title: ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial.
abstract: 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). 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.
  
  
  
  In 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.
  
  
  
  This 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.
  
  
  
  ClinicalTrials.gov, NCT02747108 . Registered on 18 April 2016.
authors.affiliation: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, PO Box 130170, Ann Arbor, MI, 48113-0170, USA. jkullgre@med.umich.edu.|Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. jkullgre@med.umich.edu.|University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA. jkullgre@med.umich.edu.
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Kullgren
authors.affiliation: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, PO Box 130170, Ann Arbor, MI, 48113-0170, USA.
authors.forename: Bradley
authors.initials: B
authors.lastname: Youles
authors.affiliation: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, PO Box 130170, Ann Arbor, MI, 48113-0170, USA.
authors.forename: Shaina
authors.initials: S
authors.lastname: Shetty
authors.affiliation: University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA.|Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
authors.forename: Caroline
authors.initials: C
authors.lastname: Richardson
authors.affiliation: Salt Lake City VA Medical Center, Salt Lake City, UT, USA.|Department of Population Health Studies, University of Utah, Salt Lake City, UT, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Fagerlin
authors.affiliation: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, PO Box 130170, Ann Arbor, MI, 48113-0170, USA.|Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.|University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA.|Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Heisler
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001835:Body Weight; D002985:Clinical Protocols; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008824:Michigan; D008875:Middle Aged; D009042:Motivation; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods*; D010358:Patient Participation; D011236:Prediabetic State / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D065840:Protective Factors; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012648:Self Care; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Brief intervention; Diabetes prevention; Patient education; Patient engagement; Screening