Civic Engagement Intervention for Heart Disease Prevention

Recruiting at 16 trial locations

Overseen By Deyaun L Villarreal, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

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

Compensation: Varies

Number of Visits: Unknown

2420 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a community randomized controlled trial to evaluate a civic engagement curriculum through which residents will identify barriers and facilitators to healthy eating and physical activity and then implement a project in their communities.

Research Team

Rebecca A. Seguin-Fowler, PhD

Principal Investigator

Texas A&M AgriLife Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+