NCT06991543

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:

  • 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,128

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

May 6, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 27, 2026

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

May 6, 2025

Last Update Submit

January 25, 2026

Conditions

Keywords

heat illnessbehaviour modificationpersonal coolingStructural modificationheat adaptationpreventionquality of life

Outcome Measures

Primary Outcomes (2)

  • 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

    from baseline to 24 months

  • Quality of Life Enhancement

    Change in the WHOQOL-BREF overall score (mean of domain scores) during two consecutive peak summer and winter seasons

    4 month, 7 month, 16 month, 19 month

Secondary Outcomes (5)

  • 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

  • Change in Indoor Heat Index

    From intervention delivery to 24 months

Other Outcomes (5)

  • Personalized Heat Exposure (°C)

    During summer months for 2 years

  • Change in Heart Rate (Beats per Minute)

    During summer months for 2 years

  • Sleep quality

    During summer months for 2 years

  • +2 more other outcomes

Study Arms (2)

Resilience and Heat Adaptation Bundle

EXPERIMENTAL

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.

Behavioral: Community education and awareness, and personal lifestyle and cooling behavior modificationOther: Participatory local structural and environmental heat mitigation solutions

Control

NO INTERVENTION

The control arm will not receive any intervention.

Interventions

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.

Also known as: behavioral change, early warning system
Resilience and Heat Adaptation Bundle

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: 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)

Resilience and Heat Adaptation Bundle

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All households within the selected clusters who provide consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilal Colony

Karachi, Pakistan

RECRUITING

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • jai K Das

    Institute for global health and development, Aga Khan University.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Associate Director, Institute for Global Health and Development

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 28, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 27, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Access Criteria
Upon reasonable request.

Locations