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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women

Conditions
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Heart Diseases, Stroke, Pre-diabetes, Hypertension, Obesity, Overweight, Stress

Intervention / Treatment
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* Behavioral: HARMONY
* Behavioral: Nutrition and Exercise Education (NEEW)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported African American or Black woman BMI= 25-39 kg/m2 (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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HARMONY<br>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. | Behavioral: HARMONY<br>* 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.<br>|
| Active Comparator: Nutrition and Exercise Education Workgroup (NEEW)<br>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. | Behavioral: Nutrition and Exercise Education (NEEW)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Amount of Moderate to Vigorous Physical Activity | 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. | Baseline, 48 weeks after first group session | 
| Change in the Dietary Risk Assessment Score | 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. | Baseline, 48 weeks after first group session | 
| Change in Veggie Meter Score | 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. | Baseline, 48 weeks after first group session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI | The participant's BMI is calculated as weight (kg) divided by height (cm). | Baseline, 48 weeks after first group session | 
| Change in Weight | The participants weight will be measured using a digital scale. | Baseline, 48 weeks after first group session | 
| Change in Waist-to-Hip Ratio | 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. | Baseline, 48 weeks after first group session | 
| Change in Percent Body Fat | 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. | Baseline, 48 weeks after first group session | 
| Change in Blood Pressure (Systolic Blood Pressure/Diastolic Blood Pressure) | The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements. | Baseline, 48 weeks after first group session | 
| Change in High Sensitivity C-Reactive Protein Amount | 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. | Baseline, 48 weeks after first group session | 
| Change in IL-6 | The participant's IL-6 levels will be obtained via phlebotomy. IL-6 is an inflammatory biomarker, and indicative of cardiovascular risk. | Baseline, 48 weeks after first group session | 
| Change in Glycosylated Hemoglobin | Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk. | Baseline, 48 weeks after first group session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HARMONY