TY - JOUR
T1 - Design and methods of "diaBEAT-it!"
T2 - A hybrid preference/randomized control trial design using the RE-AIM framework
AU - Almeida, Fabio A.
AU - Pardo, Kimberlee A.
AU - Seidel, Richard W.
AU - Davy, Brenda M.
AU - You, Wen
AU - Wall, Sarah S.
AU - Smith, Erin
AU - Greenawald, Mark H.
AU - Estabrooks, Paul A.
N1 - Funding Information:
Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number 1R18DK091811-01A1 (Almeida, PI). The content is solely of the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
PY - 2014/7
Y1 - 2014/7
N2 - 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.
AB - 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.
KW - DVD
KW - Diabetes prevention
KW - Hybrid design
KW - IVR
KW - RE-AIM
KW - Weight loss
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U2 - 10.1016/j.cct.2014.06.010
DO - 10.1016/j.cct.2014.06.010
M3 - Article
C2 - 24956325
AN - SCOPUS:84903850825
SN - 1551-7144
VL - 38
SP - 383
EP - 396
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 2
ER -