Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men
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ClinicalTrials.gov Identifier: NCT02362737 |
Recruitment Status : Unknown
Verified August 2017 by Gramercy Research Group.
Recruitment status was: Active, not recruiting
First Posted : February 13, 2015
Last Update Posted : August 3, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Disease Obesity Hypertension Diabetes Self Care Medication Adherence | Behavioral: Active and Healthy Brotherhood (AHB) | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Active and Healthy Brotherhood (AHB)
16-week behavioral intervention
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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.
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- 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
- Change sedentary behavior (minutes per week of sedentary behavior). [ Time Frame: baseline, 6 months, 12 months ]Minutes per week of sedentary behavior
- 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
- Change stress management. [ Time Frame: baseline, 6 months, 12 months ]Identification of issues and strategies that affect stress management
- Change help-seeking behaviors (Medication adherence and doctor/ER visits). [ Time Frame: baseline, 6 months, 12 months ]Medication adherence and doctor/ER visits
- Change blood pressure. [ Time Frame: baseline, 6 months, 12 months ]
- Change body weight. [ Time Frame: baseline, 6 months, 12 months ]
- Change blood glucose. [ Time Frame: baseline, 6 months, 12 months ]
- Change HbA1c. [ Time Frame: baseline, 6 months, 12 months ]

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Ages Eligible for Study: | 21 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- AA (based on self-report)
- self-reported male
- aged at least 21 years
- non-institutionalized (i.e., community-dwelling, not living in assisted living facilities, nursing homes, etc.)
- 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
- currently diagnosed with diabetes, hypertension, or cardiovascular disease
- residents of Forsyth County, NC (or surrounding areas and able to attend group sessions in Forsyth County).
Exclusion Criteria:
- have had a cardiovascular procedure (e.g., heart surgery), heart attack, heart failure, stroke in the last 6 months
- 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.
- 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.
- are currently enrolled in a chronic disease management program.
- are unwilling to accept randomization assignment or planning to move from local area in <2 years.
- 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:
- 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.
- have BP>180/>110 and/or HbA1C>12 and/or triglycerides >500.
- have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362737
United States, North Carolina | |
Gramercy Research Group | |
Winston-Salem, North Carolina, United States, 27106 |
Responsible Party: | Gramercy Research Group |
ClinicalTrials.gov Identifier: | NCT02362737 |
Other Study ID Numbers: |
AD-1403-11098 |
First Posted: | February 13, 2015 Key Record Dates |
Last Update Posted: | August 3, 2017 |
Last Verified: | August 2017 |
Chronic Disease Disease Attributes Pathologic Processes |