Predictors of Retention among African Americans in a Randomized Controlled Trial to Test the Healthy Eating and Active Living in the Spirit (HEALS) Intervention.

INTRODUCTION: Retention of racial/ethnic minority groups into research trials is necessary to fully understand and address health disparities. This study was conducted to identify participants' characteristics associated with retention of African Americans (AAs) in a randomized controlled trial (RCT) of a behavioral intervention. METHODS: Using data from an RCT conducted from 2009 to 2012 among AAs, participant-level factors were examined for associations with retention between three measurement points (ie, baseline, 3-month, and 12-month). Chi-square tests and logistic regression analyses were conducted to compare retained participants to those who were not retained in order to identify important predictors of retention. RESULTS: About 57% of participants (n=238) were retained at 12 months. Baseline characteristics that showed a statistically significant association with retention status were age, marital status, body mass index (BMI), intervention group, enrollment of a partner in the study, and perceived stress score (PSS). Multivariable logistic regression that adjusted for age, BMI, and PSS showed the odds of being retained among participants who enrolled with a partner was 2.95 (95% CI: 1.87-4.65) compared with participants who had no study partner enrolled. The odds of being retained among participants who were obese and morbidly obese were .32 and .27 (95% CI: .14-.74 and .11-.69), respectively, compared with participants who had normal weight. CONCLUSION: Having a partner enrolled in behavioral interventions may improve retention of study participants. Researchers also need to be cognizant of participants' obesity status and potentially target retention efforts toward these individuals.

The association of C-reactive protein and physical activity among a church-based population of African Americans.

OBJECTIVE: Regular physical activity can reduce systemic inflammation and, thereby, the burden of chronic inflammatory-related conditions. This study examined whether regular physical activity, measured subjectively (Rapid Assessment of Physical Activity [RAPA]) and objectively (Bodymedia's SenseWear® activity monitor [SWA]), is associated with inflammatory or glycemic control markers. METHODS: Subjects were 345 participants of the Healthy Eating and Active Living in the Spirit (HEALS) lifestyle intervention among African American (AA) churches in South Carolina from 2009 to 2012. Linear regression analyses were performed to assess the relationship between both subjectively and objectively measured physical activity and inflammatory markers including high sensitivity C-reactive protein (CRP), interleukin-6 (IL-6), and glycosylated hemoglobin (HbA1c). RESULTS: Those who participated in regular physical activity (from RAPA) had lower CRP values compared to those who were sedentary (2.3 vs. 3.8mg/L, p<0.01). Lower levels of CRP or IL-6 were observed among those in the highest quartile of active energy expenditure (CRP: 2.0 vs. 3.6 mg/L, p=0.01) or moderate-vigorous physical activity minutes (CRP=1.7 vs. 4.5mg/L, p<0.01; IL-6=1.5 vs. 2.1pg/mL, p=0.01) compared to their lowest respective quartiles as measured by the SWA. CONCLUSION: Physical activity may improve chronic inflammation, which is a primary pathophysiological mechanism for numerous chronic disorders, especially among minority populations.

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 (AA). 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.

C-reactive protein levels in African Americans: a diet and lifestyle randomized community trial.

BACKGROUND: Chronic inflammation is linked to poor lifestyle behaviors and a variety of chronic diseases that are prevalent among African Americans, especially in the southeastern U.S. PURPOSE: The goal of the study was to test the effect of a community-based diet, physical activity, and stress reduction intervention conducted in 2009-2012 on reducing serum C-reactive protein (CRP) in overweight and obese African-American adults. METHODS: An RCT intervention was designed jointly by members of African-American churches and academic researchers. In late 2012, regression (i.e., mixed) models were fit that included both intention-to-treat and post hoc analyses conducted to identify important predictors of intervention success. Outcomes were assessed at 3 months and 1 year. RESULTS: At baseline, the 159 individuals who were recruited in 13 churches and had evaluable outcome data were, on average, obese (BMI=33.1 [±7.1]) and had a mean CRP level of 3.7 (±3.9) mg/L. Reductions were observed in waist-to-hip ratio at 3 months (2%, p=0.03) and 1 year (5%, p<0.01). In female participants attending ≥60% of intervention classes, there was a significant decrease in CRP at 3 months of 0.8 mg/L (p=0.05), but no change after 1 year. No differences were noted in BMI or interleukin-6. CONCLUSIONS: In overweight/obese, but otherwise "healthy," African-American church members with very high baseline CRP levels, this intervention produced significant reductions in CRP at 3 and 12 months, and in waist-to-hip ratio, which is an important anthropometric predictor of overall risk of inflammation and downstream health effects. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01760902.