on Indoor Environments and Health in Hermosillo, Mexico', 'organization': {'class': 'OTHER', 'fullName': 'University of Auckland, New Zealand'}, 'officialTitle': 'A Cluster Randomised Controlled Trial (cRCT) Evaluating the Effects of Cool Roofs on Health, Environmental and Economic Outcomes in Hermosillo, Mexico', 'orgStudyIdInfo': {'id': '3728164'}, 'secondaryIdInfos': [{'id': '226745/Z/22/Z', 'type': 'OTHER_GRANT', 'domain': 'Wellcome Trust UK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cool roof', 'description': "Households will receive sunlight reflecting 'cool roof' coating on their roofs.", 'interventionNames': ['Other: Cool roof']}, {'type': 'NO_INTERVENTION', 'label': 'No cool roof', 'description': 'No cool roof application. Households will keep their original roofing for the duration of the trial.'}], 'interventions': [{'name': 'Cool roof', 'type': 'OTHER', 'description': 'Cool roofs are a heat-reflecting material that can be applied to existing household roofing in the form of a liquid-applied membrane. Cool roofs work by increasing solar reflectance (the ability to reflect the visible wavelengths of sunlight, reducing heat transfer to the surface) and thermal emittance (the ability to radiate absorbed solar energy) thereby reducing the amount of heat transferred into the home.', 'armGroupLabels': ['Cool roof']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hermosillo', 'state': 'Sonora', 'country': 'Mexico', 'contacts': [{'name': 'Jose Antonio Hoyo Montano', 'role': 'CONTACT', 'email': 'jose.hoyom@hermosillo.tecnm.mx', 'phone': '+526621610612'}], 'facility': 'Instituto Tecnológico de Hermosillo', 'geoPoint': {'lat': 29.08874, 'lon': -110.96677}}], 'centralContacts': [{'name': 'Aditi Bunker, Dr', 'role': 'CONTACT', 'email': 'aditi.bunker@uni-heidelberg.de', 'phone': '+49 6221 565344'}, {'name': 'Collin Tukuitonga, Sir. Dr.', 'role': 'CONTACT', 'email': 'collin.tukuitonga@auckland.ac.nz', 'phone': '+6493737599', 'phoneExt': 'Ext. 89612'}], 'overallOfficials': [{'name': 'Collin Tukuitonga, Sir. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Auckland, New Zealand'}]}, 'ipdSharingStatementModule': {'url': 'http://reflect.org.nz', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'At the time of publication.', 'ipdSharing': 'YES', 'description': 'Data that can be shared unconditionally underpinning the published research articles will be made available to other researchers at the time of publication, and data will be linked via the article DOI. Data that cannot be unconditionally shared upon publication owing to confidentiality or data protection requirements will be identified as such and a contact email will be provided in relevant publications for data access enquiries by other researchers. Individual names of study participants and identifying factors will be removed prior to data sharing.\n\nIt is expected that demographic data of people at the study sites (family size and composition, basic socioeconomic indicators) may contain personally identifiable information and location data. All such data will be removed prior to storage on online data repositories and therefore will be available to be publicly shared at the time of publication of manuscripts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aditi Bunker', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heidelberg University', 'class': 'OTHER'}, {'name': 'Rutgers University', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}, {'name': 'Secretaría de Educación Pública, México', 'class': 'OTHER_GOV'}, {'name': 'CogniFit Limited', 'class': 'UNKNOWN'}, {'name': 'EPS', 'class': 'UNKNOWN'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co-principal investigator', 'investigatorFullName': 'Aditi Bunker', 'investigatorAffiliation': 'University of Auckland, New Zealand'}}}}