Behavior, ConsumerELAGNCT03352830
Encouraging LPG Adoption in Ghana: A Factorial Randomized Clinical Trial to Enhance LPG Adoption & Sustained Use
A study testing RANAS Behavior Change Intervention and Infrastructural Intervention - Direct Delivery in people with Behavior, Consumer and Health Knowledge, Attitudes, Practice, run by Columbia University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior, Consumer, Health Knowledge, Attitudes, Practice, Health Attitude
- What is being tested?
- RANAS Behavior Change Intervention and Infrastructural Intervention - Direct Delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 781 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Aug 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Understanding Adoption of Clean Cookstoves
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.
- Being tested
- RANAS Behavior Change Intervention, Infrastructural Intervention - Direct Delivery
- Keywords
- household air pollution, health promotion, clean cookstove adoption, clean cookstove sustained use
- Medical subject headings
- Consumer Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RANAS Behavior Change InterventionBehavioural
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.
Infrastructural Intervention - Direct DeliveryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: RANAS Behavior Change Intervention; Other: Infrastructural Intervention - Direct Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start21 Aug 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Behavior, ConsumerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Darby Jack, Columbia University
- Investigators
- Darby Jack, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352830
- Sponsor's protocol ID
- AAAO4965
- Other IDs
- R01ES024489
- Acronym
- ELAG
- Status last verified
- Jan 2019
- First submitted
- 7 Sep 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 24641558Bonjour 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 23674502Lewis 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 25839201Rehfuess 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 16507460Jack 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 26395578Mosler 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 22292899Lewis 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 22296719Carrion 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Adoption of Clean Cookstoves
- ClinicalTrials.gov ID
- NCT03352830
- Acronym / sponsor ID
- ELAG / AAAO4965
- Keywords
- household air pollution, health promotion, clean cookstove adoption, clean cookstove sustained use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: RANAS Behavior Change InterventionAll 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. |
| Delivery, No Educational Intervention | Experimental | Other: Infrastructural Intervention - Direct DeliveryAll individuals in each arm will receive a new LPG cookstove. This intervention arm receives free direct delivery of their LPG cylinder refills upon demand. |
| Agent Delivery, Educational Intervention | Experimental | Behavioral: RANAS Behavior Change Intervention, Other: Infrastructural Intervention - Direct DeliveryAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RANAS Behavior Change InterventionThe 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. | Behavioural | Agent Delivery, Educational Intervention, No Delivery, Educational Intervention |
| Infrastructural Intervention - Direct DeliveryProduct 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. | Other | Agent Delivery, Educational Intervention, Delivery, No Educational Intervention |
Primary outcome
Minutes of LPG Use (via SUMS)
Time frame: 10 months
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.
1 secondary outcome
Amount of LPG refueled (via weight)
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 24641558Smith 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.
- Background: PubMed 23674502Bonjour 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.
- Background: PubMed 25839201Lewis 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.
- Background: PubMed 16507460Rehfuess 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.
- Background: PubMed 26395578Jack 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.
- Background: PubMed 22292899Mosler 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.
- Background: PubMed 22296719Lewis 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.
- Derived from this study: PubMed 29866127Carrion 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darby Jack, PhD principal investigator
Columbia University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RANAS Behavior Change Intervention and Infrastructural Intervention - Direct Delivery in people with Behavior, Consumer and Health Knowledge, Attitudes, Practice, run by Columbia University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes of LPG Use (via SUMS) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352830, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.