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Chronic Disease of Cardiovascular SystemNCT03745703

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

A study testing MOCHA in people with Chronic Disease of Cardiovascular System and Multiple Chronic Conditions, run by University of Massachusetts, Amherst at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 70 years, men onlyHealthy volunteers can take part
What is being tested?
MOCHA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
2 sitesUnited States
Study dates
3 Jun 2016to 31 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Massachusetts

    Amherst, Massachusetts, 01003

  • City of Springfield

    Springfield, Massachusetts, 01101

Other trials in United States

About this study

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.

Read the 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.

Being tested
MOCHA
Medical subject headings
Multiple Chronic Conditions, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOCHABehavioural

    Also called MOCHA+

    (see above)

Study groups in NCT03745703
Study groupRoleWhat they receive
MOCHAExperimentalBehavioral: 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
Receives: Behavioral: MOCHA
MOCHA+, "Stories Matter"ExperimentalBehavioral: 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
Receives: Behavioral: MOCHA
Wait-list controlNo interventionThere is no intervention to be administered during the 12-week wait-list control period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress, as measured by Cohen's Perceived Stress Scale

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

    Measured: Six months

  2. Stress, as measured by cortisol levels in fingernail samples

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

    Measured: Six months

Secondary outcomes (2)
  1. High blood pressure

    High blood pressure

    Measured: Six months

  2. Body Mass Index

    Weight and height will be combined to report BMI in kg/m.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2018
  2. Study start3 Jun 2016
  3. Primary completion31 Jul 2021
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Participant
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745703
Sponsor's protocol ID
2018-4898
Status last verified
Nov 2021
First submitted
9 Nov 2018
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29695204
  • 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.

    PubMed 33301990

Questions about this trial

What is this clinical trial studying?

A study testing MOCHA in people with Chronic Disease of Cardiovascular System and Multiple Chronic Conditions, run by University of Massachusetts, Amherst at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress, as measured by Cohen's Perceived Stress Scale (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03745703, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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