Culturally-Adapted Intervention for Cardiovascular Health

(MYH Trial)

Overseen By Jada Brooks

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnancy, Heart murmur, Congenital heart disease, Family history of sudden death, Orthopedic limitations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a culturally-adapted program, the Mind Your Heart Intervention, can boost heart health in American Indian women, specifically those identifying as Lumbee Indian. The study will compare two groups: one participating in an 8-week program and a control group that does not. Researchers aim to determine if the program is practical, acceptable, and effective in improving heart health. Suitable participants are women who identify as Lumbee Indian, have heart disease risk factors like being overweight or having high blood pressure, and can attend classes. As an unphased trial, this study offers a unique opportunity to contribute to culturally-tailored health solutions for the Lumbee community.

What prior data suggests that this intervention is safe for American Indian women?

Previous studies on the "Mind Your Heart" program have shown promising safety results. Research indicates that mindfulness-based programs, like this one, are generally easy for people to handle. Participants in similar studies have not reported any major negative effects. Specifically, mindfulness training has been used safely in people with heart failure and other heart-related conditions.

These studies often focus on mental and behavioral changes to improve heart health and have not shown any major side effects or health risks. This suggests that the "Mind Your Heart" program should be safe for participants. While individual experiences can vary, the available evidence supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cardiovascular health focus on medication, lifestyle changes, or surgical interventions. However, the Mind Your Heart Intervention is unique because it offers a culturally-adapted approach to improving heart health. This treatment stands out by integrating cultural relevance into its 8-week program, which may enhance patient engagement and effectiveness. Researchers are excited about its potential to address cardiovascular issues in a more personalized and culturally sensitive manner, which could lead to better adherence and improved outcomes in diverse populations.

What evidence suggests that this intervention might be an effective treatment for cardiovascular health in American Indian women?

Research has shown that mindfulness activities can improve heart health. Studies have found that practices like meditation lower stress and health issues in people with heart disease. Mind-body activities also enhance both physical and mental health in heart patients. Evidence suggests that community-based programs can reduce risk factors like obesity and high blood pressure. In this trial, participants in the Intervention Group will receive the "Mind Your Heart" program, an 8-week culturally-adapted intervention designed to improve heart health. These findings support the potential success of the "Mind Your Heart" program in enhancing heart health. ^{1 6 7 8 9}

Who Is on the Research Team?

Jada Brooks

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for American Indian women who want to improve their heart health. Participants must be able to attend classes and data collection sessions over three months.

Inclusion Criteria

I am a woman aged 18-55 who identifies as Lumbee Indian.

I do not get regular physical activity.

I am willing and able to follow the study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group attend 8 weekly classes as part of a culturally-adapted intervention

8 weeks

8 visits (in-person)

Data Collection

Participants attend 3 data collection sessions over 3 months to measure various health outcomes

3 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in cardiovascular health and other secondary outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mind Your Heart Intervention

Trial Overview

The study tests a culturally-adapted program designed to help American Indian women improve their cardiovascular health. Women are randomly assigned either to take part in the program or be in a control group for comparison.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Intervention Group: 8-week culturally-adapted intervention

Group II: Control Group Active Control 1 Intervention

Control Group: receives no intervention during the study

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10026453/

Mind Your Heart-II: Protocol for a Behavioral Randomized ...

The aims of the Mind Your Heart-II (MYH-II) study are to investigate the effects of MT on HF self-care via changes in cognitive function and interoception.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8227381/

Mindfulness-Based Interventions for Physical and ... - PMC

Efficacy of mindfulness-based stress reduction programme in reducing perceived stress and health complaints in patients with coronary heart disease.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02297737

Mindful Movement Intervention for Post-MI Patients

This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for patients who have recently had a heart attack and are not ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/jaha.117.002218

Meditation and Cardiovascular Risk Reduction

Studies of meditation suggest a possible benefit on cardiovascular risk, although the overall quality and, in some cases, quantity of study data are modest.

5.

journals.lww.com

journals.lww.com/hhmi/fulltext/2024/08040/mindfulness_in_cardiovascular_disease_patients_.11.aspx

Mindfulness in Cardiovascular Disease Patients:...

It is estimated that 46% of people reporting mental health problems are affected from chronic diseases, such as heart conditions, stroke, diabetes, and cancer.

6.

nursing.unc.edu

nursing.unc.edu/projects/mind-your-heart-intervention-for-american-indian-women

Mind Your Heart Intervention for American Indian Women

Dr. Brooks' research study “Mind Your Heart” is adapting and testing a culturally tailored cardiovascular health promotion intervention designed to prevent ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03571581

Study Details | NCT03571581 | Mind Your Heart Study

This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF).

8.

brownhealth.org

brownhealth.org/centers-services/cardiovascular-institute/cardiovascular-research/cardiovascular-institute-current

Mind Your Heart Study II

This study looks at whether mindfulness training improves medication adherence in adults with heart failure.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11145560/

Mindfulness-Based Interventions for Patients with ... - PMC - NIH

In this clinician-focused review, we aim to revisit empirical studies on MBIs for CVD with the purpose of informing clinicians' decisions on how to provide ...