292 Ethnicity & Disease, Volume 15, Spring 2005 PERCEPTIONS OF AFRICAN-AMERICAN CULTURE AND IMPLICATIONS FOR CLINICAL TRIAL DESIGN Objective: To identify unique cultural vari- ables for African Americans that might limit the effectiveness of behavioral interventions in clinical trials. Design: Focus group discussions lasting 90 minutes. Setting: Outpatient, clinical research center. Patients: Twenty-six African-American men and women, who completed the screening process but were ineligible for the PREMIER study, participated in six focus group sessions. PREMIER is a multicenter, randomized clinical trial that studies the effects of three different lifestyle interventions designed to reduce blood pressure without medication. Measurements and Main Results: Partici- pants used a value sort of cultural character- istics to select items that make them unique as African Americans. The following seven themes were consistently identified: 1) exten- sive use of nontraditional support systems; 2) general mistrust of European Americans; 3) Af- rican Americans’ being undervalued as human beings and members of American society; 4) effective use of improvisation; 5) uneven play- ing field as a result of persistent discrimination; 6) preservation of a unique ethnic identity; 7) socioeconomic status as a major influence and predictor of behaviors. Conclusions: Cultural variables can affect African-American perceptions of the feasi- bility of certain behavior modifications as health interventions and their perceptions of clinical research. Using these themes, inves- tigators can design trials and interventions that capitalize on certain cultural variables and avoid strategies that conflict with others. The identification of such cultural character- istics unique to African Americans may help to enhance the outcomes achieved by Afri- can Americans in clinical trials, improving the generalizability of results from behavior modification research. (Ethn Dis. 2005;15: 292–299) Key Words: African American, Clinical Trial, Culture, Focus Group From Duke Hypertension Center, Duke University Medical Center, Durham (JDA, RD, LPS); University of North Carolina, Chapel Hill (LCE); North Carolina. Jamy D. Ard, MD; Raegan W. Durant, MD; Lori Carter Edwards, PhD; Laura P. Svetkey, MD, MHS INTRODUCTION Major, multicenter, randomized, controlled clinical trials have demon- strated the effectiveness of lifestyle in- terventions for weight loss, blood pres- sure reduction and diabetes control. 1–4 However, closer inspection of some of these trials reveals that for a given in- tervention, African-American partici- pants were less successful at modifying cardiovascular disease (CVD) risk fac- tors than non-African Americans. 4,5 Dif- ferences in outcomes could be attribut- ed to a lack of efficacy of the given in- tervention in African-American popu- lations. However, few data support this argument. On the contrary, significant evidence from subgroup analyses of feeding studies such as DASH and DASH-Sodium suggests that the effica- cy of a healthy dietary pattern is more dramatic for African Americans than non-African Americans. 6,7 However, we have struggled to demonstrate effective- ness in the typical clinical trial setting for the African-American population. One variable that might impede the demonstration of effectiveness is cul- ture. Culture can logically be considered a potential effect modifier because health behaviors such as physical activ- ity, body weight, and dietary patterns are strongly influenced by culture. 8,9 Culture, as defined by Resnicow et al, is a highly specific pool of information, categories, rules for categorization, in- tersubjective meanings, collective repre- Address correspondence and reprint re- quests to Jamy D. Ard, MD; University of Alabama at Birmingham; 441 Webb Build- ing; 1675 University Boulevard; Birming- ham, AL 35294; 205-996-2181; 205-934- 7050 (fax); jamy.ard@uab.edu sentations, and ways of knowing, un- derstanding, and interpreting stimuli, as a result of a common history. 8 For Af- rican Americans, the influence of cul- ture on health behaviors and attitudes extends beyond food preferences to in- clude historical perspectives on partici- pation in clinical trials, attitudes about clinical trials, and beliefs about what a healthy lifestyle entails. 8 With such a large domain of potential influence, cul- ture can directly affect the number of African-American participants recruited, their degree of adherence to study pro- tocols, and their acceptance of a lifestyle intervention. Understanding the role these cultural factors play in promoting or inhibiting new behaviors in a clinical trial setting may be helpful in improving the outcomes of African Americans seeking to abolish unhealthy lifestyle habits and establish new, healthier habits. One useful tool for examining com- plex issues such as culture is the focus group method. Focus groups allow for a more in-depth exploration into partic- ipants’ experiences and explanation of certain beliefs and traditions. The focus group method has been used extensively in the literature to capture African- American ideas about perceptions of specific illnesses, various aspects of be- havioral interventions, and participating in clinical trials. 10–12 In general, these types of focus groups seek opinions about given diseases or areas of inter- vention from African-American partici- pants who have varying levels of expe- rience or knowledge about the topic area, ranging from minimal to extensive. Therefore, the usefulness of the partici- pants’ observations may depend on their level of experience or knowledge about the topic of discussion. In addition, lim-