Community Mobilization for High Blood Pressure

Recruiting at 1 trial location

Overseen By Christopher O Olopade

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Does not meet inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1280 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Community Mobilization for high blood pressure?

Research shows that community-based programs, like the one involving churches, can help lower high blood pressure by providing education, screenings, and support. These programs have been effective in raising awareness and promoting healthier behaviors, leading to improved blood pressure control, especially in high-risk communities. ^{1 2 3 4 5}

Is community mobilization for high blood pressure safe for humans?

Community mobilization efforts, like public education and community health volunteer programs, are generally considered safe as they focus on lifestyle changes and education to manage high blood pressure. These programs often involve health professionals and community leaders working together to promote healthier living, which is a safe approach for preventing and controlling high blood pressure. ^{6 7 8 9 10}

How does the Community Mobilization treatment for high blood pressure differ from other treatments?

Community Mobilization for high blood pressure is unique because it involves engaging community members and health workers to raise awareness, promote healthy behaviors, and provide culturally sensitive education. This approach focuses on lifestyle changes and community involvement rather than relying solely on medication. ^{3 4 8 11 12}

What is the purpose of this trial?

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.

Research Team

Olugbenga Ogedegbe, MD

Principal Investigator

NYU Langone Health

Christopher O Olopade

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for families in peri-urban Nigerian communities who primarily use kerosene, charcoal, or firewood for cooking. The primary cook must be a female without a paid housemaid, and the household should have 2 to 7 members. The key decision-maker at home must agree to participate and not plan to move within the next year.

Inclusion Criteria

I am a woman who does the cooking in my household.

Must not have a paid housemaid

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

Exclusion Criteria

Does not meet the inclusion criteria

Timeline

Pre-implementation

Exploration and preparation to identify barriers and facilitators of Clean Fuel-Clean Stove use and develop a culturally-tailored community mobilization strategy

Not specified

Implementation

Cluster RCT comparing community mobilization vs. self-directed condition on adoption of Clean Fuel-Clean Stove use and systolic blood pressure reduction

12 months

Multiple household visits for data collection

Post-implementation

Evaluation of the sustainability of the community mobilization strategy vs. self-directed condition on Clean Fuel-Clean Stove use

12 months

Household visits for data collection

Follow-up

Participants are monitored for sustainability of Clean Fuel-Clean Stove use and health outcomes

12 months

Treatment Details

Interventions

• Community Mobilization

Trial Overview The study tests if community mobilization (CM) can increase clean cookstove usage and reduce hypertension compared to just giving information without CM support. It's conducted in three phases: exploring barriers, implementing CM in a randomized trial of 640 households across 32 communities, then checking long-term sustainability.

Participant Groups

Group I: CM Intervention Group Experimental Treatment 1 Intervention

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

Group II: Self-Directed Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A community intervention targeting hypertension in predominantly racial/ethnic minority neighborhoods led to significant blood pressure improvements, especially in individuals with severely elevated blood pressure (≥160/100 mmHg), who saw a reduction from 165.4/98.3 mmHg to 150.4/90.8 mmHg.

After 3 months, 55.2% of participants with severely elevated blood pressure achieved controlled levels, demonstrating the effectiveness of education and empowerment strategies in managing hypertension in high-risk communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. Prendergast, HM., Escobar-Schulz, S., Del Rios, M., et al.[2022]

The American Heart Association's Check. Change. CONTROL (CCC) program, involving 4069 patients across 18 cities, showed that community-based blood pressure interventions can be effectively scaled and customized, leading to significant improvements in blood pressure.

High enrollment and engagement at various sites were linked to successful outcomes, with effective strategies including hypertension education classes, distribution of blood pressure cuffs, and active follow-up with participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program. Anderson, ML., Peragallo Urrutia, R., O'Brien, EC., et al.[2021]

Community-based programs have been effective in raising awareness and promoting healthier behaviors to control high blood pressure, emphasizing partnerships and resident involvement in screening and education.

Utilizing trained community health workers to deliver culturally sensitive education on heart health has been shown to enhance the effectiveness of these programs, potentially leading to better blood pressure management in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. Fulwood, R., Guyton-Krishnan, J., Wallace, M., et al.[2019]

A 12-week program utilizing community involvement and based on social cognitive theory significantly improved self-management strategies among 44 participants with hypertension, leading to increased self-efficacy and health-promoting behaviors.

Participants in the experimental group experienced a notable decrease in diastolic blood pressure after eight weeks, demonstrating the program's effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management improvement program combined with community involvement in Thai hypertensive population: an action research. Srichairattanakull, J., Kaewpan, W., Powattana, A., et al.[2016]

Structured health education for community health workers significantly improved hypertensive patients' knowledge about hypertension, leading to better medication adherence, which increased from 20% to 70%.

The intervention also resulted in a notable improvement in low salt diet compliance among patients, rising from 39% to 85%, while the control group showed no significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention Study for Impact Assessment of Health Education by Empowered Community Health Workers in Improving Treatment and Diet Adherence in Hypertension. Lukitasari, M., Nugroho, DA., Rohman, MS., et al.[2022]

A unified community-based approach to prevent high blood pressure is essential, emphasizing lifestyle changes that are safe and culturally appropriate, which can lead to significant health benefits.

Combining medical strategies with community programs can enhance the effectiveness of hypertension prevention efforts, highlighting the importance of collaboration between health professionals and community leaders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The primary prevention of high blood pressure: a population approach. Blackburn, H., Grimm, R., Luepker, RV., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. [2019]

4. Thailand pubmed.ncbi.nlm.nih.gov

Self-management improvement program combined with community involvement in Thai hypertensive population: an action research. [2016]

5. India pubmed.ncbi.nlm.nih.gov

An Intervention Study for Impact Assessment of Health Education by Empowered Community Health Workers in Improving Treatment and Diet Adherence in Hypertension. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Public education on hypertension: a new initiative to improve the prevention, treatment and control of hypertension in Canada. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The primary prevention of high blood pressure: a population approach. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Community health volunteer for blood pressure control in rural people with stroke in India: Pilot randomised trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

HUB city steps: a 6-month lifestyle intervention improves blood pressure among a primarily African-American community. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Nurse-led empowerment strategies for patients with hypertension: a questionnaire survey. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Adapting hypertension self-management interventions to enhance their sustained effectiveness among urban African Americans. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Understanding low mobilization for non-communicable diseases among people living with NCDs: A qualitative study on hypertension in urban South India. [2022]