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

Not Applicable

• Conditions: Hypertension; Medication Adherence; Obesity; Chronic Disease; Diabetes; Self Care
• Interventions: Behavioral: Active and Healthy Brotherhood (AHB)

• Registration Number: NCT02362737
• Lead Sponsor: Gramercy Research Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-13
• Primary Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 332

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active and Healthy Brotherhood (AHB)	Active and Healthy Brotherhood (AHB)	16-week behavioral intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change body weight.	baseline, 6 months, 12 months
Change blood glucose.	baseline, 6 months, 12 months
Change blood pressure.	baseline, 6 months, 12 months
Change HbA1c.	baseline, 6 months, 12 months

Trial Locations

Locations (1)

Gramercy Research Group; 🇺🇸 Winston-Salem, North Carolina, United States