NCT03745703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2021

Enrollment Period

5.2 years

First QC Date

November 9, 2018

Last Update Submit

November 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stress, as measured by Cohen's Perceived Stress Scale

    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

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

    Six months

Secondary Outcomes (2)

  • High blood pressure

    Six months

  • Body Mass Index

    Six months

Study Arms (3)

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

Behavioral: MOCHA

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

Behavioral: MOCHA

Wait-list control

NO INTERVENTION

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

Interventions

MOCHABEHAVIORAL

(see above)

Also known as: MOCHA+
MOCHAMOCHA+, "Stories Matter"

Eligibility Criteria

Age35 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Location

City of Springfield

Springfield, Massachusetts, 01101, United States

Location

Related Publications (2)

  • 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.

    PMID: 29695204BACKGROUND
  • 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.

    PMID: 33301990BACKGROUND

MeSH Terms

Conditions

Multiple Chronic ConditionsChronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Buchanan, DrPH

    UMass School of Public Health & Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are randomly assigned to either the MOCHA standard arm or to the enhanced MOCHA+ arm.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 19, 2018

Study Start

June 3, 2016

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

November 8, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations