- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351504
Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda
December 5, 2020 updated by: Peggy S Lai, Massachusetts General Hospital
Solar Lighting Intervention Trial to Reduce Indoor Air Pollution and Improve Adult Respiratory Health in Rural Uganda
This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda.
Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
One fifth of the global population relies on kerosene lamps for lighting, yet few studies have focused on kerosene lighting as a source of indoor air pollution.
In our preliminary studies performed in Uganda, we show that homes using solar lighting have much lower levels of indoor air pollution compared to homes using kerosene lighting.
The primary goal of this study is to determine the extent to which solar lighting will reduce kerosene use and indoor air pollution in rural Uganda, whether this intervention improves lung health, and to identify the role bacteria in our gut have on determining whether or not people will get sick from indoor air pollution.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Mbarara, Uganda
- Mbarara University of Science and Technology
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-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease
Exclusion Criteria:
- Current active tuberculosis in any family member
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control (usual lighting)
Participants will continue to use their usual lighting sources.
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Experimental: Intervention (solar lighting)
Participants will receive an indoor solar lighting system
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consisting of a solar panel, rechargeable lead acid battery, charge controller, wiring and switches to 4 lighting points fitted with LED bulbs.
This system will include a two-year service warranty.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fine particulate matter (PM2.5) and Black Carbon
Time Frame: 48 hour
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Sampling for PM2.5 and Black Carbon over 48 hours will be collected
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48 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily use of solar lighting system (hours per day)
Time Frame: baseline, 3 months, 6 months, 12 months after the intervention
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A current monitory is installed as part of the solar lighting system that measures the hours per day each light switch is turned on
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baseline, 3 months, 6 months, 12 months after the intervention
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Blood pressure
Time Frame: baseline, 3 months, 6 months, 12 months after the intervention
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Resting blood pressure
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baseline, 3 months, 6 months, 12 months after the intervention
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Forced Expiratory Volume in one Second (FEV1)
Time Frame: baseline, 3 months, 6 months, 12 months after the intervention
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Pre- and Post- bronchodilator spirometry
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baseline, 3 months, 6 months, 12 months after the intervention
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Heart rate variability
Time Frame: baseline, 3 months, 6 months, 12 months after the intervention
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Resting 10 minute heart rate variability
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baseline, 3 months, 6 months, 12 months after the intervention
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Stool microbiome
Time Frame: baseline, 3 months, 6 months, 12 months after the intervention
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Microbial sequencing of the stool will be performed
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baseline, 3 months, 6 months, 12 months after the intervention
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Qualitative interviews
Time Frame: Post-intervention
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1:1 qualitative interviews will be performed with participants
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Post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peggy S Lai, MD MPH, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2018
Primary Completion (Actual)
October 31, 2019
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
November 19, 2017
First Submitted That Met QC Criteria
November 19, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 5, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000306/PHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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