跳至主要内容
临床试验/NCT03745703
NCT03745703已完成不适用

MOCHA Moving Forward: a CBPR Investigation of Chronic Disease Prevention in Older, Low-income African-American Men

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2016年6月3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
261
试验地点
2
主要终点
Stress, as measured by Cohen's Perceived Stress Scale

研究概览

简要总结

The overall goal of the research is to discover how to reduce chronic disease health disparities among older (ages 35-70) low-income African-American men more effectively. To achieve this goal, the investigators are conducting formative exploratory research with middle-aged, low-income African-American men; testing two versions of a novel community-developed intervention, MOCHA and MOCHA+ (where MOCHA+ is a modified version of the "standard" MOCHA program, modified to incorporate narrative communication strategies); and advancing the development of a Minority Stress Model through statistical modelling to test the relative contributions of hypothesized explanatory variables identified in the formative research phase of the project.

详细描述

Low-income, African-American men continue to be disproportionately burdened by chronic diseases and associated morbidities and mortalities. Primary modifiable and interrelated causes of chronic disease include high levels of stress, low levels of physical activity, and malnutrition. There are few demonstrated effective, preventive interventions that are culturally relevant and gender appropriate for low-income, African-American men.

Local community concerns about health disparities led to a year-long series of community-wide discussions and planning that resulted in the creation of Men of Color Health Awareness (MOCHA) project. Started in 2010, in an unusual public-private partnership between the YMCA and the state Department of Public Health, MOCHA's mission is to improve the health and wellbeing of men of color in Springfield, MA and surrounding areas. MOCHA runs a 12-week program with 15-20 men per cohort to decrease chronic disease vulnerability and bolster resilience among low-income, African-American men, by addressing exercise, eating habits, and stress stemming from impoverished economic conditions, racial and class discrimination, and gender role strain. The MOCHA Steering Committee contacted a group of health disparities researchers at the University of Massachusetts School of Public Health and Health Sciences in 2012, requesting assistance in documenting the impact of MOCHA on the community.

Over 350 men ages 40-60 years have completed the MOCHA program and preliminary data indicate that the program has decreased weight, body fat percentage, and systolic blood pressure; increased self-reported fitness and vitality scores; and decreased mean stress scores on the Cohen Perceived Stress scale by 19%. Based on these preliminary data, the research team proposes to rigorously test MOCHA program effectiveness and to identify the causal pathways through which it impacts outcomes.

In addition, the MOCHA Steering Committee has expressed strong interest in strengthening the quality of their program, by incorporating narrative strategies for communicating key health concepts and information into the existing program. Current research of the investigators provides strong evidence that culture-centered narrative strategies are more effective in producing positive health effects than didactic presentations. The collaborating partners have pilot tested the feasibility of developing digital stories with the MOCHA Steering Committee, and with this proposal, the investigators are mutually excited about the possibility of integrating narrative communication strategies into the MOCHA program, henceforth called MOCHA+.

To test the effectiveness of the existing MOCHA chronic disease prevention program in decreasing stress and compare its effectiveness with a new to-be-developed MOCHA+ program (that integrates narrative communication strategies), the research team proposes to conduct a randomized-controlled trial with three arms: MOCHA, MOCHA + and wait-list control comparison groups. Using a community-based participatory research approach, the three specific aims of the proposed research are thus to:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants are randomly assigned to either the MOCHA standard arm or to the enhanced MOCHA+ arm.

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •All participants must meet all of the inclusion criteria in order to be eligible to participate in the study.
  • •Inclusion criteria include:
  • •self-identification as black, African-American, or bi-racial including black man;
  • •age between 35-70 years;
  • •insufficient or low income;
  • •lived in Springfield area for the previous 6 months;
  • •Informed consent;
  • •Understand study procedures; and
  • •Ability to comply with study procedures for the entire length of the study

排除标准

  • •Exclusion criteria include:
  • •BP>179/ 119;
  • •PTSD scale score >50
  • •Physical or movement l imitations wherein unable to perform 60 minutes of moderately vigorous physical activity 2 times per week

研究组 & 干预措施

MOCHA

Experimental

Behavioral: 12-week trial with 3 sessions per week with one small group discussion session of critical issues affecting African-American men's health each week combined with two aerobic exercise sessions each week

干预措施: MOCHA (Behavioral)

MOCHA+, "Stories Matter"

Experimental

Behavioral: 12-week trial with 3 sessions per week with one small group discussion session of critical issues affecting African-American men's health each week combined with two aerobic exercise sessions each week

干预措施: MOCHA (Behavioral)

Wait-list control

No Intervention

There is no intervention to be administered during the 12-week wait-list control period

结局指标

主要结局

Stress, as measured by Cohen's Perceived Stress Scale

时间窗: Six months

Subjective measure of stress is being collected to evaluate the impact of the MOCHA intervention

Stress, as measured by cortisol levels in fingernail samples

时间窗: Six months

Objective measure of stress is being collected to evaluate the impact of the MOCHA intervention

次要结局

  • High blood pressure(Six months)
  • Body Mass Index(Six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验