Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women.
Study Goal
The researchers aimed to test a culturally tailored mindfulness-based stress management intervention to address culturally-nuanced stress phenomena (Superwoman Schema, contextualized stress, and network stress) as barriers to healthy exercise and eating goals in African American Women.
Results Summary
The study is ongoing, collecting primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) at baseline and 4-, 8-, and 12-months post-intervention. Results will inform scalable and sustainable cardiometabolic risk-reduction programming.
Population
African American Women aged ≥18 years with cardiometabolic risk.
Effective Dosage
Not specified
Duration
12 months (with follow-ups at 4, 8, and 12 months)
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
culturally tailored mindfulness-based stress management intervention | decrease | Superwoman Schema (SWS), contextualized stress, and network stress as potential barriers to adherence to healthy exercise and eating goals | African American Women (AAW) | - | address | #1 |
culturally tailored mindfulness-based stress management intervention | increase | cardiometabolic health | African American Women (AAW) | - | help build on their strengths to promote | #2 |
culturally tailored mindfulness-based stress management intervention | increase | positive reappraisal, self-regulation, and self-efficacy as protective factors against chronic stress-inducing biobehavioral morbidity and mortality risk | African American Women (AAW) | - | enhancing | #3 |
HARMONY 1 (culturally-tailored exercise and nutrition education) | neutral | primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) | AAW ≥ 18 years old with cardiometabolic risk | - | test the effects of | #4 |
HARMONY 2 (mindfulness-based stress reduction, exercise, and nutrition education) | neutral | primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) | AAW ≥ 18 years old with cardiometabolic risk | - | test the effects of | #5 |
culturally-tailored stress management, exercise, and nutrition educational approaches | decrease | biobehavioral cardiometabolic risk | African American Women (AAW) | - | reduce | #6 |
BACKGROUND: African American Women (AAW) are at high risk for stress-related cardiometabolic (CM) conditions including obesity, heart disease, and diabetes. Prior interventions lack attention to culturally-nuanced stress phenomena (Superwoman Schema [SWS], contextualized stress, and network stress), which are positively and significantly associated with unhealthy eating and sedentary behavior. PURPOSE: The HARMONY Study is designed to test a culturally tailored mindfulness-based stress management intervention to address SWS, contextualized stress, and network stress as potential barriers to adherence to healthy exercise and eating goals. The study will help AAW build on their strengths to promote cardiometabolic health by enhancing positive reappraisal, self-regulation, and self-efficacy as protective factors against chronic stress-inducing biobehavioral morbidity and mortality risk. METHODS: This two-arm, randomized-controlled trial will test the effects of two group-based, online interventions. HARMONY 1 includes culturally-tailored exercise and nutrition education. HARMONY 2 includes mindfulness-based stress reduction, exercise, and nutrition education. We aim to recruit 200 AAW ≥ 18 years old with CM risk. RESULTS: Primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) are being collected at baseline and 4-, 8-, and 12-months post-intervention. Intent-to-treat, data analytic approaches will be used to test group differences for the primary outcomes. DISCUSSION: This study is the first to address culturally-nuanced stress phenomena in AAW (SWS, network stress, and contextualized stress) using culturally-tailored stress management, exercise, and nutrition educational approaches to reduce biobehavioral CM risk among AAW. Quantitative and qualitative results will inform the development of scalable and sustainable CM risk-reduction programming for AAW. TRIAL REGISTRATION: The Multiple PIs registered the clinical trial (Identifier: NCT04705779) and reporting of summary results in ClinicalTrials.gov in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, within the required timelines.