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Nutrition and Exercise Education for Heart Disease

N/A

Waitlist Available

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

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ambulatory

At least 18 years of age

Must not have

Use of weight loss medication

Diabetes diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 48 weeks after first group session

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a special diet and exercise plan will help African-American women stay on track with healthier eating and exercise habits by improving how well they manage themselves, handle stress, and see themselves positively.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve lifestyle changes such as diet modification and increased physical activity rather than medications, side effects may include muscle soreness from new exercises or dietary adjustments but are generally minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own without help.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication to help me lose weight.

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I have been diagnosed with diabetes.

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I can follow and respond appropriately during conversations.

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My BMI is either below 25 or above 39.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 48 weeks after first group session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 48 weeks after first group session

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 48 weeks after first group session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Amount of Moderate to Vigorous Physical Activity

Change in Veggie Meter Score

Change in the Dietary Risk Assessment Score

Secondary study objectives

Change in BMI

Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure)

Change in Glycosylated Hemoglobin

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HARMONYExperimental Treatment1 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 Control1 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.

0 / 6Eligibility criteria met