Inspire HER: Inspiring the Heart and Emotions for Radical Health

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06966258
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Cardiovascular-kidney-metabolic Syndrome
  • Diabetes
  • Hyperlipidemia
  • Hypertension
  • Kidney Disease
  • Obesity
  • Smoking

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Inspire HER Intervention — BEHAVIORAL
    The Black Impact intervention is an academic-community-government partnership adapted from the Diabetes Prevention Program and American Heart Association Check, Change, Control programs based on stakeholder feedback and to afford incorporation of additional evidence-based strategies for influencing target outcomes. The intervention is a 24-week community-based lifestyle intervention to improve cardiovascular health among Black men. Each participant will be assigned to a group with \>5 participants based on participant proximity to a central community meeting location. Each team will be guided weekly by a health coach who delivers content and coaching around the lifestyle intervention modeled on the diabetes prevention program and check, change, control blood pressure program, a community health worker who helps to address social needs and connects participants to primary care services, and a trainer who leads physical activity. Teams meet for 90 minutes per week.

Study Details

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.

Key Dates

Start date
Nov 15, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Inspire HER Intervention
    Those in the Inspire Her intervention arm will receive the 24-week intervention.
  • No Intervention: Wait-list Control
    Those in the wait-list control arm will receive usual care.

Primary Outcome Measure

Feasibility (Preliminary Effect on PREVENT Score) [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Le'Andrea Anderson, MS
[email protected]
205-996-0089
Timiya S. Nolan, PhD, ANP-BC, FAAN (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Hypertension (high blood pressure)Obesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
University of Alabama at Birmingham· Birmingham, AL

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