Clinical trial NCT06744309: Heat Adaptation Through Community-based Approaches and Research at SEACO: Structural and Behavioural Interventions (Heat Care)
Official title: Heat Adaptation Through Community-based Approaches and Research at SEACO: Structural and Behavioural Interventions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Climate Change
Heat; Weather
Heat Effect
Heat; Excess
Keywords: heat health
heat literacy
thermotolerance
Rising average temperature
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
Collaborators: name: Monash University
name: Heidelberg University
name: Ministry of Health, Malaysia
First posted: 2024-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study uses a 2 x 2 factorial design to evaluate the effectiveness of cool roofs and heat literacy education in mitigating extreme heat impacts in rural Malaysian communities. 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. Data will be collected at baseline, 3, 6, and 12 months through surveys, physical measurements, and Garmin Vivosmart 5 wearable sensor and SwitchBot meter. The primary endpoints are indoor temperature, physical activity (step count), glycemic control (HbA1c) and sleep duration. The study aims to develop an evidence-based, culturally sensitive community heat adaptation program to improve heat resilience in rural Malaysia.
Primary purpose: PREVENTION

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 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).
* Complete baseline and follow-up surveys at 3, 6, and 12 months.
* Wear a Garmin Vivosmart 5 sensor for two weeks during each data collection period to monitor heart rate, physical activity, and sleep patterns.

Detailed description: The goal of this clinical trial is to evaluate the effectiveness of structural and behavioral interventions in mitigating the health impacts of extreme heat in rural Malaysian communities. Specifically, the study will implement and assess two interventions: cool roofs (a passive cooling system) and heat literacy education. Cool roofs involve painting the roofs of selected households with UV-resistant white paint to reduce thermal absorption, thereby lowering indoor temperatures. Heat literacy education aims to enhance community awareness and preparedness for extreme heat by providing training and educational materials on recognizing heat-related illnesses and adopting personal cooling strategies.

Participants will be randomly selected from the SEACO health database, encompassing five operational sub-districts. Eligible participants include adults aged 18 years and above, living in single-story houses with suitable roofing materials. They will be randomly assigned to one of four groups: one receiving both interventions, one receiving only the cool roof intervention, one receiving only heat literacy education, and a control group receiving neither intervention. This 2 x 2 factorial design will allow researchers to compare the effects of each intervention individually and in combination.

Data collection will occur at baseline and three follow ups, intended to do 3 months, 6 months, and 12 months. SEACO data collectors will visit participants' homes to install SwitchBot heat and humidity measurement devices, conduct surveys, and take physical measurements. Participants will also wear Garmin Vivosmart 5 sensors for two weeks during each data collection period to monitor their heart rate, physical activity, and sleep patterns. We will also conduct the basic measurements such as height, weight, blood pressure, blood glucose and HbA1c. The surveys will gather information on socioeconomic and demographic characteristics, self-reported illnesses, heat exposure, heat adaptation behaviors, heat literacy, cooling strategies, self- reported sleep quality, mental health and quality of life.

The study aims to determine whether cool roofs and heat literacy education can effectively reduce indoor temperatures, improve heat adaptation behaviors, and ultimately mitigate the health risks associated with extreme heat. By analyzing data from both interventions and their combined effect, the research seeks to develop a theoretically informed, evidence-based, and culturally sensitive community-based heat adaptation program for rural Malaysia. This program could serve as a model for other climate-vulnerable regions, providing valuable insights into sustainable and practical approaches to addressing the health impacts of climate change.

Eligibility criteria: Individual Inclusion Criteria:

* 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

Individual Exclusion Criteria:

* Individuals belonging to one household with existing participants
* Bedridden individuals or those requiring assistance in movement

Household Inclusion Criteria:

* Single-story house
* Main house measurement less than 1200 sqft
* 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

Household Exclusion Criteria:

* Double-story houses, shops, or empty houses
* Houses with the facility to sprinkle water on the roof

Primary outcomes:
measure: Indoor Air Temperature
timeFrame: 12 months
measure: Step count (Physical Activity)
timeFrame: 12 months
measure: Sleep Duration
timeFrame: 12 months
measure: Glycaemic Control
timeFrame: 12 months
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: 12 months
measure: Psychological Distress
timeFrame: 12 months
measure: Heat-related Illnesses
timeFrame: 12 months
measure: Health-related Quality of Life
timeFrame: 12 months
measure: Indoor Thermal Comfort
timeFrame: 12 months
measure: Heat Adaptation Practices
timeFrame: 12 months
Other outcomes:
measure: Heat Index
timeFrame: 12 months
measure: Blood Glucose Level
timeFrame: 12 months
measure: Sleep Inventory
timeFrame: 12 months
measure: Heat Literacy
timeFrame: 12 months
Locations:
city: Segamat
country: Malaysia
facility: South East Asia Community Observatory, Monash University Malaysia
state: Johor
Study officials:
affiliation: Monash University Malaysia
name: Tin Tin Su, MBBS, Dr.Med
role: PRINCIPAL_INVESTIGATOR
References: