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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
CCM: Be willing to be randomized to either group
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am between 18 and 99 years old.
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I am open to being assigned to any treatment group.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
139 Previous Clinical Trials
21,084 Total Patients Enrolled
Cornell UniversityOTHER
166 Previous Clinical Trials
14,087,029 Total Patients Enrolled
Tufts UniversityOTHER
264 Previous Clinical Trials
659,013 Total Patients Enrolled

Media Library

Group 1 (Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05002660 — N/A
Heart Disease Research Study Groups: Group 1 (Intervention), Group 2 (Control)
Heart Disease Clinical Trial 2023: Group 1 (Intervention) Highlights & Side Effects. Trial Name: NCT05002660 — N/A
Group 1 (Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002660 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period of this clinical trial still open?

"The analysis hosted on clinicaltrials.gov reveals that the trial is actively recruiting participants since its inception on October 31st 2022, and was last updated July 6th of this year."

Answered by AI

Are there multiple venues conducting this clinical experiment in the city?

"16 sites are currently running this medical trial, which include Plainview in Plainview, Mexia in Mexia, Camden in Camden and a multitude of other locations."

Answered by AI

What is the maximum capacity of participants for this experiment?

"Affirmative, the information on clinicaltrials.gov verifies that this trial is currently enrolling participants. It was initially posted on October 31st 2022 and was recently revised on July 6th 2022. A total of 2260 people are being sought from 16 different medical facilities."

Answered by AI

What are the fundamental aims of this medical trial?

"The primary evaluation of the study, extending from Baseline to 24 months will be a shift in Simple 7 cardiovascular health score. Other secondary outcomes include changes in social support for healthy eating scale (Ball Social Support Scale with 1-5 scores), diastolic and systolic blood pressure respectively."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
California
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Groveton
Mexia
Watertown
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~1887 spots leftby Jun 2026