Trials / Completed
CompletedNCT04787978
Creating Healthier Communities Through Meaningful Partnerships: A Model From the National African American Male Wellness Initiative - OSU Partnership
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Ohio State University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: Test feasibility and acceptability of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males. Secondary Objectives: 1) Navigate participants to establish primary care and address social and patient activation needs that present barriers to wellness; 2) Examine changes in cardiovascular health as per American Heart Association Life's Simple 7 Metrics including blood pressure, cholesterol, glucose, smoking, body mass index, physical activity and dietary intake (1); and 3) Increase African American male participation in clinical trials.
Detailed description
Chronic diseases, particularly diabetes (DM), cardiovascular disease (CVD), and cancer, pose a tremendous burden for Ohio residents, health systems, and employers. This burden is not equally distributed and mortality from these diseases is greatest among African American (AA) men. The National African American Male Wellness Initiative (AAMWI) was established in Columbus, Ohio in 2004. Through numerous events including an annual walk with health fair, the AAMWI aims to reduce premature mortality among AA males. It has become the largest health initiative in Central Ohio for AA's, spanning 5 cities in Ohio and total of 16 nationally. The Ohio State University (OSU) partners with the AAMWI to advance health equity in DM, CVD, and cancer. Through our partnership, community health workers (CHWs) and health coaches (HCs) aim to activate at-risk AA men to embrace wellness by: 1) facilitating engagement with a primary care provider and addressing social determinants of health that present barriers to wellness; 2) improving participants' "Life's Simple 7" (LS7) American Heart Association (AHA) metrics (blood pressure, cholesterol, glucose, smoking, body mass index, physical activity and dietary intake) through a community team-based intervention (Lloyd-Jones, 2010); and 3) increasing participation in clinical trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Physical Activity and Education Intervention | The intervention involves peer teams, health coaches and community health workers \[CHW\]. Each participant will be assigned to a CHW and grouped into a team of 10-20 participants based on participant proximity to a Columbus Recreation and Parks Center. Each team will be assigned 4 health coaches, 2 medical students, 1 undergraduate student and 1 nursing student from OSU Health Sciences Colleges. The lifestyle intervention is 24 weeks consisting of 1 hour and 15 minutes of in person training time per week. The training time consists of 45 minutes of physical activity and 30 minutes of educational content was informed by evidence-based strategies and stakeholder feedback. Health coaches will implement the curriculum based on the Diabetes Prevention Program and the American Heart Association Check, Change, Control Program and develop team-based SMART (specific, measurable, achievable, relevant, and time-bound) wellness goals. |
Timeline
- Start date
- 2020-02-29
- Primary completion
- 2021-01-15
- Completion
- 2021-09-06
- First posted
- 2021-03-09
- Last updated
- 2023-03-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04787978. Inclusion in this directory is not an endorsement.