The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in Veggie Meter Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: HARMONY (Behavioral)
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.
干预措施: Nutrition and Exercise Education (NEEW) (Behavioral)
结局指标
主要结局
Change in Veggie Meter Score
时间窗: Baseline, 48 weeks after first group session
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.
Change in the Dietary Risk Assessment Score
时间窗: Baseline, 48 weeks after first group session
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.
Change in Amount of Moderate to Vigorous Physical Activity
时间窗: Baseline, 48 weeks after first group session
The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Participants are instructed to wear the accelerometer for seven full days; the average number of minutes of MVPA per 24-hour period is computed. Results will be reported in minutes per day.
次要结局
- Change in Weight(Baseline, 48 weeks after first group session)
- Change in Waist-to-Hip Ratio(Baseline, 48 weeks after first group session)
- Change in Percent Body Fat(Baseline, 48 weeks after first group session)
- Change in BMI(Baseline, 48 weeks after first group session)
- Change in High Sensitivity C-Reactive Protein Amount(Baseline, 48 weeks after first group session)
- Change in IL-6(Baseline, 48 weeks after first group session)
- Change in Blood Pressure (Systolic)(Baseline, 48 weeks after first group session)
- Change in Blood Pressure (Diastolic)(Baseline, 48 weeks after first group session)
- Change in Glycosylated Hemoglobin (HbA1c)(Baseline, 48 weeks after first group session)