NCT03352830

Brief Summary

Household air pollution (HAP) is a top-priority public health problem in developing countries. According to the most recent comparative risk assessment, 3.5 million people die prematurely each year as a result of HAP exposures. While uncertainties remain regarding causal links between HAP exposures and health, the time is ripe for focused research into effective interventions. Limited past research has shown that the demand for clean cookstoves is low, and that households continue to use traditional hearths even when they have clean stoves. The investigators propose to harness an existing cohort in Ghana to study factors that increase the adoption of clean cookstoves, and to test strategies to promote adoption and continued use.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
781

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
2 countries

2 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

August 21, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

September 7, 2017

Last Update Submit

January 29, 2019

Conditions

Keywords

household air pollutionhealth promotionclean cookstove adoptionclean cookstove sustained use

Outcome Measures

Primary Outcomes (1)

  • Minutes of LPG Use (via SUMS)

    The investigators will measure stove use via iButton stove use monitors. The study period will be broken into two time spans, the first and second five months of the study. Our primary outcome of interest will be aggregated minutes of stove use over the second five months of the study.

    10 months

Secondary Outcomes (1)

  • Amount of LPG refueled (via weight)

    10 months

Study Arms (4)

Control

NO INTERVENTION

All individuals in each arm will receive a new LPG cookstove. The control arm will receive an orientation for safe operation of the new LPG stove. Participants in the control arm will, however, receive no other intervention.

No Delivery, Educational Intervention

EXPERIMENTAL

All individuals in each arm will receive a new LPG cookstove. This intervention arm receives a health promotion intervention based on the Risks, Attitudes, Norms, Ability, and Self-Regulation (RANAS) model.

Behavioral: RANAS Behavior Change Intervention

Delivery, No Educational Intervention

EXPERIMENTAL

All individuals in each arm will receive a new LPG cookstove. This intervention arm receives free direct delivery of their LPG cylinder refills upon demand.

Other: Infrastructural Intervention - Direct Delivery

Agent Delivery, Educational Intervention

EXPERIMENTAL

All individuals in each arm will receive a new LPG cookstove. This intervention arm receives free direct delivery of their LPG cylinder refills upon demand. Participants in this arm also receive a health promotion intervention based on the Risks, Attitudes, Norms, Ability, and Self-Regulation (RANAS) model.

Behavioral: RANAS Behavior Change InterventionOther: Infrastructural Intervention - Direct Delivery

Interventions

The Risks, Attitudes, Norms, Abilities, and Self-Regulation (RANAS) Model is a health behavior change intervention, which has been successfully used in the area of water, sanitation, and hygiene. It draws from numerous health behavior theories, including the Theory of Planned Behavior, the Health Action Process, and the Health Belief Model. The model posits that the five factor blocks (risks, attitudes, norms, abilities, and self-regulation) that must be aligned toward the new behavior in order to influence change. A series of activities target each block accordingly.

Agent Delivery, Educational InterventionNo Delivery, Educational Intervention

Product demand is influenced, in part, by accessibility. Investigators are testing the degree to which this is true for liquefied petroleum gas (LPG) by establishing a direct delivery system for communities randomized to this treatment arm. Individuals in these communities are able to contact a 'delivery agent', contracted by the Kintampo Health Research Centre, who will: 1) retrieve their cylinder, 2) refill with LPG, and 3) return to the participant. The cost of delivery is free to the participant (paid by the study), but the participant is expected to fully pay for their own LPG.

Agent Delivery, Educational InterventionDelivery, No Educational Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously participated in the Ghana Randomized Air Pollution and Health Study (GRAPHS; NCT01335490)
  • Was originally randomized to the Biolite or Control arms of GRAPHS
  • Currently resides in the Kintampo Health Research Centre study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Kintampo Medical Research Center

Kintampo, Ghana

Location

Related Publications (8)

  • Smith KR, Bruce N, Balakrishnan K, Adair-Rohani H, Balmes J, Chafe Z, Dherani M, Hosgood HD, Mehta S, Pope D, Rehfuess E; HAP CRA Risk Expert Group. Millions dead: how do we know and what does it mean? Methods used in the comparative risk assessment of household air pollution. Annu Rev Public Health. 2014;35:185-206. doi: 10.1146/annurev-publhealth-032013-182356.

    PMID: 24641558BACKGROUND
  • Bonjour S, Adair-Rohani H, Wolf J, Bruce NG, Mehta S, Pruss-Ustun A, Lahiff M, Rehfuess EA, Mishra V, Smith KR. Solid fuel use for household cooking: country and regional estimates for 1980-2010. Environ Health Perspect. 2013 Jul;121(7):784-90. doi: 10.1289/ehp.1205987. Epub 2013 May 3.

    PMID: 23674502BACKGROUND
  • Lewis JJ, Bhojvaid V, Brooks N, Das I, Jeuland MA, Patange O, Pattanayak SK. Piloting improved cookstoves in India. J Health Commun. 2015;20 Suppl 1:28-42. doi: 10.1080/10810730.2014.994243.

    PMID: 25839201BACKGROUND
  • Rehfuess E, Mehta S, Pruss-Ustun A. Assessing household solid fuel use: multiple implications for the Millennium Development Goals. Environ Health Perspect. 2006 Mar;114(3):373-8. doi: 10.1289/ehp.8603.

    PMID: 16507460BACKGROUND
  • 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: 26395578BACKGROUND
  • Mosler HJ. A systematic approach to behavior change interventions for the water and sanitation sector in developing countries: a conceptual model, a review, and a guideline. Int J Environ Health Res. 2012;22(5):431-49. doi: 10.1080/09603123.2011.650156. Epub 2012 Jan 31.

    PMID: 22292899BACKGROUND
  • Lewis JJ, Pattanayak SK. Who adopts improved fuels and cookstoves? A systematic review. Environ Health Perspect. 2012 May;120(5):637-45. doi: 10.1289/ehp.1104194. Epub 2012 Feb 1.

    PMID: 22296719BACKGROUND
  • Carrion D, Dwommoh R, Tawiah T, Agyei O, Agbokey F, Twumasi M, Mujtaba M, Jack D, Asante KP. Enhancing LPG adoption in Ghana (ELAG): a factorial cluster-randomized controlled trial to Enhance LPG Adoption & Sustained use. BMC Public Health. 2018 Jun 4;18(1):689. doi: 10.1186/s12889-018-5622-3.

MeSH Terms

Conditions

Consumer BehaviorBehavior

Study Officials

  • Darby Jack, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not feasible for this intervention.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Environmental Health Sciences

Study Record Dates

First Submitted

September 7, 2017

First Posted

November 24, 2017

Study Start

August 21, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

De-identified participant data will be shared between the study teams at the Kintampo Health Research Center and Columbia University. This data will not include medical or clinical information.

Shared Documents
SAP, CSR
Time Frame
The information will become available to the Columbia University team upon study completion.
Access Criteria
Data will be stripped of personally-identifiable information and encrypted before sharing.

Locations