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Nutrition and Exercise Education for Heart Disease
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 48 weeks after first group session
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can walk on my own without help.
Select...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Amount of Moderate to Vigorous Physical Activity
Change in Veggie Meter Score
Change in the Dietary Risk Assessment Score
Secondary outcome measures
Change in BMI
Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure)
Change in Glycosylated Hemoglobin
+5 moreTrial 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.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,834 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,011 Total Patients Enrolled
Cheryl Giscombe, PhD, RN, PMHNP-BC, FAANPrincipal InvestigatorThe University of North Carolina at Chapel Hill, School of Nursing
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an African American or Black woman.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.You don't exercise for at least 150 minutes a week.My parent or sibling has prediabetes or diabetes.You report feeling a moderate amount of stress or have a Perceived Stress Scale-14 score higher than 5.You are able and willing to do moderate to intense exercise.Your body mass index (BMI) is between 25 and 39 kg/m2.I can walk on my own without help.I have been diagnosed with diabetes.You have had diabetes during pregnancy.I am 18 years old or older.If you score a certain amount on a questionnaire about feeling like a superwoman, you may not be able to participate in the study.You have a condition where your blood sugar is higher than normal but not high enough to be called diabetes.You or your family have a history of high cholesterol.I have not joined a weight loss or meditation program in the last 6 months.I can follow and respond appropriately during conversations.You or your family have a history of high blood pressure.My BMI is either below 25 or above 39.
Research Study Groups:
This trial has the following groups:- Group 1: Nutrition and Exercise Education Workgroup (NEEW)
- Group 2: HARMONY
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the fundamental aims of this research endeavor?
"This clinical trial's primary endpoint to evaluate over Baseline and 48 weeks post the first group session is alteration in Veg-Meter Score. Secondary endpoints include transformation of Waist-to-Hip Ratio, Weight Change, and Percentage Body Fat; which are calculated by utilising midpoint between upper iliac crest/lower costal margin midaxillary line for waist circumference, maximum width of buttocks or gluteo-femoral fold for hip circumference, digital scales to measure weight change and Lange skinfold calipers for body fat percentage respectively."
Answered by AI
What is the highest number of participants in this trial?
"Affirmative. The information available on clinicaltrials.gov attests to this medical trial's ongoing recruitment process, which began on May 20th 2021 and was last modified on January 10th 2022. At the moment, 200 patients are being sought at a single site of enrollment."
Answered by AI
Is this research project currently looking for participants?
"Clinicaltrials.gov confirms the ongoing recruitment for this medical trial, which launched on May 20th 2021 and was last modified in early January 2022."
Answered by AI
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