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Inspire HER: Inspiring the Heart and Emotions for Radical Health

NCT ID: NCT06966258

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Poor heart health puts Black women at risk for a shorter life with more illness than people of any other non-indigenous racial group. Yet, few studies have focused on improving heart health in Black women. Our team built and studied a 24-week program called Black Impact for Black men with less than ideal heart health. Black Impact provides 45 minutes of exercise and 45 minutes of healthy diet education and connects Black men with a health coach, fitness trainer, and community health worker. In the first study of Black Impact, Black men (n=74) had improved heart health equal to a 19% lower risk of death from heart disease. These men also reported less stress, improvement in being able to control their health, and fewer unmet social needs. Now, a study of Black Impact in 340 Black men is ongoing to understand how Black Impact works with respect to stress and heart health. Black women have reported a need for a similar heart health program. Based on feedback from Black women (n=56), we adapted Black Impact for Black women (Inspire HER). Thus, we propose to refine the Inspire HER program for Black women. Then, we will do a clinical trial of Inspire HER compared to routine living (usual care) in Black women with elevated heart health risk. We will find out if the Inspire HER program reduces heart health risk more than usual care. We will also assess how the Inspire HER program "gets under the skin" to affect the body's response to stress. Lastly, we will compare the response to stress between women of Inspire HER and men of Black Impact. Importantly, we expect this study will show promising improvements in heart health and risk. This Inspire HER trial will lay the foundation for larger future studies. Inspire HER, comparing data from Black Impact, may also help us understand how women and men in heart health programs 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

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

Keywords

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Cardiovascular Risk Lifestyle intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, wait-list controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The statistical analyst is blinded to the intervention group.

Study Groups

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Inspire HER Intervention

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

Group Type EXPERIMENTAL

Inspire HER Intervention

Intervention Type 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.

Wait-list Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Tuskegee University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Timiya Nolan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timiya S Nolan, PhD

Role: PRINCIPAL_INVESTIGATOR

University to Alabama at Birmingha

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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LeAndrea D Anderson

Role: CONTACT

Phone: 205-996-0089

Email: [email protected]

Facility Contacts

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Le'Andrea Anderson, MS

Role: primary

References

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Joseph JJ, Nolan TS, Williams A, McKoy A, Zhao S, Aboagye-Mensah E, Kluwe B, Odei JB, Brock G, Lavender D, Gregory J, Gray DM 2nd. Improving cardiovascular health in black men through a 24-week community-based team lifestyle change intervention: The black impact pilot study. Am J Prev Cardiol. 2022 Jan 13;9:100315. doi: 10.1016/j.ajpc.2022.100315. eCollection 2022 Mar.

Reference Type BACKGROUND
PMID: 35146467 (View on PubMed)

Other Identifiers

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25SFRNPCKMS1468507

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300014631

Identifier Type: -

Identifier Source: org_study_id