Climate Change, Heat Effect, Heat; Excess, Heat; Weather
Conditions
Keywords
heat health, heat literacy, thermotolerance, Rising average temperature
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.
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 Behavioural (heat literacy) education. Cool roofs involve painting the roofs of selected households with UV-resistant 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 risks, 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 will be collected at four time points: baseline (T0), first follow-up (T1), second follow-up (T2), and third follow-up/endline (T3). The behavioural (heat literacy) intervention will be delivered before T1. The structural (cool-roof) intervention will be implemented after T1. T1 evaluate effectiveness of behavioural intervention alone and the pre-structural assessment, while T2 and T3 represent post-structural follow-up assessments of all interventions (individually and combination). 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 each intervention 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.
Interventions
BEHAVIORALHeat Literacy Intervention
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.
OTHERStructural (Cool Roof) Intervention
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.
Sponsors
Monash University Malaysia
Monash University
Heidelberg University
Ministry of Health, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Indoor Air Temperature | 36 months | Assessed using an indoor data logger (SwitchBot) to measure air temperature within the household. |
| Step count (Physical Activity) | 36 months | Tracked using Garmin Vivosmart 5 sensors, recording steps and distance. |
| Sleep Duration | 36 months | This will be obtained using the Uppsala Sleep Inventory questionnaire which assess sleep duration. |
| Glycaemic Control | 36 months | HbA1c level which will be measured by the Hemocue® HbA1c 501 System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 36 months | This will be assessed using the Quick Inventory of Depressive Symptomatology (QIDS-SR16) questionnaire. The Quick Inventory of Depressive Symptomatology (QIDS-SR16) assesses the severity of depressive symptoms based on 16 items. The scoring for the QIDS-SR16 is as follows: Minimum possible score: 0 Maximum possible score: 27 A higher score on the QIDS-SR16 indicates more severe depressive symptoms, which means a worse outcome in terms of depression severity. Conversely, lower scores suggest fewer symptoms and thus a better outcome. |
| Psychological Distress | 36 months | This will be assessed using the Kessler Psychological Distress Scale (K10) questionnaire. The Kessler Psychological Distress Scale (K10) is a tool used to measure psychological distress. It consists of 10 items, each rated on a 5-point scale from "none of the time" (score = 1) to "all of the time" (score = 5). Minimum possible score: 10 (if the participant scores "none of the time" for all 10 items). Maximum possible score: 50 (if the participant scores "all of the time" for all 10 items). Higher scores on the K10 indicate greater psychological distress (worse outcomes) |
| Heat-related Symptoms | 36 months | This outcome tracks the heat-related symptoms among participants, such as rash, oedema, sunburn, cramps, syncope, tetany and exhaustion. Data is collected through self-reported questionnarie. The goal is to identify any reductions in heat-related symptoms due to the interventions. |
| Health-related Quality of Life | 36 months | This outcome evaluates the overall well-being of participants using the EuroQol five dimensions of health (EQ-5D) questionnaire, which covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The assessment aims to determine how the interventions impact participants' overall quality of life and well-being. The minimum value is 0 and maximum value is 100. Higher scores generally indicate better health outcomes, meaning that the person is in a state of better physical and mental health. Lower scores indicate worse health outcomes or greater health problems. |
| Indoor Thermal Comfort | 36 months | Assessed using a visual analogue scale to measure current heat experience in the household rated on a visual scale from: Very comfortable, Comfortable, Just comfortable, Just uncomfortable, Uncomfortable, and Very uncomfortable. Minimum (1) to maximum (6). The higher score is the worse outcome. |
| Heat Adaptation Practices | 36 months | This outcome evaluates participants' adaptive behaviors during periods of extreme heat, highlighting measures taken to protect themselves and their communities from heat-related health impacts. The 18-item questionnaire evaluates heat adaptation practices using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Negatively worded statements will be reversed. Scores range from 18 to 90, with higher scores indicating higher adoption in heat adaptation practices, and lower scores indicating lower adoption in heat adaptation practices. |
Countries
Malaysia
Contacts
CONTACTNurul Arneida, PhD
CONTACTNurul Syazwana Binti Dali, BSc
PRINCIPAL_INVESTIGATORTin Tin Su, MBBS, Dr.Med
Monash University Malaysia
Outcome results
None listed