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

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

[1]  L. Sharp,et al.  From idea to market: the drug approval process. , 2001, The Journal of the American Board of Family Practice.

[2]  K. Carroll,et al.  Behavioral therapies for drug abuse. , 2005, The American journal of psychiatry.

[3]  S. Larsson,et al.  Low-risk diet and lifestyle habits in the primary prevention of myocardial infarction in men: a population-based prospective cohort study. , 2014, Journal of the American College of Cardiology.

[4]  Leonard H Epstein,et al.  Family-based obesity treatment, then and now: twenty-five years of pediatric obesity treatment. , 2007, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[5]  S. Shiffman,et al.  20. Ecological Momentary Assessment , 2013 .

[6]  Thomas A Louis,et al.  Comparative effectiveness of weight-loss interventions in clinical practice. , 2011, The New England journal of medicine.

[7]  J. Fries,et al.  Lifestyle risk factors predict disability and death in healthy aging adults. , 2012, The American journal of medicine.

[8]  Christopher H Schmid,et al.  Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. , 2010, Journal of clinical epidemiology.

[9]  B. Flay Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. , 1986, Preventive medicine.

[10]  S. Murphy,et al.  A "SMART" design for building individualized treatment sequences. , 2012, Annual review of clinical psychology.

[11]  Irl B Hirsch,et al.  American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. , 2011, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[12]  H. Kraemer,et al.  Caution regarding the use of pilot studies to guide power calculations for study proposals. , 2006, Archives of general psychiatry.

[13]  Joseph E LeDoux,et al.  Noradrenergic Signaling in the Amygdala Contributes to the Reconsolidation of Fear Memory , 2006, Annals of the New York Academy of Sciences.

[14]  Dianne S Ward,et al.  Advances and Controversies in the Design of Obesity Prevention Trials , 2007, Obesity.

[15]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[16]  McGinnis Jm,et al.  Actual causes of death in the United States. , 1993 .

[17]  D. Rivera,et al.  Please Scroll down for Article Mathematical and Computer Modelling of Dynamical Systems a Dynamical Model for Describing Behavioural Interventions for Weight Loss and Body Composition Change a Dynamical Model for Describing Behavioural Interventions for Weight Loss and Body Composition Change , 2022 .

[18]  J. Gerberding,et al.  Actual causes of death in the United States, 2000. , 2004, JAMA.

[19]  Christopher O'Connor,et al.  Usefulness of psychosocial treatment of mental stress-induced myocardial ischemia in men. , 2002, The American journal of cardiology.

[20]  Victor J Stevens,et al.  Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. , 2003, JAMA.

[21]  L. Kay Bartholomew,et al.  Planning health promotion programs , 2012 .

[22]  R. Baños,et al.  Executive Functions Profile in Extreme Eating/Weight Conditions: From Anorexia Nervosa to Obesity , 2012, PloS one.

[23]  J. Calvin,et al.  The Heart Failure Adherence and Retention Trial (HART): design and rationale. , 2008, American heart journal.

[24]  G. O. Lignac [Actual causes of death]. , 1951, Nederlands tijdschrift voor geneeskunde.

[25]  B. Rounsaville,et al.  A Stage Model of Behavioral Therapies Research: Getting Started and Moving on From Stage I , 2006 .

[26]  S. Schroeder Shattuck Lecture. We can do better--improving the health of the American people. , 2007, The New England journal of medicine.

[27]  D. Mozaffarian The promise of lifestyle for cardiovascular health: time for implementation. , 2014, Journal of the American College of Cardiology.

[28]  D. Mohr,et al.  Usual and Unusual Care: Existing Practice Control Groups in Randomized Controlled Trials of Behavioral Interventions , 2011, Psychosomatic medicine.

[29]  Robert F Kushner,et al.  2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. , 2014, Journal of the American College of Cardiology.

[30]  Alan E. Kazdin,et al.  Single-Case Research Designs: Methods for Clinical and Applied Settings , 2010 .

[31]  T. Wadden,et al.  Benefits of Modest Weight Loss in Improving Cardiovascular Risk Factors in Overweight and Obese Individuals With Type 2 Diabetes , 2011, Diabetes Care.

[32]  Susan Michie,et al.  Developing and Evaluating Complex Interventions , 2015 .

[33]  S. Hollon,et al.  The Selection and Design of Control Conditions for Randomized Controlled Trials of Psychological Interventions , 2009, Psychotherapy and Psychosomatics.

[34]  C. Kawas,et al.  Activities and mortality in the elderly: the Leisure World cohort study. , 2011, The journals of gerontology. Series A, Biological sciences and medical sciences.

[35]  Nicholas T. Franklin,et al.  Behavioral and neural correlates of delay of gratification 40 years later , 2011, Proceedings of the National Academy of Sciences.

[36]  P. Greenwald,et al.  The new emphasis in cancer control. , 1985, Journal of the National Cancer Institute.

[37]  Jesse Dallery,et al.  Optimizing behavioral health interventions with single-case designs: from development to dissemination , 2014, Translational behavioral medicine.

[38]  L. Green Toward Cost-Benefit Evaluations of Health Education: Some Concepts, Methods, and Examples , 1974 .

[39]  John D E Gabrieli,et al.  Control over brain activation and pain learned by using real-time functional MRI. , 2005, Proceedings of the National Academy of Sciences of the United States of America.

[40]  Janusz Wnek,et al.  2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults , 2013, Circulation.

[41]  Maria E. Fernandez,et al.  Planning Health Promotion Programs: An Intervention Mapping Approach , 2006 .

[42]  K. Gans,et al.  Using qualitative and quantitative formative research to develop tailored nutrition intervention materials for a diverse low-income audience. , 2005, Health education research.

[43]  B. Coller Translational research: forging a new cultural identity. , 2008, The Mount Sinai journal of medicine, New York.

[44]  S. Shiffman,et al.  Ecological momentary assessment. , 2008, Annual review of clinical psychology.

[45]  D. Hadley,et al.  Evaluating the Impact of Genetic Counseling and Testing with Signal Detection Methods , 2005, Journal of Genetic Counseling.

[46]  Susan A Murphy,et al.  Developing multicomponent interventions using fractional factorial designs , 2009, Statistics in medicine.

[47]  Robert N. Anderson,et al.  Potentially Preventable Deaths from the Five Leading Causes of Death — United States, 2008–2010 , 2014, MMWR. Morbidity and mortality weekly report.

[48]  S. Fowler,et al.  Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. , 2002 .

[49]  Reneé H Moore,et al.  A two-year randomized trial of obesity treatment in primary care practice. , 2011, The New England journal of medicine.

[50]  G. Anderson,et al.  Chronic Care: Making the Case for Ongoing Care , 2010 .

[51]  S. Michie,et al.  The behaviour change wheel: A new method for characterising and designing behaviour change interventions , 2011, Implementation science : IS.

[52]  Martin T. Wells,et al.  Translating basic behavioral and social science research to clinical application: the EVOLVE mixed methods approach. , 2013, Journal of consulting and clinical psychology.

[53]  Evelyn P Whitlock,et al.  Evidence-based behavioral medicine: What is it and how do we achieve it? , 2003, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[54]  T. Ridenour,et al.  Toward Rigorous Idiographic Research in Prevention Science: Comparison Between Three Analytic Strategies for Testing Preventive Intervention in Very Small Samples , 2013, Prevention Science.

[55]  D. DeMets,et al.  Fundamentals of Clinical Trials , 1982 .