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In real-world settings, eligible populations and intervention effectiveness for a translational intervention likely vary across time. To determine the optimal strategies for effective large-scale implementation of evidence-based interventions, it is critical to investigate these potential variabilities. The purpose of this study is to evaluate whether patient characteristics and intervention effectiveness differed by year of enrollment in a multiyear evidence-based translational intervention. The Special Diabetes Program for Indians Healthy Heart (SDPI-HH) Demonstration Project is an intensive case management intervention designed to reduce cardiovascular disease risk among American Indians and Alaska Natives with diabetes. SDPI-HH participants recruited from 2006 through 2008 were included. Baseline characteristics were compared by year of enrollment. We also evaluated the differences in improvements in clinical and behavioral risk factors for cardiovascular disease among participants recruited in different years. The baseline characteristics of the three cohorts significantly differed in demographics, diabetes duration, health behaviors, level of motivation, and clinical measures. Improvements in 13 clinical and behavioral outcomes also differed by enrollment year with the 2006 cohort having the greatest number of significant improvements and the highest rates of participation and retention. Further investigation into the ways to modify the intensive case management model to address differences in levels of motivation and participation is warranted to improve the management of chronic disease in Indian health. Given the evolving nature of translational initiatives of this kind, our analysis results highlight the need to understand and adapt during the natural progression of health behavioral interventions.

Many community-based translations of evidence-based interventions are designed as one-arm studies due to ethical and other considerations. Evaluating the impacts of such programs is challenging. Here, we examine the effectiveness of the lifestyle intervention implemented by the Special Diabetes Program for Indians Diabetes Prevention (SDPI-DP) demonstration project, a translational lifestyle intervention among American Indian and Alaska Native communities. Data from the landmark Diabetes Prevention Program placebo group was used as a historical control. We compared the use of propensity score (PS) and disease risk score (DRS) matching to adjust for potential confounder imbalance between groups. The unadjusted hazard ratio (HR) for diabetes risk was 0.35 for SDPI-DP lifestyle intervention vs. control. However, when relevant diabetes risk factors were considered, the adjusted HR estimates were attenuated toward 1, ranging from 0.56 (95% CI 0.44-0.71) to 0.69 (95% CI 0.56-0.96). The differences in estimated HRs using the PS and DRS approaches were relatively small but DRS matching resulted in more participants being matched and smaller standard errors of effect estimates. Carefully employed, publicly available randomized clinical trial data can be used as a historical control to evaluate the intervention effectiveness of one-arm community translational initiatives. It is critical to use a proper statistical method to balance the distributions of potential confounders between comparison groups in this kind of evaluations.

ObjectiveEvidence for long-term translational effectiveness of lifestyle interventions in minority populations is scarce. This article reports long-term outcomes, for up to 10 years, of such an intervention to prevent diabetes in American Indian and Alaska Native (AI/AN) communities.Research design and methodsFrom January 2006 to July 2016, the Special Diabetes Program for Indians Diabetes Prevention Program implemented the Diabetes Prevention Program lifestyle intervention among 46 AI/AN health care programs. Enrolled participants underwent a thorough clinical assessment at baseline, after completing the Lifestyle Balance Curriculum (postcurriculum assessment), and annually thereafter. Proportional hazards regression was used to estimate the association between diabetes incidence and postcurriculum weight loss status.ResultsOf 8,652 enrolled participants, 65% finished the postcurriculum assessment. The assessment completion rate diminished over time to 13% in year 10. Among those with postcurriculum weight measurements, 2,028 (36%) lost >5% of their initial weight, 978 (17%) lost 3-5%, whereas 2,604 (47%) had 5% weight loss had a 64% (95% CI 54-72) lower risk of developing diabetes during the first 6 years of follow-up, whereas those with 3-5% weight loss had 40% (95% CI 24-53) lower risk.ConclusionsModerate to small weight loss was associated with substantially reduced long-term risk of diabetes in diverse AI/AN communities. High participant attrition rates and nonoptimal postcurriculum weight loss are important challenges found in this translational effort implemented in an underserved population.

ObjectiveTo investigate possible socioeconomic disparities in weight and behavioral outcomes among American Indian and Alaska Native (AI/AN) participants in a translational diabetes prevention project.Research design and methodsWe analyzed data from the Special Diabetes Program for Indians Diabetes Prevention (SDPI-DP) Program, an evidence-based lifestyle intervention to prevent diabetes in 36 AI/AN grantee sites. A total of 2,553 participants started the 16-session Lifestyle Balance Curriculum between 1 January 2006 and 31 July 2008. Linear mixed models were used to evaluate the relationships of participant and staff socioeconomic characteristics with weight and behavioral outcomes at the end of the curriculum.ResultsA strong, graded association existed between lower household income and less BMI reduction, which remained significant after adjusting for other socioeconomic characteristics. Compared with others, participants with annual income

Using multilevel analysis, this study investigated participant and site characteristics associated with participant retention in a multisite diabetes prevention translational project among American Indian and Alaska Native (AI/AN) people. We analyzed data from the Special Diabetes Program for Indians Diabetes Prevention Program (SDPI-DP), a lifestyle intervention to prevent diabetes implemented in 36 AI/AN grantee sites. A total of 2,553 participants were recruited and started the intervention between January 1, 2006 and July 31, 2008. They were offered the 16-session Lifestyle Balance Curriculum from the Diabetes Prevention Program (DPP) in the first 16-24 weeks of intervention. Generalized estimating equation models and proportional hazards models with robust standard error estimates were used to evaluate the relationships of participant and site characteristics with retention. As of July 31, 2009, about 50 % of SDPI-DP participants were lost to follow-up. Those who were younger, male, with lower household income, no family support person, and more baseline chronic pain were at higher risk for both short-term and long-term retention failure (i.e., not completing all 16 DPP sessions and loss to follow-up, respectively). Sites with large user populations and younger staff had lower likelihood of retaining participants successfully. Other site characteristics related to higher risk for retention failure included staff rating of participant disinterest in SDPI-DP and barriers to participant transportation and child/elder care. Future translational initiatives need to pay attention to both participant- and site-level factors in order to maximize participant retention.

ObjectiveDepression is a major debilitating disease. For American Indians living in tribal reservations, who endure disproportionately high levels of stress and poverty often associated with depression, determining the patterns and correlates is key to appropriate clinical assessment and intervention development. Yet little attention has been given to the cultural context of correlates for depression, including the influence of family, cultural traditions or practices, or community conditions.MethodWe used data from a large representative psychiatric epidemiological study among American Indians in 2 reservation communities to estimate nested individual and multilevel models of past-year major depressive episode (MDE) accounting for family, cultural, and community conditions.ResultsWe found that models including culturally informed individual-level measures significantly improved the model fit over demographics alone. We found significant community-level variation in the probability of past-year MDE diagnosis in 1 tribe even after accounting for individual-level characteristics.ConclusionsAccounting for culture, family, and community context will facilitate research, clinician assessment, and treatment of depression in diverse settings.