Clinical trial NCT04705779: The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
Official title: The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Stroke
Pre-diabetes
Hypertension
Obesity
Overweight
Stress
Keywords: HARMONY
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-01-12
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Amount of Moderate to Vigorous Physical Activity
timeFrame: Baseline, 48 weeks after first group session
measure: Change in the Dietary Risk Assessment Score
timeFrame: Baseline, 48 weeks after first group session
measure: Change in Veggie Meter Score
timeFrame: Baseline, 48 weeks after first group session
Secondary outcomes:
measure: Change in BMI
timeFrame: Baseline, 48 weeks after first group session
measure: Change in Weight
timeFrame: Baseline, 48 weeks after first group session
measure: Change in Waist-to-Hip Ratio
timeFrame: Baseline, 48 weeks after first group session
measure: Change in Percent Body Fat
timeFrame: Baseline, 48 weeks after first group session
measure: Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure)
timeFrame: Baseline, 48 weeks after first group session
measure: Change in High Sensitivity C-Reactive Protein Amount
timeFrame: Baseline, 48 weeks after first group session
measure: Change in IL-6
timeFrame: Baseline, 48 weeks after first group session
measure: Change in Glycosylated Hemoglobin
timeFrame: Baseline, 48 weeks after first group session
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: The University of North Carolina at Chapel Hill, School of Nursing
name: Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN
role: PRINCIPAL_INVESTIGATOR
References: