Development and evaluation of an enhanced diabetes prevention program with psychosocial support for urban American Indians and Alaska natives: A randomized controlled trial.

Diabetes is highly prevalent, affecting over 25 million adults in the US, yet it can be effectively prevented through lifestyle interventions, including the well-tested Diabetes Prevention Program (DPP). American Indian/Alaska Native (AIAN) adults, the majority of whom live in urban settings, are more than twice as likely to develop diabetes as non-Hispanic whites. Additionally, prevalent mental health issues and psychosocial stressors may facilitate progression to diabetes and hinder successful implementation of lifestyle interventions for AIAN adults. This 2-phased study first engaged community stakeholders to develop culturally-tailored strategies to address mental health concerns and psychosocial stressors. Pilot testing (completed) refined those strategies that increase engagement in an enhanced DPP for urban AIAN adults. Second, the enhanced DPP will be compared to a standard DPP in a randomized controlled trial (ongoing) with a primary outcome of body mass index (BMI) and a secondary outcome of quality of life (QoL) over 12months. Obese self-identified AIAN adults residing in an urban setting with one or more components of the metabolic syndrome (excluding waist circumference) will be randomized to the enhanced or standard DPP (n=204). We hypothesize that addressing psychosocial barriers within a culturally-tailored DPP will result in clinical (BMI) and superior patient-centered (QoL) outcomes as compared to a standard DPP. Exploratory outcomes will include cardiometabolic risk factors (e.g., waist circumference, blood pressure, fasting glucose) and health behaviors (e.g., diet, physical activity). Results of this trial may be applicable to other urban AIAN or minority communities or even diabetes prevention in general.

RCT Entities:   Population Interventions Outcomes