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临床试验/NCT06707636
NCT06707636已完成不适用

Using Life's Essential 8 to Lower Heart Disease Risk in Midlife Black Women

Ohio State University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Life's Essential 8 (LE8) score

研究概览

简要总结

This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women.

A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric.

Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.

详细描述

Conduct a RCT pilot of the modified B-SWELL consisting of 64 women randomized to B-SWELL (n=32) or control (n=32). The RCT will take place in two phases. Each phase will consist of virtual and in-person groups (n=8 for groups) for the B-SWELL and attention control. Participants will receive the B-SWELL materials (binder, flash drive) prior to start. Each weekly 90-minute session is devoted to a specific LE8 behavior. Sessions will begin with meditative practice followed by interactive presentations, review of case studies, and discussion. Coaching will occur via phone during the first weeks of the intervention with booster sessions at weeks 10 and 14. The attention control (virtual or in person) will mirror the B-SWELL in format and duration however, participants will only receive publicly available AHA materials and information. The Attention control will not receive stress information, goal setting, or coaching. Facilitators and coaches will be purposefully recruited and representative of midlife Black women.

This study will take place in Cincinnati. Women will be eligible if they identify as Black/African American; are between the ages of 45 and 64 during the trial; have a reliable phone for messaging and data collection calls; and willing to commit to the study duration and data collection phone calls (at 8, 12 and 16 weeks). Women will be excluded if they have recently immigrated or resettled in the U.S. or have major health conditions prohibiting safe participation. Having CVD will not be an exclusion as those with CVD can still show improvement in LE8. Recruitment activities will include fliers, email, snowballing, and social media. Community in-person sites will be selected based upon safety, accessibility, and resources. The C-RAB members will inform recruitment through their knowledge of the communities. For example, they may recommend that fliers be placed in particular high-traffic areas or sent to specific community organizations. C-RAB members are not personnel and, thus, will be instructed to refer any questions regarding this research to the PI and/or research staff. All C-RAB activities will be monitored by the PI.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Identifies as Black/ African American
  • Willing to adhere to the study requirements.

排除标准

  • Incarcerated or on house arrest,
  • Diagnosed with terminal illness, severe mental illness, or dementia.
  • Unable or unwilling to participate in 8 weekly sessions and 4 phone interviews.

研究组 & 干预措施

Black Women's Stress and Wellness (B-SWELL) arm

Experimental

The B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching.

干预措施: Experimental: Black Women's Stress and Wellness (B-SWELL) arm (Behavioral)

Wellness (WE) arm

Active Comparator

This is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics. Sessions will last approximately 90 minutes.

干预措施: Active Comparator: Wellness (WE) arm (Behavioral)

结局指标

主要结局

Life's Essential 8 (LE8) score

时间窗: From baseline to 16 weeks

Life's Essential 8 (LE8) is a recognized metric for cardiovascular health as defined by the American Heart Association. The LE8 score consists of 8 sub-measures. There are 4 lifestyle behaviors (Diet, Physical Activity, Nicotine Exposure and Sleep Health) and 4 health factors (BMI, Blood Lipids, Blood Glucose, and Blood Pressure). The total LE8 score is calculated as the average of the 8 individual component scores. Total scores range from 0 to 100 points. Higher scores correspond to better cardiovascular health.

次要结局

  • Patient Health Questionnaire (PHQ-9)(from baseline to 16 weeks.)
  • Pittsburgh Sleep Quality Index (PSQI)(From baseline to 16 weeks)
  • researcher-developed symptoms check list(From baseline to 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Holly Jones

Associate Professor

Ohio State University

研究点 (1)

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