Abstract
BackgroundPrediabetes is an asymptomatic condition in which patients’ blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus (T2DM). A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes, yet the effects of this screening and brief counseling are unknown.MethodsIn this parallel-design randomized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center (AAVA) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA, but have not had a hemoglobin A1c (HbA1c) test to screen for T2DM in the previous 12 months. After informed consent, participants will complete a baseline survey and be randomly assigned to, at the time of their next primary care appointment, one of two arms: (1) to have a hemoglobin A1c (HbA1c) test to screen for T2DM and receive brief, standardized counseling about these results or (2) to review a brochure about clinical preventive services. Participants will complete surveys 2 weeks, 3 months, and 12 months after their primary care appointment, and a weight measurement 12 months after their primary care appointment. The primary outcome is weight change after 12 months. The secondary outcomes are changes in perception of risk for T2DM; knowledge of T2DM prevention; self-efficacy and motivation to prevent T2DM; use of pharmacotherapy for T2DM prevention; physical activity; participation in weight management programs; and mental health. Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm. Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their understanding of and reactions to receiving a prediabetes diagnosis.DiscussionThis trial will generate foundational data on the effects of a prediabetes diagnosis and brief counseling on patients’ preventive behaviors and mediators of these behaviors that will enable the development of novel strategies to improve patient engagement in T2DM prevention.Trial registrationClinicalTrials.gov, NCT02747108. Registered on 18 April 2016.
Highlights
Prediabetes is an asymptomatic condition in which patients’ blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus (T2DM)
The landmark Diabetes Prevention Program (DPP) trial demonstrated that a lifestyle-modification program with the goals of at least 7% weight loss and at least 150 minutes of physical activity per week led to a 58% reduction in the 3-year incidence of T2DM [9]
Cardiovascular events resulting from T2DM and its associated risk factors lead to substantial morbidity and premature mortality among Veterans
Summary
Participants and recruitment We will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center (AAVA), who have an upcoming primary care appointment at the AAVA and one or more major risk factors for T2DM, but have not had an HbA1c test to screen for T2DM in the previous 12 months. Within 2 weeks of their primary care appointment, a Research Assistant will call the patient to provide standardized brief counseling based on the information in the brochure In this way, patients in the clinical preventive service brochure arm will spend an approximately equal amount of time receiving and reviewing information related to prevention as patients randomized to the HbA1c test and brief counseling arm and will serve as an attention control group. We will use data from the baseline, 2-week, 3-month, and 12-month surveys to estimate mixed-effects regression models that will model mean changes between patients who are found to have prediabetes in the HbA1c test and brief counseling arm and patients in the clinical preventive service brochure arm. The full study team will meet regularly to discuss code summaries and memos, a group consensus approach that increases the rigor of data interpretation and allows documentation of sound evidence for findings [32]
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