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Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries

Primary Purpose

Poisoning by Carbon Monoxide From Domestic Fuels, Respiratory Conditions Due to Other External Agents

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Improved, ventilated cookstove
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poisoning by Carbon Monoxide From Domestic Fuels focused on measuring improved cookstove, ventilated cookstove, behavior change, adoption, indoor air pollution, DLCO, spirometry, biomass fuel

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Moi University
  • Nepal Nutrition Intervention Project - Sarlahi (NNIPS)
  • A.B. Prisma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Commercially-made followed by locally-made improved cookstove

Locally-made followed by commercially-made improved cookstove

Arm Description

Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. Four months later the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.

Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. Four months later the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 10, 2012
Last Updated
April 1, 2015
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Universidad Peruana Cayetano Heredia, National Institutes of Health (NIH), Brown University, Moi University, Asociacion Benefica Prisma, Nepal Nutrition Intervention Project Sarlahi
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1. Study Identification

Unique Protocol Identification Number
NCT01686867
Brief Title
Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries
Official Title
Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Universidad Peruana Cayetano Heredia, National Institutes of Health (NIH), Brown University, Moi University, Asociacion Benefica Prisma, Nepal Nutrition Intervention Project Sarlahi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poisoning by Carbon Monoxide From Domestic Fuels, Respiratory Conditions Due to Other External Agents
Keywords
improved cookstove, ventilated cookstove, behavior change, adoption, indoor air pollution, DLCO, spirometry, biomass fuel

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Commercially-made followed by locally-made improved cookstove
Arm Type
Experimental
Arm Description
Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. Four months later the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.
Arm Title
Locally-made followed by commercially-made improved cookstove
Arm Type
Experimental
Arm Description
Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. Four months later the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.
Intervention Type
Device
Intervention Name(s)
Improved, ventilated cookstove
Intervention Description
An improved, ventilated cookstove incorporates the following key elements: burner openings customized to the size and shape of the cooking utensils; a flue designed to draw air into the fire box and pass it out through a chimney; a chimney, vented to the exterior, of adequate height to create a draft; an exterior port that has bidirectional openings to prevent the backflow of smoke and an access port for the chimney that permits cleaning. The investigators piloted cookstoves prior to the trial and compared their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functionality over time, preferences and cultural compatibility, and cost. The investigators selected the the Envirofit G-3300/3355, a modified Stovetec cookstove with a chimney and a locally-made improved, ventilated cookstove for use in the trial.
Primary Outcome Measure Information:
Title
Exposure to biomass fuel combustion
Description
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.
Time Frame
One year
Title
Respiratory Outcomes
Description
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.
Time Frame
One year
Title
Adoption process of improved cookstoves
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Measure change in blood pressure in women 20 to 49 years of age in three rural populations between traditional cookstoves and improved, ventilated cookstoves.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Checkley, MD, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moi University
City
Eldoret
Country
Kenya
Facility Name
Nepal Nutrition Intervention Project - Sarlahi (NNIPS)
City
Kathmandu
Country
Nepal
Facility Name
A.B. Prisma
City
Ayacucho
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
24112419
Citation
Klasen E, Miranda JJ, Khatry S, Menya D, Gilman RH, Tielsch JM, Kennedy C, Dreibelbis R, Naithani N, Kimaiyo S, Chiang M, Carter EJ, Sherman CB, Breysse PN, Checkley W; COCINAS Trial Working Group. Feasibility intervention trial of two types of improved cookstoves in three resource-limited settings: study protocol for a randomized controlled trial. Trials. 2013 Oct 10;14:327. doi: 10.1186/1745-6215-14-327.
Results Reference
derived

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Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries

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