Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men

NCT ID: NCT02362737

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-06-30

Brief Summary

This study will test ways to improve health behaviors using an intervention that has been specially designed for African-American men. The program, called Active & Healthy Brotherhood (AHB), will provide information on basic health, and healthy eating, physical activity, stress management, and how to get medical care when needed.The AHB intervention will be compared to a control group that will receive basic health information in videos and brochures.

Conditions

Chronic Disease; Obesity; Hypertension; Diabetes; Self Care; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Active and Healthy Brotherhood (AHB)

16-week behavioral intervention

Group Type: EXPERIMENTAL

Active and Healthy Brotherhood (AHB)

Intervention Type: BEHAVIORAL

Participants will attend group sessions led by trained group facilitators. The group sessions will be \~16 weekly meetings of \~90 minutes duration for 4 months. AHB participants will also engage in experiential learning opportunities. Following the intensive intervention phase, during months 5 and 6, participants will receive three structured, individual phone calls with the group facilitator.

Control

Usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active and Healthy Brotherhood (AHB)

Participants will attend group sessions led by trained group facilitators. The group sessions will be \~16 weekly meetings of \~90 minutes duration for 4 months. AHB participants will also engage in experiential learning opportunities. Following the intensive intervention phase, during months 5 and 6, participants will receive three structured, individual phone calls with the group facilitator.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. AA (based on self-report)

2. self-reported male

3. aged at least 21 years

4. non-institutionalized (i.e., community-dwelling, not living in assisted living facilities, nursing homes, etc.)

5. at high risk for developing chronic disease (e.g., not meeting current guidelines for PA and/or F&V intake; current smoker; diagnosed with high cholesterol) or

6. currently diagnosed with diabetes, hypertension, or cardiovascular disease

7. residents of Forsyth County, NC (or surrounding areas and able to attend group sessions in Forsyth County).

Exclusion Criteria

1. have had a cardiovascular procedure (e.g., heart surgery), heart attack, heart failure, stroke in the last 6 months

2. have cognitive, visual, auditory, physical functional (e.g., unable to walk unassisted), or language impairment precluding participation in group discussion, learning activities, or data collection.

3. currently achieve >150 min/wk of moderate intensity PA or >75 min/wk of vigorous intensity PA AND currently consume > 9 servings of F&V daily.

4. are currently enrolled in a chronic disease management program.

5. are unwilling to accept randomization assignment or planning to move from local area in <2 years.

6. are currently receiving chemotherapy/radiation treatments.

Participants will be required to obtain approval from a health care provider prior to participation in the study if they:

1. are unable to participate in moderate PA due to physical limitations as indicated by positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and/or physician disapproval on the PAR Medical Examination.

2. have BP>180/>110 and/or HbA1C>12 and/or triglycerides >500.

3. have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: collaborator

Project Brotherhood

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Gramercy Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gramercy Research Group

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

AD-1403-11098

Identifier Type: -

Identifier Source: org_study_id