BACKGROUND: Understanding the reach and representativeness of participants enrolled in behavioral trials, including nutrition and physical activity trials, helps inform the generalizability of study findings and potential public health impacts. Exploring the reach and representativeness of trials that target low socioeconomic and low health literate participants in rural and medically underserved areas, such as southwest Virginia (SWVA), is especially important. The proposed research is part of Talking Health, a six-month, pragmatic randomized-control trial aimed at decreasing sugar-sweetened beverage (SSB) consumption (SIPsmartER) as compared to matched contact control targeting improving physical activity (MoveMore). This community-based trial targets an 8-county region in SWVA. OBJECTIVES: Guided by the reach dimension of the RE-AIM framework, the primary objectives of this study were to determine if eligible and enrolled participants in the Talking Health trial were representative of: 1) eligible, but declined participants, and 2) the broader targeted 8-county region based on 2010 US county level census data. We hypothesized that eligible and enrolled participants would be represented in terms of age, race, ethnicity, educational attainment, income, and health literacy when compared to eligible and declined participants, as well as to the broader US census data. We also hypothesized that males would be underrepresented. METHODS: Eligibility requirements for the study included being 18 years of age or older, having reliable access to a telephone, drinking 200 kilocalories of SSB per day, and being a resident of SWVA. A variety of recruitment strategies were used such as active recruitment at health departments, free clinics, and local businesses with help from Virginia Cooperative Extension agents along with passive methods such as flyers, newspaper ads, and word of mouth. The eligibility screener included basic demographic information such as gender, age, race, marital status, occupation, income, educational attainment, number of children in household, and insurance provider. The screener also had three validated subjective health literacy questions. Statistical analysis included descriptive statistics, independent sample t-tests, Chi-square tests, and One Way ANOVA tests to examine the representativeness of enrolled participants. RESULTS: In total, 1,056 participants were screened, 620 were eligible (58.7%), and 301 (48.5%) enrolled. On average, demographic data for enrolled participants included: 93% Caucasian; 81.4% female; income of $23,173±$17,144; 32% high school (HS) education; and health literacy score 4.5±2.2(3=High, 15=Low). Among eligible participants, when comparing enrolled vs. declined participants there were significant differences (p<0.05) in educational attainment [enrolled=32% HS, declined=48% HS], health literacy scores [enrolled=4.5(2.2), declined=5.0(3.1)], gender [enrolled=81% female, declined=73% female], age [enrolled=41.8(13.4) years, declined=38.3(13.6) years], and race [enrolled=93% white, declined=88% white]. However there were no significant differences in ethnicity and income. When compared to average US Census data across the eight counties, enrolled participants had a higher educational attainment [enrolled sample=68%HS, Census=58%HS], higher proportion of females [enrolled sample=81%, Census=48%], and lower mean income [enrolled sample= $23,173, Census=$36,675]. There were no meaningful differences in terms of race and ethnicity between the enrolled sample and Census data. DISCUSSION: Contrary to our hypothesis, eligible and enrolled participants differed from non-enrolled participants in terms of age, race, education, and health literacy. Our enrolled sample was slightly older, predominately Caucasian, with higher educational attainment and higher health literacy. However, as hypothesized, there were no significant differences for ethnicity and income status, and men were underrepresented. When the study sample was compared to US Census data, the sample was well represented in terms of age, race, and ethnicity; however, enrolled participants had a much lower average annual income and a higher educational attainment. Men were also underrepresented when compared to the census data. There was no census data to compare health literacy status, which limits information regarding the representativeness of the enrolled sample. Importantly, this study has revealed the representativeness of individuals enrolled in this behavioral trial, helps inform the generalizability of study findings, and identifies future research for community-based studies targeting rural and medically underserved areas in SWVA. For example, future behavioral interventions need concerted recruitment strategies to target males, individuals with lower health literacy status, and individuals with less than a high school degree. Exploring and addressing barriers for study enrollment among these sub-groups is also important. / Master of Science

Type 2 Diabetes Mellitus (T2D) is a major public health issue. Diabetes prevalence is growing and is the 7th leading cause of death in the US. Virginia has a slightly higher prevalence than the national average. Community-based diabetes lifestyle management programs that include a physical activity component are effective at improving glycemic control and influencing lifestyle behavior changes among people with T2D. The Balanced Living with Diabetes (BLD) program uses an active learning approach to improve glycemic control and healthful lifestyles. The Lifelong Improvements through Fitness Together (LIFT) program uses behavioral strategies to improve functional fitness, participant engagement, and program adherence. Participant retention is a challenge for community-based program. Participants may start the program, but then fail to complete the program and/or adhere to program recommendations. Two pilot studies were conducted to evaluate strategies for increasing participant retention and improving outcomes. The first evaluated the implementation and impact of a retention plan implemented in BLD programs conducted from 2015-2017. There were more participants returned to the reunion class session prior the development of the retention plan. There were improvements in some health behavior and self-efficacy indicators in programs that used the retention materials, however, impacts on outcomes were mixed. Preliminary findings showed that the retention plan could be a tool for providing additional support to participants, however strategies for dissemination of the retention plan needs to be reevaluated. The second study evaluated the impact on participant engagement and program outcomes when the LIFT program is incorporated with the BLD program. There was an increase in participant retention, self-efficacy and one health behavior for physical activity and health behaviors related to diet in BLD+LIFT programs. Extension Agents are willing to implement the BLD+LIFT programs, however, clarity of program logistics is needed prior to implementation. Extension Agents indicated that implementation of these programs in locations with older adults that have greater disability may not be the best locations. Having larger studies on the effect of incorporation of LIFT with the BLD with older adult populations that have fewer co-morbidities are needed to determine the impact of addition of the LIFT program with the BLD program on program outcomes. / Doctor of Philosophy / Type 2 Diabetes is a chronic disease in which the body does not use insulin as it should or does not produce enough insulin. The Centers for Disease Control and Prevention (CDC) indicates that the prevalence of diabetes was 23.1 million among US adults in 2015. The prevalence of diabetes in Virginia is slightly higher than the national average. Community-based diabetes lifestyle management programs that include a physical activity component are effective in improving glycemic control and influencing lifestyle behavior changes among people with T2D. The Balanced Living with Diabetes (BLD) program uses an active learning approach to influence better glycemic control and healthful lifestyles. The Lifelong Improvements through Fitness Together (LIFT) program uses behavioral strategies to improve functional fitness, participant engagement, and program adherence. The challenge with implementing community-based programs is retention. Participants may initially agree to participate in a program, but then fail to complete the program and/or follow program recommendations. Two pilot studies were conducted to evaluate strategies for increasing participant retention and program outcomes. The first evaluated the implementation and impact of a retention plan implemented in BLD programs conducted from 2015-2017. There were more participants returned prior to the development of the retention plan. There were improvements in some health behavior and self-efficacy indicators in programs that used the retention materials, however, impacts on outcomes were mixed. Findings showed that the retention plan could be a useful tool for providing additional support to participants, however distribution of the retention plan needs to be reevaluated. The second study evaluated the impact of program outcomes when the LIFT program is combined with the BLD program. There was an increase in participants' self-confidence to perform physical activity and making changes in their diet in BLD+LIFT groups. Extension Agents were enthusiastic about conducting more BLD+LIFT programs, however, program procedures and the time commitment needs to be understood before doing so. Expanding the conduct of BLD programs that incorporate the LIFT program can be effective in improving glycemic control and increasing physical activity, however, working with organizations that service people that have diabetes with fewer health conditions that limit physical activity may be more effective.