| 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
|
|
|
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
|
|
|
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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [director@iiphg.org].
- 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.
- 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. |