Respiratory Conditions Due to Other External Agents Clinical Trial
Official title:
Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries
The underlying concept behind this feasibility trial is to achieve a reduction in indoor
smoke from biomass fuels and minimize changes in cooking practices such that it prompts one
of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel
sources used in developing countries include wood, dried dung, and agricultural waste. The
investigators propose to reduce indoor air pollution by replacing the household traditional
cookstove with an improved design that incorporates the following key elements:
- Burner openings customized to the size and shape of the cooking vessels in the home.
- Flue designed to draw air into the fire box under the cooking pots and pass it out
through a chimney.
- A chimney with adequate height to create a draft and vented to the exterior.
- An exterior port that has bidirectional openings to prevent backflow of smoke.
- An access port for the chimney that permits cleaning of soot.
The investigators propose to use two types of improved cookstoves that meet these criteria.
As part of piloting activities, the investigators will test several different types of
commercially-available cookstoves with a chimney, and we may also want to test a
locally-made improved cookstove. The investigators want to evaluate those designs by
comparing their ability to reduce indoor air pollution, the reliability between cookstoves
of the same type, the functioning over time, the logistics of import/build locally,
preferences and cultural compatibility, and costs. The investigators will select two types
of improved cookstoves to use in the feasibility trial.
The study design will be a crossover intervention trial in which all patients will first
have a run-in observational period of 4 months with the traditional cookstove prior to
randomization. At baseline, the investigators will obtain sociodemographic information for
each household, respiratory outcomes and other health data for the participating women, and
cooking times and practices including the types of fuels used. All 40 patients at each site
will receive the two types of improved cookstoves, one after the other: 20 will be
randomized to receive the first type of cookstove with a chimney and the other 20 to first
receive the second type of improved cookstove with a chimney. The patients will be followed
for 4 months before the crossover. The investigators will assess cooking behavioral
practices and compliance with cookstove use monthly, and respiratory and environmental
measures at the mid-point of the 4 month period to minimize carry-over effects. At the end
of second 4 month period, the investigators will switch the order of the improved cookstoves
and follow all participants for another 4 months. The investigators will assess behavior,
compliance, respiratory and environmental measures as above. The study is expected to
require 12 months to complete.
| Status | Completed |
| Enrollment | 137 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Have at least one woman aged 20 to 49 years who is the main cook. - Have a traditional (i.e., open-fire) cookstove indoors with at least 3 walls and a roof. - Are willing to have us install an improved cookstove and be willing to use it. - Have household walls of mud, brick, cement, or wood. - Capable of providing informed consent and responding to a questionnaire - Full-time resident in the area Exclusion Criteria: - Have a new improved cookstove or a chimney in the household. - Have household walls of thatch or bamboo no covered in mud. - Plans to move from the area within one year. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Kenya | Moi University | Eldoret | |
| Nepal | Nepal Nutrition Intervention Project - Sarlahi (NNIPS) | Kathmandu | |
| Peru | A.B. Prisma | Ayacucho |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins Bloomberg School of Public Health | Asociación Benéfica Prisma, Brown University, Moi University, National Institutes of Health (NIH), Nepal Nutrition Intervention Project Sarlahi, Universidad Peruana Cayetano Heredia |
Kenya, Nepal, Peru,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Exposure to biomass fuel combustion | Measure change in levels of particulate matter concentrations and carbon monoxide between traditional cookstoves and improved, ventilated cookstoves in households in three rural populations in which biomass fuels are used almost exclusively for cooking. | One year | No |
| Primary | Respiratory Outcomes | Measure change in respiratory outcomes (spirometry for FEV1 and peak expiratory flow, carboxyhemoglobin and DLCO) in women aged 20 to 49 years in three rural populations between traditional cookstoves and the improved, ventilated cookstoves. | One year | No |
| Primary | Adoption process of improved cookstoves | Assess behaviors and attitudes in women 20-49 years of age in three rural populations regarding the adoption and continued use of improved cookstoves and evaluate the reasons for their preferred choice of cookstove at the end of the trial. Methodology includes: patient direct observations, in-depth interviews, semi-structured interviews and focus groups with study staff. | One year | No |
| Secondary | Blood pressure | Measure change in blood pressure in women 20 to 49 years of age in three rural populations between traditional cookstoves and improved, ventilated cookstoves. | One year | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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