Although regular physical activity (PA) is a cornerstone of treatment for type 2 diabetes (T2D), most adults with T2D are sedentary. Randomized controlled trials (RCTs) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare settings. We sought to identify PA interventions that are effective and practical to implement in clinical practice settings. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to assess the potential for future implementation of PA interventions in clinical practice settings. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores. We searched PubMed MED-LINE from January 1980 through May 2015 for RCTs of behavioral PA interventions coordinated by clinical practices for patients with T2D. Dual investigators assessed pragmatism by PRECIS-2 scores, and study effectiveness was extracted from original RCT publications. The PRECIS-2 scores of the 46 behavioral interventions (n = 13,575 participants) ranged from 3.0 to 4.8, where 5 is the most pragmatic score. In the most pragmatic tertile of interventions (n = 16) by PRECIS-2 scores, 30.8 and 31.3% of interventions improved PA outcomes and hemoglobin A1c, respectively. A minority of published evidence-based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation. These should be tested for dissemination using implementation trial designs.

Most of the clinical research conducted with the goal of improving health is not generalizable to nonresearch settings. In addition, scientists often fail to replicate each other's findings due, in part, to lack of attention to contextual factors accounting for their relative effectiveness or failure. To address these problems, we review the literature on assessment of external validity and summarize approaches to designing for generalizability. When investigators conduct systematic reviews, a critical need is often unmet: to evaluate the pragmatism and context of interventions, as well as their effectiveness. Researchers, editors, and grant reviewers can implement key changes in how they consider and report on external validity issues. For example, the recently published expanded CONSORT figure may aid scientists and potential program adopters in summarizing participation in and representativeness of a program across different settings, staff, and patients. Greater attention to external validity is needed to increase reporting transparency, improve program dissemination, and reduce failures to replicate research.

Physical activity (PA) counseling is under-utilized in primary care for patients with type 2 diabetes mellitus (T2D), despite improving important health outcomes, including physical function. We adapted evidence-based PA counseling programs to primary care patients, staff, and leader’s needs, resulting in “Be ACTIVE” comprised of shared PA tracker data (FitBit©), six theory-informed PA coaching calls, and three in-person clinician visits. In a pilot randomized pragmatic trial, we evaluated the feasibility, acceptability, and effectiveness of Be ACTIVE. Sedentary patients with T2D were randomized to Be ACTIVE versus an enhanced control condition. Mixed methods assessments of feasibility and acceptability included costs. Objective pilot effectiveness outcomes included PA (primary outcome, accelerometer steps/week), the Short Physical Performance Battery (SPPB) physical function measure, and behavioral PA predictors. Fifty patients were randomized to Be ACTIVE or control condition. Acceptability was >90% for patients and clinic staff. Coaching and PA tracking costs of ~$90/patient met Medicare reimbursement criteria. Pre–post PA increased by ~11% (Be ACTIVE) and ~6% in controls (group difference: 1574 ± 4391 steps/week, p = .72). As compared to controls, Be ACTIVE participants significantly improved SPPB (0.9 ± 0.3 vs. −0.1 ± 0.3, p = .01, changes >0.5 points prevent falls clinically), and PA predictors of self-efficacy (p = .02) and social-environmental support (p < .01). In this pilot trial, Be ACTIVE was feasible and highly acceptable to stakeholders and yielded significant improvements in objective physical function consistent with lower fall risk, whereas PA changes were less than anticipated. Be ACTIVE may need additional adaptation or a longer duration to improve PA outcomes.

Physical activity (PA) is a cornerstone of treatment for type 2 diabetes mellitus (T2D). Among other benefits, regular PA improves physical function which can prevent institutionalization. However, effective PA interventions are not widely adopted in primary care. Our recent systematic review identified an effective PA intervention for adults with T2D that was nearly pragmatic enough for use in primary care. However, it still required adaptation to fit clinic work flows and to be reimbursed by insurance. After adapting the intervention (Be ACTIVE) to address these issues, we hypothesized Be ACTIVE would improve PA and physical function relative to randomized controls. This pragmatic pilot trial randomized adults with T2D to 12 weeks of Be ACTIVE (6 telephone behavioral counseling sessions + PA tracking (FitBit©); 3 primary care visits to teach strength exercises + monitor safety) vs. enhanced usual care (3 self-management mailings). At baseline and post-intervention, we assessed PA with Actigraph© accelerometers (steps/week) and physical function by a timed 400-meter walk (sec) and the Short Physical Performance Battery (SPPB, 0-12 scale). To date, we have completed assessments for 15 participants (n=8 Be ACTIVE, n=7 controls). Pre-post PA increased by 19.8% in the Be ACTIVE group (+5122 ± 10steps/week; data shown as mean ± SE) and decreased by 15.9% in controls (-3122 ± 1233 steps/week). SPPB scores increased by a clinically important >1-point difference in the Be ACTIVE group (+1.1 ± 0.2), and were stable in controls (+0.3 ± 0.1). The 400-meter walk time improved by 10.3% in Be ACTIVE participants (-38.3 ± 6.6 sec) and declined by 5.4% in controls (+17.3 ± 6.4 sec). Be ACTIVE is a reimbursable intervention delivered by primary care staff. Strong pilot data support that Be ACTIVE improves PA/physical function. If our data remain promising at trial completion, the next step towards broader dissemination will be to test Be ACTIVE in multiple clinical settings. Disclosure A.G. Huebschmann: Research Support; Self; Merck &Co., Inc..I.M. Leavitt: None.R. Glasgow: None.J.G. Regensteiner: None.A.L. Dunn: None.

Background: Physical activity (PA) improves important health outcomes for patients with type 2 diabetes mellitus (T2D), including physical function. We iteratively adapted the implementation strategies of pragmatic and evidence-based PA counseling programs to meet primary care stakeholders’ needs, resulting in the “Be ACTIVE” program. In a pilot randomized pragmatic trial, we evaluated the feasibility, acceptability and effectiveness of Be ACTIVE. Methods: Formative activities involved engaging multi-level stakeholders (patients, clinicians, coaches) to tailor implementation strategies for Be ACTIVE to the primary care context, while taking care to preserve the core “functions” of Be ACTIVE. Be ACTIVE included: a PA tracker (FitBit©), six theory-informed PA counseling phone calls, and three in-person clinician visits. Sedentary patients with T2D from two academic primary care clinics were randomized to Be ACTIVE vs. enhanced usual care. We used mixed methods to assess implementation outcomes of feasibility and acceptability among multi-level stakeholders, including costs. Objective effectiveness outcomes included PA (primary outcome, steps/week), physical function (secondary outcomes, including Short Physical Performance Battery (SPPB)), and behavioral PA predictors. Results: Multi-level stakeholders were engaged in formative activities to design a feasible pragmatic intervention. Fifty patients were randomized to Be ACTIVE or enhanced usual care. Acceptability was >90% for patients and clinic staff. In-person visits were fully reimbursed, and counseling costs of ~$90/patient would be reimbursable by Medicare. Pre-post PA increased by ~11% absolute in the Be ACTIVE group and by ~6% in controls (group difference: 1574 ± 4391 steps/week, p = 0.72) — less than the clinically important threshold of 4200 steps/week. Be ACTIVE participants’ physical function improved more than controls (SPPB: +0.9 ± 0.3 versus -0.1 ± 0.3, p = 0.01, changes >0.5 points are clinically important for preventing falls), and for PA predictors of self-efficacy (p=0.02) and social-environmental support (p<0.01). Conclusions: In this pilot trial, Be ACTIVE was feasible and highly acceptable to stakeholders and yielded significant improvements in objective physical function consistent with lower fall risk, while changes in PA were less than anticipated. Be ACTIVE may need adaptation or longer duration to clinically improve PA outcomes. Further optimizing the implementation strategies for sustainability is also needed.