title: Design and methods of "diaBEAT-it!": a hybrid preference/randomized control trial design using the RE-AIM framework.
abstract: BACKGROUND
  Diabetes prevention is a public health priority that is dependent upon the reach, effectiveness, and cost of intervention strategies. However, understanding each of these outcomes within the context of randomized controlled trials is problematic.
  
  
  OBJECTIVE
  To describe the methods and design of a hybrid preference/randomized control trial using the RE-AIM framework.
  
  
  METHODS
  The trial, which was developed using the RE-AIM framework, will contrast the effects of 3 interventions: (1) a standard care, small group, diabetes prevention education class (SG), (2) the small group intervention plus 12 months of interactive voice response telephone follow-up (SG-IVR), and (3) a DVD version of the small group intervention with the same IVR follow-up (DVD-IVR). Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program (DPP). Adult patients at risk for diabetes will be randomly assigned to either choice or RCT. Those assigned to choice (n=240) will have the opportunity to choose between SG-IVR and DVD-IVR. Those assigned to RCT group (n=360) will be randomly assigned to SG, SG-IVR, or DVD-IRV. Assessment of primary (weight loss, reach, & cost) and secondary (physical activity, & dietary intake) outcomes will occur at baseline, 6, 12, and 18 months.
  
  
  CONCLUSIONS
  This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach, effectiveness, and cost of different interventions.
authors: Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: falmeida@vt.edu.
authors: Fabio A
authors: FA
authors: Almeida
authors: Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: skim13@vt.edu.
authors: Kimberlee A
authors: KA
authors: Pardo
authors: Department of Psychiatry, Carilion Clinic, Roanoke, VA 24014, United States. Electronic address: rwseidel@carilionclinic.org.
authors: Richard W
authors: RW
authors: Seidel
authors: Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: bdavy@vt.edu.
authors: Brenda M
authors: BM
authors: Davy
authors: Department of Agriculture and Applied Economics, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: wenyou@vt.edu.
authors: Wen
authors: W
authors: You
authors: Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: sarahsw@vt.edu.
authors: Sarah S
authors: SS
authors: Wall
authors: Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: erinsmith@vt.edu.
authors: Erin
authors: E
authors: Smith
authors: Department of Family and Community Medicine, Carilion Clinic, Roanoke, VA 24013, United States. Electronic address: mhgreenawald@carilionclinic.org.
authors: Mark H
authors: MH
authors: Greenawald
authors: Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States; Department of Family and Community Medicine, Carilion Clinic, Roanoke, VA 24013, United States. Electronic address: estabrkp@vt.edu.
authors: Paul A
authors: PA
authors: Estabrooks
mesh_terms: D015992:Body Mass Index; D001837:Body Weights and Measures; D002755:Choice Behavior; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D004032:Diet; D015444:Exercise; D015438:Health Behavior; D006266:Health Education / Q000458:organization & administration*; D006293:Health Promotion / Q000458:organization & administration*; D006801:Humans; D008019:Life Style; D012107:Research Design; D012307:Risk Factors; D012959:Socioeconomic Factors; D015431:Weight Loss
keywords: DVD; Diabetes prevention; Hybrid design; IVR; RE-AIM; Weight loss