Inspire HER: Heart Health for Black Women
This study, called Inspire HER, is for Black women aged 30-79 who live in the Birmingham, AL area and have stage 2 or greater Cardiovascular-Kidney-Metabolic Syndrome (a group of conditions that increase your risk of heart disease, stroke, and type 2 diabetes). It aims to improve heart health through a lifestyle program that includes health education, physical activity, and social resources. The study will compare the Inspire HER program to usual care. Researchers want to see if Inspire HER is practical, if people use it, and if they like it. The study is currently unclear on its recruitment status and plans to enroll 90 participants.
- Study design
- This is an interventional study that plans to enroll 90 women. It is a randomized, wait-list controlled trial.
- What's involved
- The study involves participating in the Inspire HER program for 24 weeks. Specific details about visits or procedures are not specified.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study are measured at 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Inspire HER: Inspiring the Heart and Emotions for Radical Health
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Timiya S Nolan, PhD · PRINCIPAL_INVESTIGATOR · University to Alabama at Birmingha
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Feasibility (Preliminary Effect on PREVENT Score)24 weeks
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.
- Feasibility (Demand or Use of Intervention)24 weeks
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.
- Feasibility (Acceptability or Participant Reaction to Intervention)24 weeks
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.
- Feasibility (Implementation or Intervention FIdelity)24 weeks
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.
- Feasibility (Practicality or Efficiency of Resource Allocation)24 weeks
Practicality will be assessed using intervention cost per participant and identifying any revenue/savings. These data will be obtained by evaluating grant budgetary documentation.