The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women

The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Stroke; Hypertension; Obesity; Overweight; Stress; Pre-diabetes
• Intervention / Treatment: Behavioral: HARMONY; Behavioral: Nutrition and Exercise Education (NEEW)

Detailed Description

Among all groups of women in the US, African American women (AAW) have the highest rates of death and disability from chronic cardiometabolic (CM) illnesses. Furthermore, AAW have inadequate engagement in exercise and are least successful at achieving and sustaining CM risk-reduction goals compared to all men and women of other racial/ethnic groups, despite participating in comprehensive lifestyle interventions. These alarming disparities are due in part to disproportionately high rates of psychological stress. A shortcoming of interventions with AAW is an inadequate focus on stress exposure, including gender and racialized stress, stress physiology, and stress-related barriers to healthy eating and exercise to reduce CM risk. In response, the HARMONY study is a randomized controlled trial to test a culturally-tailored nutrition and exercise intervention to manage stress, designed to help AAW build on their strengths to promote self-management and to reduce stress-related CM risk. Certain information about the interventions is not disclosed to protect the scientific integrity of the trial.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN; Phone Number: 919-843-9491; Email: cheryl.giscombe@unc.edu
• Study Contact Backup: Name: Susan Gaylord, PhD; Phone Number: 919-966-8586; Email: gaylords@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • The University of North Carolina at Chapel Hill
      • Contact: Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN; Phone Number: 919-843-9491; Email: cheryl.giscombe@unc.edu
      • Principal Investigator: Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN
      • Principal Investigator: Susan Gaylord, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-reported African American or Black woman
• BMI= 25-39 kg/m^2 (confirmed at baseline assessment)
• At least one cardiometabolic risk factor:
• < 150 minutes of self-reported moderate to vigorous exercise
• History of gestational diabetes
• Parent or sibling with prediabetes or diabetes
• Personal or family history of hypertension (=130/80)
• Prediabetes or impaired glucose metabolism (HgbA1c 5.7-6.5)
• Personal or family history of abnormal cholesterol levels
• At least 18 years of age
• Able to read/speak English
• Willing to attend scheduled classes, complete internet surveys and biomarker assessments
• Able/willing to engage in moderate to vigorous exercise
• Ambulatory
• Superwoman Schema Questionnaire score indicating at least moderate endorsement of one or more subscales (strength: 7; motional suppression: 7; resistance of vulnerability: 8; motivation to succeed: 7; or helping others: 10) or a total score of 20 or greater
• A Perceived Stress Scale-14 score of >5 or self-report at least "some" general stress.

Exclusion Criteria:

• Pregnant/anticipated pregnancy
• Substance use, mental health or medical condition that will prevent the ability to participate in the intervention
• Use of weight loss medication
• Current or recent (<6 months prior to enrollment) engagement in another weight loss or meditation program
• Impaired cognition (inability to follow and respond appropriately during screening).
• Diabetes diagnosis
• Has a confirmed BMI lower than 25 or higher than 39
• Does not have access to a smartphone or computer with internet access
• Lives in the same household as someone who is currently in the study or was previously in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HARMONY; 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.	Behavioral: HARMONY; The HARMONY intervention will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
Active Comparator: Nutrition and Exercise Education Workgroup (NEEW); 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.	Behavioral: Nutrition and Exercise Education (NEEW); The Nutrition and Exercise Workgroup (NEEW) group will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Amount of Moderate to Vigorous Physical Activity	The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Results will be reported in minutes, with higher numbers indicating a higher amount of moderate to vigorous physical activity.	Baseline, 48 weeks after first group session
Change in the Dietary Risk Assessment Score	The participant's dietary intake will be assessed using the dietary risk assessment, which includes 54 items. The dietary risk assessment measures the healthiness of a participant's eating habits. Score ranges from 0 to 108, with higher scores associated with less healthy dietary intake.	Baseline, 48 weeks after first group session
Change in Veggie Meter Score	The participant's nutrition will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.	Baseline, 48 weeks after first group session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI	The participant's BMI is calculated as weight (kg) divided by height (cm).	Baseline, 48 weeks after first group session
Change in Weight	The participants weight will be measured using a digital scale.	Baseline, 48 weeks after first group session
Change in Waist-to-Hip Ratio	The participant's waist to hip ratio is calculated by using the mean of two waist circumference measurements divided by mean of two hip circumference measurements. Waist circumference will be measured at the midpoint between the upper iliac crest and lower costal margin in the midaxillary line. Hip circumference will be measured at the maximum width of the buttocks or gluteo-femoral fold.	Baseline, 48 weeks after first group session
Change in Percent Body Fat	The participant's percent body fat is measured using lange skinfold calipers. The final measurement will be the mean of three measurements on the right side of the body.	Baseline, 48 weeks after first group session
Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure)	The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.	Baseline, 48 weeks after first group session
Change in High Sensitivity C-Reactive Protein Amount	The participant's high sensitivity C-reactive protein levels will be obtained via phlebotomy. C-Reactive Protein is an inflammatory biomarker, and indicative of cardiovascular risk.	Baseline, 48 weeks after first group session
Change in IL-6	The participant's IL-6 levels will be obtained via phlebotomy. IL-6 is an inflammatory biomarker, and indicative of cardiovascular risk.	Baseline, 48 weeks after first group session
Change in Glycosylated Hemoglobin	Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk.	Baseline, 48 weeks after first group session

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN, The University of North Carolina at Chapel Hill, School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): February 18, 2025
• Study Completion (Estimated): February 18, 2025

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HARMONY
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Body Weight; Heart Diseases; Prediabetic State; Overweight
• Other Study ID Numbers: 20-2193; 1R01MD015388-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared up to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: The data will become available per NIH policy, which is no later than the acceptance for publication of the main findings from the dataset.
• IPD Sharing Access Criteria: All researchers who desire to access the individual participant data must enter into a data-sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No