NCT06579963

Brief Summary

Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024. 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 globally - for example in informal settlements, slums, and low-socioeconomic households - are susceptible to increased heat exposure. Heat 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 application may improve heart health, sleep and physical activity in household occupants. The long-term research goal is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will use smartwatches to measure the effects cool roof application on heart health, sleep and physical activity in four urban climate hotspots: Ouagadougou, Burkina Faso; Hermosillo, Mexico; Ahmedabad, India; and Niue, Oceania.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2024Sep 2027

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

August 28, 2024

Last Update Submit

February 25, 2026

Conditions

Keywords

Hot TemperatureHumidityHousingWearableSmartwatchHeart rateCardiovascularPhysical activitySleepCool roofHeat stress

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    Heart rate in beats per minute measured at 15-second intervals using Garmin Vivosmart 5 devices.

    Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.

Secondary Outcomes (9)

  • All-day steps

    Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.

  • Active minutes

    Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.

  • Distance walked

    Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.

  • Moderate-intensity activity minutes

    MeasuSmartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at barements 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

    Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.

  • +4 more secondary outcomes

Study Arms (2)

Cool roof

EXPERIMENTAL

Households will receive sunlight reflecting 'cool roof' coating on their roofs.

Other: Cool roof

No cool roof

NO INTERVENTION

No cool roof application. Households will keep their original roofing for the duration of the trial.

Interventions

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).

Cool roof

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Permanent household resident

You may not qualify if:

  • 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.
  • In Mexico and Niue, participants will be excluded if they do not have a smartphone with an internet connection that can connect to the smartwatch.
  • Only one participant per household.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Joseph Ki-Zerbo

Ouagadougou, Burkina Faso

Location

Indian Institute of Public Health Gandhinagar

Ahmedabad, Gandhinagar, India

Location

Instituto Tecnológico de Hermosillo

Hermosillo, Sanora, Mexico

Location

Niue

Alofi, Niue

Location

MeSH Terms

Conditions

Motor ActivityHeat Stress Disorders

Condition Hierarchy (Ancestors)

BehaviorWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

September 4, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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 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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
At the time of publication.
More information

Locations