David G. Marrero
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The 2013 inaugural recipient of the Bantz-Petronio Translating Research into Practice Award, David G. Marrero is the J.O. Ritchey Endowed Professor of Medicine, Indiana University School of Medicine. His translational research into diabetes identification and management has shown that improving risk factors depends upon tailoring disease management programs to specific populations to better address health disparities. In a practical application of this work, he and his colleagues have developed a tablet-based program that explains what risks of cardiovascular disease an individual person has and then educates on reducing those risks. He also implemented an innovative and successful program at the YMCA to assist in the identification of persons at risk for diabetes followed by educational and behavioral interventions focused on diet and exercise. This program is now the subject of a CMS demonstration project.
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Item A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014(Preventing Chronic Disease, 2015) Weinhold, Kellie R.; Miller, Carla K.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.; Gascon, Gregg M.; Indiana University School of MedicineINTRODUCTION: Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs. This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. METHODS: A pretest-posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. RESULTS: Mean (standard error [SE]) weight loss was greater in the intervention (-5.5% [0.6%]) than in the control (-0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (-8.6 [1.6] mg/dL) than in the control (-3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention. CONCLUSION: The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation.Item Center for Pediatric Obesity and Diabetes Prevention Research(Office of the Vice Chancellor for Research, 2015-04-17) Hannon, Tamara S.; Smith, Lisa G.; Carroll, Aaron E.; Marrero, David G.Background To facilitate both research and treatment of obesity in youth who are at especially high risk for diabetes, we have created the Center for Pediatric Obesity and Diabetes Prevention Research. The mission of the center is to advance the health of vulnerable populations through obesity and diabetes prevention research focusing on mechanisms of progression from obesity to type 2 diabetes, defining best practices for obesity/diabetes prevention among youth, and cost-effective translation of the research to the community. Specific Aims 1. To promote the clinical investigation of pathophysiologic mechanisms, diagnosis, and primary prevention of type 2 diabetes among vulnerable youth 2. Foster collaboration and facilitate interdisciplinary research between investigators interested in childhood obesity and diabetes prevention 3. Participate in community-based diabetes prevention research Key Ongoing Collaborative Research Projects Youth Diabetes Prevention Clinic (YDPC) – Patient-Centered Outcomes Project This program is designed to evaluate and assess the needs of adolescents (ages 10 – 21) who have evidence of prediabetes. Our goal is to successfully intervene in the trajectory toward the development of diabetes, and to promote healthy weight-control and improved well-being through an individualized treatment plan. Not only has this allowed us to address a significant unmet clinical need, but also to advance pediatric obesity patient-centered outcomes research and comparative effectiveness research in adolescent obesity / diabetes prevention. Dietary Intervention for Glucose Intolerance in Teens (DIG-IT Study) The objective of this study is to determine the impact on glycemic control, in adolescents who have prediabetes, of an individually-tailored wellness coaching strategy used to modify lifestyle habits. Additionally, the study aims to identify lifestyle factors that drive glycemic control, independent of changes in weight. We are conducting this study in in the Youth Diabetes Prevention Clinic via a collaboration with Dr. Gletsu-Miller (Purdue University). ENCOURAGE Healthy Families Study This is a randomized trial evaluating the comparative effectiveness and costs of an adaptation of the Diabetes Prevention Program (DPP) directed at mothers and their children. The intervention is a group based lifestyle program which we developed and implemented in partnership with the YMCA. We are comparing the ENCOURAGE intervention targeted to 1) mothers who have had gestational diabetes or prediabetes, and 2) mothers who have had GDM or prediabetes along with their school-aged children.Item Correlates of depression among people with diabetes: The Translating Research Into Action for Diabetes (TRIAD) study(Elsevier, 2010-12) Waitzfelder, Beth; Gerzoff, Robert B.; Karter, Andrew J.; Crystal, Stephen; Bair, Mathew J.; Ettner, Susan L.; Brown, Arleen F.; Subramanian, Usha; Lu, Shou-En; Marrero, David; Herman, William H.; Selby, Joseph V.; Dudley, R. Adams; Department of Medicine, Division of General Internal Medicine, IU School of MedicineAim The broad objective of this study was to examine multiple dimensions of depression in a large, diverse population of adults with diabetes. Specific aims were to measure the association of depression with: (1) patient characteristicsItem Validation of a Scale to Measure Patient-Perceived Barriers to Medication Use(International Society for Quality of Life Research, 2006) Marrero, David G.; Monahan, Patrick O.; Lane, Kathleen A.; Hayes, Risa P.AIMS: Medication adherence may explain why patients show very different clinical outcomes. Previous assessments of adherence have used refill rates and pill counts. Few studies have investigated patient-identified barriers to using medications as prescribed. This is particularly true for persons with diabetes, most of whom are using poly-pharmacy regimens. We created a questionnaire to measure patient perceptions of barriers to medication adherence (PBMA) targeting a predominately low income, inner-city minority population. METHODS: Twenty items (Likert scale) leading with "I sometimes don't take my diabetes medicines because..." were developed from 5 focus groups (N=48). A questionnaire including these items was mailed to 1000 patients who have diabetes. RESULTS: Using data from 267 respondents (Mean age=58, 74%female, 43% non-Hispanic Caucasian, 77% income<$15,000), exploratory factor analyses with varimax rotation identified 5 factors, that may contribute to poor medication adherence: personal access to medications (F1); communication with providers (F2); understanding or appropriately following the prescribed regimen (F3); side effects (F4) and system factors that inhibited access to medication (F5). Cronbach alphas ranged from .73 to .83 for the five factors and was .92 for total scale score. No relationships were found between total scores and gender, race, or income. Greater perception of barriers was significantly (p<0.01) associated with being younger (r= -0.21), being bothered more by physical (r= -0.40) and emotional side effects (r= 0.43), and less satisfaction with control of blood sugar by diabetes medications (r= 0.45). CONCLUSIONS: This instrument is reliable, factorially valid, and consistent with clinical observation regarding factors known to be associated with patient medication adherence. Although study participants were patients with diabetes, the PBMA may be applicable to other therapeutic areas.Item Early Response to Preventive Strategies in the Diabetes Prevention Program(Springer, Part of Springer Science+Business Media, 2013-12) Maruthur, Nisa M.; Ma, Yong; Delahanty, Linda M.; Nelson, Julie A.; Aroda, Vanita; White, Neil H.; Marrero, David; Brancati, Frederick L.; Clark, Jeanne M.; Diabetes Prevention Program Research Group; Department of Medicine, IU School of MedicineBACKGROUND Recommendations for diabetes prevention in patients with prediabetes include lifestyle modification and metformin. However, the significance of early weight loss and glucose measurements when monitoring response to these proven interventions is unknown. OBJECTIVE To quantify the relationship between early measures of weight and glucose and subsequent diabetes in patients undergoing diabetes prevention interventions. DESIGN Analysis of results from a randomized controlled trial in 27 academic medical centers in the United States. PARTICIPANTS/INTERVENTIONS 3,041 adults with hyperglycemia randomized to lifestyle (n = 1,018), metformin (n = 1,036), or placebo (n = 987) with complete follow-up in The Diabetes Prevention Program. MAIN MEASURES Independent variables were weight loss at 6 and 12 months; fasting glucose (FG) at 6 months; hemoglobin A1c (HbA1c) at 6 months; and post-load glucose at 12 months. The main outcome was time to diabetes diagnosis. KEY RESULTS After 6 months, 604 participants developed diabetes in the lifestyle (n = 140), metformin (n = 206), and placebo (n = 258) arms over 2.7 years. In the lifestyle arm, 6-month weight loss predicted decreased diabetes risk in a graded fashion: adjusted HR (95 % CI) 0.65 (0.35–1.22), 0.62 (0.33–1.18), 0.46 (0.24–0.87), 0.34 (0.18–0.64), and 0.15 (0.07–0.30) for 0–<3 %, 3–<5 %, 5–<7 %, 7–<10 %, and ≥10 % weight loss, respectively (reference: weight gain). Attainment of optimal 6-month FG and HbA1c and 12-month post-load glucose predicted >60 % lower diabetes risk across arms. We found a significant interaction between 6-month weight loss and FG in the lifestyle arm (P = 0.038). CONCLUSION Weight and glucose at 6 and 12 months strongly predict lower subsequent diabetes risk with a lifestyle intervention; lower FG predicts lower risk even with substantial weight loss. Early reduction in glycemia is a stronger predictor of future diabetes risk than weight loss for metformin. We offer the first evidence to guide clinicians in making interval management decisions for high-risk patients undertaking measures to prevent diabetes.Item Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study(Springer International Publishing, 2014-02) Marrero, D.; Pan, Q.; Barrett-Connor, E.; de Groot, M.; Zhang, P.; Percy, C.; Florez, H.; Ackermann, R.; Montez, M.; Rubin, R. R.; DPPOS Research Group; Department of Medicine, IU School of MedicinePurpose The purpose of this study is to assess if diagnosis of type 2 diabetes affected health-related quality of life (HRQoL) among participants in the Diabetes Prevention Program/Diabetes Prevention Program Outcome Study and changes with treatment or diabetes duration. Methods 3,210 participants with pre-diabetes were randomized to metformin (MET), intensive lifestyle intervention (ILS), or placebo (PLB). HRQoL was assessed using the SF-36 including: (1) 8 SF-36 subscales; (2) the physical component (PCS) and mental component summary (MCS) scores; and (3) the SF-6D. The sample was categorized by diabetes free versus diagnosed. For diagnosed subgroup, mean scores in the diabetes-free period, at 6 months, 2, 4 and 6 years post-diagnosis, were compared. Results PCS and SF-6D scores declined in all participants in all treatment arms (P <.001). MCS scores did not change significantly in any treatment arm regardless of diagnosis. ILS participants reported a greater decrease in PCS scores at 6 months post-diagnosis (P <.001) and a more rapid decline immediately post-diagnosis in SF-6D scores (P = .003) than the MET or PLB arms. ILS participants reported a significant decrease in the social functioning subscale at 6 months (P <.001) and two years (P <.001) post-diagnosis. Conclusions Participants reported a decline in measures of overall health state (SF-6D) and overall physical HRQoL, whether or not they were diagnosed with diabetes during the study. There was no change in overall mental HRQoL. Participants in the ILS arm with diabetes reported a more significant decline in some HRQoL measures than those in the MET and PLB arms that developed diabetes.Item Rationale and Design of a Comparative Effectiveness Trial to Prevent Type 2 Diabetes in Mothers and Children: The ENCOURAGE Healthy Families Study(Elsevier, 2015-01) Hannon, Tamara S.; Carroll, Aaron E.; Palmer, Kelly N.; Saha, Chandan; Childers, Wendy K.; Marrero, David G.; Department of Pediatrics, Indiana University School of MedicineThe number of youth with type 2 diabetes (T2D) is expected to quadruple over 4 decades. Gestational diabetes mellitus (GDM) is also increasing and is linked with development of T2D in women, and greater risk for T2D in adolescents exposed to GDM. Despite the increasing prevalence of T2D, approaches to prevent diabetes in high-risk youth and families are rare. To address this, we are conducting the Encourage Health Families Study (ENCOURAGE). This is a randomized trial evaluating the comparative effectiveness and costs of an adaptation of the Diabetes Prevention Program (DPP) directed at mothers who had GDM or prediabetes and their children. The intervention is a group-based lifestyle program which we developed and implemented in partnership with the YMCA. We are comparing the ENCOURAGE intervention targeted to 1) mothers who have had GDM or prediabetes, and 2) mothers who have had GDM or prediabetes along with their school-aged children. This manuscript provides 1) the rationale for a targeted approach to preventing T2D and the interventions, 2) description of the translation of the DPP curriculum, and 3) the study design and methodology. The primary aims are to determine if participation leads to 1) weight loss in high-risk mothers, and 2) youth having healthier weights and lifestyle habits. We will also evaluate costs associated with each approach. These data are essential to build a translation model of T2D prevention that is both realistic and feasible to address this growing problem in both youth and adults.Item The obesity epidemic in children: Latino children are disproportionately affected at younger ages(Elsevier, 2015-03) Liu, Gilbert C.; Hannon, Tamara; Qi, Rong; Downs, Stephen M.; Marrero, David G.; Department of Medicine, IU School of MedicineBackground and objectives National surveillance clearly illustrates that U.S. children are becoming increasingly overweight. However, the timing of the onset of childhood overweight has not been well-described. Patients and methods An accelerated failure time (AFT) model was used to describe the emergence of overweight based on a 12-year collection of height and weight data of over 40,000 children. Race, sex, insurance status and their interactions were specifically examined as predictors of earlier onset of overweight. The outcome of interest was an estimate of the age at which the model predicted that a subgroup would attain a 20% prevalence of overweight. Results The three-way interaction of race, sex, and insurance status was a significant predictor of onset of overweight. The model estimated that the publicly insured Latino male subgroup had the earliest onset of overweight, attaining a prevalence of 20% overweight by 4.3 years of age. The emergence of overweight in Latino subjects was significantly earlier than that for black or white subjects, irrespective of sex or insurance status. Conclusion Regardless of sex or insurance status, overweight emerges at significantly younger ages in Latino children when compared to black and white children. Substantial numbers of Latino male children are predicted to develop overweight at preschool ages. Obesity prevention may need to be directed toward parents or children well before children enter grade-school.Item Rationale, Design, and Baseline Characteristics of a Community-based Comparative Effectiveness Trial to Prevent Type 2 Diabetes in Economically Disadvantaged Adults: The RAPID Study(Elsevier, 2014-01) Ackermann, Ronald T.; Finch, Emily A.; Schmidt, Karen K.; Hoen, Helena M.; Hays, Laura M.; Marrero, David G.; Saha, Chandan; Department of Medicine, IU School of MedicineReaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m2 or higher and abnormal glucose metabolism (HbA1c 5.7–6.9% or fasting plasma glucose 100–125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m2. 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥ 130 mm Hg, 33.1% had a total blood cholesterol exceeding 200 mg/dL, and 74% reported a household income of < $25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.Item A translational worksite diabetes prevention trial improves psychosocial status, dietary intake, and step counts among employees with prediabetes: A randomized controlled trial(Elsevier, 2015) Miller, Carla K.; Weinhold, Kellie R.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.; Department of Medicine, IU School of MedicineObjective Few worksite trials have examined the impact of diabetes prevention interventions on psychological and behavioral outcomes. Thus, the impact of a worksite lifestyle intervention on psychosocial outcomes, food group intake, and step counts for physical activity (PA) was evaluated. Method A randomized pretest/posttest control group design with 3-month follow-up was employed from October 2012 to May 2014 at a U.S. university worksite among employees with prediabetes. The experimental group (n = 35) received a 16-week group-based intervention while the control group received usual care (n = 33). Repeated measures analysis of variance compared the change in outcomes between groups across time. Results A significant difference occurred between groups post-intervention for self-efficacy associated with eating and PA; goal commitment and difficulty; satisfaction with weight loss and physical fitness; peer social support for healthful eating; generation of alternatives for problem solving; and intake of fruits, meat, fish, poultry, nuts, and seeds (all ps < .05). The experimental group significantly increased step counts post-intervention (p = .0279) and were significantly more likely to report completing their work at study end (p = .0231). Conclusion The worksite trial facilitated improvement in modifiable psychosocial outcomes, dietary patterns, and step counts; the long-term impact on diabetes prevention warrants further investigation.