跳至主要内容
临床试验/NCT06055036
NCT06055036招募中不适用

Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention

Ohio State University2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2023年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
340
试验地点
2
主要终点
Cardiovascular Health

研究概览

简要总结

Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.

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
Single (Outcomes Assessor)

盲法说明

The statistical analyst is blinded to the intervention group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • The inclusion criteria are: 1) Black men (self-report); 2) adult age 18 years or older; 3) Life's Essential 8 total average score < 80; 4) English speaking; and 5) lives in Metropolitan Columbus, Ohio.

排除标准

  • healthcare provider-imposed limitations on physical activity.

结局指标

主要结局

Cardiovascular Health

时间窗: 24 weeks

The primary outcome for the randomized controlled trial is change in cardiovascular health at 24-week follow-up, which will be calculated using between-subject differences rather than within-subject differences, using a linear mixed-effects to evaluate changes from baseline in Life's Essential 8 score (range 0-100, higher scores are better). Study wave will be a covariate in the models. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24-weeks). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. Residual plots will examine model assumptions and model fit, with transformation of the outcomes (e.g. log, square-root, Box-Cox) used as needed to satisfy modelling assumptions (e.g. normality, constant variance) and achieve appropriate model fit.

次要结局

  • Change in Life's Essential 8 Blood Glucose(24 weeks)
  • Change in Perceived Stress(24 weeks)
  • Change in Life's Essential 8 Blood Lipids(24 weeks)
  • Change in Social Needs(24 weeks)
  • Change in Life's Essential 8 Diet (objective)(24 weeks)
  • Change in Life's Essential 8 Nicotine Exposure(24 weeks)
  • Change in Gut Microbiome Health(24 weeks)
  • Change in Life's Essential 8 Blood Pressure(24 weeks)
  • Change in Life's Essential 8 Sleep Health(24 weeks)
  • Change in carotid-femoral pulse wave velocity(24 weeks)
  • Change in patient activation(24 weeks)
  • Change in Life's Essential 8 Body Mass Index(24 weeks)
  • Change in Central Aortic Pressure(24 weeks)
  • Change in Social Functioning(24 weeks)
  • Change in Hair Cortisol(24 weeks)
  • Change in Life's Essential 8 Diet (subjective)(24 weeks)
  • Change in Life's Essential 8 Physical Activity (subjective)(24 weeks)
  • Change in Life's Essential 8 Physical Activity (objective)(24 weeks)
  • Change in Social Relationships(24 weeks)
  • Change in Conserved Transcriptional Response to Adversity(24 weeks)
  • Identify the organizational context and resources necessary to align, coordinate, and sustain academic-community-government partnerships focused on advancing cardiovascular health equity.(156 weeks)

研究者

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

Joshua Joseph, MD

Associate Professor of Internal Medicine

Ohio State University

研究点 (2)

Loading locations...

相似试验