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NCT02572414 · ClinicalTrials.gov registry record · NA
Men Together Making a Difference: Health Promotion for Black Men
A NA study of Hypertension and Diabetes, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 302
- Enrollment target
- 1
- Study location
NCT02572414: Completed NA study of Hypertension and Diabetes, sponsored by University of Pennsylvania.
NCT02572414 is a NA study of Hypertension and Diabetes that has completed, run by University of Pennsylvania. The registered enrollment target is 302 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02572414, a NA study of Hypertension and Diabetes, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 302 participants
- Enrollment target
- 1
- Study location
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 te
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Health Promotion Intervention
- BEHAVIORAL Health Awareness Control Intervention
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2015-01-08 |
| Est. Completion | 2018-12 |
| Phase | NA |
What the finished NCT02572414 record still lists
NCT02572414 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Health Promotion Intervention is the first listed.
NCT02572414 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02572414 about?
NCT02572414 is a clinical study titled "Men Together Making a Difference: Health Promotion for Black Men". 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, diab...
What is the current status of trial NCT02572414?
This trial is currently completed. It is a NA study. The enrollment target is 302 participants. The study started on 2015-01-08. Estimated completion is 2018-12.
What conditions does trial NCT02572414 study?
This clinical trial studies the following conditions: Hypertension, Diabetes, HIV, Cardiovascular Disease, Colon Cancer.
What interventions are being tested in trial NCT02572414?
The interventions under investigation include: Health Promotion Intervention (BEHAVIORAL), Health Awareness Control Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02572414?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02572414 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02572414's enrollment target sits among peer trials
302 167th of 470 higher than 302 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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