Hypertension
Conditions
Keywords
Hypertension, Cardiovascular diseases, Clean cookstove, Clean fuel, Community mobilization, Household air pollution
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.
Interventions
BEHAVIORALCommunity 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.
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Households Who Have Adopted CF-CS at Baseline | 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. |
| Percent of Households That Have Adopted CF-CS at Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Systolic Blood Pressure From Baseline to Month 12 | Baseline, 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. |
| Percent of Participants Who Have Adopted CF-CS at Month 24 | 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. |
Countries
Nigeria, United States
Contacts
PRINCIPAL_INVESTIGATOROlugbenga Ogedegbe, MD
NYU Langone Health
PRINCIPAL_INVESTIGATORChristopher O Olopade
University of Chicago
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 551 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 551 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Nigeria | 1071 participants |
| Sex: Female, Male Female | 707 Participants |
| Sex: Female, Male Male | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 620 | 14 / 628 |
| other Total, other adverse events | 0 / 620 | 0 / 628 |
| serious Total, serious adverse events | 9 / 620 | 14 / 628 |
Outcome results
None listed