Clinical trial NCT06991543: Structural Heat Adaptation and Education in Urban Setting
Official title: Structural Heat Adaptation and Education in Urban Setting (SHAPES Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heat Illness
Keywords: heat illness
behaviour modification
personal cooling
Structural modification
heat adaptation
prevention
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University College, London
First posted: 2025-05-28
Enrollment: 7128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled Trial
Primary purpose: PREVENTION

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 during periods of extreme heat in densely populated, low-income neighborhoods of Karachi, Pakistan.

Key Questions the Study Seeks to Answer:

1. Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke?
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.

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: 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

Primary outcomes:
measure: Number of Participants with Heat-Related Illness
timeFrame: from baseline to 24 months
Secondary outcomes:
measure: All-cause mortality (Number of Deaths from Any Cause)
timeFrame: from baseline to 24 months
measure: Number of Participants with At Least One Hospital Visit During Study Period
timeFrame: During summer months for 2 years
measure: Number of Participants Hospitalized for at Least 24 Hours
timeFrame: During summer months for 2 years
measure: Change in Self-Reported Thermal Comfort Score
timeFrame: from baseline to 24 months
measure: Change in Indoor Temperature (°C)
timeFrame: From intervention delivery to 24 months
measure: Change in Indoor Humidity (% Relative Humidity)
timeFrame: from baseline to 24 months
Other outcomes:
measure: Personalized Heat Exposure (°C)
timeFrame: During summer months for 2 years
measure: Change in Heart Rate (Beats per Minute)
timeFrame: During summer months for 2 years
measure: Sleep quality
timeFrame: During summer months for 2 years
measure: Physical Activity Level Based on Daily Step Count and Activity Classification
timeFrame: During summer months for 2 years
measure: Total Daily Energy Expenditure (Kilocalories)
timeFrame: During summer months for 2 years
measure: Mental Health Score Based on WHO-5 Well-Being Index
timeFrame: from baseline to 24 months
Locations:
Study officials:
affiliation: Institute for global health and development, Aga Khan University.
name: jai K Das
role: PRINCIPAL_INVESTIGATOR
References: