Clinical trial NCT05048147: Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention
Official title: Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Cardiovascular diseases
Clean cookstove
Clean fuel
Community mobilization
Household air pollution
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-17
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Exclusion Criteria:

• Does not meet the inclusion criteria

Primary outcomes:
measure: Percent of Participants who have Adopted CF-CS at Baseline
timeFrame: Baseline
measure: Percent of Participants who have Adopted CF-CS at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Change in Mean Systolic Blood Pressure from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Percent of Participants who Have Adopted CF-CS at Month 24
timeFrame: Month 24
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Olugbenga Ogedegbe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Christopher O Olopade
role: PRINCIPAL_INVESTIGATOR
References: