Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability

Abstract

Background: Although the Diabetes Prevention Program (DPP) lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults at academic centers, it requires translation into typical primary care settings. Using baseline data from the Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE) randomized controlled trial, we evaluated the potential of its two DPP-based interventions to reach their target populations and be adopted into routine use.

Methods: Overweight/obese adults with increased cardiometabolic risk enrolled from one primary care clinic. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model, we assessed reach with data on patient identification, participation, and representativeness, and adoption with data on intervention feasibility and potential for organizational diffusion.

Results: The target population was identified by searching electronic health records. Contact was attempted for 2391 patients who completed initial screening by phone (56% uptake) or online (44%). Most (88%) of those screened ineligible were not within the target population; 12% were excluded because of research requirements. Conservatively estimated participation rate was 44%. Participants (n=241) included 54% men and had a mean (SD) age of 52.9 years (10.6) and body mass index of 32 kg/m(2) (5.4). Regarding adoption, all clinic physicians agreed to participate. The feasibility of intervention implementation and dissemination was enhanced by leveraging existing intervention, training, and primary care resources.

Conclusions: E-LITE's lifestyle interventions had fair-to-good potential for primary care reach and adoption. Our trial evidence and structured reporting may inform real-world implementation of translational trials by health networks, physicians, and payers.

Trial registration: ClinicalTrials.gov NCT00842426.

Copyright © 2012 Elsevier Inc. All rights reserved.

Figures

Fig. 1

Study participant flow and intervention characteristics related to potential for reach and adoption. PCP = primary care provider. HER = electronic health record. DVD = digital versatile disc. DPP = Diabetes Prevention Program. DPSC = Diabetes Prevention Support Center. IT = information technology. AHA = American Heart Association. E-LITE = Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care. aConservative calculation method for participation rate uses the Glasgow et al. approach [25]: Participation rate=(number of participants who were randomized)∕(number of participants for whom contact was attempted and eligibility could be assumed or confirmed).