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

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05048147
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
640
2
2
39
320
8.2

Study Details

Study Description

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 University of Ibadan working with the MOH will oversee research coordination in Nigeria.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Community Mobilization
N/A

Detailed Description

This study will use CM to engage in the community dialogues, organize outreach facilitation, and advocacy for the adoption of bioethanol-based CF-CS across participating households. The choice of CM strategy is deliberate because, unlike western culture, African cultures are largely based on communal hierarchy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM Intervention Group

Cluster. RCT of 16 urban and rural communities. CHEWs will facilitate use of CF-CS and educate households on HAP exposure throughout the intervention period

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 (CHEWs), 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.

No Intervention: Self-Directed Group

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

Outcome Measures

Primary Outcome Measures

  1. Adoption of CF-CS use at 12 months period [Baseline study visit]

    Adoption of CF-CS use will be higher in communities randomized to CM than those in the self directed communities at 12 months. Adoption is 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 across the 12month intervention period. Trained study staff will collect iButtons temperature data every 2 weeks during 2month assessment windows at baseline, 6 months, and 12 months

  2. Adoption of CF-CS use at 12 months [6 months study visit]

    Adoption of CF-CS use will be higher in communities randomized to CM than those in the self directed communities at 12 months. Adoption is 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 across the 12month intervention period. Trained study staff will collect iButtons temperature data every 2 weeks during 2month assessment windows at baseline, 6 months, and 12 months

  3. Adoption of CF-CS use at 12 months [12 months study visit]

    Adoption of CF-CS use will be higher in communities randomized to CM than those in the self directed communities at 12 months. Adoption is 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 across the 12month intervention period. Trained study staff will collect iButtons temperature data every 2 weeks during 2month assessment windows at baseline, 6 months, and 12 months

Secondary Outcome Measures

  1. Change in Mean systolic Blood Pressure reduction at 12 months [Baseline study visit, 6- month study visit and 12-month study visit]

    Mean systolic BP will be lower in the households of communities randomized to CM than those in self-directed communities at 12 months. It will be assessed as the mean change in systolic BP from baseline to 12 months between the CM intervention group and the self-directed group. BP readings will be assessed with a validated automated BP device.BP measurements: Three readings will be taken by trained research coordinators using an automated BP monitor with the participant seated comfortably for 5 minutes prior to the measurements, following the American Heart Association guidelines. The average of three BP readings will be used as the measure for each study visit. The same procedure will be followed at baseline, 6- and 12-month study visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Primary adult must be a female cook;

  • Be married or have a stable relationship;

  • Must not have a paid housemaid;

  • Family size must be a minimum of 2 and no more than 7 members;

  • The apartment rented or owned must have 4 rooms separated by walls;

  • Family must use Kerosene, charcoal or firewood as primary cooking fuel;

  • The kitchen must be separate or shared within the house or outside the house;

  • The person spoken to at enrollment must be the home key decision maker;

  • Must not cook or sell food for profession; and

  • Must have no plans for relocation in the next year.

Exclusion Criteria:
  • Does not meet the inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637
2 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Olugbenga Ogedegbe, MD, NYU Langone Health
  • Principal Investigator: Christopher O Olopade, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05048147
Other Study ID Numbers:
  • 21-00586
  • R01HL157091
First Posted:
Sep 17, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022