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Clinical Trials/NCT02362737
NCT02362737
Unknown
Not Applicable

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

Gramercy Research Group1 site in 1 country332 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Gramercy Research Group
Enrollment
332
Locations
1
Primary Endpoint
Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA).
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 30, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Gramercy Research Group
Responsible Party
Sponsor

Eligibility Criteria

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 \>
  • have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)

Outcomes

Primary Outcomes

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 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 sedentary behavior (minutes per week of sedentary behavior).

Time Frame: baseline, 6 months, 12 months

Minutes per week of sedentary behavior

Change help-seeking behaviors (Medication adherence and doctor/ER visits).

Time Frame: baseline, 6 months, 12 months

Medication adherence and doctor/ER visits

Secondary Outcomes

  • 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)

Study Sites (1)

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