title: Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research.
abstract: The management of many health disorders often entails a sequential, individualized approach whereby treatment is adapted and readapted over time in response to the specific needs and evolving status of the individual. Adaptive interventions provide one way to operationalize the strategies (e.g., continue, augment, switch, step-down) leading to individualized sequences of treatment. Often, a wide variety of critical questions must be answered when developing a high-quality adaptive intervention. Yet, there is often insufficient empirical evidence or theoretical basis to address these questions. The Sequential Multiple Assignment Randomized Trial (SMART)-a type of research design-was developed explicitly for the purpose of building optimal adaptive interventions by providing answers to such questions. Despite increasing popularity, SMARTs remain relatively new to intervention scientists. This manuscript provides an introduction to adaptive interventions and SMARTs. We discuss SMART design considerations, including common primary and secondary aims. For illustration, we discuss the development of an adaptive intervention for optimizing weight loss among adult individuals who are overweight.
authors.affiliation: 214NU Institute for Social Research, University of Michigan, 426 Thompson Street, Ann Arbor, MI 48104-2321 USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Almirall
authors.affiliation: 214NU Institute for Social Research, University of Michigan, 426 Thompson Street, Ann Arbor, MI 48104-2321 USA.
authors.forename: Inbal
authors.initials: I
authors.lastname: Nahum-Shani
authors.affiliation: HealthPartners Institute for Education and Research, Minneapolis, USA.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Sherwood
authors.affiliation: Department of Statistics and Institute for Social Research, University of Michigan, Ann Arbor, USA.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Murphy
keywords: Adaptive treatment strategies; Dynamic treatment regimens or regimes; Experimental design; Individualized or personalized behavioral interventions; Timing and sequencing of intervention components