Susan M Czajkowski1, Lynda H Powell2, Nancy Adler3, Sylvie Naar-King4, Kim D Reynolds5, Christine M Hunter6, Barbara Laraia7, Deborah H Olster8, Frank M Perna9, Janey C Peterson10, Elissa Epel3, Josephine E Boyington1, Mary E Charlson10. 1. Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health. 2. Department of Preventive Medicine, Rush University Medical Center. 3. Department of Psychiatry, Center for Health and Community, University of California, San Francisco. 4. Pediatric Prevention Research Center, Wayne State University. 5. School of Community and Global Health, Claremont Graduate University. 6. Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. 7. Division of Community Health and Human Development, School of Public Health, University of California, Berkeley. 8. Office of Behavioral and Social Sciences Research, Office of the Director, National Institutes of Health. 9. Behavioral Research Program, National Cancer Institute, National Institutes of Health. 10. Center for Integrative Medicine, Weill Cornell Medical College.
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 sciences 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 developing behavioral treatments for preventing and treating chronic diseases. METHOD: The Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development features a flexible and progressive process, prespecified 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 prespecified 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. (PsycINFO Database Record (c) 2015 APA, all rights reserved).
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 sciences 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 developing behavioral treatments for preventing and treating chronic diseases. METHOD: The Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development features a flexible and progressive process, prespecified 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 prespecified 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. (PsycINFO Database Record (c) 2015 APA, all rights reserved).
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