Recruiting

Inspire HER & Black Impact

Sponsor:

University of Alabama at Birmingham

Code:

NCT06966258

Conditions

Cardiovascular-kidney-metabolic Syndrome

Cardiovascular Diseases

Hypertension

Diabetes

Hyperlipidemia

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Inspire HER Intervention

Study Details

Brief summary:

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.

Conditions

Cardiovascular-kidney-metabolic Syndrome

Cardiovascular Diseases

Hypertension

Diabetes

Hyperlipidemia

Study ID

NCT06966258

Start date

Nov 15, 2025

Status verified date

Dec, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Black women (self-report)
  • Adult ages 30-79 years
  • Stage 2 or greater Cardiovascular-Kidney-Metabolic Syndrome
  • English speaking
  • Lives in Metropolitan Birmingham, AL area.

Exclusion Criteria:

\- Healthcare provider-imposed physical activity limitations.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Inspire HER Intervention

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.

Primary outcome measure

  • Feasibility (Preliminary Effect on PREVENT Score) [ Time Frame: 24 weeks ]
  • Feasibility (Demand or Use of Intervention) [ Time Frame: 24 weeks ]
  • Feasibility (Acceptability or Participant Reaction to Intervention) [ Time Frame: 24 weeks ]
  • Feasibility (Implementation or Intervention FIdelity) [ Time Frame: 24 weeks ]
  • Feasibility (Practicality or Efficiency of Resource Allocation) [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

LeAndrea D Anderson

205-996-0089leandreaanderson@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Le'Andrea Anderson, MS

205-996-0089leandreaanderson@uabmc.edu

Principal Investigator:

Timiya S. Nolan, PhD, ANP-BC, FAAN

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • Cardiovascular Risk
  • Lifestyle intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-29.