Trial Outcomes & Findings for Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention (NCT NCT05048147)
NCT ID: NCT05048147
Last Updated: 2026-06-30
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1280 participants
Primary outcome timeframe
Baseline
Results posted on
2026-06-30
Participant Flow
Unit of analysis: Communities
Participant milestones
| Measure |
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.
|
Self-Directed Group
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
|---|---|---|
|
Overall Study
STARTED
|
620 16
|
628 16
|
|
Overall Study
COMPLETED
|
520 16
|
551 16
|
|
Overall Study
NOT COMPLETED
|
100 0
|
77 0
|
Reasons for withdrawal
| Measure |
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.
|
Self-Directed Group
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
14
|
|
Overall Study
Lost to Follow-up
|
26
|
12
|
|
Overall Study
Relocation
|
44
|
44
|
|
Overall Study
Dropped out due to personal reasons
|
21
|
7
|
Baseline Characteristics
Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention
Baseline characteristics by cohort
| Measure |
CM Intervention Group
n=520 Participants
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.
|
Self-Directed Group
n=551 Participants
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
Total
n=1071 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.0 years
n=20 Participants
|
40.0 years
n=20 Participants
|
40.0 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
335 Participants
n=20 Participants
|
372 Participants
n=20 Participants
|
707 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=20 Participants
|
179 Participants
n=20 Participants
|
364 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
520 Participants
n=20 Participants
|
551 Participants
n=20 Participants
|
1071 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
520 Participants
n=20 Participants
|
551 Participants
n=20 Participants
|
1071 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Nigeria
|
520 participants
n=20 Participants
|
551 participants
n=20 Participants
|
1071 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
CM Intervention Group
n=291 Households
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.
|
Self-Directed Group
n=303 Households
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
|---|---|---|
|
Percent of Households Who Have Adopted CF-CS at Baseline
|
58.4 Percentage of households
|
61.6 Percentage of households
|
PRIMARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
CM Intervention Group
n=228 Households
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.
|
Self-Directed Group
n=246 Households
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
|---|---|---|
|
Percent of Households That Have Adopted CF-CS at Month 12
|
77.0 Percentage of households
|
82.7 Percentage of households
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Participants with abnormal BP value were excluded from the analysis.
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.
Outcome measures
| Measure |
CM Intervention Group
n=513 Participants
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.
|
Self-Directed Group
n=546 Participants
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
|---|---|---|
|
Change in Mean Systolic Blood Pressure From Baseline to Month 12
|
5.5 mmHg
Interval 1.9 to 9.09
|
5.82 mmHg
Interval 3.56 to 8.08
|
SECONDARY outcome
Timeframe: Month 24Measure 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.
Outcome measures
Outcome data not reported
Adverse Events
CM Intervention Group
Serious events: 9 serious events
Other events: 0 other events
Deaths: 9 deaths
Self-Directed Group
Serious events: 14 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
CM Intervention Group
n=620 participants at risk
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.
|
Self-Directed Group
n=628 participants at risk
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
|
|---|---|---|
|
General disorders
Old age (death)
|
0.48%
3/620 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
0.48%
3/628 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
|
Cardiac disorders
Cardiac arrest (death)
|
0.00%
0/620 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
0.32%
2/628 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
|
General disorders
Unknown reason (death)
|
0.97%
6/620 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
1.1%
7/628 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
|
General disorders
Malaria (death)
|
0.00%
0/620 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
0.16%
1/628 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
|
General disorders
Stroke (death)
|
0.00%
0/620 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
0.16%
1/628 • 12 months
AE and SAE were assessed by study coordinator during regular follow-up visit and were monitored by site investigator.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place