CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled
Drug / intervention
HARMONY +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04705779
NCT04705779N/ACompleted
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The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women

University of North Carolina, Chapel Hill·interventional·Posted Jan 12, 2021·Updated Jan 29, 2026

In Brief

A clinical study evaluating HARMONY and Nutrition and Exercise Education (NEEW) for Heart Diseases and 6 related conditions. Completed, enrolled 175 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases, Stroke, Pre-diabetes, Hypertension, Obesity, Overweight, Stress
CountriesUnited States
CollaboratorsNational Institute on Minority Health and Health Disparities (NIMHD)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 12, 2021
Enrollment StartMay 20, 2021
Primary CompletionFeb 7, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.5 years ago

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.