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

Primary Purpose

Chronic Disease, Obesity, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active and Healthy Brotherhood (AHB)
Sponsored by
Gramercy Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease

Eligibility Criteria

21 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Gramercy Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active and Healthy Brotherhood (AHB)

Control

Arm Description

16-week behavioral intervention

Usual care.

Outcomes

Primary Outcome Measures

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
Change sedentary behavior (minutes per week of sedentary behavior).
Minutes per week of sedentary behavior
Change dietary intake (Fruit and vegetable servings, % fat, sodium and fiber intake).
Fruit and vegetable servings, % fat, sodium and fiber intake
Change stress management.
Identification of issues and strategies that affect stress management
Change help-seeking behaviors (Medication adherence and doctor/ER visits).
Medication adherence and doctor/ER visits

Secondary Outcome Measures

Change blood pressure.
Change body weight.
Change blood glucose.
Change HbA1c.

Full Information

First Posted
January 30, 2015
Last Updated
August 2, 2017
Sponsor
Gramercy Research Group
Collaborators
Patient-Centered Outcomes Research Institute, Arizona State University, Project Brotherhood, University of North Carolina, Chapel Hill, Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02362737
Brief Title
Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gramercy Research Group
Collaborators
Patient-Centered Outcomes Research Institute, Arizona State University, Project Brotherhood, University of North Carolina, Chapel Hill, Vanderbilt University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Obesity, Hypertension, Diabetes, Self Care, Medication Adherence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active and Healthy Brotherhood (AHB)
Arm Type
Experimental
Arm Description
16-week behavioral intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Behavioral
Intervention Name(s)
Active and Healthy Brotherhood (AHB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA).
Description
Minutes per week in Total physical activity (PA) and light, moderate, vigorous PA
Time Frame
baseline, 6 months, 12 months
Title
Change sedentary behavior (minutes per week of sedentary behavior).
Description
Minutes per week of sedentary behavior
Time Frame
baseline, 6 months, 12 months
Title
Change dietary intake (Fruit and vegetable servings, % fat, sodium and fiber intake).
Description
Fruit and vegetable servings, % fat, sodium and fiber intake
Time Frame
baseline, 6 months, 12 months
Title
Change stress management.
Description
Identification of issues and strategies that affect stress management
Time Frame
baseline, 6 months, 12 months
Title
Change help-seeking behaviors (Medication adherence and doctor/ER visits).
Description
Medication adherence and doctor/ER visits
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change blood pressure.
Time Frame
baseline, 6 months, 12 months
Title
Change body weight.
Time Frame
baseline, 6 months, 12 months
Title
Change blood glucose.
Time Frame
baseline, 6 months, 12 months
Title
Change HbA1c.
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 >500. have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)
Facility Information:
Facility Name
Gramercy Research Group
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States

12. IPD Sharing Statement

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

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