Structural Heat Adaptation and Education in Rural Setting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAga Khan University
About this trial
This study aims to understand whether simple, low-cost interventions, such as improved home cooling, practical advice, and minor home modifications, can help protect people's health and quality of life during periods of extreme heat in rural, low-income villages of Matiari, Pakistan.
Key Questions the Study Seeks to Answer:
1. Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke and improve quality of life? 2. Can they lower indoor temperatures and improve sleep quality, comfort, and daily functioning?
To answer these questions, researchers will compare communities where families receive heat-related support and information with similar communities that do not, to assess any differences in health and well-being. Endline venous blood sampling will be conducted for biobanking only.
What Participants Can Expect:
* Answer questions about their health, living conditions, and how they cope with heat * Have small temperature sensors placed inside their homes * Some participants may wear a lightweight wristband that tracks sleep and heart rate * In selected households, cooling improvements will be made, such as adding shade, applying reflective roof paint, or enhancing airflow
Purpose:
This study seeks to identify affordable and effective strategies to help families stay safe during extreme heat, and to use these insights to support other vulnerable communities facing similar challenges.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All households within the selected clusters who provide consent.
Disqualifiers
Households planning to move away from the study site within the next 6 months
Individuals with severe mental or physical health conditions that preclude participation
Trial design
Design model
Parallel
Treatments tested in this trial
Community education and awareness
BehavioralThis component of the ReHAB will be achieved through community mobilization, which will encompass awareness and motivational activities throughout the intervention duration. Community groups (CGs) will be formed in each of the 11 clusters. Both male and female CGs will be formed separately and will be responsible for community mobilization activities, surveillance for primary outcome. Each CG will comprise of 6-8 members and will be a diverse group of people with varying qualifications, including local government members, local elders/elites, religious leaders, and prominent male and female members of the community. they could also name their respective CGs to enhance association, identity, and affiliation. These CGs will facilitate culturally tailored workshops, dissemination of early warnings regarding heat waves, awareness sessions, and door-to-door outreach focused on heat-health fundamentals. CGs will also maintain simple logbooks to track any incidence of heat related illness.
Participatory local structural and environmental heat mitigation solutions
Other interventionParticipatory local structural and environmental heat mitigation solutions will be delivered through community participatory approach where the community and project will share the cost of intervention to improve ownership. This contribution can be monetary or non-monetary, for example, provision of labor or supplies. The modifications include: 1. Paints (Solar Reflective Paints, Lime Paints) 2. Shading (Façade, Roof) 3. Energy Sufficiency (Solar Panels with complete accessories) 4. Community Shading (Plantation, Street Shading, Field Shading space) 5. Ventilation (Windows, Wind catchers) 6. External Renders
Treatment groups
7,128 Participants
are divided into 2 treatment groupsGroup A: Heat Adaptation BundleExperimental treatment 2 interventions
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Heat-Related Illness
Heat-related illness is defined as any condition resulting from prolonged heat exposure, including heat stroke, heat exhaustion, heat syncope, heat cramps, or heat rash. Data will be collected through weekly household surveillance, and community group reports.
Time frame
from baseline to 24 months2
Quality of Life Enhancement
Change in the WHO Quality of Life Brief Tool (WHOQOL-BREF) overall score (mean of domain scores) during two consecutive peak summer and winter seasons. The WHOQOL-BREF questionnaire assess the quality of life across four domains, uses a 5-point Likert scale for its 26 items, with higher scores indicating a better quality of life. The scores are generally transformed into a 0-100 scale for reporting
Time frame
4 month, 7 month, 16 month, 19 monthSecondary outcomes
1
All-cause mortality (Number of Deaths from Any Cause)
All-cause mortality refers to the total number of deaths from any cause among trial participants during the study period, confirmed via household visits and healthcare facility records.
Time frame
from baseline to 24 months2
Number of Participants with At Least One Hospital Visit During Study Period
Defined as the number of participants who visited a secondary or tertiary healthcare facility for any reason during the study period, confirmed by self-report and facility-based records.
Time frame
During summer months for 2 years3
Number of Participants Hospitalized for at Least 24 Hours
Defined as the number of participants who were admitted to a hospital for at least 24 consecutive hours during the study period, verified through hospital admission records and participant reports.
Time frame
During summer months for 2 years4
Change in Self-Reported Thermal Comfort Score
Thermal comfort will be assessed using a modified version of the CHEQ-5 thermal comfort survey. Participants rate their satisfaction with indoor thermal conditions. The scale ranges from 1 (very uncomfortable) to 5 (very comfortable). Higher scores indicate better thermal comfort. Assessments will be conducted at baseline, and then monthly.
Time frame
from baseline to 24 monthsOther outcomes
1
Personalized Heat Exposure (°C)
Defined as the average temperature experienced by an individual, measured continuously using wearable temperature monitors. Data will be collected across both indoor and outdoor settings for each participant.
Time frame
During summer months for 2 years2
Change in Heart Rate (Beats per Minute)
Heart rate will be measured using Fitbit Inspire 3 devices. Data are recorded at hourly intervals. The outcome will be reported as the change in average heart rate from baseline to follow-up.
Time frame
During summer months for 2 years3
Sleep quality
Sleep quality will be assessed using Fitbit Inspire 3, which detects sleep stages (REM, light, deep) and wakefulness. Data include total sleep time, sleep efficiency, and time spent in each stage. Higher efficiency and longer sleep duration indicate better sleep quality.
Time frame
During summer months for 2 years4
Physical Activity Level Based on Daily Step Count and Activity Classification
Measured using Fitbit Inspire 3 devices. Participants will be categorized as sedentary, lightly active, moderately active, or very active based on daily movement data (step counts, active minutes). Categories follow Fitbit's proprietary activity classification algorithm.
Time frame
During summer months for 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aga Khan University
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborator
University College, London
Collaborator
Source ClinicalTrials.gov