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

November 3, 2022 updated by: University of Massachusetts, Amherst
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.

Study Overview

Detailed Description

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:

  1. Further refine a Minority Stress Model developed by Co-PI Graham, to capture and explain the dynamic, reciprocal and synergistic interactions of factors affecting the health of low-income African-American men;
  2. (a) Determine the effectiveness of the MOCHA program in decreasing stress among low-income African-American men, as measured by both self-report (Cohen's Perceived Stress Scale) and bio-physiological measures of cortisol (assessed in hair samples); and (b) Determine whether the MOCHA+ program is significantly more effective than the MOCHA program in decreasing stress among low-income African-American men, on these same measures;
  3. Assess the effects of the MOCHA and MOCHA+ interventions on mediating variables along hypothesized causal pathways identified through intervention mapping and the construction of a logic model, based on the Minority Stress Model finalized in achieving Aim 1.

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • University of Massachusetts
      • Springfield, Massachusetts, United States, 01101
        • City of Springfield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

All participants must meet all of the inclusion criteria in order to be eligible to participate in the study.

Inclusion criteria include:

  1. self-identification as black, African-American, or bi-racial including black man;
  2. age between 35-70 years;
  3. insufficient or low income;
  4. lived in Springfield area for the previous 6 months;
  5. Informed consent;
  6. Understand study procedures; and
  7. Ability to comply with study procedures for the entire length of the study

Exclusion Criteria:

Exclusion criteria include:

  1. BMI>40;
  2. BP>179/ 119;
  3. PTSD scale score >50
  4. Physical or movement l imitations wherein unable to perform 60 minutes of moderately vigorous physical activity 2 times per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
(see above)
Other Names:
  • MOCHA+
EXPERIMENTAL: MOCHA+, "Stories Matter"
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
(see above)
Other Names:
  • MOCHA+
NO_INTERVENTION: Wait-list control
There is no intervention to be administered during the 12-week wait-list control period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress, as measured by Cohen's Perceived Stress Scale
Time Frame: Six months
Subjective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Six months
Stress, as measured by cortisol levels in fingernail samples
Time Frame: Six months
Objective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High blood pressure
Time Frame: Six months
High blood pressure
Six months
Body Mass Index
Time Frame: Six months
Weight and height will be combined to report BMI in kg/m.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Buchanan, DrPH, UMass School of Public Health & Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2016

Primary Completion (ACTUAL)

July 31, 2021

Study Completion (ACTUAL)

July 31, 2021

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (ACTUAL)

November 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-4898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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