Cited by 1,176Behavioral Health and InterventionsHealth Policy Implementation ScienceBehavioral and Psychological Studies

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

Open access
Czajkowski, Susan M., Powell, Lynda H., Adler, Nancy, Naar-King, Sylvie, Reynolds, Kim D., Hunter, Christine M., Laraia, Barbara, Olster, Deborah H. +5 more·2015·Health Psychology

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

Integrity signals

Registry

Crossref · 10.1037/hea0000161

Cites

54 of 54 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 20 cited sources checked · 0 supported · 0 flagged

  • Interpretationnone given

    When Phase IIb results show a behavioral treatment has a clinically meaningful effect on the behavioral risk factor in the target patient group and the control does not, this supports advancing to a Phase III efficacy trial.

    “Phase IIb data showing that a behavioral treatment produces a clinically significant signal on the behavioral risk factor in patients with the specified clinical problem, while the chosen control does not, supports moving to a Phase III efficacy trial.”
    Quote in the paperSubstantial claim
  • Premisecitation

    Behavior is a central factor in preventing and managing chronic disease.

    “It is widely acknowledged that behavior plays a central role in the prevention and management of chronic disease.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Mokdad, Marks, Stroup, & Gerberding, 2004

      Not checked in the free run.

    • cites Schroeder, 2007

      Not checked in the free run.

  • Premisecitation

    Understanding how an intervention works is not necessary to show that it is effective.

    “While understanding the mechanisms through which an intervention produces its effects can be useful in developing better-targeted interventions, it is not critical to understand mechanisms of action in order to demonstrate an intervention’s effectiveness (Blumenthal, Babyak, Wei, O’Connor, Waugh, Eisenstein, Mark, Sherwood, et al., 2002).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Blumenthal, Babyak, Wei, O’Connor, Waugh, Eisenstein, Mark, Sherwood, et al., 2002

      Not checked in the free run.

  • Premisecitation

    A 5% weight loss is a biomedical target.

    “a 5% weight loss as a biomedical target (Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006)”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006

      Not checked in the free run.

  • Interpretationreasoning

    When a Phase III trial yields positive results, proof for every link in the chain makes it more credible that the effects seen came from the proposed pathways.

    “If the trial produces positive results, evidence specifically supporting each link of the chain strengthens the assertion that the observed effects were due to hypothesized pathways.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 17
  • May combine two claims. 9
  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    Without a progressive development approach that uses varied designs and methods, promising treatments may be abandoned too early because they fail tests that are too strict for an evolving understanding of their core elements.

    “Without a progressive approach to treatment development that embraces a variety of designs and methods, there is a risk that promising treatments will be abandoned prematurely because they fail tests that are too stringent for an evolving understanding of their fundamental elements.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The recent rise of evidence-based behavioral medicine provides clear standards for rigor.

    “Past models have emphasized the value of a systematic, phased approach to behavioral treatment development, and the recent emergence of evidence-based behavioral medicine (Davidson, Goldstein, Kaplan, Kaufmann, Knatterud, Orleans, Spring, Trudeau, & Whitlock, 2002) provides clear standards for rigor.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Davidson, Goldstein, Kaplan, Kaufmann, Knatterud, Orleans, Spring, Trudeau, & Whitlock, 2002

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    The ORBIT model complements and extends prior efforts by offering a systematic, well-defined process for investigators to meet rigorous standards.

    “The ORBIT model complements and extends these efforts in proposing a systematic, well-defined process by which the investigator can achieve these rigorous standards.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Interpretationnone given

    Moderators can be studied in Phase Ib to adapt treatments so they are maximally effective across all patients at risk.

    “Moreover, moderators (also called a priori subgroups in clinical trial methodology) can be studied in Phase Ib with the goal of adapting treatments so they are maximally powerful across all patients at risk.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.

    Interpretationreasoning

    Building a robust evidence base for the value of behavioral treatments in clinical care could greatly expand patient choices, improve quality of care, prevent or delay disease and disability, and lower health care costs for individuals and society.

    “Creating a robust evidence base for the value of behavioral treatments in clinical care has enormous potential to expand choices for patients, improve quality of care, prevent or delay disease and disability, and, most urgently, lower health care costs not only for individual patients but for society as a whole.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.

    Interpretationnone given

    Exchange between clinicians and applied behavioral scientists can raise the significance of research questions and identify targets that matter in clinical practice.

    “Crosstalk between clinicians in medical practice and applied behavioral scientists can increase the significance of the questions posed and identify targets that have meaning in clinical practice.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    Without the early discovery and innovation typical of basic science, behavioral treatments are less likely to become robust enough to yield clinically significant results.

    “Without the early discovery and innovation that is characteristic of basic science, the potential for behavioral treatments to be robust enough to produce clinically significant results is undercut.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    A 5% reduction in percent fat and 150 minutes per week of moderately vigorous physical activity are behavioral targets.

    “both dietary changes (e.g., a 5% reduction in percent fat) and increases in physical activity (e.g., 150 minutes/week of moderately vigorous physical activity) as behavioral targets (Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006)”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Interpretationnone given

    In the ORBIT model, physiological mechanisms linking a behavioral risk factor to biomedical risk can be examined in early Phase Ia studies to help justify the choice of behavioral risk factor and its clinical significance cutpoint.

    “In the ORBIT model, physiological mechanisms by which the behavioral risk factor translates into biomedical risk (referred to as biologic plausibility in epidemiology) can be focused on in early Phase Ia studies to help justify the choice of a behavioral risk factor and its cutpoint for clinical significance.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationreasoning

    Such exchange can help evaluate a behavioral treatment's viability as an alternative or adjunct, its side effects, its quality-of-life effects, and its cost-effectiveness relative to existing treatments.

    “Such crosstalk can facilitate the evaluation of a behavioral treatment’s viability as an alternative or adjunctive treatment, its side effect profile and effects on quality of life, and its potential cost-effectiveness relative to existing treatments.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.

    Interpretationnone given

    A progressive, transdisciplinary approach that moves basic behavioral science into clinical use is expected to improve behavioral treatments, support their testing in rigorous trials, increase success, and aid uptake in practice.

    “It suggests that use of a progressive, transdisciplinary framework to facilitate the translation of basic behavioral science findings to clinical application will strengthen behavioral treatments, encourage their testing in rigorous efficacy and effectiveness trials, promote success, and foster dissemination into clinical practice.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Interpretationreasoning

    Exchange between basic and applied behavioral and social scientists can encourage innovative approaches to common problems, yielding new methods for motivating patients, sustaining change, or reducing impulsivity by supporting executive function.

    “Crosstalk between basic and applied behavioral and social scientists can foster innovative approaches to common problems, leading to novel methods for motivating patients to stick with early changes, sustaining change by mobilizing social networks, or maximizing executive function as a way to minimize impulsivity.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationreasoning

    When randomized designs with attention control groups, fixed protocols, and blinded outcome follow-up are used universally, especially in early treatment development, they can reduce creativity, hinder discovery, and yield weak treatments.

    “There is a strong rationale for such methods, but when used universally, particularly in the early phases of treatment development, their use can undercut creativity, impede discovery, and produce weak treatments.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Most behavioral treatments are currently tested using randomized designs with attention control groups, fixed protocols, and blinding to outcomes until follow-up is complete.
  • May combine two claims.

    Premisecitation

    The biomedical field has industry backing for early translational research and a clear pathway for drug or device development, from basic science to FDA-required Phase III efficacy trials.

    “This contrasts with the biomedical arena which benefits from industry support for early translational research and has a well-defined process for developing a new drug or device, starting with basic science research and progressing to the FDA-required Phase III efficacy trial.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Friedman, Furburg, & DeMets, 1998

      Not checked in the free run.

    • cites Lipsky & Sharp, 2001

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    fMRI research has shown that biofeedback can directly change neural activity in specific brain regions and that these changes can affect chronic clinical pain.

    “Research using fMRI has shown that biofeedback can directly alter neural activity in specific brain regions and these changes can affect chronic clinical pain (deCharms, Maeda, Glover, Ludlow, Pauly, Soneji, Gabrieli, & Mackey, 2005).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites deCharms, Maeda, Glover, Ludlow, Pauly, Soneji, Gabrieli, & Mackey, 2005

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    All studies in the illustration could be conducted by one investigator, one team, or a loosely connected group of investigators.

    “All of the studies presented in this illustration could be conducted by a single investigator, by a single team of investigators, or by a group of investigators who are, at best, loosely connected.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    Without input from clinical practice, treatments that succeed by statistical significance may yield effects too small to be clinically meaningful.

    “Without input from clinical practice, treatments that are judged to be successful because they achieve statistical significance may produce results that are too small to be clinically meaningful.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Clinical guidelines recommend lifestyle change as the initial treatment step for insulin resistant patients.

    “Clinical guidelines promote lifestyle change as the first step in treatment of insulin resistant patients (Handelsman, Mechanick, Blonde, Gruberger, Bloomgarden, Bray, Dagogo-Jack, Davidson, et al., 2011), but few validated lifestyle interventions are available.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Handelsman, Mechanick, Blonde, Gruberger, Bloomgarden, Bray, Dagogo-Jack, Davidson, et al., 2011

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Coller (2008) noted that a key skill for successful translation is articulating a health need or clinical question with the precision of a basic science hypothesis.

    “Coller (2008) has observed that one of the key skills necessary for a successful translational effort is the ability to articulate a health need or clinical question requiring a solution “with the precision of a basic science hypothesis.””
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Coller (2008)

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Drug development follows a staged sequence: preclinical basic science, Phase I dose-finding, Phase II biologic activity testing, and Phase III efficacy trials that assess clinically meaningful endpoints.

    “It begins with preclinical basic science studies in animal or in vitro models to understand the disease process. Phase I and II studies turn to humans and focus on small numbers of highly-selected subjects. Phase I “dose-finding” studies determine the maximally tolerated dose of a candidate drug, while Phase II studies determine the impact of this maximally tolerated dose on significant biologic”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Friedman, Furburg, & DeMets, 1998

      Not checked in the free run.

    • cites Lipsky & Sharp, 2001

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    If small early phase studies are framed as essential steps in a research program aimed at efficacy and effectiveness trials, their value becomes clearer.

    “However, if they are conceptualized as crucial steps in a program of research that is directed toward efficacy and effectiveness trials to answer pressing clinical problems, their value becomes more apparent.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Small early phase studies run the risk of being judged not very important.
21 of 21
  • The paper relies on this without support.

    Applying bench findings to the bedside (Translation I research) is rare in behavioral science.

    “Translation I research in which “bench” findings are applied to the “bedside” is uncommon in the behavioral arena.”
  • The paper relies on this without support.

    Knowledge about fundamental human processes is not being optimally used for pressing behavioral health problems.

    “Advances in understanding fundamental human processes such as motivation, emotion, cognition, self-regulation, decision-making, stress, and social networks are not being optimally applied to pressing behavioral health problems.”
  • The paper relies on this without support.

    Promising behavioral treatments in development are often abandoned instead of refined when they fail early tests.

    “Promising behavioral treatments “in the pipeline” are often abandoned, rather than refined, if they fail early tests.”
  • The paper relies on this without support.

    Some treatments that succeed in early studies are not advanced to Phase III efficacy trials, while others enter Phase III prematurely without sufficient early-phase development.

    “In some cases, treatments that achieve success in early studies are not pushed toward rigorous testing in Phase III efficacy trials, while others are tested in Phase III trials prematurely, without undergoing adequate development and refinement in early-phase studies.”
  • The paper relies on this without support.

    Behavioral treatments for physical health outcomes lack governmental regulation and a widely accepted development process.

    “Since the development of behavioral treatments that target physical health outcomes has not been regulated by any governmental agency, it has not been guided by any widely recognized and agreed-upon process.”
  • The paper relies on this without support.

    No established pathway currently exists to translate basic behavioral science discoveries into treatments ready for Phase III efficacy testing.

    “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.”
  • The authors state this as an assumption.

    Research efficiency and quality are enhanced when a collaborative team of investigators integrates diverse studies into a chain of evidence justifying a Phase III trial.

    “An essential assumption of the ORBIT model is that research efficiency and quality are enhanced when a collaborative team of investigators works to integrate diverse studies into a chain of evidence that justifies a Phase III trial.”
  • The paper relies on this without support.

    Few validated lifestyle interventions are available for insulin resistant patients.

    “Clinical guidelines promote lifestyle change as the first step in treatment of insulin resistant patients (Handelsman, Mechanick, Blonde, Gruberger, Bloomgarden, Bray, Dagogo-Jack, Davidson, et al., 2011), but few validated lifestyle interventions are available.”
  • The paper relies on this without support.

    All elements needed to go from ideas to an efficacy trial currently exist, but the pathway for doing so is not well-defined.

    “Currently, all of the elements needed to go from ideas to the efficacy trial exist, but the pathway for doing so is not well-defined.”
  • The paper relies on this without support.

    Most behavioral treatments are currently tested using randomized designs with attention control groups, fixed protocols, and blinding to outcomes until follow-up is complete.

    “Currently, most behavioral treatments are tested in the same way using randomized designs with attention control groups, fixed protocols, and blinding to outcomes until follow-up is complete.”
  • The paper relies on this without support.

    Demand is growing for primary and secondary prevention strategies that can reduce the burden of costly chronic diseases which primarily have behavioral causes.

    “Currently, a window of opportunity exists in which demand is growing for primary and secondary prevention strategies that can reduce the burden of costly chronic diseases which primarily have behavioral causes.”
  • The paper relies on this without support.

    Small early phase studies run the risk of being judged not very important.

    “Small, early phase studies run the risk of being judged to be not very important.”
12 of 12

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Intervention Mapping citation adds an author absent from the reference

    Minor

    The in-text citation includes Fernandez, but the matching 2011 reference lists only Bartholomew, Parcel, Kok, and Gottlieb.

  • Davidson citation has conflicting years

    Minor

    The text cites this Davidson work as published in 2002, while the corresponding reference lists 2003.

  • ORBIT initiative citation has conflicting years

    Minor

    The in-text citation dates the Office of Behavioral and Social Sciences Research initiative to 2010, but its reference-list entry is dated 2011.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. Friedman LM Furberg CD DeMets DL 1998 Fundamentals of Clinical Trials 3 New York Springer-Verlag
  2. Wansink B 2010 Designing Interventions that Stick: Behavioral Event Monitoring Presented at NIH Workshop on “Translating Ideas into Interventions: The Process of Developing Behavorial Interventions December 6–7, 2010 Bethesda, MD Available at http://www.nihorbit.org/ORBIT%20Content/Workshops%20and%20Conferences.aspx?PageView=Shared

Cited by

Sorted by citations

Authors
Czajkowski, S. M., Powell, L. H., Adler, N., Naar-King, S., Reynolds, K. D., Hunter, C. M., Laraia, B., Olster, D. H., Perna, F. M., Peterson, J. C., Epel, E., Boyington, J. E., & Charlson, M. E.
Affiliations
  • National Institutes of Health (US)
  • Rush University Medical Center (US)
  • University of California, San Francisco (US)
  • Claremont Graduate University (US)
  • University of California, Berkeley (US)
  • Weill Cornell Medicine (US)
Venue
Health Psychology
Published
2015-10
Volume
34
Issue
10
Pages
971-982
ISSN
  • 0278-6133 (ISSN-L)
  • 1930-7810
OpenAlex
W1985326609
Cited by
1,161
References
54
Citations by year
2026: 118 · 2025: 152 · 2024: 158 · 2023: 142 · 2022: 116 · 2021: 119 · 2020: 191 · 2019: 69 · 2018: 48 · 2017: 20 · 2016: 21 · 2015: 4 · 2014: 1
FWCI
50.16
Type
journal article
Language
en
Open access
Locations
  • Health Psychology (publishedVersion, other-oa)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Scholarship @ Claremont (The Claremont Colleges) (submittedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • National Institute on Aging
  • American Federation for Aging Research
  • John A. Hartford Foundation
  • Atlantic Philanthropies (K23AG042869)
Topics
  • Social Sciences › Psychology › Applied Psychology › Behavioral Health and Interventions
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
Keywords
ORBIT model, chronic disease prevention, chronic disease treatment
MeSH terms
Behavior Therapy, Chronic Disease, Humans, Biomedical Research

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-06.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-06.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review