Abstract A69: The dietary inflammatory index is associated with inflammatory biomarkers among a population of African Americans from South Carolina

Abstract Chronic, systemic inflammation is mechanistically involved in processes associated with most major chronic diseases. The Dietary Inflammatory Index (DII) was developed to measure diet-based inflammatory potential, a strong risk factor for systemic inflammation. Participants included those attending baseline measurement clinics for the Healthy Eating and Active Living in the Spirit (HEALS) educational and behavioral intervention (2009-2012). HEALS, a randomized control trial set in faith-based communities, enrolled African Americans (AA) at high risk of chronic inflammation and related diseases. Baseline data were utilized for these analyses. Prior to each clinic visit, participants completed a questionnaire packet to assess demographic characteristics, physical activity, sleep habits (Pittsburgh Sleep Quality Index), health history, depression/stress, and social desirability, approval, and support. Dietary data were collected using a 144-item food frequency questionnaire (FFQ) which was modified based on the Block/NCI instrument. Dietary data from this FFQ, processed using the Nutrient Data System for Research (version 2012, Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota) was used to compute the DII. The DII is comprised of various micro and macronutrients, as well as several individual food items (collectively termed ‘food parameters’); each of which has an inflammatory effect score based on research from 1,943 diet and inflammation research articles. A “world” database (11 populations from around the world) consisting of means and standard deviations for the food parameters was subtracted from an individual's actual dietary intake and divided by its standard deviation, creating a z-score, which were centered around 0 and multiplied by the inflammatory effect score. These were summed across all parameters to create the overall DII score, which were categorized into quartiles. During clinic visits, participants had their blood pressure, height, weight, and percent body fat (via bioelectrical impedance assessment) measured. Physical activity levels were measured using Bodymedia's SenseWear® physical activity armband monitors. Blood samples were collected to characterize inflammatory biomarkers (i.e., high-sensitivity c-reactive protein [CRP] and interleukin-6 [IL-6]). In addition to using quantile regression for the main analyses, logistic regression was utilized when CRP was categorized as ≤3.0mg/L vs. &amp;gt;3.0mg/L. The population was middle-aged (average = 56.9±11.3 years), obese (mean BMI=32.6±6.9kg/m2) and primarily female (80%). Various population characteristics were described according to DII quartiles. Higher DII values were associated with younger age, being married or living with a partner, being employed fulltime, and having a higher BMI. Quantile regression was used to estimate the adjusted 25th, 75th, and 90th percentiles of both CRP and IL-6. The 75th and 90th percentiles of CRP for the fourth quartile of the DII were significantly greater than for the first DII quartile (β0.75=3.95, 95% confidence interval [95%CI]=1.71-6.19; β0.90=6.83, 95%CI=1.11-12.55). No significant findings were observed for IL-6. Logistic regression analyses agreed with the quantile regression results for CRP. Those in DII quartile 4 had 3.17 times (95%CI=1.52-6.62) the odds of having CRP values greater than 3.0mg/L compared to those in DII quartile 1. This is the first construct validation of the DII in an all AA population. Chronic inflammation is a risk factor for many major chronic diseases, diseases that AA suffer from disproportionately. Therefore, the DII may serve as a useful tool to track dietary inflammatory potential among AA populations, which, in turn, may reduce risk of chronic disease among these populations. Citation Format: Michael Wirth, Nitin Shivappa, Lisa Davis, Thomas Hurley, Andrew Ortaglia, Ruby Drayton, Steven Blair, James Hebert. The dietary inflammatory index is associated with inflammatory biomarkers among a population of African Americans from South Carolina. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A69.</jats:p

Abstract B19: Developing HPV educational programs in faith-based settings: Results of a community-based participatory research study

Abstract Purpose: African-American (AA) women in South Carolina experience excess cervical cancer incidence and mortality despite reporting higher rates of screening. The reasons for this observation are complex and not well understood. The faith-based setting is potentially a model setting to address cancer disparities. The purpose was to explore the acceptance of and opportunities for providing HPV vaccine education in faith-based settings. Methods: The research was community-based and participatory and conducted in collaboration with the State Baptist Young Woman's Auxiliary Health Ministry members in Region 6, five churches (Manning Baptist Church, New Hopewell Baptist Church, Little Mt. Zion Baptist Church, Mt. Pisgah Baptist Church, and Majority Baptist Church), and Carolina Community Based Health Supports Networks. Church liaisons and community data collectors were trained to identify, recruit, and collect data from eligible participants using a closed-ended questionnaire and semi-structured guide. Descriptive data were analyzed in SAS. Qualitative data were analyzed and interpreted using constant comparison and content analysis methods. Results: A total of 20 in-depth interviews and 10 focus groups (96 participants) were conducted. All participants (n=116) were AA and the majority of participants were female (92%); were insured (95%); had completed high school or beyond (89%). The mean age of participants was 38.8 years. Less than half (41%) correctly identified HPV as a main cause of cervical cancer, but 75% of participants had heard of HPV. Most participants (77%) supported a school requirement for HPV vaccination. The in-depth interviews and focus groups provided information on the content and nature of cervical cancer prevention and control educational programs, including HPV vaccines, in faith-based settings. Most participants felt that the church was an appropriate setting for HPV education and discussions about the HPV vaccine and emphasized the importance of involving youth and adults in such efforts. While there was support for HPV vaccination, there were several comments regarding the age, safety, and unknown aspects of the HPV vaccine. Findings were presented back to participants and interested others in feedback sessions held in the partnering churches. Conclusion: Participants’ knowledge of HPV and cervical cancer was average. There was general interest and support of the HPV vaccine among participants, but participants want more information, especially regarding safety. According to participants, the church is an ideal place to conduct programs, but programs need buy-in, support, and collaboration from leaders and stakeholders. Youth and adults should be the focus of such a program planned in partnership with church leaders. There was much discussion on the importance of engaging youth. The findings from this study are encouraging and show that this population of southern, AA church members are accepting of the HPV vaccine, feel that HPV education is needed, and are receptive to an HPV and cervical cancer educational program in the church. The findings are being used to inform development of faith-based interventions to increase knowledge about HPV and cervical cancer and promote informed decision making about HPV vaccines, and potentially decrease excess cervical cancer mortality. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):B19.</jats:p

Abstract A25: Evaluating the process of implementing and disseminating a lay health-delivered prevention program in faith-based settings to address health disparities

Abstract Background: Social and behavioral determinants contribute to health disparities among African-Americans (AAs). Cancer disparities among AAs in the Southeastern United States are some of the most extreme in the United States. Community-based participatory research (CBPR) is a useful approach to reduce health disparities by actively involving members of AA churches as equal partners with different expertise to establish and deliver prevention programs. Such programs often use lay health educators from the target population with varied levels of knowledge and skills to implement prevention programs. Lay health educations must be trained appropriately for high quality implementation to ensure successful dissemination as well as the sustainability of cancer prevention programs. The purpose was to evaluate the process of involving lay health educators to deliver prevention programs to address health disparities. Methods: Using CBPR, the main goal of Dissemination and Implementation of a Diet and Activity Community Trial In Churches (DIDACTIC) is to implement an evidence-based diet and physical activity intervention called Healthy Eating and Active Living in the Spirit (HEALS), which consists of 12 weekly sessions and nine monthly booster sessions over a one-year period. The dissemination and implementation phase follows a randomized controlled trial (RCT)of HEALS from August 2008-December 2014. During the RCT phase, 54 lay health educators – church education team (CET) – were trained by the intervention coordinator to deliver HEALS in 21 AA churches in South Carolina to 438 participants. For DIDACTIC, based on lessons learned during the RCT phase, a mentoring approach to training CETs was implemented to increase capacity for future replication and to maximize sustainability. Mentors were identified from CETs during the RCT phase to assist in training and supporting implementation during DIDACTIC. In November 2014, a systematic training process began for 10 mentors who then trained 38 CETs from 11 AA churches to disseminate the HEALS program to 400 participants. Mentors and CETs complete pre- and post-test evaluations during training and two follow-up assessments 12 weeks following the weekly intervention sessions and at one year at the end of the intervention. In addition, mentors and CETs complete weekly reflection forms to assess the implementation process. Mentors observe CETs to evaluate implementation. Results: An iterative process of reviewing training evaluation data is used to make improvements. Baseline evaluation data show that after training, mentors and CETs feel knowledgeable to oversee and facilitate the HEALS program. Mentors provide regular feedback on the effectiveness of CET facilitation through observations of intervention sessions. CETs provide weekly feedback on how the intervention is being received by participants based on how they have been trained to carry out the program. In combination, evaluation efforts are providing timely, important feedback on opportunities for real-time improvement for dissemination and implementation. Involving members of the target population as implementers has been important to the intervention delivery process as well as efforts to address health disparities. Conclusion: The process of training lay health educators allows prevention programs to be culturally- and contextually-appropriate in the AA church. So far, we have seen much enthusiasm from CETs from our first three waves of DIDACTIC to be mentors for future waves, thus establishing a pipeline for sustainability by increasing individual capacity and agency to deliver prevention programs. We therefore anticipate high potential for replication among other churches in the state. It is our long term goal to use the results to improve the training of mentors and CETs in order to optimize outcomes of cancer prevention programs and their sustainability to address health disparities. Citation Format: Andrea S. Gibson, Heather M. Brandt, Asa Revels, Lisa Davis, Camille Peay, Jacqueline Talley, Cassandra Wineglass, Ruby F. Drayton, James R. Hebert. Evaluating the process of implementing and disseminating a lay health-delivered prevention program in faith-based settings to address health disparities. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A25.</jats:p

Abstract A27: Effects of the Healthy Eating and Active Living in the Spirit (HEALS) educational and behavioral intervention on inflammation among an African American faith community

Abstract The Healthy Eating and Active Living in the Spirit (HEALS) educational and behavioral intervention (2009-2012) was designed to test the effect of a diet, physical activity, and stress reduction intervention on inflammation levels in African Americans at high risk of chronic inflammation and disease in a faith-based community. African-American churches, located in and around Columbia, South Carolina were randomized into a 12-month intervention arm or delayed-intervention arm that served as the study's control group. The 12-week intervention included weekly sessions on cooking, healthy recipes, physical activity, stress reduction, and tracking weight and blood pressure. After the 12-week intervention, participants were invited to attend monthly booster sessions for an additional 9 months to reinforce and expand on topics introduced in the initial 12-week phase. Control churches had to delay the intervention until after churches randomized to the intervention first completed the 12-month follow-up. Participants attended clinics at baseline, 12 weeks (immediately post-intervention for the intervention group), and at 1-year. Prior to each clinic visit participants completed a questionnaire packet to assess demographic characteristics, dietary intake, physical activity, depression/stress, health history, sleep habits, social support, and social desirability and approval. During clinic visits, participants had their blood pressure, height, weight, and percent body fat (via bioelectrical impedance assessment) measured. Physical activity levels were objectively measured using Bodymedia's SenseWear® physical activity armband monitors. Blood samples were collected to characterize inflammatory biomarkers (i.e., high-sensitivity c-reactive protein [CRP] and interleukin-6 [IL-6]). Of the 627 potential participants from randomized churches, 434 attended clinic 1 (baseline, 233 intervention, 201 controls). Clinic 2 (12-weeks from baseline) was attended by 155 intervention and 155 control arm participants. A total of 113 intervention arm and 128 control arm participants attended Clinic 3 (12 months from baseline). The average age of the study population was 56.9±11.3 and the population was primarily female (80%) and obese (BMI=32.6±6.9kg/m2). Baseline lifestyle factors associated with inflammatory biomarkers included total active energy expenditure (quartile 4 compared to quartile 1: CRP = 2.0 vs. 3.6 mg/L, p=0.01) and minutes of moderate-to-vigorous physical activity minutes (quartile 4 compared to quartile 1: CRP=1.7 vs. 4.5 mg/L, p&amp;lt;0.01; IL-6=1.5 vs. 2.1 pg/mL, p=0.01). Among male participants, the intervention group had significantly lower mean adjusted CRP values compared to controls (2.6 vs. 3.7mg/L, p=0.05) at the 12-week follow-up. However, this finding was not observed among female participants. At the 1-year follow-up no statistically significant differences for inflammatory markers between intervention and control arms were observed overall or separately in males and females. However, among male participants the difference in CRP between intervention and controls remained but was not statistically significant (2.6 vs. 3.9, p=0.17). A more beneficial effect from this diet, physical activity, and stress reduction behavioral and educational intervention was observed among African-American male participants than among African-American female participants. It is possible that a more intensive intervention is necessary to evince and sustain more noticeable changes in inflammation levels. Additionally, targeting those who are more motivated to make lifestyle changes may increase effectiveness of future lifestyle interventions. Citation Format: Michael D. Wirth, James R. Hebert, Heather M. Brandt, Lisa Davis, Briana Davis, Brook E. Harmon, Thomas G. Hurley, Ruby Drayton, Swann A. Adams, Steven N. Blair. Effects of the Healthy Eating and Active Living in the Spirit (HEALS) educational and behavioral intervention on inflammation among an African American faith community. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A27.</jats:p

Abstract 1764: Predictors of participants’ retention among African Americans in the Healthy Eating and Living in The Spirit (HEALS) trial

Abstract Background: Recruitment and retention of minority racial/ethnic groups is necessary to assess and address cancer health disparities in the United States. The objective of this study was to characterize participants’ retention status and identify baseline participant factors associated with retention among an entirely African American (AA) population in a randomized controlled trial (RCT). Methods: Using data from the Healthy Eating and Living in the Spirit (HEALS) program, an RCT conducted from 2009 to 2012 among AAs in South Carolina we examined participant-level factors associated with retention. We used SAS v9.4 to compute chi square tests and fit logistic regressions in order to compare 220 (53.14%) retained to 194 not-retained participants with the goal of identifying important predictors of retention. Among the entire study population, main predictor variable of interest was network distance in miles from home of participants to the clinic venue (i.e. their church) whereas among participants randomized to the intervention arm, a second predictor was percentage of intervention classes attended. Results: Baseline characteristics that were significantly associated with retention status included group assignment, age, body mass index (BMI), distance from home to clinic site(s), and partner enrollment in the study. Participants who lived in locations &amp;gt;5 miles from the clinic sites were more likely to be retained in the study (OR = 1.58; 95% CI: 1.04 - 2.4) compared to participants who lived &amp;lt;5 miles away from the clinic. Older participants (&amp;gt;60 years) were 3.3 times as likely (95% CI: 1.59 - 6.81) than those aged &amp;lt; 41 years to be retained while individuals randomized to the control group were more likely to be retained (OR = 1.63; 95% CI: 1.06 - 2.50) compared with those randomized to the study group. Those who were obese were less likely to be retained (OR = 0.37; 95% CI: 0.17 - 0.79) compared to those who had normal BMI. Participants who had their partner enrolled in the study were less likely to be retained (OR = 0.59; 95% CI: 0.36-0.95) compared with participants who did not have their partners enrolled. Among individuals randomized to the intervention arm, attending 60% of the classes in the first 3 months of the RCT was strongly predictive of being retained in the study with an odds ratio of 4.31 (95% CI: 2.25 - 8.24) compared with those who did not complete 60% of the classes. Conclusions: Participants who lived further away (&amp;gt;5 miles) and attending 60% or more of the intervention classes was strongly predictive of being retained in the study. Ensuring that there is a run-in period as part of the screening procedure for all participants before randomization will help project managers to identify participants that are likely to be retained in the study and more studies need to be done to know why those who lived farther away were more likely to be retained. Citation Format: Oluwole A. Babatunde, Swann A. Adams, Michael D. Wirth, Jan M. Eberth, Jameson Sofge, Brook Harmon, Lisa Davis, Ruby Drayton, Tom Hurley, Heather M. Brandt, James R. Hebert. Predictors of participants’ retention among African Americans in the Healthy Eating and Living in The Spirit (HEALS) trial. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 1764.</jats:p

A Comparison of a Centralized Versus De-centralized Recruitment Schema in Two Community-Based Participatory Research Studies for Cancer Prevention

Use of community-based participatory research (CBPR) approaches is increasing with the goal of making more meaningful and impactful advances in eliminating cancer-related health disparities. While many reports have espoused its advantages, few investigations have focused on comparing CBPR-oriented recruitment and retention. Consequently, the purpose of this analysis was to report and compare two different CBPR approaches in two cancer prevention studies. We utilized frequencies and chi-squared tests to compare and contrast subject recruitment and retention for two studies that incorporated a randomized, controlled intervention design of a dietary and physical activity intervention among African Americans. One study utilized a de-centralized approach to recruitment in which primary responsibility for recruitment was assigned to the general AA community of various church partners whereas the other incorporated a centralized approach to recruitment in which a single lay community individual was hired as research personnel to lead recruitment and intervention delivery. Both studies performed equally well for both recruitment and retention (75 and 88% recruitment rates and 71 and 66% retention rates) far exceeding those rates traditionally cited for cancer clinical trials (~5%). The de-centralized approach to retention appeared to result in statistically greater retention for the control participants compared to the centralized approach (77 vs 51%, P<0.01). Consequently, both CBPR approaches appeared to greatly enhance recruitment and retention rates of AA populations. We further note lessons learned and challenges to consider for future research opportunities