## Protocol Section
### Identification Module
**NCT ID:** NCT04705779

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 20-2193
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**ID:** 1R01MD015388-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01MD015388-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-02-18

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-07

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-06

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2025-02-18

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-05-20

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2021-01-12
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-08
**Study First Submit QC Date:** 2021-01-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Minority Health and Health Disparities (NIMHD)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Heart Diseases

- Stroke

- Pre-diabetes

- Hypertension

- Obesity

- Overweight

- Stress

**Keywords:**

- HARMONY

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 174

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: HARMONY

**Label:** HARMONY

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Nutrition and Exercise Education (NEEW)

**Label:** Nutrition and Exercise Education Workgroup (NEEW)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HARMONY

**Description:** 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.

**Name:** HARMONY

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Nutrition and Exercise Education Workgroup (NEEW)

**Description:** 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.

**Name:** Nutrition and Exercise Education (NEEW)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Results will be reported in minutes, with higher numbers indicating a higher amount of moderate to vigorous physical activity.

**Measure:** Change in Amount of Moderate to Vigorous Physical Activity

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's dietary intake will be assessed using the dietary risk assessment, which includes 54 items. The dietary risk assessment measures the healthiness of a participant's eating habits. Score ranges from 0 to 108, with higher scores associated with less healthy dietary intake.

**Measure:** Change in the Dietary Risk Assessment Score

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's nutrition will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.

**Measure:** Change in Veggie Meter Score

**Time Frame:** Baseline, 48 weeks after first group session

#### Secondary Outcomes

**Description:** The participant's BMI is calculated as weight (kg) divided by height (cm).

**Measure:** Change in BMI

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participants weight will be measured using a digital scale.

**Measure:** Change in Weight

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's waist to hip ratio is calculated by using the mean of two waist circumference measurements divided by mean of two hip circumference measurements. Waist circumference will be measured at the midpoint between the upper iliac crest and lower costal margin in the midaxillary line. Hip circumference will be measured at the maximum width of the buttocks or gluteo-femoral fold.

**Measure:** Change in Waist-to-Hip Ratio

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's percent body fat is measured using lange skinfold calipers. The final measurement will be the mean of three measurements on the right side of the body.

**Measure:** Change in Percent Body Fat

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.

**Measure:** Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure)

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's high sensitivity C-reactive protein levels will be obtained via phlebotomy. C-Reactive Protein is an inflammatory biomarker, and indicative of cardiovascular risk.

**Measure:** Change in High Sensitivity C-Reactive Protein Amount

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** The participant's IL-6 levels will be obtained via phlebotomy. IL-6 is an inflammatory biomarker, and indicative of cardiovascular risk.

**Measure:** Change in IL-6

**Time Frame:** Baseline, 48 weeks after first group session

**Description:** Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk.

**Measure:** Change in Glycosylated Hemoglobin

**Time Frame:** Baseline, 48 weeks after first group session

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chapel Hill

**Country:** United States

**Facility:** The University of North Carolina at Chapel Hill

**State:** North Carolina

**Zip:** 27599

#### Overall Officials

**Official 1:**

**Affiliation:** The University of North Carolina at Chapel Hill, School of Nursing

**Name:** Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** All researchers who desire to access the individual participant data must enter into a data-sharing agreement.

**Description:** Deidentified individual data that supports the results will be shared up to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

**IPD Sharing:** YES

**Time Frame:** The data will become available per NIH policy, which is no later than the acceptance for publication of the main findings from the dataset.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M14117

- Name: Prediabetic State

- Relevance: HIGH

- As Found: Pre-diabetes

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M20295

- Name: Glucose Intolerance

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000050177

- Term: Overweight

- ID: D000011236

- Term: Prediabetic State

### Misc Info Module

- Version Holder: 2024-05-24
