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

Obesity Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02362737
• Other study ID #: AD-1403-11098
• Status: Active, not recruiting
• Phase: N/A
• First received: January 30, 2015
• Last updated: August 2, 2017
• Start date: January 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2017
• Source: Gramercy Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 332
• Est. completion date: June 30, 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	Gramercy Research Group	Winston-Salem	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Gramercy Research Group	Arizona State University, Patient-Centered Outcomes Research Institute, Project Brotherhood, University of North Carolina, Chapel Hill, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change sedentary behavior (minutes per week of sedentary behavior).	Minutes per week of sedentary behavior	baseline, 6 months, 12 months
Primary	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
Primary	Change stress management.	Identification of issues and strategies that affect stress management	baseline, 6 months, 12 months
Primary	Change help-seeking behaviors (Medication adherence and doctor/ER visits).	Medication adherence and doctor/ER visits	baseline, 6 months, 12 months
Secondary	Change blood pressure.		baseline, 6 months, 12 months
Secondary	Change body weight.		baseline, 6 months, 12 months
Secondary	Change blood glucose.		baseline, 6 months, 12 months
Secondary	Change HbA1c.		baseline, 6 months, 12 months