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

NCT05048147 | Active Not Recruiting DMC

• 2 other identifiers: 21-00586R01HL157091
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

Hypertension; Cardiovascular diseases; Clean cookstove; Clean fuel; Community mobilization; Household air pollution

Outcome Measures

Primary Outcomes (2)

• Percent of Participants 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 Participants who 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

Secondary Outcomes (2)

• Change in Mean Systolic Blood Pressure from Baseline to Month 12

  Baseline, Month 12

• Percent of Participants who Have Adopted CF-CS at Month 24

  Month 24

Study Arms (2)

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

Behavioral: Community Mobilization

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

Interventions

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.

CM Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 41513415 DERIVED

• 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.

  PMID: 40935430 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Olugbenga Ogedegbe, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Christopher O Olopade

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 17, 2021
• Study Start: April 11, 2023
• Primary Completion: March 26, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: 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.

Locations

US (2)