Heat IllnessSHAPESNCT06983483
Structural Heat Adaptation and Education in Rural Setting
A study testing Community education and awareness and Participatory local structural and environmental heat mitigation solutions in people with Heat Illness and Quality of Life, run by Aga Khan University at 1 site in Pakistan.
Trial 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 quality of life during periods of extreme heat in rural, low-income villages of Matiari, Pakistan. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heat Illness, Quality of Life
- What is being tested?
- Community education and awareness and Participatory local structural and environmental heat mitigation solutions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,128 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All households within the selected clusters who provide consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Matiari
Jai Das, +922134864717, jai.das@aku.edu
About this study
Official title: Structural Heat Adaptation and Education in Rural Setting (SHAPES 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:
Read more
- Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke and improve 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. 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.
- Conditions
- Heat Illness, Quality of Life
- Being tested
- Community education and awareness, Participatory local structural and environmental heat mitigation solutions
- Keywords
- heat illness, behaviour modification, personal cooling, Structural modification, heat adaptation, prevention, rural, Quality of life
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community education and awarenessBehavioural
Also called behavioral change, early warning system
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.
Participatory local structural and environmental heat mitigation solutionsOther
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)
- External Renders
| Study group | Role | What they receive |
|---|---|---|
| Heat Adaptation Bundle | Experimental | The Resilience and Heat Adaptation Bundle (ReHAB) consists of two components; community education and awareness 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. Receives: Behavioral: Community education and awareness; Other: Participatory local structural and environmental heat mitigation solutions |
| Control | No intervention | The control arm will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 24 months
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
Measured: 4 month, 7 month, 16 month, 19 month
Secondary outcomes (6)
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.
Measured: from baseline to 24 months
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.
Measured: During summer months for 2 years
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.
Measured: During summer months for 2 years
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.
Measured: from baseline to 24 months
Change in Indoor Heat Index
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.
Measured: From intervention delivery to 24 months
Universal Thermal Climate Index (UTCI)
Defined as a biometeorological index that describes the human body's physiological response to the environment. It integrates air temperature, humidity, wind speed, and radiant temperature to assess the overall thermal stress on the human body
Measured: From baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heat IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University College, London
- Responsible party
- Principal investigator, Dr Jai Kumar Das, Aga Khan University
- Investigators
- jai K Das, Principal investigator, Institute for Global Health and Development, Aga Khan University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983483
- Sponsor's protocol ID
- 11559
- Other IDs
- 226752/Z/22/Z
- Acronym
- SHAPES
- Status last verified
- Jun 2026
- First submitted
- 6 May 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Das JK, Naqvi SK, Bonell A, Burman C, Augustin J, Qamar S, Rizvi A, Chauhadry IA, Naqvi AA, Jamali MK, Naqvi H, Tabassum F, Cousens S, Bhutta ZA. Structural heat adaptation and education in a rural setting of Pakistan: protocol for a randomised controlled trial. BMJ Open. 2026 Aug 31;16(8):e121448. doi: 10.1136/bmjopen-2026-121448.
PubMed 42674797
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Heat Adaptation and Education in Rural Setting (SHAPES Trial)
- ClinicalTrials.gov ID
- NCT06983483
- Acronym / sponsor ID
- SHAPES / 11559
- Conditions
- Heat Illness, Quality of Life
- Keywords
- heat illness, behaviour modification, personal cooling, Structural modification, heat adaptation, prevention, rural, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,128 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University College, London
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke and improve 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. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Heat Adaptation Bundle | Experimental | Behavioral: Community education and awareness, Other: Participatory local structural and environmental heat mitigation solutionsThe Resilience and Heat Adaptation Bundle (ReHAB) consists of two components; community education and awareness 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. |
| Control | No intervention | –The control arm will not receive any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All households within the selected clusters who provide consent.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community education and awarenessAlso: behavioral change, early warning systemThis 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. | Behavioural | Heat Adaptation Bundle |
| Participatory local structural and environmental heat mitigation solutionsParticipatory 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 | Other | Heat Adaptation Bundle |
Primary outcome
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.
Quality of Life Enhancement
Time frame: 4 month, 7 month, 16 month, 19 month
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
6 secondary outcomes
All-cause mortality (Number of Deaths from Any Cause)
Time frame: from baseline to 24 months
Number of Participants with At Least One Hospital Visit During Study Period
Time frame: During summer months for 2 years
Number of Participants Hospitalized for at Least 24 Hours
Time frame: During summer months for 2 years
Change in Self-Reported Thermal Comfort Score
Time frame: from baseline to 24 months
Change in Indoor Heat Index
Time frame: From intervention delivery to 24 months
Universal Thermal Climate Index (UTCI)
Time frame: From baseline to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42674797Das JK, Naqvi SK, Bonell A, Burman C, Augustin J, Qamar S, Rizvi A, Chauhadry IA, Naqvi AA, Jamali MK, Naqvi H, Tabassum F, Cousens S, Bhutta ZA. Structural heat adaptation and education in a rural setting of Pakistan: protocol for a randomised controlled trial. BMJ Open. 2026 Aug 31;16(8):e121448. doi: 10.1136/bmjopen-2026-121448.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jai K Das principal investigator
Institute for Global Health and Development, Aga Khan University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community education and awareness and Participatory local structural and environmental heat mitigation solutions in people with Heat Illness and Quality of Life, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jai K Das (+922134864717 ext. 64717, jai.das@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Heat-Related Illness (time frame: from baseline to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06983483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.