# THE HARMONY Study - A culturally-relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women.

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $641,906

## Abstract

Project Summary/Abstract
African American women (AAW) have higher rates of death and disability from chronic cardiometabolic (CM)
illnesses compared to any other group of women in the US, including diabetes, cardiovascular disease, and
stroke. 80% of AAW are overweight or obese, and they are the largest US sociodemographic group with
inadequate engagement in exercise. Nearly 50% of AAW have cardiovascular disease, and AAW have more
than twice the rate of diabetes compared to White women. Compelling evidence shows that AAW are least
successful at achieving and sustaining CM risk-reduction goals compared to 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 exposure to psychological stress. Culturally-relevant stressors
in AAW are positively and significantly associated with perceived stress, depressive symptoms, unhealthy
eating, and physical inactivity in AAW – CM risk factors. A shortcoming of interventions with AAW is their
inadequate focus on stress exposure, including gender and racialized stress, stress physiology and stress-
related barriers to healthy eating and exercise known to reduce CM risk. To address this shortcoming, we
propose a randomized controlled trial to test a culturally-tailored mindfulness-based stress management
intervention. This RCT is designed to help AAW build on their strengths to promote stress management and
improved CM health by enhancing positive reappraisal, self-regulation, and self-efficacy, all of which are
cognitive-behavioral facilitators of self-management and positively impacted by mindfulness training. In this 2-
arm CM-risk reduction RCT with 200 AAW ≥ 18 years old with CM risk, we will be powered to detect group
differences in exercise and healthy eating behaviors Specific aims are: AIM 1: Test the hypothesis that AAW
participating in an 8-session culturally-relevant mindfulness-based intervention to reduce CM risk have: AIM 1A
(primary) greater sustained improvements in exercise and healthy eating behaviors and AIM 1B (secondary)
greater reduction in CM risk biomarkers (BMI, % body fat, waist to hip ratio [WHR], BP, and inflammatory
cytokines [High Sensitivity C-Reactive Protein; hs-CRP])) at 4, 8, and 12 months, compared to AAW in an
attention-control CM risk reduction intervention without mindfulness. AIM 2 (exploratory: Test the hypothesis
that improvements in mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy
mediate the effects of the intervention on exercise and healthy eating. We will work with a community health
agency and a community advisory board to facilitate the implementation and success of our intervention. We
address the NIH call to identify interventions that promote self-management to reduce disparities through a
culturally-tailored, community-based mindfulness-based intervention for AAW that targets resilience i...

## Key facts

- **NIH application ID:** 10049832
- **Project number:** 1R01MD015388-01A1
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Susan Gaylord
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $641,906
- **Award type:** 1
- **Project period:** 2020-07-29 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10049832

## Citation

> US National Institutes of Health, RePORTER application 10049832, THE HARMONY Study - A culturally-relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women. (1R01MD015388-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10049832. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*