Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men
1 other identifier
interventional
332
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 30, 2015
CompletedFirst Posted
Study publicly available on registry
February 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedAugust 3, 2017
August 1, 2017
2.5 years
January 30, 2015
August 2, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (4)
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
Study Arms (2)
Active and Healthy Brotherhood (AHB)
EXPERIMENTAL16-week behavioral intervention
Control
NO INTERVENTIONUsual care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gramercy Research Grouplead
- Patient-Centered Outcomes Research Institutecollaborator
- Arizona State Universitycollaborator
- Project Brotherhoodcollaborator
- University of North Carolina, Chapel Hillcollaborator
- Vanderbilt Universitycollaborator
Study Sites (1)
Gramercy Research Group
Winston-Salem, North Carolina, 27106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 13, 2015
Study Start
January 1, 2015
Primary Completion
July 1, 2017
Study Completion
June 30, 2018
Last Updated
August 3, 2017
Record last verified: 2017-08