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

University of North Carolina, Chapel Hill175 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

175

Conditions

Heart Diseases

Interventions

HARMONYBEHAVIORAL

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.

Nutrition and Exercise Education (NEEW)BEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Amount of Moderate to Vigorous Physical Activity

The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Participants are instructed to wear the accelerometer for seven full days; the average number of minutes of MVPA per 24-hour period is computed. Results will be reported in minutes per day.