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

Not Applicable

Active, not recruiting

• Conditions: Heart Diseases; Stroke; Obesity; Stress; Overweight; Pre-diabetes; Hypertension
• Interventions: Behavioral: HARMONY; Behavioral: Nutrition and Exercise Education (NEEW)

• Registration Number: NCT04705779
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Study Start: 2021-05-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-02-18
• Study Completion: 2025-02-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 174

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HARMONY	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.
Nutrition and Exercise Education Workgroup (NEEW)	Nutrition and Exercise Education (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.

Primary Outcome Measures

Name	Time	Method
Change in Veggie Meter Score	Baseline, 48 weeks after first group session	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.
Change in Amount of Moderate to Vigorous Physical Activity	Baseline, 48 weeks after first group session	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.
Change in the Dietary Risk Assessment Score	Baseline, 48 weeks after first group session	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.

Secondary Outcome Measures

Name	Time	Method
Change in BMI	Baseline, 48 weeks after first group session	The participant's BMI is calculated as weight (kg) divided by height (cm).
Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure)	Baseline, 48 weeks after first group session	The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.
Change in IL-6	Baseline, 48 weeks after first group session	The participant's IL-6 levels will be obtained via phlebotomy. IL-6 is an inflammatory biomarker, and indicative of cardiovascular risk.
Change in Weight	Baseline, 48 weeks after first group session	The participants weight will be measured using a digital scale.
Change in Waist-to-Hip Ratio	Baseline, 48 weeks after first group session	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.
Change in High Sensitivity C-Reactive Protein Amount	Baseline, 48 weeks after first group session	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.
Change in Glycosylated Hemoglobin	Baseline, 48 weeks after first group session	Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk.
Change in Percent Body Fat	Baseline, 48 weeks after first group session	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.

Trial Locations

Locations (1)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States