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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT04705779
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HARMONY — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 20, 2021
Status verified
Mar 2025
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025

Study Design

Enrollment
175 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: HARMONY
    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.
  • Active Comparator: Nutrition and Exercise Education Workgroup (NEEW)
    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.

Primary Outcome Measure

Change in Amount of Moderate to Vigorous Physical Activity [ Time Frame: Baseline, 48 weeks after first group session ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Hypertension (high blood pressure)Obesity / overweightStroke
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight lossNeurologyBrain disorders
By research site
The University of North Carolina at Chapel Hill· Chapel Hill, NC

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