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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obesity; Diabetes; Chronic Disease; Medication Adherence; Self Care
• Intervention / Treatment: Behavioral: Active and Healthy Brotherhood (AHB)

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27106
      • Gramercy Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change blood pressure.	baseline, 6 months, 12 months
Change body weight.	baseline, 6 months, 12 months
Change blood glucose.	baseline, 6 months, 12 months
Change HbA1c.	baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Gramercy Research Group
• Collaborators: Patient-Centered Outcomes Research Institute; Vanderbilt University; University of North Carolina, Chapel Hill; Arizona State University; Project Brotherhood

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: AD-1403-11098