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CTRI Number  CTRI/2024/10/075504 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Cluster Randomized Trial 
Public Title of Study   Assessing the Effects of Cool Roofs on Health Using Smartwatches in Ahmedabad, India 
Scientific Title of Study   The effects of cool roofs on health using smartwatches: a cluster-randomized controlled trial in Ahmedabad, India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT06579963  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Bunker 
Designation  Consultant 
Affiliation  University of Heidelberg 
Address  Department of Public Health Science, Room No.ED-01, Indian Institute of Public Health Gandhinagar, Opp. Air Force Head Quarters, Nr. Lekawada, Gandhinagar
Im Neuenheimer Feld 130/3, 69120 Heidelberg, Germany
Gandhinagar
GUJARAT
382042
India 
Phone    
Fax    
Email  aditi.bunker@uni-heidelberg.de  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandul Yasobant 
Designation  Assistant Professor 
Affiliation  Indian Institute of Public Health Gandhinagar 
Address  Department of Public Health Science, Room No. FF-04, Indian Institute of Public Health Gandhinagar, Opp. Air Force Head Quarters, Nr. Lekawada, Gandhinagar

Gandhinagar
GUJARAT
382041
India 
Phone  9861357331  
Fax    
Email  yasobant@iiphg.org  
 
Details of Contact Person
Public Query
 
Name  Dr Anish Sinha 
Designation  Associate Professor and I/c Registrar 
Affiliation  Indian Institute of Public Health Gandhinagar 
Address  Department of Public Health Programme, Room No. GF-02, Opp.Air Force HeadQuarters, Nr. Lekawada

Gandhinagar
GUJARAT
382042
India 
Phone  9377470505  
Fax    
Email  asinha@iiphg.org  
 
Source of Monetary or Material Support  
The study is sponsored by the University of Auckland and funded by the Wellcome Trust UK, a UK-based charitable organization. Address: The University of Auckland, Building 507,GraftonCampus, 22-30 Park Avenue, Grafton ,Auckland 1023, NEW ZEALAND Sika AG, India has donated cool roof materials. 
 
Primary Sponsor  
Name  University of Aukland 
Address  University of Auckland, M&HS Building 505, 85 Park Rd, Grafton, Auckland,1023, New Zealand 
Type of Sponsor  Other [Academic and Research Institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anish Sinha  Indian Institute of Public Health Gandhinagar  Department of Public Health Programme, Room No. GF-02, Opp.Air Force HeadQuarters, Nr. Lekawada
Gandhinagar
GUJARAT 
09377470505

asinha@iiphg.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Institute of Public Health Gandhinagar Institutional Ethics Committee (IIPHG-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Resting Heart Rate, All-day steps, Distance walked, Active minutes, Moderate-intensity activity minutes, Vigorous-intensity activity duration, Sleep quantity, Awake duration, Sleep score  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cool Roof  Households will receive sunlight reflecting ‘cool roof’ coating on their roofs. 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). The duration for the trial will be 14 months. 
Comparator Agent  Regular Roof  No cool roof application. Households will keep their original roofing for the duration of the trial. The duration for the trial will be 14 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Permanent household resident 
 
ExclusionCriteria 
Details  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. Only one participant per household. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Heartrate  Heart rate in beats per minute measured at 15-second intervals using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month.
The outcomes will be measured at baseline and then every month until one year. 
 
Secondary Outcome  
Outcome  TimePoints 
All-day steps  The number of steps measured daily using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Distance walked  The total distance walked daily using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Active minutes  The total number of minutes of active exercise daily using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Moderate-intensity activity minutes  The total number of minutes of moderate-intensity activity daily using Garmin Vivosmart 5 devices. Measurements 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. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Sleep quantity  The number of hours spent asleep each night using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Time in sleep stages

 
The number of hours spent in sleep stages each night using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Awake duration

 
The number of hours spent awake during sleep time each night using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
Sleep score  The Garmin sleep score (0-100) each night using Garmin Vivosmart 5 devices. Measurements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [director@iiphg.org].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - 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. It is expected that the 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 sto
Brief Summary  

Increasing heat exposure from climate change is causing and exacerbating heat-related illnesses in millions worldwide – particularly in low resource settings. Ambient air temperatures in India have broken record highs in 2024. 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 in India – generated through empirical studies – guiding the uptake of interventions to reduce indoor heat stress in vulnerable communities.

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 investigate the effects of cool-roof use on heart rate, sleep and physical activity in Ahmedabad, India.

This trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in Ahmedabad. Findings will inform local policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change. 
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