Civic Engagement Intervention for Heart Disease Prevention

Not currently recruiting at 16 trial locations

Overseen By Deyaun L Villarreal, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: Cognitive impairment, Severe visual impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how community involvement can help prevent heart disease by promoting healthy eating and physical activity. Participants in the intervention group will join a Change Club to identify obstacles and solutions for a healthier lifestyle and work on community projects. The other group will not participate in any activities during the study. People living in certain towns in NY and TX, who speak English, and struggle with meeting physical activity guidelines may be a good fit. As an unphased study, this trial offers a unique opportunity to contribute to community health improvements and personal wellness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on community engagement rather than medication changes.

What prior data suggests that this civic engagement intervention is safe for heart disease prevention?

Research shows that involvement in community activities, such as joining local groups, positively impacts health and well-being. Studies have found that participating in these activities can enhance overall health, including heart health.

Specific safety data is unnecessary for this type of activity because it doesn't involve medication or medical procedures. Instead, it emphasizes social engagement and community participation. These activities are generally safe and not known to cause harm.

Overall, participating in community activities as part of this study is expected to be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel, community-based approach to preventing heart disease. Unlike traditional treatments that focus on medication or lifestyle changes on an individual level, this intervention leverages civic engagement by involving Change Club members in community improvement projects, aiming to create healthier environments. This method could not only inspire broader participation and support within communities but also foster sustainable changes that benefit public health on a larger scale. The hope is to see if these community-driven efforts can effectively reduce heart disease risk factors more than typical individual-based interventions.

What evidence suggests that this civic engagement intervention is effective for heart disease prevention?

This trial will compare a civic engagement intervention with a control group to assess its impact on heart disease prevention. Research has shown that community programs can help people learn more about heart disease and adopt healthier habits, such as eating better and exercising more. For instance, one study found that these programs greatly increased people's understanding of heart disease and its risk factors. Another study showed that programs outside of traditional healthcare settings can improve public health and make health outcomes more equal. Evidence also suggests that when community members participate in health projects, it can lead to better health results. Overall, these programs have been successful in promoting healthier lifestyles and improving heart health. ^{4 5 6 7 8}

Who Is on the Research Team?

Rebecca A. Seguin-Fowler, PhD

Principal Investigator

Texas A&M AgriLife Research

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-99 living in designated towns in NY and TX, who score poorly on health behaviors like physical activity. It's open to Change Club members, their friends and family, and community residents. People with cognitive impairments or severe sensory disabilities that prevent participation are excluded.

Inclusion Criteria

CCM: Live in one of the designated towns in NY and TX

FFM: Be family members or friends identified by a CCM

I am willing to be assigned to any treatment group by chance.

Exclusion Criteria

I do not have any cognitive issues that would stop me from completing study tasks.

I do not have severe vision problems that would stop me from completing study tasks.

Inability to read (as it precludes completion of assessments and/or intervention)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Change Club members participate in meetings and implement community environment changes

24 months

Regular meetings

Follow-up

Participants are monitored for changes in health outcomes and community engagement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Group 1 (Intervention)
• Group 2 (Control)

Trial Overview The study tests a civic engagement curriculum aimed at improving healthy eating and physical activity by having participants identify local barriers, then work on a project to address them. Participants will be randomly assigned to either the intervention group or a control group.

How Is the Trial Designed?

Group I: Group 2 (Control) Experimental Treatment 1 Intervention

Control group participants will participate in no intervention activities during the 3-year research study.

Group II: Group 1 (Intervention) Experimental Treatment 1 Intervention

For Change Club members (CCM) only: CCM will participate in meetings of the Change Club and continue implementation of a change to the community environment for up to an additional 24 months. Change Club members will also be asked to recruit 10 or more friends and family members (FFM) to participate in the research study. In addition, 100 community residents (CR) will be recruited into the study. Family members, friends and community residents do not participate in the Change Club, but may hear about Change Club activities in their community.

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Tufts University

Collaborator

Trials

271

Recruited

595,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8386815/

Community-Based Interventions for Cardiovascular Disease ... Community-based interventions successfully improved population knowledge on CVD and risk factors and influenced physical activity and dietary practices.

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001349

Implementation of Evidence-Based Behavioral ... Extending cardiovascular disease prevention beyond health care settings is needed to improve population health and to advance health equity.

3. heart.org heart.org/en/-/media/Files/About-Us/Policy-Research/Policy-Positions/Public-Health-Advocacy/Civic-Engagement-and-Population-Health.pdf?sc_lang=en

Civic Engagement and Population Health Policy Statement ... This policy statement outlines evidence regarding the efficacy of civic engagement in improving health outcomes, priorities for the American Heart Association's.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666667722000253

Type and effectiveness of community-based interventions ... Overall, most studies showed that CBIs significantly improved knowledge related to CVDs. Conclusion: Community-based CVD preventive interventions are effective ...

5. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-024-01670-y

Process evaluation findings from Strong Hearts, Healthy ... SHHC-2.0 was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8588761/

An Important Social Determinant of Cardiovascular Disease Existing evidence demonstrates a protective effect of social support, social cohesion, and community engagement on overall health and wellbeing.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772487525001680

Design and Rationale of the Community-led Initiative on ... This community-led initiative to reduce CVD risk among older Black adults in underserved areas of Baltimore uses a quasi-experimental design ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5777283/

A National Heart, Lung, and Blood Institute Workshop Report Reducing cardiovascular disparities through community-engaged implementation research: A National Heart, Lung, and Blood Institute workshop report.