Intervening to Improve Infant Health in Ghana

NCT01335490 | Completed DMC

• 2 other identifiers: AAAF35201R01ES019547-01A1
• Study Type: interventional
• Target: 1,414
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Very Low Birth Weight Baby; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Low birth weight

  Birth

Secondary Outcomes (1)

• Acute lower respiratory disease

  12 months

Study Arms (3)

Biolite Cook Stove

EXPERIMENTAL

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

LPG Cook Stove

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel OTHER

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.

Biolite Cook Stove; LPG Cook Stove

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Global Alliance for Clean Cookstoves: collaborator
• Thrasher Research Fund: collaborator

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Kintampo Medical Research Center

Kintampo, Ghana

Location

Related Publications (9)

• Agyapong PD, Jack D, Kaali S, Colicino E, Mujtaba MN, Chillrud SN, Osei M, Gennings C, Agyei O, Kinney PL, Kwarteng A, Perzanowski M, Dwommoh Prah RK, Tawiah T, Asante KP, Lee AG. Household Air Pollution and Child Lung Function: The Ghana Randomized Air Pollution and Health Study. Am J Respir Crit Care Med. 2024 Mar 15;209(6):716-726. doi: 10.1164/rccm.202303-0623OC.

  PMID: 38016085 DERIVED

• Boamah-Kaali E, Jack DW, Ae-Ngibise KA, Quinn A, Kaali S, Dubowski K, Oppong FB, Wylie BJ, Mujtaba MN, Gould CF, Gyaase S, Chillrud S, Owusu-Agyei S, Kinney PL, Asante KP, Lee AG. Prenatal and Postnatal Household Air Pollution Exposure and Infant Growth Trajectories: Evidence from a Rural Ghanaian Pregnancy Cohort. Environ Health Perspect. 2021 Nov;129(11):117009. doi: 10.1289/EHP8109. Epub 2021 Nov 29.

  PMID: 34842444 DERIVED

• Jack DW, Ae-Ngibise KA, Gould CF, Boamah-Kaali E, Lee AG, Mujtaba MN, Chillrud S, Kaali S, Quinn AK, Gyaase S, Oppong FB, Carrion D, Agyei O, Burkhart K, Ana-Aro JA, Liu X, Berko YA, Wylie BJ, Etego SA, Whyatt R, Owusu-Agyei S, Kinney P, Asante KP. A cluster randomised trial of cookstove interventions to improve infant health in Ghana. BMJ Glob Health. 2021 Aug;6(8):e005599. doi: 10.1136/bmjgh-2021-005599.

  PMID: 34452940 DERIVED

• Kinney PL, Asante KP, Lee AG, Ae-Ngibise KA, Burkart K, Boamah-Kaali E, Twumasi M, Gyaase S, Quinn A, Oppong FB, Wylie BJ, Kaali S, Chillrud S, Yawson A, Jack DW, Owusu-Agyei S. Prenatal and Postnatal Household Air Pollution Exposures and Pneumonia Risk: Evidence From the Ghana Randomized Air Pollution and Health Study. Chest. 2021 Nov;160(5):1634-1644. doi: 10.1016/j.chest.2021.06.080. Epub 2021 Jul 21.

  PMID: 34298005 DERIVED

• Ae-Ngibise KA, Wylie BJ, Boamah-Kaali E, Jack DW, Oppong FB, Chillrud SN, Gyaase S, Kaali S, Agyei O, Kinney PL, Mujtaba M, Wright RJ, Asante KP, Lee AG. Prenatal maternal stress and birth outcomes in rural Ghana: sex-specific associations. BMC Pregnancy Childbirth. 2019 Oct 29;19(1):391. doi: 10.1186/s12884-019-2535-9.

  PMID: 31664941 DERIVED

• Lee AG, Kaali S, Quinn A, Delimini R, Burkart K, Opoku-Mensah J, Wylie BJ, Yawson AK, Kinney PL, Ae-Ngibise KA, Chillrud S, Jack D, Asante KP. Prenatal Household Air Pollution Is Associated with Impaired Infant Lung Function with Sex-Specific Effects. Evidence from GRAPHS, a Cluster Randomized Cookstove Intervention Trial. Am J Respir Crit Care Med. 2019 Mar 15;199(6):738-746. doi: 10.1164/rccm.201804-0694OC.

  PMID: 30256656 DERIVED

• Quinn AK, Ae-Ngibise KA, Kinney PL, Kaali S, Wylie BJ, Boamah E, Shimbo D, Agyei O, Chillrud SN, Mujtaba M, Schwartz JE, Abdalla M, Owusu-Agyei S, Jack DW, Asante KP. Ambulatory monitoring demonstrates an acute association between cookstove-related carbon monoxide and blood pressure in a Ghanaian cohort. Environ Health. 2017 Jul 21;16(1):76. doi: 10.1186/s12940-017-0282-9.

  PMID: 28732501 DERIVED

• Jack DW, Asante KP, Wylie BJ, Chillrud SN, Whyatt RM, Ae-Ngibise KA, Quinn AK, Yawson AK, Boamah EA, Agyei O, Mujtaba M, Kaali S, Kinney P, Owusu-Agyei S. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial. Trials. 2015 Sep 22;16:420. doi: 10.1186/s13063-015-0930-8.

  PMID: 26395578 DERIVED

• Boamah EA, Asante K, Ae-Ngibise K, Kinney PL, Jack DW, Manu G, Azindow IT, Owusu-Agyei S, Wylie BJ. Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control. JMIR Res Protoc. 2014 Dec 18;3(4):e77. doi: 10.2196/resprot.3797.

  PMID: 25525828 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Patrick Kinney, ScD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

US (1); GH (1)