Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss
Dr. Almirall will serve as Consortium PI at the University of Michigan. He will advise the project team on the design, conduct, and analysis of the SMART design for this weight loss study. Specifically, during an in-person visit to Health Partners in Year 1 of the study and on once-monthly phone calls thereafter, Dr. Almirall will advise on methodological and analytic issues that may arise during the conduct of a SMART, including advising the PI (Dr. Sherwood) and the project statistician (Dr. Crain) on a) a plan that anticipates common contingencies (such as treatment drop-out) and the implications of this for the design of the embedded adaptive interventions as well as data analysis, b) issues related to the distinction between treatment outcomes (early response/non-response rate) and blind, study outcomes, c) study consent in the conduct of SMART, d) how to set up the blocked-stratified sequential randomizations (this is unique for SMART studies), e) the distinction between, and measurement of, baseline and time-varying tailoring variables and how they can be used to devise a more deeply-tailored adaptive intervention for weight loss, and f) Dr. Almirall will advise the PI and the project statistician on the use of appropriate data analysis methods specific to data arising from SMART (e.g., weighted-and-replicated regression and Q-Learning regression). He will also contribute to manuscripts.
Funding: National Cancer Institute (subcontract: 1 R01 CA 188892)
Funding Period: 8/19/2014 to 7/31/2016