Men Together Making a Difference: Health Promotion for Black Men

NCT02572414 | Completed

• 2 other identifiers: 813202R01MD006232
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Cardiovascular Disease; Diabetes; Hypertension; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Adherence to Department of Health and Human Services physical activity guideline

  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.

  up to 12 months post-intervention

Secondary Outcomes (2)

• Weighted average physical activity

  up to 12 months post-intervention

• Adherence to 5-a-Day diet guideline

  up to 12 months post-intervention

Study Arms (2)

Health Promotion Intervention

EXPERIMENTAL

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

Health Awareness Control

ACTIVE COMPARATOR

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

Interventions

Health Promotion Intervention BEHAVIORAL

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.

Also known as: Men Together Making a Difference Intervention

Health Promotion Intervention

Health Awareness Control Intervention BEHAVIORAL

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.

Also known as: Control Intervention

Health Awareness Control

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• John B Jemmott III, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 8, 2015
• Study Start: January 8, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)