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Men Together Making a Difference: Health Promotion for Black Men

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ClinicalTrials.gov Identifier: NCT02572414
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

African American men infected with HIV are living longer and are acquiring the same chronic non-communicable diseases affecting the general population of African American men age 40 years and older. African American men have disproportionately high rates of cardiovascular disease, hypertension, diabetes, kidney disease, and cancer, particularly prostate and colon cancer, but HIV is associated with an increased risk for co-morbidity from these conditions, a risk heightened by not only HIV infection itself, but also its treatment with antiretroviral therapy (ART). The risk for many of these chronic diseases is tied to behavior: risk is increased by physical inactivity and unhealthful diet. Although the high risk for behavior-linked chronic diseases among HIV-positive individuals has been recognized, there is a lack of evidence-based interventions specifically tailored to their needs.

Hence, the broad objective of this research is to identify strategies to empower HIV positive African American men to engage in behaviors that reduce their risk of chronic diseases. This research will test the efficacy of a theory-based, contextually appropriate health promotion intervention in inducing positive changes in behaviors linked to risk of chronic diseases among HIV positive African American men age 40 years or older and will identify the theoretical variables that mediate its efficacy.

In a randomized controlled trial, African American HIV positive men age 40 or older who are receiving ART for HIV will be randomized to the Men Together Making a Difference Health Promotion Intervention, which consists of three, 3-hour weekly intervention sessions, or the 1 session Health Awareness Control Group. The Men Together Making a Difference Health Promotion Intervention is based on social cognitive theory and the reasoned action approach integrated with formative research. Data will be collected at baseline, immediately post, and 3, 6 and 12 months post intervention. The trial will test whether the Men Making a Difference Health Promotion Intervention increases self-reported physical activity compared with the Health Awareness Control Group.


Condition or disease Intervention/treatment Phase
HIV Cardiovascular Disease Diabetes Hypertension Colon Cancer Behavioral: Health Promotion Intervention Behavioral: Health Awareness Control Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Health Promotion for HIV Positives: A Randomized Trial With HIV Positive Black Men
Actual Study Start Date : January 8, 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Health Promotion Intervention
Men Together Making a Difference Health Promotion Intervention consisted of three, 3-hour weekly small-group intervention sessions led by a trained facilitator using a detailed, scripted manual designed to increase adherence to guidelines for physical activity, 5-a-Day diet, and colon cancer screening.
Behavioral: Health Promotion Intervention
Men Together Making a Difference Health Promotion Intervention, which included three, 3-hour weekly sessions, implemented in small groups by trained facilitators using scripted manuals, was designed to increase self-efficacy, outcome expectancy, and skills for behaviors tied to cardiovascular disease, diabetes, hypertension, and cancer. It encouraged men to adhere to guidelines for physical activity, 5-a-Day diet, and colon cancer screening. It encouraged at least 30 min of moderate-intensity aerobic activity on 5 days or at least 20 min of vigorous-intensity aerobic activity on 4 days and muscle-strengthening activity on at least 2 days each week. Participants identified their personal barriers to engaging in the recommended behaviors and strategies for surmounting those barriers.
Other Name: Men Together Making a Difference Intervention

Active Comparator: Health Awareness Control
Health Awareness Control Intervention consisted of one 1-hour small-group session led by a trained facilitator. Participants viewed and discussed video clips on physical activity, fruit and vegetable consumption, and colon cancer screening.
Behavioral: Health Awareness Control Intervention
Health Awareness Control Intervention consisted of one 1-hour small-group session led by a trained facilitator. Participants viewed and discussed video clips on physical activity, fruit and vegetable consumption, and colon cancer screening.
Other Name: Control Intervention




Primary Outcome Measures :
  1. Adherence to Department of Health and Human Services physical activity guideline [ Time Frame: up to 12 months post-intervention ]
    A binary variable indicating whether the participant met the 2008 Department of Health and Human Services physical activity guideline of engaging in muscle-strengthening activity on 2 days and engaging in either 20 min of vigorous-intensity activity on at least 4 days or 30 min of moderate-intensity activity on at least 5 days in the previous 7 days.


Secondary Outcome Measures :
  1. Weighted average physical activity [ Time Frame: up to 12 months post-intervention ]
    The weighted average physical activity is calculated by averaging days of vigorous and moderate aerobic activity, giving the average a weight of 5 and the days of strength building activity a weight of 2, taking the sum, and dividing the sum by 7.

  2. Adherence to 5-a-Day diet guideline [ Time Frame: up to 12 months post-intervention ]
    A binary variable indicating whether the participant met the 5-a-Day guideline of consuming at least 5 servings of fruit and vegetables daily in the previous 30 days



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 years or older
  • Self-identify as Black or African American
  • Receiving ART for HIV

Exclusion Criteria:

  • Blood pressure of 180/110 mm Hg or higher
  • Plan to relocate beyond a reasonable distance from the study in the next 18 months or do not have an address where they can receive mail
  • Participated in any health promotion intervention trial targeting physical activity, diet, or prostate or colon cancer screening in the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572414


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: John B Jemmott III, PhD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02572414    
Other Study ID Numbers: 813202
R01MD006232 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Cardiovascular Diseases