Results Summary
What was the research about?
Compared with men of other races in the United States, black men are more likely to have long-term, or chronic, health problems such as high blood pressure or diabetes. These problems increase their chances of poor quality of life, stroke, and early death. Healthy behaviors, such as exercising and eating fruits and vegetables, can reduce the risk of chronic health problems.
In this study, the research team wanted to learn if a program called Active & Healthy Brotherhood, or AHB, designed for black men, would help them increase their daily exercise. The team compared men in AHB with men who received basic education on managing chronic health problems. The team also looked at how AHB affected other healthy behaviors and signs of health problems, such as high blood pressure and blood sugar.
What were the results?
After 6 and 12 months, black men who were in AHB and men who received only basic education didn’t differ in overall daily exercise. But compared with men who had basic education, men in AHB had
- Larger decreases in blood pressure and sugar after 6 months
- Larger increases in steps per day after 12 months
- Larger decreases in daily calories from saturated fat and total fat at 12 months
The two groups didn’t differ in
- Time spent being inactive per day
- Body fat, blood cholesterol, and how well their kidneys worked
- Healthcare visits and how well they followed their medicine plans
- Stress management
- Quality of life
Who was in the study?
The study included 333 black men from four counties in North Carolina. Men in the study didn’t exercise often or eat enough fruits and vegetables, or they had diabetes, high blood pressure, or heart disease. The average age was 51.
What did the research team do?
The research team assigned men in the study by chance to one of the two groups. The AHB group received 1 basic education session and then 16 weekly sessions. The sessions focused on being active, eating healthy, and managing stress. They included small-group activities for the men to discuss health goals and support each other. After AHB ended, the men received three phone calls to talk about goals and ways to achieve them. The second group received the basic education session and information about improving healthy behaviors.
Men in the study wore fitness trackers. The trackers measured daily exercise, time spent being inactive, and walking. The men completed surveys about healthy behaviors at the start of the study and at follow-up visits 6 and 12 months later.
Black men served as members of the research team and provided feedback throughout the study.
What were the limits of the study?
Fewer men joined the study than the research team expected. Also, 25 percent of men in the AHB program didn’t attend any weekly sessions. These factors limited the team’s ability to see differences between AHB and basic education.
Future research could continue to look for ways to help black men improve their health and could explore better ways to engage black men in these studies.
How can people use the results?
Health educators can use these results when considering ways to help black men improve their health.
Professional Abstract
Objective
To compare the effectiveness of a culturally tailored healthy lifestyle program with education on chronic disease management in improving daily physical activity, other healthy behaviors, and health-related outcomes among African-American men with or at high risk for chronic diseases
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population |
333 African-American men with or at high risk for chronic diseases |
| Interventions/ Comparators |
|
| Outcomes |
Primary: overall daily physical activity Secondary: sedentary behavior, steps per day, dietary behavior, medication adherence, stress management, help-seeking behaviors, body mass index, blood pressure, glucose, hemoglobin A1c, serum creatinine, glomerular filtration rate, lipid panel, quality of life |
| Timeframe | 1-year follow-up for primary outcome |
Compared with men of other races in the United States, African-American men have disproportionately higher rates of chronic disease. This randomized controlled trial assessed the effectiveness of a culturally tailored healthy lifestyle program called Active & Healthy Brotherhood (AHB) for managing and reducing the risk for chronic diseases among African-American men. In a prior pilot study, the research team tailored AHB to address stressors associated with living up to gender-role norms and barriers African-American men face to being active, eating healthy, and managing stress.
In this study, the research team randomly assigned participants to AHB or to the education-only group. AHB included a basic health education session and 16 weekly sessions on building self-efficacy for healthy lifestyle skills. Sessions included small-group exercises to enhance social support and accountability for healthy lifestyle goals. After AHB, participants received three phone calls to review progress, identify barriers to healthy behaviors and solutions, recognize successes, and adjust goals. The education-only group received the basic health education session and information about improving healthy behaviors.
The study included 333 African-American men from four counties in North Carolina. Study participants were not meeting guidelines for physical activity or fruit and vegetable intake or had diabetes, hypertension, or cardiovascular disease. The average age was 51.
Study participants wore fitness trackers to measure daily physical activity, sedentary behavior, and daily walking. They also completed assessments on health-related outcomes at the beginning of the study and again at follow-up assessments 6 and 12 months later.
African-American men served as members of the research team, helped design AHB, and provided feedback throughout the study.
Results
After 6 and 12 months, participants in AHB and those men in the education-only group did not differ significantly in overall daily physical activity.
After six months, participants in AHB had larger decreases in blood pressure, hemoglobin A1c and glucose levels (all p<0.05), after adjusting for baseline values and age. These differences were not maintained at 12-month follow-up. After 12 months, participants in AHB had larger increases in steps per day and larger decreases in daily calories from saturated fat and total fat (all p<0.05), after adjusting for baseline values and age. The two groups did not differ significantly in any other secondary outcomes at either timepoint.
Limitations
The study did not reach its recruitment goal of 400 participants; 25% of participants assigned to AHB did not attend any sessions. These factors limited the study’s ability to detect effects from AHB.
Conclusions and Relevance
Although overall daily physical activity did not improve, African-American men in AHB had larger improvements in steps per day and nutrition-related outcomes compared with those men who received only education on chronic disease management.
Future Research Needs
Future research could continue to investigate ways to manage and reduce risk for chronic diseases among African-American men and to better engage African-American men as participants in clinical research studies.
Final Research Report
View this project's final research report.
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the drop-out rate was high in the study and particularly high in the intervention group, where 45.5 percent dropped out before the outcome assessment compared with 27.7 percent of the control group. This difference in drop-out rates could lead to inaccurate estimates of the effects of the intervention. The reviewers suggested comparing people across several variables to see if there were any systematic demographic or clinical differences between study participants and those who dropped out. The researchers added a statement to the limitations section about the high level of loss to follow-up and mentioned that possible differences between those who dropped out and those who did not were study limitations. They also described future analyses they planned to conduct about the impact of the intervention among individuals they identified as attenders and their plans to report these analyses in future manuscripts and presentations. The researchers stated that they are still working on the best way to define attenders, but it is likely that they will compare three groups of participants: those who attended no sessions, those who attended some sessions, and those who attended most or all of the sessions.
- The reviewers asked about the unexpected result that perceived stress scores rose for participants in the intervention group compared to the control group. The researchers added discussion to their report to explain this finding. They said that they attributed the increased scores to intervention participants becoming more aware of and acknowledging their own stress.
- The reviewers commented that the analyses for the large number of secondary outcomes, about 50, did not include statistical controls for multiple comparisons. The number of secondary outcomes reflected all of the outcomes that PCORI had funded the researchers to assess, but the lack of correction for multiple comparisons could lead to false positive results where an outcome was found to be significantly different between groups when the result was due to measurement error. The reviewers recommended adding a sentence to the analysis section about interpreting significant findings cautiously since the analyses did not control for multiple comparisons. The researchers added this language at the end of the analytical and statistical approaches subsection of the report methods. They added it again when describing baseline analyses in the results.