Abstract
BackgroundDiabetes and prediabetes are chronic conditions that affect over 40% of the US adult population combined. Regular physical activity can benefit people with diabetes through improved glucose control and can reduce the conversion of prediabetes to diabetes. Studies are needed in settings where people with these conditions can be identified and provided the skills and support to increase physical activity. The primary care setting meets this need, but there are insufficient high-quality trials to recommend this approach be broadly implemented.MethodsWe conducted a randomized, 24-week pilot study in Southern California to assess the feasibility of using information technology systems available in primary care for identifying potential participants, test methods for obtaining physical activity clearance, conducting mail-based assessments, and delivering telephone-based motivational interviewing to increase physical activity. Eligibility criteria included age between 18 and 74 years, diabetes or prediabetes, and physically inactive based on a clinical assessment tool. At baseline and follow-up, physical activity was assessed by a 7-day accelerometry, cardiometabolic risk factors were collected from electronic medical records, and psychosocial factors were assessed from validated questionnaires administered through a mail survey. Participants were block randomized into intervention or usual care. Staff collecting outcome data were blinded to group assignment. Analysis of covariance was used to assess the difference at follow-up between the intervention and usual care, adjusting for baseline.ResultsA total of 67 participants were randomized. Follow-up mail assessments were completed by 53 participants. Of 224 potential intervention calls, 194 were completed (87%). Psychosocial measures significantly improved in four of the five factors for physical activity motivation relative to participants in the usual care arm. The more internally focused factors for exercise self-regulation and outcome expectancies scores were significantly greater for participants in intervention compared with usual care. Moderate to vigorous physical activity improved in intervention participants relative to usual care, but the difference was not statistically significant. No adverse events were noted.ConclusionsThe objectives of this pilot study were met. If a fully powered trial is successful, primary care settings with “behind-the-scenes” information technology support may be appropriate to increase physical activity among patients with prediabetes and diabetes.Trial registrationExercise Promotion in Primary Care (EPPC), NCT03429088, registered on February 5, 2018.
Highlights
Diabetes and prediabetes are chronic conditions that affect over 40% of the US adult population combined
Objective measures to assess physical activity are needed [14]. In response to these recommendations, we conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses the physical activity of its patients, is a feasible approach to improve physical activity among patients with diabetes and prediabetes
We assessed physical activity assessed from accelerometers, psychosocial measures such as quality of life, weight change, and cardiometabolic risk factors such as blood pressure and glycated hemoglobin (HbA1c)
Summary
Study design This pilot tested the elements of a two-armed study with parallel group of a 24-week physical activity intervention among physically inactive prediabetic and diabetic patients not prescribed insulin. Study staff attended a monthly primary care provider and clinic staff meeting to present the study’s background and rationale and explain the “ask;” that is, to determine if a potentially eligible patient could safely increase his/her physical activity, and if so, to clear them for exercise by either placing a code in the patient’s EMR or asking the clinic staff to relay the information to study staff. Study staff meetings included case discussions on participants’ achievements and challenges toward goals; any medical-related issues participants had (e.g., hbA1c monitoring) were referred back to their primary care provider. Qualitative assessment After completion of the study, semi-structured interview guides were prepared for primary care providers, clinic staff, and participants to identify strengths and weaknesses of the study approach. Interviews were conducted in person (physicians and clinic staff ) and by phone (participants), and all were audio recorded
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