Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention

NCT ID: NCT05048147

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Community Mobilization

Intervention Type: 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.

Self-Directed Group

Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primary adult must be a female cook;
• Must not have a paid housemaid;
• Family size must be a minimum of 2 and no more than 7 members;
• Family must use Kerosene, charcoal, LPG, or firewood as primary cooking fuel;
• The person spoken to at enrollment must be the home key decision maker;
• Must have no plans for relocation in the next year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olugbenga Ogedegbe, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Christopher O Olopade

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40935430 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HL157091

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-00586

Identifier Type: -

Identifier Source: org_study_id