Fabio A Almeida1, Kimberlee A Pardo2, Richard W Seidel3, Brenda M Davy4, Wen You5, Sarah S Wall6, Erin Smith7, Mark H Greenawald8, Paul A Estabrooks9. 1. Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: falmeida@vt.edu. 2. Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: skim13@vt.edu. 3. Department of Psychiatry, Carilion Clinic, Roanoke, VA 24014, United States. Electronic address: rwseidel@carilionclinic.org. 4. Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: bdavy@vt.edu. 5. Department of Agriculture and Applied Economics, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: wenyou@vt.edu. 6. Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: sarahsw@vt.edu. 7. Fralin Translational Obesity Research Center, Department of Human Nutrition, Foods and Exercise, Virginia Tech, Blacksburg, VA 24061, United States. Electronic address: erinsmith@vt.edu. 8. Department of Family and Community Medicine, Carilion Clinic, Roanoke, VA 24013, United States. Electronic address: mhgreenawald@carilionclinic.org. 9. 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.
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. PURPOSE: 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. CONCLUSION: 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.
RCT Entities:
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. PURPOSE: 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. CONCLUSION: 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.
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