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Clinical Trials/NCT04787978
NCT04787978
Completed
Not Applicable

Creating Healthier Communities Through Meaningful Partnerships: A Model From the National African American Male Wellness Initiative - OSU Partnership

Ohio State University1 site in 1 country74 target enrollmentFebruary 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Ohio State University
Enrollment
74
Locations
1
Primary Endpoint
Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 29, 2020
End Date
September 6, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joshua Joseph, MD

Assistant Professor of Medicine

Ohio State University

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

Outcomes

Primary Outcomes

Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males

Time Frame: 24 weeks

Feasibility, as assessed via retention, will be measured using attendance in the study procedure logs over the course of the study.

Acceptability of a 24-week community-based lifestyle intervention to change cardiovascular health among African American males

Time Frame: 24 weeks

Protocol acceptability (satisfaction, usefulness, plans and change of behavior to apply health promotion strategies) will be assessed via structured questions in focus groups including satisfaction, usefulness and attainment of self-identified Specific, Measurable, Attainable, Relevant and Time-Based (SMART) goals.

Change in cardiovascular health (a composite measure of blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index).

Time Frame: 24 weeks

Cardiovascular health will be assessed with seven metrics: smoking status, diet (Diet Health Questionnaire-III), physical activity (International Physical Activity Questionnaire), body mass index (kg/m2), serum cholesterol (mg/dl) and blood pressure (mmHg) and fasting glucose (mg/dl). Each baseline metric will be scored and categorized as poor, intermediate or ideal, as specified by AHA recommendations, with consideration of medication use (i.e. antihypertensive, lipid-lowering, glucose-lowering) where appropriate (Lloyd-Jones et al, 2010). Points will be allocated for each of the seven baseline metrics with scores of 0 poor, 1 intermediate or 2 ideal with a total score ranging from 0-14. Change in this score over 24 weeks will be examined (Joseph et al, 2016).

Secondary Outcomes

  • Change in cardiovascular health (blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index as a composite measure (1,2)).(12 weeks)
  • Proportion of Participants with a Primary Care Provider(24 weeks)
  • Change in Patient Activation(24 weeks)

Study Sites (1)

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