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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2025-02-07

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.

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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.

Conditions

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Heart Diseases Stroke Pre-diabetes Hypertension Obesity Overweight Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

HARMONY

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Nutrition and Exercise Education (NEEW)

Intervention Type 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.

Interventions

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HARMONY

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.

Intervention Type BEHAVIORAL

Nutrition and Exercise Education (NEEW)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No