22 resultados para generalised linear mixed model

em DigitalCommons@The Texas Medical Center


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Hierarchical linear growth model (HLGM), as a flexible and powerful analytic method, has played an increased important role in psychology, public health and medical sciences in recent decades. Mostly, researchers who conduct HLGM are interested in the treatment effect on individual trajectories, which can be indicated by the cross-level interaction effects. However, the statistical hypothesis test for the effect of cross-level interaction in HLGM only show us whether there is a significant group difference in the average rate of change, rate of acceleration or higher polynomial effect; it fails to convey information about the magnitude of the difference between the group trajectories at specific time point. Thus, reporting and interpreting effect sizes have been increased emphases in HLGM in recent years, due to the limitations and increased criticisms for statistical hypothesis testing. However, most researchers fail to report these model-implied effect sizes for group trajectories comparison and their corresponding confidence intervals in HLGM analysis, since lack of appropriate and standard functions to estimate effect sizes associated with the model-implied difference between grouping trajectories in HLGM, and also lack of computing packages in the popular statistical software to automatically calculate them. ^ The present project is the first to establish the appropriate computing functions to assess the standard difference between grouping trajectories in HLGM. We proposed the two functions to estimate effect sizes on model-based grouping trajectories difference at specific time, we also suggested the robust effect sizes to reduce the bias of estimated effect sizes. Then, we applied the proposed functions to estimate the population effect sizes (d ) and robust effect sizes (du) on the cross-level interaction in HLGM by using the three simulated datasets, and also we compared the three methods of constructing confidence intervals around d and du recommended the best one for application. At the end, we constructed 95% confidence intervals with the suitable method for the effect sizes what we obtained with the three simulated datasets. ^ The effect sizes between grouping trajectories for the three simulated longitudinal datasets indicated that even though the statistical hypothesis test shows no significant difference between grouping trajectories, effect sizes between these grouping trajectories can still be large at some time points. Therefore, effect sizes between grouping trajectories in HLGM analysis provide us additional and meaningful information to assess group effect on individual trajectories. In addition, we also compared the three methods to construct 95% confident intervals around corresponding effect sizes in this project, which handled with the uncertainty of effect sizes to population parameter. We suggested the noncentral t-distribution based method when the assumptions held, and the bootstrap bias-corrected and accelerated method when the assumptions are not met.^

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Patients who had started HAART (Highly Active Anti-Retroviral Treatment) under previous aggressive DHHS guidelines (1997) underwent a life-long continuous HAART that was associated with many short term as well as long term complications. Many interventions attempted to reduce those complications including intermittent treatment also called pulse therapy. Many studies were done to study the determinants of rate of fall in CD4 count after interruption as this data would help guide treatment interruptions. The data set used here was a part of a cohort study taking place at the Johns Hopkins AIDS service since January 1984, in which the data were collected both prospectively and retrospectively. The patients in this data set consisted of 47 patients receiving via pulse therapy with the aim of reducing the long-term complications. ^ The aim of this project was to study the impact of virologic and immunologic factors on the rate of CD4 loss after treatment interruption. The exposure variables under investigation included CD4 cell count and viral load at treatment initiation. The rates of change of CD4 cell count after treatment interruption was estimated from observed data using advanced longitudinal data analysis methods (i.e., linear mixed model). Using random effects accounted for repeated measures of CD4 per person after treatment interruption. The regression coefficient estimates from the model was then used to produce subject specific rates of CD4 change accounting for group trends in change. The exposure variables of interest were age, race, and gender, CD4 cell counts and HIV RNA levels at HAART initiation. ^ The rate of fall of CD4 count did not depend on CD4 cell count or viral load at initiation of treatment. Thus these factors may not be used to determine who can have a chance of successful treatment interruption. CD4 and viral load were again studied by t-tests and ANOVA test after grouping based on medians and quartiles to see any difference in means of rate of CD4 fall after interruption. There was no significant difference between the groups suggesting that there was no association between rate of fall of CD4 after treatment interruption and above mentioned exposure variables. ^

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Quantitative real-time polymerase chain reaction (qPCR) is a sensitive gene quantitation method that has been widely used in the biological and biomedical fields. The currently used methods for PCR data analysis, including the threshold cycle (CT) method, linear and non-linear model fitting methods, all require subtracting background fluorescence. However, the removal of background fluorescence is usually inaccurate, and therefore can distort results. Here, we propose a new method, the taking-difference linear regression method, to overcome this limitation. Briefly, for each two consecutive PCR cycles, we subtracted the fluorescence in the former cycle from that in the later cycle, transforming the n cycle raw data into n-1 cycle data. Then linear regression was applied to the natural logarithm of the transformed data. Finally, amplification efficiencies and the initial DNA molecular numbers were calculated for each PCR run. To evaluate this new method, we compared it in terms of accuracy and precision with the original linear regression method with three background corrections, being the mean of cycles 1-3, the mean of cycles 3-7, and the minimum. Three criteria, including threshold identification, max R2, and max slope, were employed to search for target data points. Considering that PCR data are time series data, we also applied linear mixed models. Collectively, when the threshold identification criterion was applied and when the linear mixed model was adopted, the taking-difference linear regression method was superior as it gave an accurate estimation of initial DNA amount and a reasonable estimation of PCR amplification efficiencies. When the criteria of max R2 and max slope were used, the original linear regression method gave an accurate estimation of initial DNA amount. Overall, the taking-difference linear regression method avoids the error in subtracting an unknown background and thus it is theoretically more accurate and reliable. This method is easy to perform and the taking-difference strategy can be extended to all current methods for qPCR data analysis.^

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Mixed longitudinal designs are important study designs for many areas of medical research. Mixed longitudinal studies have several advantages over cross-sectional or pure longitudinal studies, including shorter study completion time and ability to separate time and age effects, thus are an attractive choice. Statistical methodology used in general longitudinal studies has been rapidly developing within the last few decades. Common approaches for statistical modeling in studies with mixed longitudinal designs have been the linear mixed-effects model incorporating an age or time effect. The general linear mixed-effects model is considered an appropriate choice to analyze repeated measurements data in longitudinal studies. However, common use of linear mixed-effects model on mixed longitudinal studies often incorporates age as the only random-effect but fails to take into consideration the cohort effect in conducting statistical inferences on age-related trajectories of outcome measurements. We believe special attention should be paid to cohort effects when analyzing data in mixed longitudinal designs with multiple overlapping cohorts. Thus, this has become an important statistical issue to address. ^ This research aims to address statistical issues related to mixed longitudinal studies. The proposed study examined the existing statistical analysis methods for the mixed longitudinal designs and developed an alternative analytic method to incorporate effects from multiple overlapping cohorts as well as from different aged subjects. The proposed study used simulation to evaluate the performance of the proposed analytic method by comparing it with the commonly-used model. Finally, the study applied the proposed analytic method to the data collected by an existing study Project HeartBeat!, which had been evaluated using traditional analytic techniques. Project HeartBeat! is a longitudinal study of cardiovascular disease (CVD) risk factors in childhood and adolescence using a mixed longitudinal design. The proposed model was used to evaluate four blood lipids adjusting for age, gender, race/ethnicity, and endocrine hormones. The result of this dissertation suggest the proposed analytic model could be a more flexible and reliable choice than the traditional model in terms of fitting data to provide more accurate estimates in mixed longitudinal studies. Conceptually, the proposed model described in this study has useful features, including consideration of effects from multiple overlapping cohorts, and is an attractive approach for analyzing data in mixed longitudinal design studies.^

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The joint modeling of longitudinal and survival data is a new approach to many applications such as HIV, cancer vaccine trials and quality of life studies. There are recent developments of the methodologies with respect to each of the components of the joint model as well as statistical processes that link them together. Among these, second order polynomial random effect models and linear mixed effects models are the most commonly used for the longitudinal trajectory function. In this study, we first relax the parametric constraints for polynomial random effect models by using Dirichlet process priors, then three longitudinal markers rather than only one marker are considered in one joint model. Second, we use a linear mixed effect model for the longitudinal process in a joint model analyzing the three markers. In this research these methods were applied to the Primary Biliary Cirrhosis sequential data, which were collected from a clinical trial of primary biliary cirrhosis (PBC) of the liver. This trial was conducted between 1974 and 1984 at the Mayo Clinic. The effects of three longitudinal markers (1) Total Serum Bilirubin, (2) Serum Albumin and (3) Serum Glutamic-Oxaloacetic transaminase (SGOT) on patients' survival were investigated. Proportion of treatment effect will also be studied using the proposed joint modeling approaches. ^ Based on the results, we conclude that the proposed modeling approaches yield better fit to the data and give less biased parameter estimates for these trajectory functions than previous methods. Model fit is also improved after considering three longitudinal markers instead of one marker only. The results from analysis of proportion of treatment effects from these joint models indicate same conclusion as that from the final model of Fleming and Harrington (1991), which is Bilirubin and Albumin together has stronger impact in predicting patients' survival and as a surrogate endpoints for treatment. ^

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Background. The parents of a sick child likely experience situational anxiety due to their young child being unexpectedly hospitalized. The emotional upheaval may be great enough that their anxiety inhibits them in providing positive support to their hospitalized child. Because anxiety affects psychological distress as well as behavioral distress, identifying parental distress helps parents improving their coping mechanisms. ^ Purpose. The study compared situational anxiety levels between Taiwanese fathers and mothers and focused on differences between parental anxiety levels at the beginning of the child's unplanned hospitalization and at time of discharge. The study also identified factors related to the parents' distress and use of coping mechanisms. ^ Methods. A descriptive, comparative research design was used to determine the difference between the anxiety levels of 62 Taiwanese father-mother dyads during the situational crisis of their child's unexpected hospitalization. The Mandarin version (M) of Visual Analog Scale (VAS-M), State-Trait Anxiety Inventory (STAI-M), and the Index of Parent Participation/Hospitalized Child (IPP/HC-M) were used to differentiate maternal and paternal anxiety levels and identify factors related to the parents' distress. Questionnaires were completed by parents within 24-36 hours of the child's hospital admission and within 24 hours prior to discharge. A paired t-test, two sample t-test, and linear mixed regression model were used to test and support the study hypothesis. ^ Results. The findings reveal that the mothers' anxiety levels did not significantly differ from the fathers' anxiety level when their child had a sudden admission to the hospital. In particular, parental state anxiety levels did not decrease during the child's hospital stay and subsequent discharge. Moreover, anxiety levels did not differ between parents regardless of whether the child's disease was acute or chronic. The most effective factor related to parental situational anxiety was parental perception of the severity of the child's illness. ^ Conclusions. Parental anxiety was found to be significantly related to changes in their perception of the severity of their child's illness. However, the study was not able to illustrate how parental involvement in the child's hospital care was related to parental perception of the severity of their child's illness. Future studies, using a qualitative approach to gamer more information as to what variables influence parental anxiety during a situational crisis, may provide a richer database from which to modify key variables as well as the instruments used to improve the quality of the data obtained. ^

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The objectives of this dissertation were to evaluate health outcomes, quality improvement measures, and the long-term cost-effectiveness and impact on diabetes-related microvascular and macrovascular complications of a community health worker-led culturally tailored diabetes education and management intervention provided to uninsured Mexican Americans in an urban faith-based clinic. A prospective, randomized controlled repeated measures design was employed to compare the intervention effects between: (1) an intervention group (n=90) that participated in the Community Diabetes Education (CoDE) program along with usual medical care; and (2) a wait-listed comparison group (n=90) that received only usual medical care. Changes in hemoglobin A1c (HbA1c) and secondary outcomes (lipid status, blood pressure and body mass index) were assessed using linear mixed-models and an intention-to-treat approach. The CoDE group experienced greater reduction in HbA1c (-1.6%, p<.001) than the control group (-.9%, p<.001) over the 12 month study period. After adjusting for group-by-time interaction, antidiabetic medication use at baseline, changes made to the antidiabetic regime over the study period, duration of diabetes and baseline HbA1c, a statistically significant intervention effect on HbA1c (-.7%, p=.02) was observed for CoDE participants. Process and outcome quality measures were evaluated using multiple mixed-effects logistic regression models. Assessment of quality indicators revealed that the CoDE intervention group was significantly more likely to have received a dilated retinal examination than the control group, and 53% achieved a HbA1c below 7% compared with 38% of control group subjects. Long-term cost-effectiveness and impact on diabetes-related health outcomes were estimated through simulation modeling using the rigorously validated Archimedes Model. Over a 20 year time horizon, CoDE participants were forecasted to have less proliferative diabetic retinopathy, fewer foot ulcers, and reduced numbers of foot amputations than control group subjects who received usual medical care. An incremental cost-effectiveness ratio of $355 per quality-adjusted life-year gained was estimated for CoDE intervention participants over the same time period. The results from the three areas of program evaluation: impact on short-term health outcomes, quantification of improvement in quality of diabetes care, and projection of long-term cost-effectiveness and impact on diabetes-related health outcomes provide evidence that a community health worker can be a valuable resource to reduce diabetes disparities for uninsured Mexican Americans. This evidence supports formal integration of community health workers as members of the diabetes care team.^

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Background: Children's active commuting to school, i.e. walking or cycling to school, was associated with greater moderate-to-vigorous physical activity, although studies among ethnic minorities are sparse. Objectives: Among a low-income, ethnic minority sample of fourth grade students from eight public schools, we examined (1) correlates of active commuting to school and (2) the relationship between active commuting to school and moderate-to-vigorous physical activity. Methods: We conducted a cross-sectional analysis of baseline measurements from a sample of participants (n=149) aged 9-12 years from a walk to school intervention study in Houston, Texas. The primary outcome was the weekly rate of active commuting to school. Daily moderate-to-vigorous physical activity, measured by accelerometers, was a secondary outcome. Child self-efficacy (alpha=0.75), parent self-efficacy (alpha=0.88), and parent outcome expectations (alpha=0.78) were independent variables. Participant characteristics (age, gender, race/ethnicity, distance from home to school, acculturation, and BMI percentile) were independent sociodemographic variables. We used mixed-model regression analyses to account for clustering by school and a stepwise procedure with backward elimination of non-significant interactions and covariates to identify significant moderators and predictors. School-level observations of student pedestrians were assessed and compared using chi-square tests of independence. Results: Among our sample, which was 61.7% Latino, the overall rate of active commuting to school was 43%. In the mixed model for active commuting to school, parent self-efficacy (std. beta = 0.18, p=0.018) and age (std. beta = 0.18, p=0.018) were positively related. Latino students had lower rates of active commuting to school than non-Latinos ( 16.5%, p=0.040). Distance from home to school was inversely related to active commuting to school (std. beta = 0.29, p<0.001). In the mixed model for moderate-to-vigorous physical activity, active commuting to school was positively associated (std. beta = 0.31, p <0.001). Among the Latino subsample, child acculturation was negatively associated with active commuting to school (std. beta = -0.23, p=0.01). With regard to school-level pedestrian safety observations, 37% of students stopped at the curb and 2.6% looked left-right-left before crossing the street. Conclusion: Although still below national goals, the rate of active commuting was relatively high, while the rate of some pedestrian safety behaviors was low among this low-income, ethnic minority population. Programs and policies to encourage safe active commuting to school are warranted and should consider the influence of parents, acculturation, and ethnicity.

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The objective of this longitudinal study, conducted in a neonatal intensive care unit, was to characterize the response to pain of high-risk very low birth weight infants (<1,500 g) from 23 to 38 weeks post-menstrual age (PMA) by measuring heart rate variability (HRV). Heart period data were recorded before, during, and after a heel lanced or wrist venipunctured blood draw for routine clinical evaluation. Pain response to the blood draw procedure and age-related changes of HRV in low-frequency and high-frequency bands were modeled with linear mixed-effects models. HRV in both bands decreased during pain, followed by a recovery to near-baseline levels. Venipuncture and mechanical ventilation were factors that attenuated the HRV response to pain. HRV at the baseline increased with post-menstrual age but the growth rate of high-frequency power was reduced in mechanically ventilated infants. There was some evidence that low-frequency HRV response to pain improved with advancing PMA.

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BACKGROUND: The nonsteroidal anti-inflammatory drug (NSAID), indomethacin (Indo), has a large number of divergent biological effects, the molecular mechanism(s) for which have yet to be fully elucidated. Interestingly, Indo is highly amphiphilic and associates strongly with lipid membranes, which influence localization, structure and function of membrane-associating proteins and actively regulate cell signaling events. Thus, it is possible that Indo regulates diverse cell functions by altering micro-environments within the membrane. Here we explored the effect of Indo on the nature of the segregated domains in a mixed model membrane composed of dipalmitoyl phosphatidyl-choline (di16:0 PC, or DPPC) and dioleoyl phosphatidyl-choline (di18:1 PC or DOPC) and cholesterol that mimics biomembranes. METHODOLOGY/PRINCIPAL FINDINGS: Using a series of fluorescent probes in a fluorescence resonance energy transfer (FRET) study, we found that Indo induced separation between gel domains and fluid domains in the mixed model membrane, possibly by enhancing the formation of gel-phase domains. This effect originated from the ability of Indo to specifically target the ordered domains in the mixed membrane. These findings were further confirmed by measuring the ability of Indo to affect the fluidity-dependent fluorescence quenching and the level of detergent resistance of membranes. CONCLUSION/SIGNIFICANCE: Because the tested lipids are the main lipid constituents in cell membranes, the observed formation of gel phase domains induced by Indo potentially occurs in biomembranes. This marked Indo-induced change in phase behavior potentially alters membrane protein functions, which contribute to the wide variety of biological activities of Indo and other NSAIDs.

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BACKGROUND: Little is known about the effects of hypothermia therapy and subsequent rewarming on the PQRST intervals and heart rate variability (HRV) in term newborns with hypoxic-ischemic encephalopathy (HIE). OBJECTIVES: This study describes the changes in the PQRST intervals and HRV during rewarming to normal core body temperature of 2 newborns with HIE after hypothermia therapy. METHODS: Within 6 h after birth, 2 newborns with HIE were cooled to a core body temperature of 33.5 degrees C for 72 h using a cooling blanket, followed by gradual rewarming (0.5 degrees C per hour) until the body temperature reached 36.5 degrees C. Custom instrumentation recorded the electrocardiogram from the leads used for clinical monitoring of vital signs. Generalized linear mixed models were calculated to estimate temperature-related changes in PQRST intervals and HRV. Results: For every 1 degrees C increase in body temperature, the heart rate increased by 9.2 bpm (95% CI 6.8-11.6), the QTc interval decreased by 21.6 ms (95% CI 17.3-25.9), and low and high frequency HRV decreased by 0.480 dB (95% CI 0.052-0.907) and 0.938 dB (95% CI 0.460-1.416), respectively. CONCLUSIONS: Hypothermia-induced changes in the electrocardiogram should be monitored carefully in future studies.

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A patient classification system was developed integrating a patient acuity instrument with a computerized nursing distribution method based on a linear programming model. The system was designed for real-time measurement of patient acuity (workload) and allocation of nursing personnel to optimize the utilization of resources.^ The acuity instrument was a prototype tool with eight categories of patients defined by patient severity and nursing intensity parameters. From this tool, the demand for nursing care was defined in patient points with one point equal to one hour of RN time. Validity and reliability of the instrument was determined as follows: (1) Content validity by a panel of expert nurses; (2) predictive validity through a paired t-test analysis of preshift and postshift categorization of patients; (3) initial reliability by a one month pilot of the instrument in a practice setting; and (4) interrater reliability by the Kappa statistic.^ The nursing distribution system was a linear programming model using a branch and bound technique for obtaining integer solutions. The objective function was to minimize the total number of nursing personnel used by optimally assigning the staff to meet the acuity needs of the units. A penalty weight was used as a coefficient of the objective function variables to define priorities for allocation of staff.^ The demand constraints were requirements to meet the total acuity points needed for each unit and to have a minimum number of RNs on each unit. Supply constraints were: (1) total availability of each type of staff and the value of that staff member (value was determined relative to that type of staff's ability to perform the job function of an RN (i.e., value for eight hours RN = 8 points, LVN = 6 points); (2) number of personnel available for floating between units.^ The capability of the model to assign staff quantitatively and qualitatively equal to the manual method was established by a thirty day comparison. Sensitivity testing demonstrated appropriate adjustment of the optimal solution to changes in penalty coefficients in the objective function and to acuity totals in the demand constraints.^ Further investigation of the model documented: correct adjustment of assignments in response to staff value changes; and cost minimization by an addition of a dollar coefficient to the objective function. ^

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A historical prospective study was designed to assess the man weight status of subjects who participated in a behavioral weight reduction program in 1983 and to determine whether there was an association between the dependent variable weight change and any of 31 independent variables after a 2 year follow-up period. Data was obtained by abstracting the subjects records and from a follow-up questionnaire administered 2 years following program participation. Five hundred nine subjects (386 females and 123 males) of 1460 subjects who participated in the program, completed and returned the questionnaire. Results showed that mean weight was significantly different (p < 0.001) between the measurement at baseline and after a 2 year follow-up period. The mean weight loss of the group was 5.8 pounds, 10.7 pounds for males and 4.2 pounds for females after a 2 year follow-up period. A total of 63.9% of the group, 69.9% of males and 61.9% of females were still below their initial weight after the 2 year follow-up period. Sixteen of the 31 variables assessed utilizing bivariate analyses were found to be significantly (p (LESSTHEQ) 0.05) associated with weight change after a 2 year follow-up period. These variables were then entered into a multivariate linear regression model. A total of 37.9% of the variance of the dependent variable, weight change, was accounted for by all 16 variables. Eight of these variables were found to be significantly (p (LESSTHEQ) 0.05) predictive of weight change in the stepwise multivariate process accounting for 37.1% of the variance. These variables included: Two baseline variables (percent over ideal body weight at enrollment and occupation) and six follow-up variables (feeling in control of eating habits, percent of body weight lost during treatment, frequency of weight measurement, physical activity, eating in response to emotions, and number of pounds of weight gain needed to resume a diet). It was concluded that a greater amount of emphasis should be placed on the six follow-up variables by clinicians involved in the treatment of obesity, and by the subjects themselves to enhance their chances of success at long-term weight loss. ^

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The global social and economic burden of HIV/AIDS is great, with over forty million people reported to be living with HIV/AIDS at the end of 2005; two million of these are children from birth to 15 years of age. Antiretroviral therapy has been shown to improve growth and survival of HIV-infected individuals. The purpose of this study is to describe a cohort of HIV-infected pediatric patients and assess the association between clinical factors, with growth and mortality outcomes. ^ This was a historical cohort study. Medical records of infants and children receiving HIV care at Mulago Pediatric Infectious Disease Clinic (PIDC) in Uganda between July 2003 and March 2006 were analyzed. Height and weight measurements were age and sex standardized to Centers for Disease Control and prevention (CDC) 2000 reference. Descriptive and logistic regression analyses were performed to identify covariates associated with risk of stunting or being underweight, and mortality. Longitudinal regression analysis with a mixed model using autoregressive covariance structure was used to compare change in height and weight before and after initiation of highly active antiretroviral therapy (HAART). ^ The study population was comprised of 1059 patients 0-20 years of age, the majority of whom were aged thirteen years and below (74.6%). Mean height-for-age before initiation of HAART was in the 10th percentile, mean weight-for-age was in the 8th percentile, and the mean weight-for-height was in the 23rd percentile. Initiation of HAART resulted in improvement in both the mean standardized weight-for-age Z score and weight-for-age percentiles (p <0.001). Baseline age, and weight-for-age Z score were associated with stunting (p <0.001). A negative weight-for-age Z score was associated with stunting (OR 4.60, CI 3.04-5.49). Risk of death decreased from 84% in the >2-8 years age category to 21% in the >13 years age category respectively, compared to the 0-2 years of age (p <0.05). ^ This pediatric population gained weight significantly more rapidly than height after starting HAART. A low weight-for-age Z score was associated with poor survival in children. These findings suggest that age, weight, and height measurements be monitored closely at Mulago PIDC. ^

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Purpose of the study. This study had two components. The first component of the study was the development and implementation of an infrastructure that integrated Promotores who teach diabetes self-management into a community clinic. The second component was a six-month randomized clinical trial (RCT) designed to test the effectiveness of the Promotores in changing knowledge, beliefs, and HbA1c levels among Mexican American patients with type 2 diabetes. ^ Methods. Starfield's adaptation of the Donbedian structure, process, and outcome methodology was used to develop a clinic infrastructure that allowed the integration of Promotores as diabetes educators. The RCT of the culturally sensitive Promotores-led 10-week diabetes self-management program compared the outcomes of 63 patients in the intervention group with 68 patients in a wait-list, usual care control group. Participants were Mexican Americans, at least 18 years of age, with type 2 diabetes, who were patients at a Federally Qualified Health Center on the Texas-Mexico border. At baseline, three months, and six months, data were collected using the Diabetes Knowledge Questionnaire (DKQ, the Health Beliefs Questionnaire (HBQ, and HbA1c levels were drawn by the clinic laboratory. A mixed model methodology was used to analyze the data. ^ Results. The infrastructure to support a Promotores-led diabetes self-management course designed in concert with administration, the physicians, and the CDE, resulted in (1) employment of Promotores to teach diabetes self-management courses; (2) integration of provider and nurse oversight of course design and implementation; (3) management of Promotora training, and the development of teaching competencies and skills; (4) coordination of care through communication and documentation policies and procedures; (5) utilization of quality control mechanisms to maintain patient safety; and (6) promotion of a culturally competent approach to the educational process. The RCT resulted in a significant improvement in the intervention group's DKQ scores over time (F [1, 129] = 4.77, p = 0.0308), and in treatment by time (F [2, 168] = 5.85, p = 0.0035). Neither the HBQ scores nor the HbA1c changed over time. However, the baseline HbA1c was 7.49, almost at the therapeutic level. The DKQ, HBQ, and HbA1c results were significantly affected by age; the DKQ and HbA1c by years with diabetes. ^ Conclusions. The clinic model provides a systematic approach to safely address the educational needs of large numbers of patients with type 2 diabetes who live in communities that suffer from a lack of health care professionals. The Promotores-led diabetes self-management course improved the knowledge of patients with diabetes and may be a culturally sensitive strategy for meeting patient educational needs. The low baseline HbA1c levels in this border community suggested that patients in this Federally Qualified Health Center on the Texas-Mexico border were experiencing good medical management of their diabetes. ^