search
Back to results

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

Primary Purpose

Hypertension, Diabetes, Sedentary Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity and Education Intervention
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AAMWI-OSU Intervention

Arm Description

In this single-arm pilot program, 100 African American male participants will be enrolled who have poor or average cardiovascular health (< 4 life's simple 7 metrics in the ideal range) to a physical activity, education and patient activation intervention.

Outcomes

Primary Outcome Measures

Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
Feasibility, as assessed via enrollment, will be measured using the baseline study procedure logs.
Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
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
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).
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 Outcome Measures

Change in cardiovascular health (blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index as a composite measure (1,2)).
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 12 weeks will be examined (Joseph et al, 2016).
Proportion of Participants with a Primary Care Provider
The change in proportion of participants with a primary care provider will be examined from 0 to 24 weeks.
Change in Patient Activation
Change in Insignia Health Patient Activation Measure will be examined from 0 to 24 weeks (Hibbard et al, 2004).

Full Information

First Posted
March 4, 2021
Last Updated
March 21, 2023
Sponsor
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT04787978
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 29, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Sedentary Behavior, High Cholesterol, Diet, Healthy, Smoking Reduction, Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm pilot program
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AAMWI-OSU Intervention
Arm Type
Experimental
Arm Description
In this single-arm pilot program, 100 African American male participants will be enrolled who have poor or average cardiovascular health (< 4 life's simple 7 metrics in the ideal range) to a physical activity, education and patient activation intervention.
Intervention Type
Other
Intervention Name(s)
Physical Activity and Education Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
Description
Feasibility, as assessed via enrollment, will be measured using the baseline study procedure logs.
Time Frame
Week 1
Title
Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
Description
Feasibility, as assessed via retention, will be measured using attendance in the study procedure logs over the course of the study.
Time Frame
24 weeks
Title
Acceptability of a 24-week community-based lifestyle intervention to change cardiovascular health among African American males
Description
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.
Time Frame
24 weeks
Title
Change in cardiovascular health (a composite measure of blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index).
Description
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).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in cardiovascular health (blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index as a composite measure (1,2)).
Description
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 12 weeks will be examined (Joseph et al, 2016).
Time Frame
12 weeks
Title
Proportion of Participants with a Primary Care Provider
Description
The change in proportion of participants with a primary care provider will be examined from 0 to 24 weeks.
Time Frame
24 weeks
Title
Change in Patient Activation
Description
Change in Insignia Health Patient Activation Measure will be examined from 0 to 24 weeks (Hibbard et al, 2004).
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell Gray, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20089546
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.
Results Reference
background
PubMed Identifier
27272340
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.
Results Reference
background
PubMed Identifier
15230939
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs