← Back to Search

Civic Engagement Intervention for Heart Disease Prevention

N/A

Waitlist Available

Led By Rebecca A. Seguin-Fowler, PhD

Research Sponsored by Texas A&M University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-99

Be older than 18 years old

Must not have

Inability to communicate due to severe, uncorrectable hearing loss or speech disorder (if it precludes completion of assessments and/or intervention)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a civic engagement curriculum to see if it helps residents identify and implement projects to improve healthy eating and physical activity in their communities.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational activities rather than medical treatments, traditional side effects are not expected. However, participants may experience stress or frustration related to project planning and implementation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 99 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot communicate effectively due to severe hearing loss or speech issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score

Secondary study objectives

Change in (community) social cohesion

Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score

Change in alcohol consumption

+33 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (Control)Experimental Treatment1 Intervention

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

Group II: Group 1 (Intervention)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Group 1 (Intervention)

2017

N/A

~190

0 / 2Eligibility criteria met