InflammationREACCTINGNCT04633135

Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana

A study testing Philips stove and Gyapa stove in people with Inflammation and Growth Retardation, run by University of Colorado, Boulder.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 0 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Inflammation, Growth Retardation
What is being tested?: Philips stove and Gyapa stove
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: 1 Jan 2012to 31 Dec 2017
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 0 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Individual Participants:
Classified as "rural"
Uses biofuel as main cooking fuel source (firewood, animal waste, crop residue/sawdust)
Uses borehole as main water source (to facilitate social network analysis linking household's knowledge and attitudes toward stoves to experience of social contacts);
Does not have electricity (to permit possible addition of lighting intervention at a later date);
Has a woman in household aged 18-55 and at least one child under five (since women and children are the most vulnerable to cookstove smoke and are thus the main focus of our health measures).

Show all 10Show fewer

Clusters:
No more than 25% classified as urban
Accessible year-round (determined by field staff)
Having at least 10 eligible households (in line with the participant criteria above)

Who cannot join

Household could not be located
Household declined to participate

About this study

REACCTING (Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana) is an interdisciplinary randomized cookstove intervention study in the Kassena-Nankana District of Northern Ghana. The study tests two types of biomass burning stoves that have the potential to meet local cooking needs and represent different "rungs" in the cookstove technology ladder: a locally-made, low-tech Gyapa rocket stove and the imported, highly efficient Philips gasifier stove. Intervention households were randomized into four different groups, three of which received different combinations of two improved stoves, while the fourth group serves as a control for the duration of the study. Diverse measurements assess different points along the causal chain linking the intervention to final outcomes of interest. The investigators assess stove use and cooking behavior, cooking emissions, household air pollution and personal exposure, health burden, and local to regional air quality. Integrated analysis and modeling will tackle a range of interdisciplinary science questions, including examining ambient exposures among the regional population, assessing how those exposures might change with different technologies and behaviors, and estimating the comparative impact of local behavior and technological changes versus regional climate variability and change on local air quality and health outcomes.

Conditions: Inflammation, Growth Retardation
Being tested: Philips stove, Gyapa stove
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Philips stoveDevice
Also called Gasifier stove
Philips Smokeless stove HD4012LS
Gyapa stoveDevice
Also called Rocket stove
Wood stove made in Ghana

Study groups in NCT04633135
Study group	Role	What they receive
Control	No intervention	Households enrolled in the control arm of the study did not receive either improved cookstove
Gyapa/Gyapa	Experimental	Households enrolled in the Gyapa/Gyapa arm of the study received two Gyapa stoves for free Receives: Device: Gyapa stove
Gyapa/Philips	Experimental	Households enrolled in the Gyapa/Philips arm of the study received one Gyapa stove and one Philips stove for free Receives: Device: Philips stove; Device: Gyapa stove
Philips/Philips	Experimental	Households enrolled in the Philips/Philips arm of the study received two Philips stoves for free Receives: Device: Philips stove

What is being measured

The primary outcome is the main question the study is designed to answer.

Health (Biomarkers of inflammation)
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Measured: At baseline
Health (Biomarkers of inflammation)
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Measured: At 6 months
Health (Biomarkers of inflammation)
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Measured: At 12 months
Health (Biomarkers of inflammation)
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Measured: At 18 months
Height
Height of participants
Measured: At baseline
Height
Height of participants
Measured: At 6 months
Height
Height of participants
Measured: At 12 months
Height
Height of participants
Measured: At 18 months
Weight
Weight of participants
Measured: At baseline
Weight
Weight of participants
Measured: At 6 months
Weight
Weight of participants
Measured: At 12 months
Weight
Weight of participants
Measured: At 18 months
Mid-arm circumference
Measurement of mid-upper arm circumference of participants
Measured: At baseline
Mid-arm circumference
Measurement of mid-upper arm circumference of participants
Measured: At 6 months
Mid-arm circumference
Measurement of mid-upper arm circumference of participants
Measured: At 12 months
Mid-arm circumference
Measurement of mid-upper arm circumference of participants
Measured: At 18 months

Secondary outcomes (9)

Personal exposure to fine particulate matter (PM2.5)
48 hour integrated personal PM2.5 concentrations from filter measurements
Measured: 48 hour deployment periods
Personal exposure to carbon monoxide (CO)
Daily average and integrated personal CO concentrations
Measured: 48 hour deployment periods
Kitchen area concentrations of carbon monoxide (CO)
Daily average and integrated kitchen area CO concentrations
Measured: 48 hour deployment periods
Kitchen area concentrations of fine particulate matter (PM2.5)
48 hour integrated kitchen area PM2.5 concentrations from filter measurements
Measured: 48 hour deployment periods
Self-reported stove usage
Surveys administered to respondents (primary cooks)
Measured: At baseline
Self-reported stove usage
Surveys administered to respondents (primary cooks)
Measured: At 6 months
Self-reported stove usage
Surveys administered to respondents (primary cooks)
Measured: At 12 months
Self-reported stove usage
Surveys administered to respondents (primary cooks)
Measured: At 18 months
Stove usage as measured by devices
Continuous stove usage indicators as measured by temperature loggers on stoves
Measured: Throughout data collection period, approximately 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201231 Dec 2017

First posted18 Nov 2020
Study start1 Jan 2012
Primary completion31 Dec 2016
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InflammationStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: There were 4 groups, 3 intervention and 1 control, all operating over the same period.
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04633135
Sponsor's protocol ID: REACCTING
Other IDs: GEO-1211668, RD-8354201
Acronym: REACCTING
Status last verified: Nov 2020
First submitted: 14 Sep 2020
Last updated: 18 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified data are available upon request.

Publications

Dickinson KL, Kanyomse E, Piedrahita R, Coffey E, Rivera IJ, Adoctor J, Alirigia R, Muvandimwe D, Dove M, Dukic V, Hayden MH, Diaz-Sanchez D, Abisiba AV, Anaseba D, Hagar Y, Masson N, Monaghan A, Titiati A, Steinhoff DF, Hsu YY, Kaspar R, Brooks B, Hodgson A, Hannigan M, Oduro AR, Wiedinmyer C. Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana (REACCTING): study rationale and protocol. BMC Public Health. 2015 Feb 12;15:126. doi: 10.1186/s12889-015-1414-1.
PubMed 25885780
Abdo M, Kanyomse E, Alirigia R, Coffey ER, Piedrahita R, Diaz-Sanchez D, Hagar Y, Naumenko DJ, Wiedinmyer C, Hannigan MP, Oduro AR, Dickinson KL. Health impacts of a randomized biomass cookstove intervention in northern Ghana. BMC Public Health. 2021 Dec 4;21(1):2211. doi: 10.1186/s12889-021-12164-y.
PubMed 34863138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana
ClinicalTrials.gov ID: NCT04633135
Acronym / sponsor ID: REACCTING / REACCTING
Conditions: Inflammation, Growth Retardation
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: University of Colorado, BoulderUniversity, hospital or other
Collaborators: Environmental Protection Agency (EPA), U.S. National Science Foundation
Study start: 1 Jan 2012 (actual)
Primary completion: 31 Dec 2016 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 18 Nov 2020 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: There were 4 groups, 3 intervention and 1 control, all operating over the same period.

Arm	Type	Receives
Control	No intervention	–Households enrolled in the control arm of the study did not receive either improved cookstove
Gyapa/Gyapa	Experimental	Device: Gyapa stoveHouseholds enrolled in the Gyapa/Gyapa arm of the study received two Gyapa stoves for free
Gyapa/Philips	Experimental	Device: Philips stove, Device: Gyapa stoveHouseholds enrolled in the Gyapa/Philips arm of the study received one Gyapa stove and one Philips stove for free
Philips/Philips	Experimental	Device: Philips stoveHouseholds enrolled in the Philips/Philips arm of the study received two Philips stoves for free

Who may qualify

Ages: 0 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Classified as "rural"
Uses biofuel as main cooking fuel source (firewood, animal waste, crop residue/sawdust)
Uses borehole as main water source (to facilitate social network analysis linking household's knowledge and attitudes toward stoves to experience of social contacts);
Does not have electricity (to permit possible addition of lighting intervention at a later date);
Has a woman in household aged 18-55 and at least one child under five (since women and children are the most vulnerable to cookstove smoke and are thus the main focus of our health measures).

Key exclusion criteria (2 listed)

Household could not be located
Household declined to participate

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
Philips stoveAlso: Gasifier stovePhilips Smokeless stove HD4012LS	Device	Gyapa/Philips, Philips/Philips
Gyapa stoveAlso: Rocket stoveWood stove made in Ghana	Device	Gyapa/Gyapa, Gyapa/Philips

Primary outcome

Health (Biomarkers of inflammation)
Time frame: At baseline
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Health (Biomarkers of inflammation)
Time frame: At 6 months
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Health (Biomarkers of inflammation)
Time frame: At 12 months
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Health (Biomarkers of inflammation)
Time frame: At 18 months
Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
Height
Time frame: At baseline
Height of participants
Height
Time frame: At 6 months
Height of participants
Height
Time frame: At 12 months
Height of participants
Height
Time frame: At 18 months
Height of participants
Weight
Time frame: At baseline
Weight of participants
Weight
Time frame: At 6 months
Weight of participants
Weight
Time frame: At 12 months
Weight of participants
Weight
Time frame: At 18 months
Weight of participants
Mid-arm circumference
Time frame: At baseline
Measurement of mid-upper arm circumference of participants
Mid-arm circumference
Time frame: At 6 months
Measurement of mid-upper arm circumference of participants
Mid-arm circumference
Time frame: At 12 months
Measurement of mid-upper arm circumference of participants
Mid-arm circumference
Time frame: At 18 months
Measurement of mid-upper arm circumference of participants

9 secondary outcomes

Personal exposure to fine particulate matter (PM2.5)
Time frame: 48 hour deployment periods
Personal exposure to carbon monoxide (CO)
Time frame: 48 hour deployment periods
Kitchen area concentrations of carbon monoxide (CO)
Time frame: 48 hour deployment periods
Kitchen area concentrations of fine particulate matter (PM2.5)
Time frame: 48 hour deployment periods
Self-reported stove usage
Time frame: At baseline
Self-reported stove usage
Time frame: At 6 months
Self-reported stove usage
Time frame: At 12 months
Self-reported stove usage
Time frame: At 18 months
Stove usage as measured by devices
Time frame: Throughout data collection period, approximately 2 years.

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 18 Nov 2020.
Background: PubMed 25885780Dickinson KL, Kanyomse E, Piedrahita R, Coffey E, Rivera IJ, Adoctor J, Alirigia R, Muvandimwe D, Dove M, Dukic V, Hayden MH, Diaz-Sanchez D, Abisiba AV, Anaseba D, Hagar Y, Masson N, Monaghan A, Titiati A, Steinhoff DF, Hsu YY, Kaspar R, Brooks B, Hodgson A, Hannigan M, Oduro AR, Wiedinmyer C. Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana (REACCTING): study rationale and protocol. BMC Public Health. 2015 Feb 12;15:126. doi: 10.1186/s12889-015-1414-1.
Derived from this study: PubMed 34863138Abdo M, Kanyomse E, Alirigia R, Coffey ER, Piedrahita R, Diaz-Sanchez D, Hagar Y, Naumenko DJ, Wiedinmyer C, Hannigan MP, Oduro AR, Dickinson KL. Health impacts of a randomized biomass cookstove intervention in northern Ghana. BMC Public Health. 2021 Dec 4;21(1):2211. doi: 10.1186/s12889-021-12164-y.
Individual participant dataSharing planned: No. De-identified data are available upon request.

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RecruitingPhase 1
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RecruitingPhase 4
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Philips stove and Gyapa stove in people with Inflammation and Growth Retardation, run by University of Colorado, Boulder.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Health (Biomarkers of inflammation) (time frame: At baseline). The study lists 16 primary outcomes in all. 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 NCT04633135, which also lists 2 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 18 Nov 2020.