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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Universidad Peruana Cayetano Heredia
Brown University
Moi University
Asociación Benéfica Prisma
Nepal Nutrition Intervention Project Sarlahi
Information provided by (Responsible Party):
William Checkley, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01686867
First received: September 10, 2012
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Poisoning by Carbon Monoxide From Domestic Fuels
Respiratory Conditions Due to Other External Agents
Device: Improved, ventilated cookstove

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Exposure to biomass fuel combustion [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measure change in blood pressure in women 20 to 49 years of age in three rural populations between traditional cookstoves and improved, ventilated cookstoves.


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Commercially-made followed by locally-made improved cookstove
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.
Device: Improved, ventilated cookstove

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.

Experimental: Locally-made followed by commercially-made improved cookstove
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.
Device: Improved, ventilated cookstove

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.


  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686867

Contacts
Contact: William Checkley, MD, PhD (443) 287-8741 wcheckl1@jhmi.edu
Contact: Elizabeth Klasen, MSPH +51 1 989041607 emklasen@gmail.com

Locations
Kenya
Moi University Not yet recruiting
Eldoret, Kenya
Contact: Sylvester Kimaiyo, MBChB, MMed    254721781605    skimaiyo@yahoo.com   
Contact: Charles Sherman, MD, MPH    4015292374    cbsherman@gmail.com   
Principal Investigator: Sylvester Kimaiyo, MBChB, MMed         
Nepal
Nepal Nutrition Intervention Project - Sarlahi (NNIPS) Not yet recruiting
Kathmandu, Nepal
Contact: Subarna Khatry, MBBS    9774261805    skk@mos.com.np   
Contact: Jim Tielsch, PhD    4109552436    jtielsch@jhsph.edu   
Principal Investigator: Subarna Khatry, MBBS         
Sub-Investigator: Steve LeClerq, MPH         
Peru
A.B. Prisma Recruiting
Ayacucho, Peru
Contact: Jaime Miranda, MD, PhD    5112416978    jaime.miranda@upch.pe   
Contact: Elizabeth Klasen, MSPH    51989041607    eklasen@jhsph.edu   
Principal Investigator: Jaime Miranda, MD, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Universidad Peruana Cayetano Heredia
Brown University
Moi University
Asociación Benéfica Prisma
Nepal Nutrition Intervention Project Sarlahi
Investigators
Principal Investigator: William Checkley, MD, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Checkley, Assistant Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01686867     History of Changes
Other Study ID Numbers: COCINAS, HHSN268200900033C
Study First Received: September 10, 2012
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board
Peru: Ethics Committee
Nepal: Health Research Council
Kenya: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
improved cookstove
ventilated cookstove
behavior change
adoption
indoor air pollution
DLCO
spirometry
biomass fuel

Additional relevant MeSH terms:
Poisoning
Carbon Monoxide Poisoning
Chemically-Induced Disorders
Gas Poisoning

ClinicalTrials.gov processed this record on October 01, 2014