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

Primary Purpose

Chronic Disease of Cardiovascular System, Multiple Chronic Conditions, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOCHA
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease of Cardiovascular System

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts
  • City of Springfield

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

MOCHA

MOCHA+, "Stories Matter"

Wait-list control

Arm Description

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: 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

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

Outcomes

Primary Outcome Measures

Stress, as measured by Cohen's Perceived Stress Scale
Subjective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Stress, as measured by cortisol levels in fingernail samples
Objective measure of stress is being collected to evaluate the impact of the MOCHA intervention

Secondary Outcome Measures

High blood pressure
High blood pressure
Body Mass Index
Weight and height will be combined to report BMI in kg/m.

Full Information

First Posted
November 9, 2018
Last Updated
November 3, 2022
Sponsor
University of Massachusetts, Amherst
Collaborators
University of Massachusetts, Worcester, YMCA
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1. Study Identification

Unique Protocol Identification Number
NCT03745703
Brief Title
MOCHA Moving Forward: a CBPR Investigation of Chronic Disease Prevention in Older, Low-income African-American Men
Official Title
MOCHA Moving Forward: a CBPR Investigation of Chronic Disease Prevention in Older, Low-income African-American Men
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2016 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
University of Massachusetts, Worcester, YMCA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: 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; (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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease of Cardiovascular System, Multiple Chronic Conditions, Chronic Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study design uses a wait-list control to test the effectiveness and relative effectiveness of a community-driven MOCHA intervention, including discussions of salient health topics (such as stress and anger management) and an enhanced version MOCHA+, which incorporates narrative communication strategies to strenghten comprehnsion, retention and motivation.
Masking
Participant
Masking Description
Participants are randomly assigned to either the MOCHA standard arm or to the enhanced MOCHA+ arm.
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOCHA
Arm Type
Experimental
Arm Description
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
Arm Title
MOCHA+, "Stories Matter"
Arm Type
Experimental
Arm Description
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
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
There is no intervention to be administered during the 12-week wait-list control period
Intervention Type
Behavioral
Intervention Name(s)
MOCHA
Other Intervention Name(s)
MOCHA+
Intervention Description
(see above)
Primary Outcome Measure Information:
Title
Stress, as measured by Cohen's Perceived Stress Scale
Description
Subjective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Time Frame
Six months
Title
Stress, as measured by cortisol levels in fingernail samples
Description
Objective measure of stress is being collected to evaluate the impact of the MOCHA intervention
Time Frame
Six months
Secondary Outcome Measure Information:
Title
High blood pressure
Description
High blood pressure
Time Frame
Six months
Title
Body Mass Index
Description
Weight and height will be combined to report BMI in kg/m.
Time Frame
Six months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Exclusion criteria include: BMI>40; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Buchanan, DrPH
Organizational Affiliation
UMass School of Public Health & Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States
Facility Name
City of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29695204
Citation
Graham LF, Scott L, Lopeyok E, Douglas H, Gubrium A, Buchanan D. Outreach Strategies to Recruit Low-Income African American Men to Participate in Health Promotion Programs and Research: Lessons From the Men of Color Health Awareness (MOCHA) Project. Am J Mens Health. 2018 Sep;12(5):1307-1316. doi: 10.1177/1557988318768602. Epub 2018 Apr 26.
Results Reference
background
PubMed Identifier
33301990
Citation
Valdez LA, Gubrium AC, Markham J, Scott L, Hubert A, Meyer J, Buchanan D. A culturally and gender responsive stress and chronic disease prevention intervention for low/no-income African American men: The MOCHA moving forward randomized control trial protocol. Contemp Clin Trials. 2021 Feb;101:106240. doi: 10.1016/j.cct.2020.106240. Epub 2020 Dec 7.
Results Reference
background

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

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