Chronic DiseaseNCT02362737
Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men
A study testing Active and Healthy Brotherhood (AHB) in people with Chronic Disease and Obesity, run by Gramercy Research Group at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Obesity, Hypertension
- What is being tested?
- Active and Healthy Brotherhood (AHB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Gramercy Research Group
Winston-Salem, North Carolina, 27106
About this study
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.
- Conditions
- Chronic Disease, Obesity, Hypertension, Diabetes, Self Care, Medication Adherence
- Being tested
- Active and Healthy Brotherhood (AHB)
- Medical subject headings
- Chronic Disease, Obesity, Hypertension, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active and Healthy Brotherhood (AHB)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active and Healthy Brotherhood (AHB) | Experimental | 16-week behavioral intervention Receives: Behavioral: Active and Healthy Brotherhood (AHB) |
| Control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 months, 12 months
Change sedentary behavior (minutes per week of sedentary behavior).
Minutes per week of sedentary behavior
Measured: 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
Measured: baseline, 6 months, 12 months
Change stress management.
Identification of issues and strategies that affect stress management
Measured: baseline, 6 months, 12 months
Change help-seeking behaviors (Medication adherence and doctor/ER visits).
Medication adherence and doctor/ER visits
Measured: baseline, 6 months, 12 months
Secondary outcomes (4)
Change blood pressure.
Measured: baseline, 6 months, 12 months
Change body weight.
Measured: baseline, 6 months, 12 months
Change blood glucose.
Measured: baseline, 6 months, 12 months
Change HbA1c.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gramercy Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Arizona State University, Project Brotherhood, University of North Carolina, Chapel Hill, Vanderbilt University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362737
- Sponsor's protocol ID
- AD-1403-11098
- Status last verified
- Aug 2017
- First submitted
- 30 Jan 2015
- Last updated
- 3 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men
- ClinicalTrials.gov ID
- NCT02362737
- Acronym / sponsor ID
- AD-1403-11098
- Conditions
- Chronic Disease, Obesity, Hypertension, Diabetes, Self Care, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Gramercy Research GroupUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Arizona State University, Project Brotherhood, University of North Carolina, Chapel Hill, Vanderbilt University
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active and Healthy Brotherhood (AHB) | Experimental | Behavioral: Active and Healthy Brotherhood (AHB)16-week behavioral intervention |
| Control | No intervention | –Usual care. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Active and Healthy Brotherhood (AHB) |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
Related trials for Chronic Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active and Healthy Brotherhood (AHB) in people with Chronic Disease and Obesity, run by Gramercy Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA). (time frame: baseline, 6 months, 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.