Inspire HER: Inspiring the Heart and Emotions for Radical Health

NCT06966258 | Recruiting

• 2 other identifiers: IRB-30001463125SFRNPCKMS1468507
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

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

Keywords

Cardiovascular Risk; Lifestyle intervention

Outcome Measures

Primary Outcomes (5)

• Feasibility (Preliminary Effect on PREVENT Score)

  The primary outcome for the randomized controlled trial is change in cardiovascular risk as defined by PREVENT Score (a 10-year risk estimator of cardiovascular events for individuals 30-79 years of age; measure utilizes sex, age, cholesterol blood pressure, body mass index, glomerular filtration rate, diabetes, smoking status, anti-hypertensive medication, lipid-lowering medication, urine creatinine, hemoglobin A1C, and social deprivation index). PREVENT score ranges from low (\<5%) to high (\>20%) risk with low risk being better. Linear mixed effects models with random intercepts will evaluate the change from baseline to 24 weeks in primary (PREVENT score). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. We will also evaluate qualitative exit (focus group) survey data to understand perceived effect.

  24 weeks

• Feasibility (Demand or Use of Intervention)

  Demand will be assessed by percent recruited of number contacted, participant self-rating of participation, percent using information at home. These data will be obtained from study records and exit survey (focus group) responses.

  24 weeks

• Feasibility (Acceptability or Participant Reaction to Intervention)

  Acceptability will be assessed by participant satisfaction with the intervention and participant attendance, perceptions of usefulness, and plans/real change of behavior to apply health promotion strategies. These data will be obtained by study records and exit (focus group) surveys.

  24 weeks

• Feasibility (Implementation or Intervention FIdelity)

  Implementation will be assessed using the Inspire HER curriculum and participant opinions of how the intervention was administered. These data will be obtained via study records and exit (focus group) surveys.

  24 weeks

• Feasibility (Practicality or Efficiency of Resource Allocation)

  Practicality will be assessed using intervention cost per participant and identifying any revenue/savings. These data will be obtained by evaluating grant budgetary documentation.

  24 weeks

Secondary Outcomes (4)

• Dose-Response on Preliminary Effect

  24 weeks

• Change in Conserved Transcriptional Response to Adversity

  24 weeks

• Change in 12,13-diHOME Expression and Associations with Biomarkers

  24 weeks

• Mechanistic transcriptomic stress and inflammatory response to Inspire HER in Black women as compared to Black men in Black Impact:

  24 weeks

Study Arms (2)

Inspire HER Intervention

EXPERIMENTAL

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

Behavioral: Inspire HER Intervention

Wait-list Control

NO INTERVENTION

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

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.

Inspire HER Intervention

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Healthcare provider-imposed physical activity limitations.

Sponsors & Collaborators

• Tuskegee University: collaborator
• University of Alabama at Birmingham: lead
• American Heart Association: collaborator
• Ohio State University: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Hyperlipidemias; Kidney Diseases; Obesity; Smoking

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Timiya S Nolan, PhD

  University to Alabama at Birmingha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeAndrea D Anderson

CONTACT

205-996-0089; leandreaanderson@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyst is blinded to the intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, wait-list controlled trial

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 3/31/2025; available without end date
• Access Criteria: Inspire HER will generate primary qualitative and quantitative data. Qualitative data will be derived from focus group interviews with participants and partners of the Inspire HER intervention. To facilitate data interpretation, documentation files (txt files) such as a data dictionary, interview and survey questionnaires, informed consent script and study protocol will be made publicly available via Dryad. Quantitative data will be derived from participants' survey responses about cardiometabolic and social health. We will produce data management and analytic files (CSV files) that will be posted on GitHub. Because of the sensitive nature of community-based research, policies and guidelines will require having a faculty member with expertise in health equity research, IRB approval, and a community partner to help interpret findings and create/enact a dissemination plan.

Locations

US (1)