Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial.

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.

We report results from a pragmatic and behavioral theory-based physical activity (PA) coaching program, termed "Be ACTIVE," for patients with type 2 diabetes that was designed to improve PA and function for patients and to be reimbursable and feasible for primary care teams. As compared to those who did not receive coaching, patients who received Be ACTIVE had physical function improvements that lowered their risk of falls. Be ACTIVE was delivered with fidelity and was highly acceptable to the key primary care stakeholders of patients, clinic staff coaches, and clinicians. Patients particularly liked the focus on setting goals to do enjoyable activities, the accountability of wearing a PA monitor, and the support of their coach. Clinical care professionals felt that their role of encouraging behavior change (coach) and safety monitoring (clinician) aligned well with their clinical expertise, and was professionally rewarding. Coaches felt the program helped them guide many patients to overcome preexisting negative perceptions of PA and develop intrinsic motivations to be active. The costs of clinic coach time and PA tracker rental needed to deliver the 12-week program could be reimbursed by the Medicare Chronic Disease Management programs, albeit with a patient co-payment required.

Making Health Research Matter: A Call to Increase Attention to External Validity.

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.

How can clinical practices pragmatically increase physical activity for patients with type 2 diabetes? A systematic review.

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 MEDLINE 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.