Clinical trial NCT06966258: Inspire HER: Inspiring the Heart and Emotions for Radical Health
Official title: Inspire HER: Inspiring the Heart and Emotions for Radical Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular-kidney-metabolic Syndrome
Cardiovascular Diseases
Hypertension
Diabetes
Hyperlipidemia
Kidney Disease
Obesity
Smoking
Keywords: Cardiovascular Risk
Lifestyle intervention
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Ohio State University
name: Tuskegee University
First posted: 2025-05-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, wait-list controlled trial
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (Preliminary Effect on PREVENT Score)
timeFrame: 24 weeks
measure: Feasibility (Demand or Use of Intervention)
timeFrame: 24 weeks
measure: Feasibility (Acceptability or Participant Reaction to Intervention)
timeFrame: 24 weeks
measure: Feasibility (Implementation or Intervention FIdelity)
timeFrame: 24 weeks
measure: Feasibility (Practicality or Efficiency of Resource Allocation)
timeFrame: 24 weeks
Secondary outcomes:
measure: Dose-Response on Preliminary Effect
timeFrame: 24 weeks
measure: Change in Conserved Transcriptional Response to Adversity
timeFrame: 24 weeks
measure: Change in 12,13-diHOME Expression and Associations with Biomarkers
timeFrame: 24 weeks
measure: Mechanistic transcriptomic stress and inflammatory response to Inspire HER in Black women as compared to Black men in Black Impact:
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University to Alabama at Birmingha
name: Timiya S Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.