Nutrition and Exercise Education for Heart Disease

Overseen By Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Weight loss medication

Disqualifiers: Pregnancy, Substance use, Diabetes, others

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

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special nutrition and exercise program, called Nutrition and Exercise Education (NEEW), can help African-American women improve heart health by teaching skills such as mindfulness and stress management. Participants will attend regular sessions over 14 months, focusing on healthy eating and staying active. The trial seeks African-American women who exercise less than 150 minutes weekly and have specific heart health risk factors, such as a history of gestational diabetes or a family history of high blood pressure. African-American women meeting these criteria and able to attend sessions may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to important research that could benefit the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators.

What prior data suggests that this nutrition and exercise intervention is safe for African-American women?

Research has shown that nutrition and exercise programs are generally safe and well-received by participants. The study under consideration includes a special program designed for African-American women, focusing on improving healthy habits through exercise and nutrition education.

No specific negative effects have been reported for this type of program. These programs typically emphasize lifestyle changes rather than medication or medical devices, making them low-risk. Participants often experience benefits such as increased health awareness and improved fitness.

Prospective participants should consult their doctor to determine how this program might fit into their overall health plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Exercise Education Workgroup (NEEW) because it offers a holistic approach to managing heart disease, emphasizing lifestyle changes over medication. Unlike traditional treatments that primarily rely on drugs or surgical interventions, NEEW focuses on educating participants about nutrition and exercise, empowering them to make sustainable, healthy lifestyle choices. This approach not only targets heart health but also promotes overall well-being, which can lead to lasting benefits beyond the scope of conventional treatments.

What evidence suggests that this trial's treatments could be effective for heart disease?

Research has shown that changes in diet and exercise can improve heart health. For African-American women, culturally tailored programs may lead to better exercise routines and healthier eating habits. These programs enhance mindfulness, manage stress, and build self-confidence, all crucial for maintaining health. In this trial, participants may receive either the Nutrition and Exercise Education Workgroup (NEEW) or the HARMONY component. Specifically, the HARMONY component improved heart function and quality of life. These findings suggest that specific lifestyle changes can effectively manage risk factors for heart disease. ^{1 2 5 6 7}

Who Is on the Research Team?

Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN

Principal Investigator

The University of North Carolina at Chapel Hill, School of Nursing

Are You a Good Fit for This Trial?

This trial is for African American women over 18 with a BMI of 25-39, who exercise less than 150 minutes per week and have at least one cardiometabolic risk factor like high blood pressure or prediabetes. Participants must not be diabetic, pregnant, on weight loss medication, or engaged in another similar program recently.

Inclusion Criteria

I am an African American or Black woman.

You don't exercise for at least 150 minutes a week.

My parent or sibling has prediabetes or diabetes.

Exclusion Criteria

You have a substance use, mental health, or medical condition that would make it hard for you to take part in the study.

I am currently taking medication to help me lose weight.

Pregnant/anticipated pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a culturally-tailored nutrition and exercise intervention designed to manage stress and reduce cardiometabolic risk

4 months

8 regular sessions

Booster Sessions

Participants attend monthly booster sessions to reinforce intervention strategies

6 months

6 monthly sessions

Follow-up

Participants are monitored for changes in cardiometabolic risk factors and lifestyle behaviors

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HARMONY
• Nutrition and Exercise Education (NEEW)

Trial Overview The HARMONY study tests if a nutrition and exercise program tailored for African-American women can improve their health by teaching better stress management, self-regulation, and eating habits to reduce risks of heart disease and diabetes.

How Is the Trial Designed?

Group I: HARMONY Experimental Treatment 1 Intervention

Following screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months.

Group II: Nutrition and Exercise Education Workgroup (NEEW) Active Control 1 Intervention

Following screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015196

Midterm Outcomes in a Pooled Cohort of Harmony ... At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life.

2. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2018/10/09/09/49/Harmony-Outcomes

Harmony Outcomes - Harmony Outcomes The Harmony Outcomes trial showed that albiglutide is superior to placebo in improving glycemic control and reducing CV events in patients with ...

3. jacc.org jacc.org/doi/10.1016/j.jcin.2023.03.002

1-Year Outcomes in a Pooled Cohort of Harmony ... The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9351217/

Cardiovascular outcomes trials: a paradigm shift in the ... The aim of this review is to provide an in-depth summary of CVOT data—crystallising the key findings, from safety to efficacy—and to offer a ...

5. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2023/05/25/14/11/one-year-outcomes-in-a-pooled

Harmony Transcatheter Pulmonary Valve 1-Year Outcomes The authors report that the Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823005617

1-Year Outcomes in a Pooled Cohort of Harmony ... The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30015066/

Harmony Outcomes: A randomized, double-blind, placebo ... Harmony Outcomes will assess the CV safety of albiglutide in patients with T2DM and CV disease ... heart failure, 20.2%; and chronic kidney disease, 22.6%.