search
Back to results

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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Mobilization
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Hypertension, Cardiovascular diseases, Clean cookstove, Clean fuel, Community mobilization, Household air pollution

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ChicagoRecruiting
  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CM Intervention Group

Self-Directed Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 1, 2021
Last Updated
May 1, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05048147
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Cardiovascular diseases, Clean cookstove, Clean fuel, Community mobilization, Household air pollution

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CM Intervention Group
Arm Type
Experimental
Arm Description
Cluster. RCT of 16 urban and rural communities. Community mobilizers and health education officers will facilitate use of CF-CS and educate households on HAP exposure throughout the intervention period
Arm Title
Self-Directed Group
Arm Type
No Intervention
Arm Description
Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention
Intervention Type
Behavioral
Intervention Name(s)
Community Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Participants who have Adopted CF-CS at Baseline
Description
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.
Time Frame
Baseline
Title
Percent of Participants who have Adopted CF-CS at Month 12
Description
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.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Change in Mean Systolic Blood Pressure from Baseline to Month 12
Description
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.
Time Frame
Baseline, Month 12
Title
Percent of Participants who Have Adopted CF-CS at Month 24
Description
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.
Time Frame
Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olugbenga Ogedegbe, MD
Phone
212-263-4183
Email
olugbenga.ogedegbe@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lloyd Gyamfi
Phone
646-501-3469
Email
Lloyd.Gyamfi@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olugbenga Ogedegbe, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher O Olopade
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher O Olopade
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olugbenga Ogedegbe, MD
Phone
212-263-4183
Email
olugbenga.ogedegbe@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs