NCT01686867

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

September 10, 2012

Last Update Submit

April 1, 2015

Conditions

Keywords

improved cookstoveventilated cookstovebehavior changeadoptionindoor air pollutionDLCOspirometrybiomass fuel

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Blood pressure

    One year

Study Arms (2)

Commercially-made followed by locally-made improved cookstove

EXPERIMENTAL

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

Locally-made followed by commercially-made improved cookstove

EXPERIMENTAL

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

Interventions

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.

Commercially-made followed by locally-made improved cookstoveLocally-made followed by commercially-made improved cookstove

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Moi University

Eldoret, Kenya

Location

Nepal Nutrition Intervention Project - Sarlahi (NNIPS)

Kathmandu, Nepal

Location

A.B. Prisma

Ayacucho, Ayacucho, Peru

Location

Related Publications (1)

  • 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.

Study Officials

  • William Checkley, MD, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 18, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations