Clinical trial NCT02362737: Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Obesity
Hypertension
Diabetes
Self Care
Medication Adherence
Lead sponsor: Gramercy Research Group
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Arizona State University
name: Project Brotherhood
name: University of North Carolina, Chapel Hill
name: Vanderbilt University
First posted: 2015-02-13
Enrollment: 332
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA).
timeFrame: baseline, 6 months, 12 months
measure: Change sedentary behavior (minutes per week of sedentary behavior).
timeFrame: baseline, 6 months, 12 months
measure: Change dietary intake (Fruit and vegetable servings, % fat, sodium and fiber intake).
timeFrame: baseline, 6 months, 12 months
measure: Change stress management.
timeFrame: baseline, 6 months, 12 months
measure: Change help-seeking behaviors (Medication adherence and doctor/ER visits).
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change blood pressure.
timeFrame: baseline, 6 months, 12 months
measure: Change body weight.
timeFrame: baseline, 6 months, 12 months
measure: Change blood glucose.
timeFrame: baseline, 6 months, 12 months
measure: Change HbA1c.
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Gramercy Research Group
state: North Carolina
Study officials:
References: