Research ArticleDiabetes Prevention Program Translation in the Veterans Health Administration
Introduction
Prediabetes, or abnormally elevated blood sugar levels that do not yet meet the threshold for Type 2 diabetes, is prevalent and associated with significant risk of progression to Type 2 diabetes.1, 2, 3, 4 However, evidence from RCTs, including the Diabetes Prevention Program (DPP) Study, shows progression to diabetes can be prevented with intensive lifestyle interventions involving dietary change, physical activity, and weight loss.1, 2, 5, 6, 7 Thus, numerous studies have evaluated translations of DPP-based lifestyle interventions into real-world settings.8, 9, 10, 11 However, important evidence gaps remain in real-world DPP effectiveness as most studies have used uncontrolled pre–post, single-site study designs and very few have examined diabetes-related outcomes or expenditures.8, 9, 10, 11
To address these important gaps, the authors conducted a multisite clinical demonstration trial in the Veterans Affairs (VA) that assessed change in weight; hemoglobin A1c (HbA1c); and health expenditures. This was a pragmatic comparative effectiveness trial of two group-based lifestyle interventions that varied in content, intensity, and delivery (Appendix Table 1, available online): the VA-DPP and the usual care MOVE!® weight management program (MOVE!). VA-DPP included more sessions (i.e., higher intensity); had closed groups led by a single instructor; and standardized goals for all participants, which might increase group cohesion. Therefore, it was hypothesized that VA-DPP would lead to greater weight loss and improved HbA1c over 12 months among overweight/obese participants with prediabetes versus MOVE!.12
Section snippets
Study Sample
This was a prospective, pragmatic, non-randomized comparative effectiveness trial conducted from 2012 to 2015. This non-randomized design reflects the challenge of implementing VA-DPP with high fidelity balanced against the pragmatic need to adapt to local clinical context.13, 14 A Transparent Reporting of Evaluations with Nonrandomized Designs statement is provided in Appendix Table 2 (available online).15 The degree to which pragmatic considerations drove study design decisions was assessed
Results
Between August 2012 and January 2014, a total of 1,830 patients were assessed for eligibility (Figure 1).25, 26 An additional 20 patients were contacted but excluded from analyses because of incomplete screening information. A total of 387 eligible individuals were systematically assigned to VA-DPP (n=273) or MOVE! (n=114). The number of participants assigned to VA-DPP was higher than that assigned to MOVE! because the number of candidate participants often failed to reach 40 within the 2-month
Discussion
This study found that VA-DPP resulted in significantly more 6-month weight loss than MOVE!, but these differences were not significant at 12 months, nor were differences in HbA1c or VA expenditures. Based on a recent systematic review of DPP translation studies, the VA-DPP compares favorably with the minority (41%) of studies included in the review that succeeded in achieving moderate or high weight loss (>2.4 kg).10 However, this was a comparative effectiveness trial, which included an active
Conclusions
A pragmatic trial of VA-DPP resulted in higher participation rates with significantly greater 6-month weight loss and a non-significant trend toward greater 12-month weight loss compared with MOVE!. Thus, MOVE! may be enhanced by aligning more closely to VA-DPP to augment the reach (for at-risk individuals) and individual-level effectiveness (of individual weight loss). This is one of the first studies to include a predominantly male cohort and highlights the continued difficulty in recruiting
Acknowledgments
All authors made substantial contributions to conception and design or analysis and interpretation of data and drafting of the article or critical revision for important intellectual content. CRR, LJD, MLM, and SKD designed the study. TM wrote the first draft of the manuscript. RGH, HMK, JAB, CRR, LJD, TM, and MAY analyzed the data. TM, LJD, MAY, MLM, SKD, JEW, NIS, CB, MH, FM, RGH, HMK, LSK, and CRR reviewed and edited the manuscript. TM is the guarantor of this article. Portions of this
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2018, American Journal of Preventive MedicineCitation Excerpt :Among 1,830 patients assessed for eligibility, 387 eligible individuals were systematically assigned to in-person DPP (n = 273) or MOVE! ( n = 114, details available elsewhere15). Among these, 262 participants (n = 198 VA-DPP, n = 64 MOVE!)