Clinical trial NCT04787978: Creating Healthier Communities Through Meaningful Partnerships: A Model From the National African American Male Wellness Initiative - OSU Partnership
Official title: Creating Healthier Communities Through Meaningful Partnerships: A Model From the National African American Male Wellness Initiative - OSU Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Sedentary Behavior
High Cholesterol
Diet, Healthy
Smoking Reduction
Weight Loss
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm pilot program
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* African American men (self-report)
* Adult age 18 years or older
* Poor or average cardiovascular health (\< 4 LS7 metrics in the ideal range) from the American Heart Association 2020 Guidelines
* Participant is appropriate for group setting.

Exclusion Criteria:

* Non-English speaking
* Living outside of the Metro Columbus Area
* Unable to perform physical activity

Primary outcomes:
measure: Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
timeFrame: Week 1
measure: Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
timeFrame: 24 weeks
measure: Acceptability of a 24-week community-based lifestyle intervention to change cardiovascular health among African American males
timeFrame: 24 weeks
measure: Change in cardiovascular health (a composite measure of blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index).
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in cardiovascular health (blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index as a composite measure (1,2)).
timeFrame: 12 weeks
measure: Proportion of Participants with a Primary Care Provider
timeFrame: 24 weeks
measure: Change in Patient Activation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Darrell Gray, MD
role: STUDY_DIRECTOR
References:
citation: Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Van Horn L, Greenlund K, Daniels S, Nichol G, Tomaselli GF, Arnett DK, Fonarow GC, Ho PM, Lauer MS, Masoudi FA, Robertson RM, Roger V, Schwamm LH, Sorlie P, Yancy CW, Rosamond WD; American Heart Association Strategic Planning Task Force and Statistics Committee. Defining and setting national goals for cardiovascular health promotion and disease reduction: the American Heart Association's strategic Impact Goal through 2020 and beyond. Circulation. 2010 Feb 2;121(4):586-613. doi: 10.1161/CIRCULATIONAHA.109.192703. Epub 2010 Jan 20.
citation: Joseph JJ, Echouffo-Tcheugui JB, Carnethon MR, Bertoni AG, Shay CM, Ahmed HM, Blumenthal RS, Cushman M, Golden SH. The association of ideal cardiovascular health with incident type 2 diabetes mellitus: the Multi-Ethnic Study of Atherosclerosis. Diabetologia. 2016 Sep;59(9):1893-903. doi: 10.1007/s00125-016-4003-7. Epub 2016 Jun 8.
citation: Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.