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

• ClinicalTrials.gov Identifier: NCT02362737
• Recruitment Status: Unknown
• First Posted: February 13, 2015
• Last Update Posted: August 3, 2017
• Sponsor: Gramercy Research Group
• Collaborators: Patient-Centered Outcomes Research Institute; Arizona State University; Project Brotherhood; University of North Carolina, Chapel Hill; Vanderbilt University
• Information provided by (Responsible Party): Gramercy Research Group

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Disease; Obesity; Hypertension; Diabetes; Self Care; Medication Adherence	Behavioral: Active and Healthy Brotherhood (AHB)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Study Start Date: January 2015
• Actual Primary Completion Date: July 2017
• Estimated Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active and Healthy Brotherhood (AHB); 16-week behavioral intervention	Behavioral: 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.
No Intervention: Control; Usual care.

Outcome Measures

Primary Outcome Measures :

1. Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA). [ Time Frame: baseline, 6 months, 12 months ]
   Minutes per week in Total physical activity (PA) and light, moderate, vigorous PA
2. Change sedentary behavior (minutes per week of sedentary behavior). [ Time Frame: baseline, 6 months, 12 months ]
   Minutes per week of sedentary behavior
3. Change dietary intake (Fruit and vegetable servings, % fat, sodium and fiber intake). [ Time Frame: baseline, 6 months, 12 months ]
   Fruit and vegetable servings, % fat, sodium and fiber intake
4. Change stress management. [ Time Frame: baseline, 6 months, 12 months ]
   Identification of issues and strategies that affect stress management
5. Change help-seeking behaviors (Medication adherence and doctor/ER visits). [ Time Frame: baseline, 6 months, 12 months ]
   Medication adherence and doctor/ER visits

Secondary Outcome Measures :

1. Change blood pressure. [ Time Frame: baseline, 6 months, 12 months ]
2. Change body weight. [ Time Frame: baseline, 6 months, 12 months ]
3. Change blood glucose. [ Time Frame: baseline, 6 months, 12 months ]
4. Change HbA1c. [ Time Frame: baseline, 6 months, 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 64 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, North Carolina

Gramercy Research Group

Winston-Salem, North Carolina, United States, 27106

Sponsors and Collaborators

Gramercy Research Group

Patient-Centered Outcomes Research Institute

Arizona State University

Project Brotherhood

University of North Carolina, Chapel Hill

Vanderbilt University

More Information

• Responsible Party: Gramercy Research Group
• ClinicalTrials.gov Identifier: NCT02362737
• Other Study ID Numbers: AD-1403-11098
• First Posted: February 13, 2015
• Last Update Posted: August 3, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

Chronic Disease; Disease Attributes; Pathologic Processes