From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases.

Abstract

Objective Given the critical role of behavior in preventing and treating chronic diseases, it is important to accelerate the development of behavioral treatments that can improve chronic disease prevention and outcomes. Findings from basic behavioral and social science research hold great promise for addressing behaviorally-based clinical health problems, yet there is currently no established pathway for translating fundamental behavioral science discoveries into health-related treatments ready for Phase III efficacy testing. This article provides a systematic framework for guiding efforts to translate basic behavioral science findings into behavioral treatments for preventing and treating chronic illness. Methods The ORBIT model for behavioral treatment development is described as involving a flexible and progressive process, pre-specified clinically significant milestones for forward movement, and return to earlier stages for refinement and optimization. Results This article presents the background and rationale for the ORBIT model, a summary of key questions for each phase, a selection of study designs and methodologies well-suited to answering these questions, and pre-specified milestones for forward or backward movement across phases. Conclusions The ORBIT model provides a progressive, clinically-relevant approach to increasing the number of evidence-based behavioral treatments available to prevent and treat chronic diseases.

Transdisciplinary translational behavioral (TDTB) research: opportunities, barriers, and innovations

“…An early example is the Stage Model of Treatment Development, originally a three-stage model for developing treatments in mental health and substance abuse [15] that has been revised to encompass six stages of intervention development and testing [16] More recently, the NIH has supported development of the ORBIT model (Obesity-Related Behavioral Intervention Trials, www.nihorbit.org) [17], which focuses exclusively on the early-phase (pre-efficacy) development of behavioral treatments, primarily for chronic physical diseases. The ORBIT framework encompasses two overarching phases of intervention development, entitled BPhase I^(Intervention Design) and BPhase II^(Preliminary Testing) and each includes two distinct sub-phases.…”

Statistical methodologies to pool across multiple intervention studies

“…The consortia include the COPTR (four studies) [4], the Early Adult Reduction of weight through LifestYle intervention (EARLY; seven studies) [5], the Obesity-Related Behavioral Intervention Trials (ORBIT; seven studies) [6], and the Lifestyle Interventions For Expectant Moms (LIFE-Moms, seven studies). COPTR is testing multilevel intervention approaches to prevent excess weight gain in youth and to reduce weight among overweight and obese youth.…”

The Childhood Obesity Declines Project: Implications for Research and Evaluation Approaches

“…As an example of controlled experimental design, the NIH-funded ORBIT studies were small clinical trials designed to establish proof of concept and feasibility of novel behavioral approaches to impact mechanisms effecting obesity-related individual behavior of underserved minority individuals across the lifespan, including children. 20 Studies were developed to test a wide variety of mechanisms that could guide intervention trials, from individual-based factors to environmental manipulation, to reduce rates of obesity.…”