Inspire HER: Inspiring the Heart and Emotions for Radical Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inspire HER Intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular-kidney-metabolic Syndrome, Cardiovascular Diseases, Hypertension, Diabetes. Basic parameters: 30 years — 79 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral 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 participan
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Dose-Response on Preliminary Effect [Time frame: 24 weeks]
- Change in Conserved Transcriptional Response to Adversity [Time frame: 24 weeks]
- Change in 12,13-diHOME Expression and Associations with Biomarkers [Time frame: 24 weeks]
- Mechanistic transcriptomic stress and inflammatory response to Inspire HER in Black women as compared to Black men in Black Impact: [Time frame: 24 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Publications
- 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. PMID 35146467
Identifiers
NCT: NCT06966258 · IRB-300014631 · 25SFRNPCKMS1468507