Inspire HER for Cardiovascular Disease

Overseen By LeAndrea D Anderson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Physical activity limitations

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Poor heart health puts Black women at risk for a shorter life with more illness than people of any other non-indigenous racial group. We will refine and conduct a randomized, wait-list controlled trial of Inspire HER (a heart health lifestyle intervention for Black women that provides health education, physical activity, and social resources). We will also compare Inspire HER and Black Impact (a heart health intervention for Black men) data to study how women and men respond differently to stress. This trial aligns with American Heart Association's pledge to address heart health equity through new interventions that consider the person and the circumstances with which they live.

Who Is on the Research Team?

Timiya S Nolan, PhD

Principal Investigator

University to Alabama at Birmingha

Are You a Good Fit for This Trial?

This trial is for Black women at risk of heart-related issues like high blood pressure, diabetes, and obesity. Participants should be interested in improving their lifestyle through health education and physical activity. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

English speaking

Lives in Metropolitan Birmingham, AL area.

I am a Black woman.

Exclusion Criteria

My doctor has restricted my physical activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Inspire HER intervention, which includes health education, physical activity, and social resources

24 weeks

Regular visits for intervention activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inspire HER

Trial Overview The Inspire HER intervention is being tested to see if it can improve heart health in Black women by providing health education, promoting physical activity, and offering social support. The study will also compare results with a similar program for Black men.

How Is the Trial Designed?

Group I: Inspire HER Intervention Experimental Treatment 1 Intervention

Those in the Inspire Her intervention arm will receive the 24-week intervention.

Group II: Wait-list Control Active Control 1 Intervention

Those in the wait-list control arm will receive usual care.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Tuskegee University

Collaborator

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+