Intervening to Improve Infant Health in Ghana

July 14, 2017 updated by: Columbia University

Intervening to Improve Birth Weight and Infant Respiratory Health in Rural Ghana

The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies.

The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of communities in Ghana.

Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead to a significant increase in average birth weight in newborns.

Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of severe acute lower respiratory disease during the first 12 months of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

2. Overview of design and analysis [per CONSORT 2010] 2.1 Trial design [CONSORT 3a] The study is a three-arm cluster randomized trial, with two intervention arms and a control arm. The primary justification for intervening at the village level is that an individual level randomization, which would entail treatments and controls living side-by-side in a village, could lead to conflict within villages.

2.2 Study Participants [CONSORT 4a, 4b] The study will take place in the catchment area of Kintampo Health Research Centre. This comprises a population of 146,000. The study population is primarily rural and agricultural, and cooks primarily with biomass fuels. The study area is well described in Owusu-Agyei et al. 2012 (38).

A cluster was eligible to participate if it:

  • Is located in Kintampo North or South Districts (this is the core study area for KHRC)
  • Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
  • Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
  • Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).

A woman will be eligible to participate in the study if she:

  • Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
  • Is carrying a live singleton fetus (twins will be excluded)
  • Is the primary cook in her household or compound; and
  • Is a non-smoker. 2.3 Interventions [CONSORT 5]

The study has three arms:

  1. LPG intervention arm, in which households receive a two burner LPG cookstove and monthly gas deliveries;
  2. An efficient biomass arm, in which households receive two BioLite cookstoves; and
  3. A control arm 2.4 Outcomes [CONSORT 6a]

The primary health outcome measures for the study are:

  1. Infant weight at birth, and
  2. Physician assessed pneumonia. Baseline assessments of outcomes No baseline data for ALRI prevalence from Ghana is available. Our study will thus provide very valuable baseline data regarding this important disease.

KHRC has, in the course of conducting other research projects, captured some information regarding birth weight; statistics calculated from these data were used as inputs into power calculations. These data are described in (39).

2.5 Sample size [CONSORT 7a, 7b] For the three-arm design, we calculate that we need to enroll households to achieve our target of 1225 births (assuming that 85% of the pregnancies will result in a recorded birth after, accounting for move out, drop out, and still birth rates). These will be spread across 35 or more clusters, as outlined in the following table.

Clusters Births Enrollment BioLite 13 455 525 Control 13 455 525 LPG 9 315 365 total 35 1225 1415

Study Type

Interventional

Enrollment (Actual)

1414

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

  • Ghana
      • Kintampo, Ghana
        • Kintampo Medical Research Center
  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

A cluster was eligible to participate if it:

  • Is located in Kintampo North or South Districts (this is the core study area for KHRC)
  • Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
  • Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
  • Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).

A woman will be eligible to participate in the study if she:

  • Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
  • Is carrying a live singleton fetus (twins will be excluded)
  • Is the primary cook in her household or compound; and
  • Is a non-smoker.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Biolite Cook Stove
Provision of two cook stoves to each subject. Each stove burns wood fuel, but more efficiently than a traditional three stone fire.
Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel
The cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester.
Experimental: LPG Cook Stove
Provision of a two-burner liquified petroleum gas stove to each subject, along with fuel needed for the family during the follow up period.
Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel
The cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Low birth weight
Time Frame: Birth
Birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute lower respiratory disease
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Environmental Health Sciences (NIEHS)
Thrasher Research Fund
Global Alliance for Clean Cookstoves

Investigators

  • Principal Investigator: Patrick Kinney, ScD, Columbia University

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.

General Publications

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

August 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAF3520
  • 1R01ES019547-01A1 (U.S. NIH Grant/Contract)

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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