Men Together Making a Difference: Health Promotion for Black Men

NCT02572414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2019-02-06

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • John B Jemmott III, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-08
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02572414 on ClinicalTrials.gov