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

174 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test whether a culturally-tailored nutrition and exercise intervention designed for African-American women will lead to sustained improvements in exercise and healthy eating through improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.

Research Team

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

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+