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

University of North Carolina (UNC)

Status: Completed

Conditions: Hypertension; Overweight; Stroke; Pre-diabetes; Obesity; Heart Diseases; Stress

Treatments: Behavioral: HARMONY; Behavioral: Nutrition and Exercise Education (NEEW)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04705779

20-2193

1R01MD015388-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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175 participants in 2 patient groups

HARMONY

Experimental group

Description:

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.

Treatment:

Behavioral: HARMONY

Nutrition and Exercise Education Workgroup (NEEW)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nutrition and Exercise Education (NEEW)