Inspire HER: Inspiring the Heart and Emotions for Radical Health

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Feasibility (Preliminary Effect on PREVENT Score) [Срок оценки: 24 weeks]
• Feasibility (Demand or Use of Intervention) [Срок оценки: 24 weeks]
• Feasibility (Acceptability or Participant Reaction to Intervention) [Срок оценки: 24 weeks]
• Feasibility (Implementation or Intervention FIdelity) [Срок оценки: 24 weeks]
• Feasibility (Practicality or Efficiency of Resource Allocation) [Срок оценки: 24 weeks]

Вторичные конечные точки (4)

• Dose-Response on Preliminary Effect [Срок оценки: 24 weeks]
• Change in Conserved Transcriptional Response to Adversity [Срок оценки: 24 weeks]
• Change in 12,13-diHOME Expression and Associations with Biomarkers [Срок оценки: 24 weeks]
• Mechanistic transcriptomic stress and inflammatory response to Inspire HER in Black women as compared to Black men in Black Impact: [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

\- Healthcare provider-imposed physical activity limitations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Alabama at Birmingham — Birmingham

Публикации

• 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

Идентификаторы

NCT: NCT06966258 · IRB-300014631 · 25SFRNPCKMS1468507

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗