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Background: Healthier lifestyles in early pregnancy are associated with lower rates of pregnancy complications, childhood adiposity, and maternal and child cardiovascular risks. However, it is not known whether lifestyle coaching initiated prior to pregnancy can affect behavior and attitudes during pregnancy. Methods: Three hundred and twenty six women planning pregnancy within 2 years with BMI ≥27 kg/m2 were randomized to a behavioral weight loss intervention or to usual care. Analyses reported here examined the intervention's impact on mid-pregnancy diet quality and activity levels; program acceptability; and effects of pregnancy on intervention engagement. Results: One hundred and sixty eight participants experienced pregnancy during the study (intervention: 91; usual care: 77). From randomization to mid-pregnancy, participants who received the intervention had larger increases in fruit intake than usual care participants (+0.67 vs. +0.06 cups; p = 0.02) and engaged in more vigorous-intensity activity (3.9 [5.5] vs. 1.2 [3.0] Met-hr/week p = 0.002) and sports/exercise (17.0 [14.1] vs. 11.0 [9.5] Met-hr/week; p = 0.03); the groups also differed in changes in sedentary time (-4.9 [15.0] vs. +0.5 [7.6] Met-hr/week; p = 0.02). Intervention satisfaction was high (>80%), and experiencing pregnancy during the intervention was associated with higher engagement. Conclusion: A coaching-based intervention beginning in pre-pregnancy successfully helped women attain healthier diet and exercise habits in mid-pregnancy. Clinical trials registration: Registered with ClinicalTrials.gov, NCT02346162, first registered on January 26, 2015, before date of initial participant enrollment (May 2015), https://clinicaltrials.gov/ct2/show/NCT02346162.
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INTRODUCTION: Implementation of a Diabetes Prevention Program (DPP) in both in-person and digital health-care settings has been increasing. The purpose of this article is to describe the protocol of a mixed-methods, natural experiment study designed to evaluate the implementation of DPP in a large, integrated health system. METHODS: Kaiser Permanente Northwest patients who were 19 to 75 years with prediabetes (hemoglobin A1c or glycated hemoglobin, 5.7-6.4) and obesity (body mass index ≥ 30 kg/m2) were invited, via the Kaiser Permanente Northwest patient portal, to participate in the digital (n = 4124) and in-person (n = 2669) DPP during 2016 through 2018. Primary (weight) and secondary (hemoglobin A1c or glycated hemoglobin level) outcome data will be obtained from electronic health records. A cost-effectiveness analysis as well as qualitative interviews with patients (enrolled and not enrolled in the DPP) and stakeholders will be conducted to examine further implementation, acceptability, and sustainability. CONCLUSION: The mixed-methods, natural experiment design we will use to evaluate Kaiser Permanente Northwest's implementation of the digital and in-person DPP builds on existing evidence related to the effectiveness of these two DPP delivery modes and will contribute new knowledge related to best practices for implementing and sustaining the DPP within large health systems over the long term.