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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048147
• Other study ID #: 21-00586
• Secondary ID: R01HL157091
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Olugbenga Ogedegbe, MD
• Phone: 212-263-4183
• Email: olugbenga.ogedegbe[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1280
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Exclusion Criteria:

• Does not meet the inclusion criteria

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
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.	Month 24