Structural Heat Adaptation and Education in Urban Setting (SHAPES Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Aga Khan University
- Enrollment
- 7,128
- Locations
- 1
- Primary Endpoint
- Quality of Life Enhancement
Study Overview
Brief Summary
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 improve quality of life during periods of extreme heat in densely populated, low-income neighborhoods of Karachi, Pakistan.
Key Questions the Study Seeks to Answer:
- Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke and improve the quality of life?
- 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All households within the selected clusters who provide consent.
Exclusion Criteria
- •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
Arms & Interventions
Control
The control arm will not receive any intervention.
Resilience and Heat Adaptation Bundle
Intervention Arm: Resilience and Heat Adaptation Bundle (ReHAB):
The ReHAB consists of three components; community education and awareness, personal lifestyle and cooling behavior modification, and participatory local structural and environmental heat mitigation solutions. The behavioral and educational interventions will be delivered through community mobilization whereas structural interventions will encompass modifications in the existing structures to lower the indoor ambient temperature and reduce heat effects.
Intervention: Community education and awareness, and personal lifestyle and cooling behavior modification (Behavioral)
Resilience and Heat Adaptation Bundle
Intervention Arm: Resilience and Heat Adaptation Bundle (ReHAB):
The ReHAB consists of three components; community education and awareness, personal lifestyle and cooling behavior modification, and participatory local structural and environmental heat mitigation solutions. The behavioral and educational interventions will be delivered through community mobilization whereas structural interventions will encompass modifications in the existing structures to lower the indoor ambient temperature and reduce heat effects.
Intervention: Participatory local structural and environmental heat mitigation solutions (Other)
Outcomes
Primary Outcomes
Quality of Life Enhancement
Time Frame: 4 month, 7 month, 16 month, 19 month
Change in the WHOQOL-BREF overall score (mean of domain scores) during two consecutive peak summer and winter seasons
Number of Participants with Heat-Related Illness
Time Frame: from baseline to 24 months
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
Secondary Outcomes
- Change in Indoor Heat Index(From intervention delivery to 24 months)
- All-cause mortality (Number of Deaths from Any Cause)(from baseline to 24 months)
- Number of Participants with At Least One Hospital Visit During Study Period(During summer months for 2 years)
- Number of Participants Hospitalized for at Least 24 Hours(During summer months for 2 years)
- Change in Self-Reported Thermal Comfort Score(from baseline to 24 months)
Investigators
Dr Jai Kumar Das
Associate Professor, Associate Director, Institute for Global Health and Development
Aga Khan University