The rationale, design, and baseline characteristics of XXXX : A community-based comparative effectiveness trial of lifestyle intervention and @entity2449 among Latinas with @entity5710 .

@entity1 @entity6 @entity5710 @entity3916 @entity1674 @entity3918 @entity413 @entity165 @entity2449
Promotora Effectiveness Versus @entity2449 Trial ( @entity3918 ) is a randomized comparative effectiveness trial of a lifestyle intervention based on the @entity6 Prevention Program delivered by community health workers (or promotoras), @entity2449 , and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age>= 20years, fluent Spanish-speaking status, BMI >= 23kg/m(2), and @entity5710 . We enrolled 92 @entity1 and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or @entity2449 . The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma @entity413 , hemoglobin @entity3916 (HbA1c), total @entity165 , @entity1674 , LDL @entity165 , HDL @entity165 , and insulin. @entity3918 @entity1 are socioeconomically disadvantaged Latinas with a mean annual household income of  15,527  9922 and educational attainment of 9.7  3.6years. Eighty-six percent of @entity1 are foreign born, 20% have a prior history of gestational @entity6 , and 71% have a first-degree relative with diagnosed @entity6 . At baseline, @entity3918 @entity1 had a mean age of 45.1  12.5years, weight of 178.8  39.3lbs, BMI of 33.3  6.5kg/m(2), HbA1c of 5.9  0.2%, and waist circumference of 97.4  11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The @entity3918 study successfully recruited and randomized an understudied population of Latinas with @entity5710 . This trial will be the first U.S. study to test the comparative effectiveness of @entity2449 and lifestyle intervention versus standard care among prediabetic adults in a "real-world" setting.
