An interventional study of MOCHA in Chronic Disease of Cardiovascular System, Multiple Chronic Conditions and Chronic Disease, sponsored by University of Massachusetts, Amherst. Completed at 2 sites in United States. Open to male participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Prevention
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.
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:
The proposed research will proceed in two stages. During the first 18 months, phase one of the study will focus on (a) formative research designed to further elaborate the minority stress model and (b) the incorporation of narrative communications strategies into the MOCHA+ intervention. In phase two, the investigators will recruit 240 low-income African-American men between 35-65 years of age over a three-year period to participate in a randomized controlled trial, with three arms: MOCHA, MOCHA+, or wait-list control. The primary research endpoint is bio-physiological assessment of the ELISA cortisol hair-test (average hormone levels over the past 3 months), administered at pre, post, and 3 month follow-up, as well as self-reported stress levels using Cohen's Perceived Stress scale. Secondary outcomes include the bio-physiological indicators of blood pressure and BMI.
The proposed research will determine the effectiveness of MOCHA in reducing stress and whether it can be further strengthened by introducing narrative communication strategies. The results of the proposed research will contribute to the development of an enhanced theoretical model of factors affecting low-income African-American male health and to the evidence base of effective interventions aimed at chronic disease prevention and control programs in this population.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's enrollment of 261 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
Browse Multiple Chronic Conditions studies →University of Massachusetts, Amherst is the lead sponsor of 48 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
All participants must meet all of the inclusion criteria in order to be eligible to participate in the study.
Inclusion criteria include:
Exclusion Criteria:
Exclusion criteria include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: MOCHA
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
Behavioral: MOCHA
There is no intervention to be administered during the 12-week wait-list control period
(see above)
Also known as: MOCHA+
Stress, as measured by Cohen's Perceived Stress Scale
Subjective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Time frame: Six months
Stress, as measured by cortisol levels in fingernail samples
Objective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Time frame: Six months
High blood pressure
High blood pressure
Time frame: Six months
Body Mass Index
Weight and height will be combined to report BMI in kg/m.
Time frame: Six months
Plan to share: No
Ran from Jun 2016 to primary completion in Jul 2021, 61 months.
Of 59 non-industry interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 61 months is above that.
Counting every sponsor, half of 59 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Amherst