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NCT Number: NCT06744309

Heat Adaptation Through Community-based Approaches and Research at SEACO: Structural and Behavioural Interventions (Heat Care)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South East Asia Community Observatory, Monash University Malaysia

Segamat, Johor, 85000, Malaysia

Location contact

Mohd Azrizan Bin Bakir, MBBCh

CONTACT

[email protected]

+607-9311897

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat Literacy Intervention

Behavioral

The behavioral intervention aims to improve heat literacy among participants through an 8-12 week education and training program. It includes three main modules: enhancing community awareness of hot weather, 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.

Structural (Cool Roof) Intervention

Other

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.

Primary outcomes

  1. Indoor Air Temperature

    Time frame: 12 months

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

  2. Step count (Physical Activity)

    Time frame: 12 months

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

  3. Sleep Duration

    Time frame: 12 months

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

  4. Glycaemic Control

    Time frame: 12 months

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

Secondary outcomes

  1. Depressive Symptoms

    Time frame: 12 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.

  2. Psychological Distress

    Time frame: 12 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)

  3. Heat-related Illnesses

    Time frame: 12 months

    This outcome tracks the incidence and severity of heat-related illnesses among participants, such as heat exhaustion and heat stroke. Data is collected through self-reported health metrics. The goal is to identify any reductions in heat-related illnesses due to the interventions.

  4. Health-related Quality of Life

    Time frame: 12 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.

  5. Indoor Thermal Comfort

    Time frame: 12 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.

  6. Heat Adaptation Practices

    Time frame: 12 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.

Other outcomes

  1. Heat Index

    Time frame: 12 months

    Assessed using an indoor data logger (SwitchBot) to measure heat index within the household.

  2. Blood Glucose Level

    Time frame: 12 months

    Random blood glucose, which will be measured using a home blood glucose monitoring system (Accu Chek Instant S)

  3. Sleep Inventory

    Time frame: 12 months

    This will be obtained using the Uppsala Sleep Inventory questionnaire, which assesses an individual's difficulty initiating sleep, maintaining sleep, and individual's daytime sleepiness.

  4. Heat Literacy

    Time frame: 12 months

    This outcome assesses participants' ability to access, understand, appraise, and apply information to make judgments and take decisions in everyday life to mitigate heat effects on health using structured questionnaire. The index is standardized to unified metrics from 0 to 50. 0 represents the lowest heat literacy and 50 the highest heat literacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Nurul Syazwana Binti Dali, BSc

CONTACT

[email protected]

+60127674277

Pei Jean Tan, PhD

CONTACT

[email protected]

+603 5514 6374

Sponsors and collaborators

Lead sponsor

Monash University Malaysia

Other

Collaborators

  • Heidelberg University
  • Ministry of Health, Malaysia
  • Monash University

Registry information

Official study title

Heat Adaptation Through Community-based Approaches and Research at SEACO: Structural and Behavioural Interventions

Acronym: Heat Care

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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