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

NCT04787978 | Completed

• 1 other identifier: 2019H0302
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes; Sedentary Behavior; High Cholesterol; Diet, Healthy; Smoking Reduction; Weight Loss

Outcome Measures

Primary Outcomes (4)

• 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.

  Week 1

• 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.

  24 weeks

• 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.

  24 weeks

• 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).

  24 weeks

Secondary Outcomes (3)

• 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 Arms (1)

AAMWI-OSU Intervention

EXPERIMENTAL

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.

Other: Physical Activity and Education Intervention

Interventions

Physical Activity and Education Intervention OTHER

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.

AAMWI-OSU Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

• 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.

  PMID: 20089546 BACKGROUND

• 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.

  PMID: 27272340 BACKGROUND

• 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.

  PMID: 15230939 BACKGROUND

• Joseph JJ, Nolan TS, Brock G, Williams A, Zhao S, McKoy A, Kluwe B, Metlock F, Campanelli K, Odei JB, Khumalo MT, Lavender D, Gregory J, Gray DM. Improving mental health in black men through a 24-week community-based lifestyle change intervention: the black impact program. BMC Psychiatry. 2024 Jan 9;24(1):34. doi: 10.1186/s12888-023-05064-5.

  PMID: 38195473 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Sedentary Behavior; Hypercholesterolemia; Smoking Reduction; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Health Behavior; Smoking; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Darrell Gray, MD

  Ohio State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: single-arm pilot program

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: February 29, 2020
• Primary Completion: January 15, 2021
• Study Completion: September 6, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)