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CompletedNCT03352830ELAGUpdated Jan 31, 2019

Encouraging LPG Adoption in Ghana: A Factorial Randomized Clinical Trial to Enhance LPG Adoption & Sustained Use

An interventional study of RANAS Behavior Change Intervention and Infrastructural Intervention - Direct Delivery in Behavior, Consumer, Health Knowledge, Attitudes, Practice and Health Attitude, sponsored by Columbia University. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Columbia University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
781
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Health conditions resulting from household air pollution (HAP) are responsible for approximately 3.9 million premature deaths each year. Exposure to HAP is the third largest preventable contributor to illness worldwide. Even so, HAP exposures persist since 3 billion individuals worldwide continue to rely on biomass fuel for cooking and heating, especially in the developing world. Though the transition away from traditional biomass stoves is projected curb the health effects of HAP by mitigating exposure, the benefits of newer clean cookstove technologies can only be fully realized if use of these stoves is exclusive and sustained. Most studies indicate that the provision of clean cookstoves to these individuals is, on its own, insufficient to encourage and foster adoption. In order to better understand how to promote clean cookstove adoption, the proposed study aims to (1) develop an educational intervention to promote clean cookstove adoption and sustained use and (2) determine the influence of liquid petroleum gasoline (LPG) accessibility on product demand.

Households enrolled into the control and the BioLite arms of GRAPHS (the parent study) will receive clean LPG cookstoves for their participation in the study (clinicaltrials.gov registration: NCT01335490). The objective of this study is to test the relative impact of two approaches to encourage stove use: providing a behavior change intervention and offering convenient access to LPG refueling. The investigators hypothesize that these interventions will increase overall use of LPG cook stoves.

Prior evidence on the role of health information in promoting the adoption of health-promoting technology is limited, and the results are mixed. Although little work has been done to investigate the importance of accessibility to sustained use of cookstoves, accessibility remains one of the basic market drivers of product demand.

A total of 27 communities will be cluster randomized, with 979 study households nested throughout the sites. The study arms will be arranged as a 2x2 factorial design, with approximately equal numbers of households in each arm.

02

Conditions studied

  • Behavior, Consumer
  • Health Knowledge, Attitudes, Practice
  • Health Attitude

Keywords

  • household air pollution
  • health promotion
  • clean cookstove adoption
  • clean cookstove sustained use
03

In context

Consumer Behavior

42 studies on the registry are indexed under Consumer Behavior; 6 are open to participants now.

This study's enrollment of 781 is above the median of 142 across 32 interventional studies indexed under Consumer Behavior.

Browse Consumer Behavior studies →

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion criteria -- an individual is eligible to participate in the study if she:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
781 participants (actual)

Study arms

  • No intervention
    Control

    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.

  • Experimental
    No Delivery, Educational Intervention

    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

  • Experimental
    Delivery, No Educational Intervention

    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

  • Experimental
    Agent Delivery, Educational Intervention

    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 Intervention · Other: Infrastructural Intervention - Direct Delivery

Interventions

  • BehavioralRANAS Behavior Change Intervention

    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.

  • OtherInfrastructural Intervention - Direct Delivery

    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.

06

What researchers measure

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.

    Time frame: 10 months

Secondary outcomes

  1. Amount of LPG refueled (via weight)

    The investigators will measure stove use alternatively via biweekly weighing of LPG cylinders. The study period will be broken into two time spans, the first and second five months of the study. Our secondary outcome of interest will be aggregated kilograms of LPG over the second five months of the study.

    Time frame: 10 months

07

Study locations

2 sites
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Kintampo Medical Research Center
    Kintampo, Ghana
08

References and documents

Publications

  • 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. PubMed 24641558 ↗
  • 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. PubMed 23674502 ↗
  • 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. PubMed 25839201 ↗
  • 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. PubMed 16507460 ↗
  • 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. PubMed 26395578 ↗
  • 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. PubMed 22292899 ↗
  • 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. PubMed 22296719 ↗
  • 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. PubMed 29866127 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Statistical analysis plan, Clinical study report

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Oct 2018, 14 months.

Of 20 interventional studies with no phase under Consumer Behavior, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 14 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2017
First posted
Nov 24, 2017
StartActual
Aug 21, 2017
Primary completionActual
Oct 31, 2018
CompletionActual
Oct 31, 2018
Last update
Jan 31, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03352830
Collaborators
Kintampo Health Research Centre, Ghana, National Institute of Environmental Health Sciences (NIEHS)
Responsible party
Darby Jack (Assistant Professor of Environmental Health Sciences, Columbia University) — Principal investigator
First posted
Nov 24, 2017
Start date
Aug 21, 2017
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Jan 31, 2019

Study contacts

Darby Jack, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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