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NCT Number: NCT06991543

Structural Heat Adaptation and Education in Urban Setting

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:

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

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.

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Key information

Conditions

Heat Illness Heat Stress Disorders Quality of Life Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Community education and awareness, and personal lifestyle and cooling behavior modification

Behavioral

This 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.

Other names: behavioral change, early warning system

Participatory local structural and environmental heat mitigation solutions

Other

Participatory 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:

  • Paints (Solar Reflective Paints, Lime Paints)
  • Shading (Façade, Roof)
  • Energy Sufficiency (Solar Panels with complete accessories)
  • Community Shading (Plantation, Street Shading, Field Shading space)
  • Ventilation (Windows, Wind catchers)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. All-cause mortality (Number of Deaths from Any Cause)

    Time frame: from baseline to 24 months

    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.

  2. Number of Participants with At Least One Hospital Visit During Study Period

    Time frame: During summer months for 2 years

    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.

  3. Number of Participants Hospitalized for at Least 24 Hours

    Time frame: During summer months for 2 years

    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.

  4. Change in Self-Reported Thermal Comfort Score

    Time frame: from baseline to 24 months

    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 afterwards.

  5. Change in Indoor Heat Index

    Time frame: From intervention delivery to 24 months

    Measured as the difference in average indoor heat index before and after intervention using fixed indoor temperature loggers (iButton sensors or Temp-U data loggers). Data collected continuously throughout the study.

Other outcomes

  1. Personalized Heat Exposure (°C)

    Time frame: During summer months for 2 years

    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.

  2. Change in Heart Rate (Beats per Minute)

    Time frame: During summer months for 2 years

    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.

  3. Sleep quality

    Time frame: During summer months for 2 years

    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.

  4. Physical Activity Level Based on Daily Step Count and Activity Classification

    Time frame: During summer months for 2 years

    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.

  5. Total Daily Energy Expenditure (Kilocalories)

    Time frame: During summer months for 2 years

    Measured using Fitbit Inspire 3. This includes calories burned through basal metabolic rate and physical activity. Reported as the average number of kilocalories burned per day per participant.

Study contacts

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

Jai K Das

CONTACT

[email protected]

+922134864717 ext. 64717

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • University College, London

Registry information

Official study title

Structural Heat Adaptation and Education in Urban Setting (SHAPES Trial)

Acronym: SHAPES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 28, 2025
Registry last updated
Jan 27, 2026

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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