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临床试验/NCT06744309
NCT06744309招募中不适用

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

Monash University Malaysia3 个研究点 分布在 1 个国家目标入组 1,110 人开始时间: 2024年12月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,110
试验地点
3
主要终点
Indoor Air Temperature

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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 Exclusion Criteria:
  • Double-story houses, shops, or empty houses
  • Houses with the facility to sprinkle water on the roof

研究组 & 干预措施

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.

干预措施: Heat Literacy Intervention (Behavioral)

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.

干预措施: Structural (Cool Roof) Intervention (Other)

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.

干预措施: Heat Literacy Intervention (Behavioral)

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.

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.

干预措施: Structural (Cool Roof) Intervention (Other)

结局指标

主要结局

Indoor Air Temperature

时间窗: 12 months

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

Step count (Physical Activity)

时间窗: 12 months

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

Sleep Duration

时间窗: 12 months

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

Glycaemic Control

时间窗: 12 months

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

Step count (Physical Activity)

时间窗: 36 months

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

Indoor Air Temperature

时间窗: 36 months

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

Sleep Duration

时间窗: 36 months

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

Glycaemic Control

时间窗: 36 months

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

次要结局

  • Depressive Symptoms(12 months)
  • Psychological Distress(12 months)
  • Heat-related Illnesses(12 months)
  • Health-related Quality of Life(12 months)
  • Indoor Thermal Comfort(12 months)
  • Heat Adaptation Practices(12 months)
  • 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)
  • Heat Adaptation Practices(36 months)

研究者

发起方
Monash University Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tin Tin Su

Professor

Monash University Malaysia

研究点 (3)

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