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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL157091 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Using a focused implementation research framework, the EPIS (Exploration, Preparation, Implementation and Sustainment) model in a type-2 hybrid design, the study will be conducted in 3 phases: 1) A pre-implementation phase that will use the Exploration and Preparation domains of EPIS to: a) explore barriers and facilitators of Clean Fuel- Clean- Stove (CF-CS) use, and b) develop a culturally-tailored CM strategy for CF-CS use; 2) An Implementation phase that will use the Implementation domain of EPIS to compare in a cluster RCT of 32 peri-urban communities (640 households), the effect of CM vs. a self-directed condition (i.e. receipt of information on CF-CS use without CM) on adoption of CF-CS use; and systolic BP reduction; 3) A post-implementation phase that will use the Sustainment domain of EPIS to evaluate the effect of CM strategy vs. self-directed condition on sustainability of the CF-CS use in 640 households across the randomly assigned 32 peri-urban communities in Nigeria. The Lagos State University College of Medicine (LASUCOM) working with the MOH will oversee research coordination in Nigeria.
This study will use CM to engage in the community dialogues, organize outreach facilitation, and advocacy for the adoption of bioethanol-based and liquified petroleum gas (LPG) CF-CS across participating households. The choice of CM strategy is deliberate because, unlike western culture, African cultures are largely based on communal hierarchy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM Intervention Group | Experimental | Cluster. RCT of 16 urban and rural communities. Community mobilizers and health education officers will facilitate use of CF-CS (bioethanol and LPG fuels/stoves) and educate households on HAP exposure throughout the intervention period |
|
| Self-Directed Group | No Intervention | Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Mobilization | Behavioral | The Community Mobilization (CM) strategy will include: (1) Community advisory board [comprising local community-based organizations, government officials, and residents], that will provide leadership support and buy-in for adoption of Clean Fuel- Clean- Stove (CF-CS) use; (2) Trained MoH community health extension workers, community health officers, community mobilizers and health education officers, who will form community action teams (CAT) to facilitate the implementation of CF-CS use via provision of support, knowledge exchange and performance feedback to the primary cooks in participating households; (3) Community dialogues with residents and households focused on shared concerns on the significance and importance of CF-CS use. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Households Who Have Adopted CF-CS at Baseline | Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits. | Baseline |
| Percent of Households That Have Adopted CF-CS at Month 12 | Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Systolic Blood Pressure From Baseline to Month 12 | Blood pressure readings assessed with a validated automated BP device. At each visit, three readings will be taken by trained research coordinators using an automated BP monitor. The average of three BP readings will be used as the measure for each study visit. | Baseline, Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
• Does not meet the inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Olugbenga Ogedegbe, MD | NYU Langone Health | Principal Investigator |
| Christopher O Olopade | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| NYU Langone Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41513415 | Derived | Onakomaiya DO, Mishra S, Colvin C, Ogunyemi R, Aderibigbe AA, Fagbemi T, Adeniji MR, Li S, Kanneh N, Aifah A, Vedanthan R, Olopade CO, Wright K, Ogedegbe G, Wall SP. Stakeholders' perspectives on implementation of a clean fuel: clean stove intervention for reduction of household air pollution and hypertension in Lagos, Nigeria - a qualitative study. BMJ Open. 2026 Jan 9;16(1):e101218. doi: 10.1136/bmjopen-2025-101218. | |
| 40935430 | Derived |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data. To achieve aims in the approved proposal. Requests should be directed to olugbenga.ogedegbe@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | CM Intervention Group | Cluster. RCT of 16 urban and rural communities. Community mobilizers and health education officers will facilitate use of CF-CS (bioethanol and LPG fuels/stoves) and educate households on HAP exposure throughout the intervention period Community Mobilization: The Community Mobilization (CM) strategy will include: (1) Community advisory board [comprising local community-based organizations, government officials, and residents], that will provide leadership support and buy-in for adoption of Clean Fuel- Clean- Stove (CF-CS) use; (2) Trained MoH community health extension workers, community health officers, community mobilizers and health education officers, who will form community action teams (CAT) to facilitate the implementation of CF-CS use via provision of support, knowledge exchange and performance feedback to the primary cooks in participating households; (3) Community dialogues with residents and households focused on shared concerns on the significance and importance of CF-CS use. |
| FG001 | Self-Directed Group | Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CM Intervention Group | Cluster. RCT of 16 urban and rural communities. Community mobilizers and health education officers will facilitate use of CF-CS (bioethanol and LPG fuels/stoves) and educate households on HAP exposure throughout the intervention period Community Mobilization: The Community Mobilization (CM) strategy will include: (1) Community advisory board [comprising local community-based organizations, government officials, and residents], that will provide leadership support and buy-in for adoption of Clean Fuel- Clean- Stove (CF-CS) use; (2) Trained MoH community health extension workers, community health officers, community mobilizers and health education officers, who will form community action teams (CAT) to facilitate the implementation of CF-CS use via provision of support, knowledge exchange and performance feedback to the primary cooks in participating households; (3) Community dialogues with residents and households focused on shared concerns on the significance and importance of CF-CS use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Households Who Have Adopted CF-CS at Baseline | Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits. | The study enrolled 310 households in the CM group and 314 in the self-directed group; some households were missing data due to iButton damage or data quality issues. | Posted | Number | Percentage of households | Baseline | Households | Households |
|
12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CM Intervention Group | Cluster. RCT of 16 urban and rural communities. Community mobilizers and health education officers will facilitate use of CF-CS (bioethanol and LPG fuels/stoves) and educate households on HAP exposure throughout the intervention period Community Mobilization: The Community Mobilization (CM) strategy will include: (1) Community advisory board [comprising local community-based organizations, government officials, and residents], that will provide leadership support and buy-in for adoption of Clean Fuel- Clean- Stove (CF-CS) use; (2) Trained MoH community health extension workers, community health officers, community mobilizers and health education officers, who will form community action teams (CAT) to facilitate the implementation of CF-CS use via provision of support, knowledge exchange and performance feedback to the primary cooks in participating households; (3) Community dialogues with residents and households focused on shared concerns on the significance and importance of CF-CS use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Old age (death) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olugbenga Ogedegbe, MD | NYU Langone Health | 212-263-4183 | olugbenga.ogedegbe@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2024 | May 4, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2021 | Jul 2, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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|
| Percent of Participants Who Have Adopted CF-CS at Month 24 | Measure of sustainability. Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits. | Month 24 |
| New York |
| New York |
| 10016 |
| United States |
| University of Ibadan | Ibadan | 200001 | Nigeria |
| Lagos State University College of Medicine | Lagos | 101233 | Nigeria |
| Wright O, Olopade CO, Aifah AA, Fagbemi T, Hade EM, Mishra S, Onakomaiya DO, Kanneh N, Chen W, Colvin CL, Ogunyemi R, Sogbossi E, Erinosho E, Ojengbede O, Taiwo O, Johnson MA, Vedanthan R, Wall S, Lwelunmor J, Idris O, Ogedegbe G. Community mobilisation for adoption of clean cookstoves and clean fuel to reduce household air pollution and blood pressure in Lagos, Nigeria: protocol for a cluster-randomised trial. BMJ Open. 2025 Sep 10;15(9):e098483. doi: 10.1136/bmjopen-2024-098483. |
| Relocation |
|
| Dropped out due to personal reasons |
|
| BG001 | Self-Directed Group | Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Self-Directed Group | Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention |
|
|
| Primary | Percent of Households That Have Adopted CF-CS at Month 12 | Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits. | The study enrolled 310 households in the CM group and 314 in the self-directed group; some households were missing data due to iButton damage or data issues, or because they didn't complete the 12-month follow-up visit. | Posted | Number | Percentage of households | Month 12 | Households | Households |
|
|
|
| Secondary | Change in Mean Systolic Blood Pressure From Baseline to Month 12 | Blood pressure readings assessed with a validated automated BP device. At each visit, three readings will be taken by trained research coordinators using an automated BP monitor. The average of three BP readings will be used as the measure for each study visit. | Participants with abnormal BP value were excluded from the analysis. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, Month 12 |
|
|
|
| Secondary | Percent of Participants Who Have Adopted CF-CS at Month 24 | Measure of sustainability. Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits. | Not Posted | Jun 2027 | Month 24 | Participants |
| 9 |
| 620 |
| 9 |
| 620 |
| 0 |
| 620 |
| EG001 | Self-Directed Group | Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention | 14 | 628 | 14 | 628 | 0 | 628 |
| Cardiac arrest (death) | Cardiac disorders | Systematic Assessment |
|
| Unknown reason (death) | General disorders | Systematic Assessment |
|
| Malaria (death) | General disorders | Systematic Assessment |
|
| Stroke (death) | General disorders | Systematic Assessment |
|
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