HypertensionNCT04787978
Creating Healthier Communities Through Meaningful Partnerships: A Model From the National African American Male Wellness Initiative - OSU Partnership
A study testing Physical Activity and Education Intervention in people with Hypertension and Diabetes, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypertension, Diabetes, Sedentary Behavior
- What is being tested?
- Physical Activity and Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2020to 6 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-English speaking
- Living outside of the Metro Columbus Area
- Unable to perform physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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.
Read the 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
- Hypertension, Diabetes, Sedentary Behavior, High Cholesterol, Diet, Healthy, Smoking Reduction
- Being tested
- Physical Activity and Education Intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus, Sedentary Behavior, Hypercholesterolemia, Smoking Reduction, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity and Education InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical Activity and Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)).
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).
Measured: 12 weeks
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.
Measured: 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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start29 Feb 2020
- Primary completion15 Jan 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm pilot program
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Joseph, MD, Ohio State University
- Investigators
- Darrell Gray, MD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787978
- Sponsor's protocol ID
- 2019H0302
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20089546Joseph 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.
PubMed 27272340Hibbard 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.
PubMed 15230939Joseph 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.
PubMed 38195473
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Healthier Communities Through Meaningful Partnerships: A Model From the National African American Male Wellness Initiative - OSU Partnership
- ClinicalTrials.gov ID
- NCT04787978
- Acronym / sponsor ID
- 2019H0302
- Conditions
- Hypertension, Diabetes, Sedentary Behavior, High Cholesterol, Diet, Healthy, Smoking Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 29 Feb 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm pilot program
| Arm | Type | Receives |
|---|---|---|
| AAMWI-OSU Intervention | Experimental | Other: Physical Activity and Education InterventionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Non-English speaking
- Living outside of the Metro Columbus Area
- Unable to perform physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity and Education InterventionThe 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. | Other | AAMWI-OSU Intervention |
Primary outcome
Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males
Time frame: Week 1
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
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).
3 secondary outcomes
Change in cardiovascular health (blood pressure, cholesterol, glucose, physical activity, smoking status, and body mass index as a composite measure (1,2)).
Time frame: 12 weeks
Proportion of Participants with a Primary Care Provider
Time frame: 24 weeks
Change in Patient Activation
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 20089546Lloyd-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.
- Background: PubMed 27272340Joseph 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.
- Background: PubMed 15230939Hibbard 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.
- Derived from this study: PubMed 38195473Joseph 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrell Gray, MD study director
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Education Intervention in people with Hypertension and Diabetes, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a 24-week community-based lifestyle intervention to improve cardiovascular health among African American males (time frame: Week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787978, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.