NCT06744309

Brief Summary

The goal of this clinical trial is to learn if structural and behavioral interventions can mitigate the health effects of extreme heat in rural Malaysian communities. The study focuses on implementing cool roofs (a passive cooling system) and heat literacy education to improve heat adaptation behaviors. The study is funded by Wellcome (Heat Adaptation award - 226737\_Z\_22\_Z) The main questions it aims to answer are:

  • Does the implementation of cool roofs reduce indoor temperatures and related heat stress in rural households?
  • Does heat literacy education improve community awareness and behaviors related to coping with extreme heat? Researchers will compare four groups: one receiving both cool roofs and heat literacy interventions, one receiving only the cool roof intervention, one receiving only heat literacy education, and a control group receiving neither intervention. Participants will be asked to:
  • Have their roofs painted with UV-resistant white paint (for cool roof intervention groups).
  • Participate in educational sessions and training on heat-related health risks and coping strategies (for heat literacy intervention groups).
  • Participants will undergo assessments at baseline (T0), first follow-up (T1), second follow-up (T2), and third follow-up/endline (T3). The T1 assessment occurs after completion of behavioral intervention and prior to the structural intervention.
  • Wear a Garmin Vivosmart 5 sensor for two weeks during each data collection period to monitor heart rate, physical activity, and sleep patterns.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,110

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress51%
Dec 2024Jul 2028

First Submitted

Initial submission to the registry

December 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

December 26, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

2.9 years

First QC Date

December 11, 2024

Last Update Submit

September 11, 2026

Conditions

Keywords

heat healthheat literacythermotoleranceRising average temperature

Outcome Measures

Primary Outcomes (4)

  • Indoor Air Temperature

    Assessed using an indoor data logger (SwitchBot) to measure air temperature within the household.

    36 months

  • Step count (Physical Activity)

    Tracked using Garmin Vivosmart 5 sensors, recording steps and distance.

    36 months

  • Sleep Duration

    This will be obtained using the Uppsala Sleep Inventory questionnaire which assess sleep duration.

    36 months

  • Glycaemic Control

    HbA1c level which will be measured by the Hemocue® HbA1c 501 System.

    36 months

Secondary Outcomes (6)

  • Depressive Symptoms

    36 months

  • Psychological Distress

    36 months

  • Heat-related Symptoms

    36 months

  • Health-related Quality of Life

    36 months

  • Indoor Thermal Comfort

    36 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Heat Index

    36 months

  • Blood Glucose Level

    36 months

  • Sleep Inventory

    36 months

  • +1 more other outcomes

Study Arms (4)

Group A (Cool Roof and Heat Literacy Interventions)

ACTIVE COMPARATOR

Cool roof intervention: Roofs will be painted with UV-resistant paint to reduce thermal absorption. Heat literacy intervention: Participants will receive education and training on heat-related health risks and coping strategies. Participants will receive the behavioural intervention after the baseline and prior to T1. The structural cool-roof intervention will be implemented after T1.

Behavioral: Heat Literacy InterventionOther: Structural (Cool Roof) Intervention

Group B (Cool Roof Intervention Only)

ACTIVE COMPARATOR

Cool Roof intervention: Roofs will be painted with UV-resistant white paint to reduce thermal absorption. Participants will receive the structural cool-roof intervention after T1 assessment.

Other: Structural (Cool Roof) Intervention

Group C (Heat Literacy Intervention Only)

ACTIVE COMPARATOR

-Heat literacy intervention: Participants will receive education and training on heat-related health risks and coping strategies. Participants will receive the behavioural intervention after the baseline (T0) follow by T1 assessment.

Behavioral: Heat Literacy Intervention

Group D (Control Group)

NO INTERVENTION

No intervention will be provided, serving as a control group for comparison. Participants will not receive any intervention but will undergo assessments at T0, T1, T2, and T3.

Interventions

The behavioral intervention aims to improve heat literacy among participants through an 8-12 week education and training program. It includes four main modules: enhancing community awareness of hot weather, identification of high risk groups, recognizing and responding to heat-related illnesses, and teaching personal cooling strategies. Participants will use SwitchBot meters to monitor indoor temperature and humidity, access real-time weather information, and learn about heat wave warnings. They will receive educational materials, including infographics, videos, and one-to-one training from field staff. The content of intervention and delivery methods will be refined through co-design workshops with stakeholders and community members to ensure they are practical and culturally appropriate. The goal is to equip participants with the knowledge and skills to protect themselves from extreme heat, resulting in better heat adaptation behaviors and improved health outcomes.

Group A (Cool Roof and Heat Literacy Interventions)Group C (Heat Literacy Intervention Only)

The structural intervention in this study involves implementing cool roofs to reduce indoor temperature and mitigate the effects of extreme heat in rural Malaysian communities. Selected households will have their roofs painted with UV-resistant paint, which reflects direct sunlight and reduces thermal absorption. This intervention aims to decrease the amount of solar energy absorbed by the roof, thereby lowering indoor temperature and reducing the physiological heat strain on residents. By maintaining cooler indoor environment, the cool roof intervention seeks to alleviate the health risks associated with prolonged exposure to high temperature.

Group A (Cool Roof and Heat Literacy Interventions)Group B (Cool Roof Intervention Only)

Eligibility Criteria

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

You may qualify if:

  • Adults aged at least 18 years old
  • Willing to participate in all study components
  • Consent to roof painting and installation of heat and humidity measurement devices
  • Consent to wear the supplied wearables (Garmin Vivosmart 5) for data collection
  • No plans to relocate during the study period
  • Possess a smartphone for receiving health education materials

You may not qualify if:

  • Individuals belonging to one household with existing participants
  • Bedridden individuals or those requiring assistance in movement
  • Single-story house
  • Built with brick or brick and wooden
  • Roof made of zinc, ceramic/clay, or mixed, suitable for cool roof painting
  • Minimal to no requirement for roof repair
  • No plans for renovation during the study period
  • Double-story houses, shops, or empty houses
  • Houses with the facility to sprinkle water on the roof

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South East Asia Community Observatory, Monash University Malaysia

Segamat, Johor, 85000, Malaysia

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Tin Tin Su, MBBS, Dr.Med

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Arneida, PhD

CONTACT

Nurul Syazwana Binti Dali, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No, the study does not involve masking (blinding). Due to the nature of the interventions-cool roof installation and heat literacy education-it is not possible to blind the participants or the field team members (including researchers). However, the random selection and assignment of participants to intervention and control groups will be conducted by a statistician who is not part of the research team, ensuring an unbiased allocation process.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: The study uses a 2 x 2 factorial two-stage randomized controlled trial design with delayed, response-independent randomization of the second factor (cool-roof). Participants, randomly selected from the SEACO database, will be divided into four groups: both interventions, cool roof only, heat literacy only, and control. Cool roofs involve painting roofs with UV-resistant white paint to reduce heat absorption, while heat literacy includes 8-12 weeks of education on heat awareness and personal cooling strategies. The primary research objective is to investigate the effects of behavioral and structural (cool-roof) interventions individually, and the potential effects of the combined intervention on the primary outcomes - indoor air temperature, physical activity (step count), sleep duration, glycemic control (HbA1c level) - and secondary outcomes, including mental health , reporting heat-related symptoms, health-related quality of life, indoor thermal comfort and heat adaptation practices
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 20, 2024

Study Start

December 26, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No There is no plan to make IPD available. The MUHREC requirement to comply with the term "Retention and storage of data - The Chief Investigator is responsible for the storage and retention of the original data pertaining to the project for a minimum period of five years".

Locations