From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases
Open accessAbstract
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
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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
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- cites Schroeder, 2007
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- 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
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- 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
- Premisecitation
Interventions promoting healthy lifestyles, based on behavioral research and developed stepwise, have been shown to effectively reduce weight, blood pressure, cholesterol, and diabetes incidence, among other clinical outcomes.
“Interventions that encourage healthy lifestyle behaviors, grounded in fundamental behavioral research and developed incrementally over time, have proven highly effective in reducing weight, blood pressure, cholesterol levels, and incidence of diabetes, among other clinically important outcomes (Appel, Clark, Yeh, Wang, Coughlin, Daumit, Miller, Dalcin et al., 2011; Appel, Champagne, Harsha, Cooper”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Appel, Clark, Yeh, Wang, Coughlin, Daumit, Miller, Dalcin et al., 2011
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- cites Appel, Champagne, Harsha, Cooper, Obarzanek, Elmer, Stevens, Vollmer, et al., 2003
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- cites Knowler, Barrett-Connor, Fowler, Hamman, Lachin, Walker, Nathan, Diabetes Prevention Program Research Group, 2002
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- Interpretationreasoning
In negative Phase III trials, evidence for each link helps distinguish whether null results arose from a failed hypothesis that behavioral risk factor change causes biomedical outcome change or from a treatment that did not affect its targets.
“Evidence collected for each link of the chain in negative trials can help determine whether null findings were due to a failure of the hypothesis that change in the behavioral risk factor is causally related to change in the biomedical outcome or a failure of the treatment to affect its targets.”
Quote in the paperSubstantial claim - Premisecitation
A 30% reduction in diabetes compared with standard drug treatment is clinically significant.
“a Phase Ia review of epidemiological studies and clinical trials provides empirical support for the clinical significance of a 30% reduction in diabetes over standard drug treatment (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
Without a consistent framework for progressing to a behavioral efficacy trial, behavioral and social science researchers are less able to produce evidence that clinical gatekeepers and third-party payers find meaningful.
“Without a consistent framework to support progression toward the behavioral efficacy trial, the ability of behavioral and social science researchers to provide the type of evidence that is meaningful to clinical gatekeepers and third-party payers is compromised.”
Quote in the paperNot a substantial claim - Premisecitation
A feasibility pilot yields an unstable estimate of the effect size for the primary endpoint in a Phase III efficacy trial.
“Although a feasibility pilot study produces an unstable estimate of the effect size on the primary endpoint of the Phase III efficacy trial (Kraemer, Mintz, Noda & Tinklenberg, 2006), it should be considered along with accumulated effect sizes from similar past trials to determine the sample size needed for the efficacy trial.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Kraemer, Mintz, Noda & Tinklenberg, 2006
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- Premisecitation
Health-promoting behaviors can lower or postpone the onset of chronic disease and disability.
“Engaging in health-promoting behaviors can reduce or delay the onset of chronic disease and disability (Paganini-Hill, Kawas & Corrada, 2011).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Paganini-Hill, Kawas & Corrada, 2011
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- Interpretationreasoning
A sequence of studies can allow researchers to describe the proposed route through which a treatment might improve a biomedical or clinical outcome.
“Such a series of studies make it possible to articulate the hypothesized pathway by which the proposed treatment may improve the biomedical or clinical outcome (Figure 3).”
Quote in the paperSubstantial claim - Interpretationreasoning
When strong evidence already links a behavioral or biomedical risk factor to a clinical outcome, efficacy trial evidence that a behavioral treatment changes that risk factor may be enough to affect clinical practice.
“For example, where well-established evidence exists linking a behavioral or biomedical risk factor to a clinical outcome (e.g., evidence of association between smoking and heart or lung disease), evidence from an efficacy trial that a behavioral treatment affects that behavioral or biomedical risk factor (e.g., smoking) may be sufficient to influence clinical practice.”
Quote in the paperSubstantial claim - Interpretationcitation
Articulating a hypothesized pathway and measuring each link allows more precise interpretation of Phase III trial results.
“The value of articulating a hypothesized pathway, and collecting measurements for each of its links, lies in the ability to more precisely interpret the results of Phase III trials (Powell, Calvin, Mendes de Leon, Richardson, Grady, Flynn, Rucker-Whitaker, Janssen, et al., 2008).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Powell, Calvin, Mendes de Leon, Richardson, Grady, Flynn, Rucker-Whitaker, Janssen, et al., 2008
Not checked in the free run.
- Interpretationreasoning
Evidence that an intervention affects a treatment target may be sufficient to proceed to a clinical endpoint trial without evidence that it affects a behavioral risk factor.
“In other cases, evidence of an intervention’s effect on a treatment target may be adequate for proceeding to a clinical endpoint trial without evidence of the intervention’s effect on a behavioral risk factor.”
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).
InterpretationreasoningWithout 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe 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
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Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningThe 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 claimClassified as probably not a substantial claim.
Interpretationnone givenModerators 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 claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
InterpretationreasoningBuilding 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 claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone givenExchange 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 claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenWithout 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 claimMay combine two claims.
PremisecitationA 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 givenIn 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 claimClassified as probably not a substantial claim. May combine two claims.
InterpretationreasoningSuch 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 claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone givenA 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 claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
InterpretationreasoningExchange 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 claimMay combine two claims.
InterpretationreasoningWhen 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.
PremisecitationThe 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
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- cites Lipsky & Sharp, 2001
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May combine two claims.
PremisecitationfMRI 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
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Interpretationnone givenAll 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 claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenWithout 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationClinical 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).
PremisecitationColler (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)
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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationDrug 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
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Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningIf 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.
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.”
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?
Other work has suggested that rooting analysis in behavioural science terminology can help facilitate relevant understanding and application within the field of behavioural science.
“As a result we opted to rooted our analysis in behavioural science terminology as other work has suggested that this approach can help facilitate relevant understanding and application within the field of behavioural science [63].”
From Barriers and facilitators to diet, physical activity and lifestyle behavior intervention adherence: a qualitative systematic review of the literature (2023) · cites this paper as [63]
The Summary and Conclusions discusses applying behavioral-science findings through the ORBIT model and encouraging crosstalk among researchers. It does not address whether rooting an analysis in behavioral-science terminology facilitates understanding or application within the field; searches for terminology and common language found no such passage. No page numbers were provided in our copy. (LLM, conf=0.74)
Experimental — accuracy not yet measuredThe ORBIT model provides a progressive and iterative approach for developing and testing new interventions.
“The ORBIT model was first introduced in 2015 and provides a progressive and iterative approach for developing and testing new interventions.”
From A nonrandomized pilot of a group, video-based telehealth intervention to reduce diabetes distress in parents of youth with type 1 diabetes mellitus (2022) · cites this paper as [13]
A key difference of the ORBIT model versus other approaches is its focus on using small, fluid, and cost-effective formative studies to develop and refine interventions ahead of launching expensive efficacy trials.
“A key difference of the ORBIT model versus other approaches is its focus on using small, fluid, and cost-effective formative studies to develop and refine interventions ahead of launching expensive efficacy trials [13].”
From A nonrandomized pilot of a group, video-based telehealth intervention to reduce diabetes distress in parents of youth with type 1 diabetes mellitus (2022) · cites this paper as [13]
The ORBIT model defines four phases of treatment development.
“The ORBIT model defines four phases of treatment development.”
From A nonrandomized pilot of a group, video-based telehealth intervention to reduce diabetes distress in parents of youth with type 1 diabetes mellitus (2022) · cites this paper as [13]
Per the ORBIT model, evidence of achieving these milestones indicates a treatment may be appropriate for Phase 2 proof of concept or randomized pilot testing.
“Per the ORBIT model, evidence of achieving these milestones indicate a treatment may be appropriate for Phase 2 proof of concept or randomized pilot testing. [13]”
From A nonrandomized pilot of a group, video-based telehealth intervention to reduce diabetes distress in parents of youth with type 1 diabetes mellitus (2022) · cites this paper as [13]
The study used the ORBIT model for behavioral intervention development to standardize study methods and help refine the intervention.
“Some potential strengths of this study include our use of the ORBIT model for behavioral intervention development to standardize study methods and help refine the intervention [13]”
From A nonrandomized pilot of a group, video-based telehealth intervention to reduce diabetes distress in parents of youth with type 1 diabetes mellitus (2022) · cites this paper as [13]
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
MinorThe in-text citation includes Fernandez, but the matching 2011 reference lists only Bartholomew, Parcel, Kok, and Gottlieb.
“Intervention Mapping (Bartholomew, Parcel, Kok, Gottlieb & Fernandez, 2011)”
“4. Bartholomew L Parcel G Kok G Gottlieb G 2011 Planning health promotion programs: Intervention mapping San Francisco Jossey-Bass”
Davidson citation has conflicting years
MinorThe text cites this Davidson work as published in 2002, while the corresponding reference lists 2003.
“Davidson, Goldstein, Kaplan, Kaufmann, Knatterud, Orleans, Spring, Trudeau, & Whitlock, 2002”
“14. Davidson KW Goldstein M Kaplan RM Kaufmann PG Knatterud GL Orleans CT Spring B Trudeau KJ Whitlock EP 2003 Evidence-based behavioral medicine: what is it and how do we achieve it?”
ORBIT initiative citation has conflicting years
MinorThe in-text citation dates the Office of Behavioral and Social Sciences Research initiative to 2010, but its reference-list entry is dated 2011.
“Office of Behavioral and Social Sciences Research, 2010”
“37. Office of Behavioral and Social Sciences Research 2011 Available at http://grants.nih.gov/grants/guide/pa-files/PA-11-063.html”
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BackgroundControl over brain activation and pain learned by using real-time functional MRI
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A stage model of behavioral therapies research: getting started and moving on from stage I.
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. Caution regarding the use of pilot studies to guide power calculations for study proposals.
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Behavioral and neural correlates of delay of gratification 40 years later
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A "SMART" Design for Building Individualized Treatment Sequences
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Family-based obesity treatment, then and now: Twenty-five years of pediatric obesity treatment.
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A Two-Year Randomized Trial of Obesity Treatment in Primary Care Practice
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Behavioral Therapies for Drug Abuse
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“A number of prior efforts describing behavioral treatment development include: Green’s (1974) PRECEDE/PROCEED model for health program planning; Greenwald & Cullen’s (1985) 5-phase cancer control model; Flay’s 8- stage health promotion model; the National Institute of Drug Abuse’s (NIDA) Stage Model (Carroll & Onken,…”
InfluentialChronic Care: Making the Case for Ongoing Care
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Evidence-based behavioral medicine: What is it and how do we achieve it?
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Ecological Momentary Assessment
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Executive Functions Profile in Extreme Eating/Weight Conditions: From Anorexia Nervosa to Obesity
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Noradrenergic Signaling in the Amygdala Contributes to the Reconsolidation of Fear Memory
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Low-Risk Diet and Lifestyle Habits in the Primary Prevention of Myocardial Infarction in Men
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Potentially preventable deaths from the five leading causes of death--United States, 2008-2010.
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From idea to market: the drug approval process.
Lipsky, M. S., & Sharp, L. K. (2001) · PubMed · Cited by 170 · see citing works
Toward Cost-Benefit Evaluations of Health Education: Some Concepts, Methods, and Examples
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The new emphasis in cancer control
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Usefulness of psychosocial treatment of mental stress-induced myocardial ischemia in men
Blumenthal, J. A., Babyak, M. A., Jiang, W., O’Connor, C. M., WAUGH, R. A., Eisenstein, E. L., Mark, D. B., Sherwood, A., Woodley, P. S., Irwin, R. J., et al. (2002) · The American Journal of Cardiology · doi:10.1016/s0002-9149(01)02194-4 · Cited by 135 · see citing works
Lifestyle Risk Factors Predict Disability and Death in Healthy Aging Adults
Chakravarty, E. F., Hubert, H. B., Krishnan, E., Bruce, B., Lingala, V. B., & Fries, J. F. (2012) · The American Journal of Medicine · doi:10.1016/j.amjmed.2011.08.006 · Cited by 107 · see citing works
Developing multicomponent interventions using fractional factorial designs
Chakraborty, B., Collins, L. M., Strecher, V. J., & Murphy, S. A. (2009) · Statistics in Medicine · doi:10.1002/sim.3643 · Cited by 107 · see citing works
Advances and Controversies in the Design of Obesity Prevention Trials
Stevens, J., Taber, D. R., Murray, D. M., & Ward, D. S. (2007) · Obesity · doi:10.1038/oby.2007.257 · Cited by 87 · see citing works
Navarro-Barrientos, J. E., Rivera, D. E., & Collins, L. M. (2011) · Mathematical and Computer Modelling of Dynamical Systems · doi:10.1080/13873954.2010.520409 · Cited by 87 · see citing works
Activities and Mortality in the Elderly: The Leisure World Cohort Study
Paganini‐Hill, A., Kawas, C. H., & Corrada, M. M. (2011) · The Journals of Gerontology Series A · doi:10.1093/gerona/glq237 · Cited by 85 · see citing works
Dallery, J., & Raiff, B. R. (2014) · Translational Behavioral Medicine · doi:10.1007/s13142-014-0258-z · Cited by 79 · cited 1× · see citing works
“Small single case or case series studies can be used to evaluate dose, safety, tolerability, and impact of introduction of new treatment components (Dallery & Raiff, 2014; Kazdin, 1982).”
BackgroundStrolla, L. O. (2005) · Health Education Research · doi:10.1093/her/cyh072 · Cited by 76 · see citing works
(2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.03.004 · Cited by 63 · see citing works
Peterson, J. C., Czajkowski, S. M., Charlson, M. E., Link, A. R., Wells, M. T., Isen, A. M., Mancuso, C. A., Allegrante, J. P., Boutin‐Foster, C., Ogedegbe, G. G., et al. (2012) · Journal of Consulting and Clinical Psychology · doi:10.1037/a0029909 · Cited by 48 · see citing works
Self-citationTranslational research: forging a new cultural identity
Coller, B. S. (2008) · Mount Sinai Journal of Medicine A Journal of Translational and Personalized Medicine · doi:10.1002/msj.20064 · Cited by 44 · see citing works
The Heart Failure Adherence and Retention Trial (HART): Design and rationale
Powell, L. H., Calvin, J. E., de Leon, C. F. M., Richardson, D., Grady, K. L., Flynn, K. J., Rucker-Whitaker, C. S., Janssen, İ., Kravitz, G., & Eaton, C. (2008) · American Heart Journal · doi:10.1016/j.ahj.2008.05.011 · Cited by 34 · see citing works
Self-citationRidenour, T. A., Pineo, T., Maldonado‐Molina, M. M., & Lich, K. H. (2013) · Prevention Science · doi:10.1007/s11121-012-0311-4 · Cited by 34 · see citing works
The Promise of Lifestyle for Cardiovascular Health
Mozaffarian, D. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.06.1191 · Cited by 14 · see citing works
Evaluating the Impact of Genetic Counseling and Testing with Signal Detection Methods
Palmer, C. G. S., & Hadley, D. W. (2005) · Journal of Genetic Counseling · doi:10.1007/s10897-005-1497-4 · Cited by 6 · cited 1× · see citing works
“Signal detection methods can be useful for identification of subgroups for which tailoring of treatment could optimize their outcomes (Palmer & Hadley, 2005).”
Method
Flagged first, then by citations
Research works printed but not linked: 2
- Friedman LM Furberg CD DeMets DL 1998 Fundamentals of Clinical Trials 3 New York Springer-Verlag
- 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
Chu, C., Buchman-Schmitt, J. M., Stanley, I. H., Hom, M. A., Tucker, R. P., Hagan, C. R., Rogers, M. L., Podlogar, M. C., Chiurliza, B., Ringer, F. B., et al. (2017) · Psychological Bulletin · doi:10.1037/bul0000123 · Cited by 1,231 · see citing works
Taxonomy of approaches to developing interventions to improve health: a systematic methods overview
O’Cathain, A., Croot, L., Sworn, K., Duncan, E., Rousseau, N. S., Turner, K. M., Yardley, L., & Hoddinott, P. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0425-6 · Cited by 581 · see citing works
Nielsen, L., Riddle, M., King, J. W., Aklin, W. M., Chen, W., Clark, D., Collier, E., Czajkowski, S., Esposito, L., Ferrer, R., et al. (2018) · Behaviour Research and Therapy · doi:10.1016/j.brat.2017.07.002 · Cited by 446 · see citing works
“A core principle of SOBC is that studies of mechanisms of change should be a standard feature of all phases of a clinical trial (Czajkowski et al., 2015; Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014; Riddle & Ferrer, 2015).”
BackgroundSelf-citationHealth Behavior Change: Moving from Observation to Intervention
Sheeran, P., Klein, W. M. P., & Rothman, A. J. (2016) · Annual Review of Psychology · doi:10.1146/annurev-psych-010416-044007 · Cited by 439 · see citing works
The Handbook of Behavior Change
Hagger, M. S., Cameron, L. D., Hamilton, K., Hankonen, N. E., & Lintunen, T. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318 · Cited by 420 · see citing works
Changing Behavior Using the Theory of Planned Behavior
Ajzen, I., & Schmidt, P. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.002 · Cited by 303 · see citing works
Developing Behavior Change Interventions for Self-Management in Chronic Illness
Araújo‐Soares, V., Hankonen, N. E., Presseau, J., Rodrigues, A., & Sniehotta, F. F. (2018) · European Psychologist · doi:10.1027/1016-9040/a000330 · Cited by 237 · see citing works
“ORBIT model (Czajkowski et al., 2015) To provide guidance on the process of treatment development by suggesting the use of a progressive, transdisciplinary framework to facilitate the translation of basic behavioural science findings to clinical application.”
BackgroundMethodFreedland, K. E., King, A. C., Ambrosius, W. T., Mayo-Wilson, E., Mohr, D. C., Czajkowski, S. M., Thabane, L., Collins, L. M., Rebok, G. W., Treweek, S. P., et al. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2019.02.011 · Cited by 218 · see citing works
“Similarly, in the Design phase (Phase I) of t he Obesity-Related Behavioral Intervention Trials (ORBIT) framework for developing behavioral interventions [30], small-N or single-case designs examine the intervention’s components, dosa ge parameters, targets, and modes of delivery without between-group comparators.”
BackgroundMethodSelf-citationDeslippe, A. L., Soanes, A., Bouchaud, C. C., Beckenstein, H., Slim, M., Plourde, H., & Cohen, T. R. (2023) · International Journal of Behavioral Nutrition and Physical Activity · doi:10.1186/s12966-023-01424-2 · Cited by 241 · see citing works
“As a result we opted to rooted our analysis in behavioural science terminology as other work has suggested that this approach can help facilitate relevant understanding and application within the field of behavioural science [63].”
Improving translation of animal models of addiction and relapse by reverse translation
Venniro, M., Banks, M. L., Heilig, M., Epstein, D. H., & Shaham, Y. (2020) · Nature Reviews Neuroscience · doi:10.1038/s41583-020-0378-z · Cited by 212 · see citing works
Brown, C. E. B., Richardson, K. E., Pizzirani, B., Atkins, L., Yücel, M., & Segrave, R. A. (2024) · BMC Public Health · doi:10.1186/s12889-023-17621-4 · Cited by 257 · see citing works
“…leveraged with behavioural intervention development tools and frameworks (e.g., the BCW [17], Obesity-Related Behavioural Intervention Trials model [91], Intervention Mapping [92], and the Medical Research Council guidelines for developing complex interventions [93, 94]) to develop evidence-based…”
MethodKnown knowns and known unknowns on behavior change interventions and mechanisms of action
Hagger, M. S., Moyers, S. A., McAnally, K., & McKinley, L. E. (2020) · Health Psychology Review · doi:10.1080/17437199.2020.1719184 · Cited by 165 · see citing works
“In this context, development of optimally efficacious, effective, cost-effective, implementable, and scalable behavioural interventions presents a grand challenge to scientists in the fields of social and behavioural science and allied disciplines including public health, behavioural and preventive medicine, and healt…”
BackgroundPrecision Health: The Role of the Social and Behavioral Sciences in Advancing the Vision
Hekler, E. B., Tiro, J. A., Hunter, C. M., & Nebeker, C. (2020) · Annals of Behavioral Medicine · doi:10.1093/abm/kaaa018 · Cited by 147 · see citing works
“Other frameworks potentially useful for articulating an appropriate research pipeline for precision health include, but are not limited to: the dynamic sustainability framework [78], disruptive innovations models [79], rapid relevant and responsive research model [80], the Obesity-Related Behavioral Intervention Trial…”
MethodSelf-citationThomas, J. J., Becker, K. R., Kuhnle, M. C., Jo, J. H., Harshman, S. G., Wons, O. B., Keshishian, A. C., Hauser, K., Breithaupt, L., Liebman, R. E., et al. (2020) · International Journal of Eating Disorders · doi:10.1002/eat.23355 · Cited by 146 · see citing works
“The ORBIT model of intervention development suggests that successful proof-of-concept studies be followed up with randomized controlled trials (Czajkowski et al., 2015).”
MethodChanging Behavior Using the Model of Action Phases
Keller, L., Gollwitzer, P. M., & Sheeran, P. (2020) · The Handbook of Behavior Change · doi:10.1017/9781108677318.006 · Cited by 147 · see citing works
Beets, M. W., Weaver, R. G., Ioannidis, J. P. A., Geraci, M., Brazendale, K., Decker, L., Okely, A. D., Lubans, D. R., van Sluijs, E. M. F., Jago, R., et al. (2020) · International Journal of Behavioral Nutrition and Physical Activity · doi:10.1186/s12966-020-0918-y · Cited by 142 · see citing works
A Framework to Evaluate Devices That Assess Physical Behavior
Keadle, S. K., Lyden, K. A., Strath, S. J., STAUDENMAYER, J. W., & Freedson, P. S. (2019) · Exercise and Sport Sciences Reviews · doi:10.1249/jes.0000000000000206 · Cited by 114 · see citing works
Gabrielli, S., Rizzi, S., Bassi, G., Carbone, S., Maimone, R., Marchesoni, M., & Forti, S. (2021) · JMIR mHealth and uHealth · doi:10.2196/27965 · Cited by 125 · see citing works
“The study design was based on a mixed methods approach and encompassed two phases of the ORBIT (Obesity-Related Behavioral Intervention Trials) framework [30] for intervention design (Phase I) and preliminary testing (Phase IIa).”
MethodBeets, M. W., von Klinggraeff, L., Weaver, R. G., Armstrong, B., & Burkart, S. A. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00909-w · Cited by 111 · see citing works
“As described in translational science frameworks [13, 14], as an intervention moves progressively across the “ maturity continuum ” , there is a need to demonstrate that an intervention can be conducted (i.e., implemented) and shows promise for impacting one or more primary and/or secondary…”
Pardini, S., Gabrielli, S., Dianti, M., Novara, C., Zucco, G. M., Mich, O., & Forti, S. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19127237 · Cited by 126 · see citing works
“The study design was based on a mixed-methods approach inspired by the Obesity-Related Behavioral Intervention Trials (ORBIT) framework [46] for design (Phase Ib) of digital interventions and their preliminary testing (Phase IIa).”
MethodA Roadmap for the Development of Applied Computational Psychiatry
Paulus, M., Huys, Q., & Maia, T. (2016) · Biological Psychiatry: Cognitive Neuroscience and Neuroimaging · doi:10.1016/j.bpsc.2016.05.001 · Cited by 108 · see citing works
“The development cycle of biomarkers, drugs, and medical devices involves fi ve different types of studies: 1) preclinical studies; 2) clinical assay development; 3) longitudinal and cross-sectional repository studies; 4) prospective studies; and 5) RCTs (47,49,59,60).”
BackgroundMindfulness-Based Programs: Why, When, and How to Adapt?
Loucks, E. B., Crane, R. S., Sanghvi, M. A., Montero‐Marín, J., Proulx, J. A., Brewer, J. A., & Kuyken, W. (2022) · Global Advances in Health and Medicine · doi:10.1177/21649561211068805 · Cited by 116 · see citing works
Mason, A. E., Jhaveri, K., Cohn, M., & Brewer, J. A. (2018) · Journal of Behavioral Medicine · doi:10.1007/s10865-017-9884-5 · Cited by 106 · see citing works
“As indicated for early intervention testing by the ObesityRelated Behavioral Intervention Trials (ORBIT) framework (Czajkowski et al., 2015), we administered a theorydriven, self-paced, smartphone-delivered intervention focusing on craving-related eating in a proof-of-concept, single-arm, unmasked…”
BackgroundMethodInfluentialChanging Behavior Using the Health Action Process Approach
Schwarzer, R., & Hamilton, K. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.007 · Cited by 107 · see citing works
Return to Work Interventions for Cancer Survivors: A Systematic Review and a Methodological Critique
Lamore, K., Dubois, T., Rothe, U., Leonardi, M., Girard, I., Manuwald, U., Nazarov, S., Silvaggi, F., Guastafierro, E., Scaratti, C., et al. (2019) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph16081343 · Cited by 105 · see citing works
“[43] is the most recognized in the scientific community”
BackgroundSeng, E. K., Singer, A. B., Metts, C., Grinberg, A. S., Patel, Z. S., Marzouk, M., Rosenberg, L., Day, M., Minen, M. T., Lipton, R. B., et al. (2019) · Headache: The Journal of Head and Face Pain · doi:10.1111/head.13657 · Cited by 103 · see citing works
Psychological Outcomes in Adolescent and Young Adult Cancer Survivors
McGrady, M. E., Willard, V. W., Williams, A. M., & Brinkman, T. M. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.23.01465 · Cited by 104 · see citing works
Statistical methodologies to pool across multiple intervention studies
Bangdiwala, S. I., Bhargava, A., O’Connor, D. P., Robinson, T. N., Michie, S., Murray, D. M., Stevens, J., Belle, S. H., Templin, T., & PRATT, C. A. (2016) · Translational Behavioral Medicine · doi:10.1007/s13142-016-0386-8 · Cited by 100 · see citing works
“…(Pratt et al 2013), the Early Adult Reduction of weight through LifestYle intervention (EARLY; 7 studies) (Lytle et al 2014), the Obesity Related Behavioral Intervention Trials (ORBIT; 7 studies) (Czajkowski et al 2015), and the Lifestyle Interventions For Expectant Moms (LIFE-Moms, 7 studies).”
BackgroundThe HOPE Pilot Study: Harnessing Patient-Reported Outcomes and Biometric Data to Enhance Cancer Care
Wright, A. A., Raman, N., Staples, P. C., Schonholz, S. M., Cronin, A. M., Carlson, K. W., Keating, N. L., & Onnela, J.-P. “. (2018) · JCO Clinical Cancer Informatics · doi:10.1200/cci.17.00149 · Cited by 93 · see citing works
Laddu, D., Ma, J., Kaar, J. L., Ozemek, C., Durant, R. W., Campbell, T. S., Welsh, J. A., & Turrise, S. L. (2021) · Circulation · doi:10.1161/cir.0000000000001026 · Cited by 97 · see citing works
Selzler, A., Wald, J., Sedeno, M. F., Jourdain, T., Janaudis‐Ferreira, T., Goldstein, R. S., Bourbeau, J., & Stickland, M. K. (2017) · Chronic Respiratory Disease · doi:10.1177/1479972317724570 · Cited by 95 · see citing works
“The purpose of the ORBIT model is to provide a structured framework for developing behavioral interventions that optimizes and integrates fundamental behavioral and social sciences research into practically relevant treatments to prevent/manage chronic diseases.(48) The ORBIT model outlines a progressive and iterative…”
MethodCiarrochi, J., Hayes, S. C., Oades, L. G., & Hofmann, S. G. (2022) · Frontiers in Psychology · doi:10.3389/fpsyg.2021.809362 · Cited by 95 · see citing works
“If the goal is to build a treatment package that works for many people, models like ORBIT (Czajkowski et al., 2015) could be used to systematically evaluate treatment components, combine them into a proof of concept package, and then conduct pilot and feasibility testing.”
MethodCognitive-behavioral therapy for adults with avoidant/restrictive food intake disorder
Thomas, J. J., Becker, K. R., Breithaupt, L., Murray, H. B., Jo, J. H., Kuhnle, M. C., Dreier, M. J., Harshman, S., Kahn, D. L., Hauser, K., et al. (2021) · Journal of Behavioral and Cognitive Therapy · doi:10.1016/j.jbct.2020.10.004 · Cited by 88 · see citing works
Lim, S. L., Ong, K. W., Johal, J., Han, C. Y., Yap, Q. V., Chan, Y. H., Chooi, Y. C., Zhang, Z. P., Chandra, C. C., Thiagarajah, A. G., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.12417 · Cited by 87 · see citing works
Improving Transition to Adulthood for Students with Autism: A Randomized Controlled Trial of STEPS
White, S., Smith, I. C., Miyazaki, Y., Conner, C. M., Elias, R., & Capriola-Hall, N. N. (2019) · Journal of Clinical Child & Adolescent Psychology · doi:10.1080/15374416.2019.1669157 · Cited by 69 · see citing works
“We considered these power values to be acceptable given the ORBIT model suggests small samples prior to more resource-intensive large-scale trials (Czajkowski et al., 2015) and given that our primary aims were to examine feasibility and preliminary efficacy via within-person change.”
MethodSleeping for Two: An Open-Pilot Study of Cognitive Behavioral Therapy for Insomnia in Pregnancy
Tomfohr-Madsen, L. M., Clayborne, Z. M., Rouleau, C. R., & Campbell, T. S. (2017) · Behavioral Sleep Medicine · doi:10.1080/15402002.2016.1141769 · Cited by 86 · see citing works
“,created a fixed treatment package; see Appendix 1 for group curriculum), and Phase IIa (i.e., test piloted the intervention; Czajkowski et al., 2015).”
BackgroundLim, S. L., Johal, J., Ong, K. W., Han, C. Y., Chan, Y. H., Lee, Y. M., & Loo, W. M. (2020) · JMIR mhealth and uhealth · doi:10.2196/14802 · Cited by 79 · see citing works
“nBuddy was developed using the Obesity-Related Behavioral Intervention Trials model for behavioral treatment as a framework for translating behavioral science discoveries into treatments, which is a flexible and robust process to design, conduct, and evaluate mobile app–based behavioral interventions [23].”
MethodJoyal‐Desmarais, K., Scharmer, A., Madzelan, M. K., See, J. V., Rothman, A. J., & Snyder, M. (2022) · Psychological Bulletin · doi:10.1037/bul0000377 · Cited by 88 · see citing works
Vieten, C., Laraia, B. A., Kristeller, J. L., Adler, N. E., Coleman‐Phox, K., Bush, N. R., Wahbeh, H., Duncan, L. G., & Epel, E. S. (2018) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-018-1757-6 · Cited by 78 · see citing works
“We used the Obesity-Related Behavioral Intervention Trials (ORBIT) model of intervention development [43], which outlines clear phases for a flexible and progressive process, with clinically relevant milestones for forward movement and return to earlier stages for refinement and optimization.”
MethodSelf-citationThinking Health-related Behaviors in a Climate Change Context: A Narrative Review
Chevance, G., Fresán, U., Hekler, E. B., Edmondson, D. E., Lloyd, S. J., Ballester, J., Litt, J., Cvijanović, I., Araújo‐Soares, V., & Bernard, P. (2022) · Annals of Behavioral Medicine · doi:10.1093/abm/kaac039 · Cited by 76 · see citing works
The Behavioral Medicine Research Council: Its origins, mission, and methods.
Freedland, K. E. (2019) · Health Psychology · doi:10.1037/hea0000731 · Cited by 76 · see citing works
“(Czajkowski et al., 2015, p. 5) This is a radical departure from the less ambitious short-term goals that have traditionally motivated much of our research.”
BackgroundVranceanu, A.-M., Jacobs, C., Lin, A., Greenberg, J., Funes, C. J., Harris, M. B., Heng, M., Macklin, E., & Ring, D. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0416-7 · Cited by 61 · see citing works
Dube, L., Bright, K., Hayden, K. A., & Gordon, J. L. (2023) · Human Reproduction Update · doi:10.1093/humupd/dmac034 · Cited by 75 · see citing works
Self-care research: How to grow the evidence base?
Jaarsma, T., Strömberg, A., Dunbar, S. B., Fitzsimons, D., Lee, C. S., Middleton, S., Vellone, E., Freedland, K. E., & Riegel, B. J. (2020) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2020.103555 · Cited by 68 · see citing works
Mosnaim, G. S., Li, H., Martin, M. A., Richardson, D., Belice, P. J., Avery, E., Silberstein, A., Leigh, J., Kenyon, R. V., Jones, S., et al. (2015) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2014.10.011 · Cited by 71 · see citing works
Self-citationFelder, J. N., Laraia, B. A., Coleman‐Phox, K., Bush, N. R., Suresh, M., Thomas, M., Adler, N. E., Epel, E. S., & Prather, A. A. (2017) · Behavioral Sleep Medicine · doi:10.1080/15402002.2016.1266488 · Cited by 64 · see citing works
“The parent study was designed according to the ORBIT model for developing behavioral treatments (Czajkowski et al., 2015).”
MethodSelf-citationCassidy, A. R., Butler, S., Briend, J., Calderon, J., Casey, F. A., Crosby, L. E., Fogel, J., Gauthier, N. S., Raimondi, C., Marino, B. S., et al. (2021) · Cardiology in the Young · doi:10.1017/s1047951121002158 · Cited by 69 · see citing works
Tomfohr‐Madsen, L. M., Madsen, J. W., Bonneville, D., Virani, S., Plourde, V., Barlow, K. M., Yeates, K. O., & Brooks, B. L. (2019) · Journal of Head Trauma Rehabilitation · doi:10.1097/htr.0000000000000504 · Cited by 70 · see citing works
Multilevel Interventions Targeting Obesity: Research Recommendations for Vulnerable Populations
Stevens, J., PRATT, C. A., Boyington, J., Nelson, C. R., Truesdale, K. P., Ward, D. S., Lytle, L. A., Sherwood, N. E., Robinson, T. N., Moore, S. M., et al. (2016) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2016.09.011 · Cited by 70 · see citing works
Self-citationGreenberg, J., Popok, P., Lin, A. C., Kulich, R. J., James, P., Macklin, E. A., Millstein, R. A., Edwards, R. R., & Vranceanu, A. (2020) · JMIR Formative Research · doi:10.2196/18703 · Cited by 59 · see citing works
“Consistent with our first hypothesis and the goals of both the ORBIT and NCCIH intervention development stage models, both programs met or exceeded the a-priori set feasibility benchmarks.”
BackgroundMethodResultInfluentialEpel, E. S., Laraia, B. A., Coleman‐Phox, K., Leung, C. W., Vieten, C., Mellin, L. M., Kristeller, J. L., Thomas, M., Stotland, N. E., Bush, N. R., et al. (2019) · International Journal of Behavioral Medicine · doi:10.1007/s12529-019-09779-2 · Cited by 72 · see citing works
“The intervention development process was based on the ORBIT model [40].”
BackgroundMethodInfluentialSelf-citationSelf-Compassion and Psycho-Physiological Recovery From Recalled Sport Failure
Ceccarelli, L. A., Giuliano, R. J., Glazebrook, C. M., & Strachan, S. M. (2019) · Frontiers in Psychology · doi:10.3389/fpsyg.2019.01564 · Cited by 73 · see citing works
“First, we followed a wellcontrolled, laboratory scenario which is appropriate for early stages of research (Czajkowski et al., 2015).”
MethodGreenberg, J., Lin, A. C., Zale, E. L., Kulich, R. J., James, P., Millstein, R. A., Shapiro, H., Schatman, M. E., Edwards, R. R., & Vranceanu, A. (2019) · Journal of Pain Research · doi:10.2147/jpr.s222448 · Cited by 55 · see citing works
“Feasibility And Acceptability Assessments Assessment milestones were set a priori and were based on guidelines for feasibility studies.(40,41) Feasibility of recruitment was assessed by determining the proportion of contacted patients who agreed to participate.”
MethodThe Cambridge Handbook of Substance and Behavioral Addictions
Sussman, S. Y. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591 · Cited by 63 · see citing works
Naar, S., Czajkowski, S. M., & Spring, B. J. (2018) · Health Psychology · doi:10.1037/hea0000657 · Cited by 64 · see citing works
Self-citationMobile applications for the treatment of tobacco use and dependence
Vilardaga, R., Casellas-Pujol, E., McClernon, J. F., & Garrison, K. A. (2019) · Current Addiction Reports · doi:10.1007/s40429-019-00248-0 · Cited by 64 · see citing works
Roy, A., Druker, S., Hoge, E. A., & Brewer, J. A. (2020) · JMIR mHealth and uHealth · doi:10.2196/15608 · Cited by 55 · see citing works
“Previously, we used the Obesity-Related Behavioral Intervention Trials framework to develop an app to target anxiety as a behavioral risk factor of interest (Phase I) [32].”
MethodHeiney, S. P., Donevant, S. B., Adams, S. A., Parker, P. D., Chen, H., & Levkoff, S. E. (2020) · JMIR Aging · doi:10.2196/17142 · Cited by 55 · see citing works
“However, previous studies suggest that a quasiexperimental design is appropriate when participants are unlikely to change their behavior without an intervention (ie, inclusion of a usual care group would not add information during pilot testing) [37,38].”
BackgroundGardner, B., Rebar, A. L., & Lally, P. J. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.041 · Cited by 69 · see citing works
Changing Behavior Using Social Cognitive Theory
Łuszczyńska, A., & Schwarzer, R. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.003 · Cited by 71 · see citing works
Posttraumatic stress disorder and positive memories: Clinical considerations
Contractor, A. A., Brown, L. A., Caldas, S. V., Banducci, A. N., Taylor, D. J., Armour, C., & Shea, M. T. (2018) · Journal of Anxiety Disorders · doi:10.1016/j.janxdis.2018.06.007 · Cited by 54 · see citing works
Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers: A Pilot Study
Patten, C. A., Bronars, C. A., Douglas, K. S. V., USSHER, M. H., Levine, J. A., Tye, S. J., Hughes, C. A., Brockman, T. A., Decker, P. A., DeJesus, R. S., et al. (2016) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntw208 · Cited by 55 · see citing works
Dose–response research in digital health interventions: Concepts, considerations, and challenges.
McVay, M. A., Bennett, G. G., Steinberg, D., & Voils, C. I. (2019) · Health Psychology · doi:10.1037/hea0000805 · Cited by 55 · see citing works
“For example, the expert-developed ORBIT model of intervention development and testing distinguishes between the delivery of intervention and the behaviors in which participants engage (i.e., the behavioral targets; Czajkowski et al., 2015).”
MethodUnderstanding diabetes and the role of psychology in its prevention and treatment.
Hunter, C. M. (2016) · American Psychologist · doi:10.1037/a0040344 · Cited by 52 · see citing works
“…also a need for research focused on “bench to bedside” translation to take the existing basic behavioral and social science findings and use those data to inform the development and testing of novel interventions to address the range of behavioral and psychosocial needs (Czajkowski et al., 2015).”
BackgroundSelf-citationChow, E. J., Doody, D. R., Di, C., Armenian, S. H., Baker, K. S., Bricker, J. B., Gopal, A. K., Hagen, A. M., Ketterl, T. G., Lee, S. J., et al. (2020) · Journal of Cancer Survivorship · doi:10.1007/s11764-020-00949-w · Cited by 45 · see citing works
“However, the direction of effect supported the intervention and provided important information on potential effect sizes that can inform the design of a more robustly powered followup study [33].”
BackgroundFalck, R. S., Davis, J. C., Best, J. R., Chan, P., LI, L. C., Wyrough, A. B., Bennett, K. J., Backhouse, D., & Liu-Ambrose, T. Y. L. (2020) · Journal of Alzheimer s Disease · doi:10.3233/jad-200383 · Cited by 54 · see citing works
Algeo, N., Bennett, K., & Connolly, D. (2021) · BMC Cancer · doi:10.1186/s12885-021-08613-x · Cited by 53 · see citing works
Sood, E., Lisanti, A. J., Woolf‐King, S. E., Wray, J., Kasparian, N. A., Jackson, E., Gregory, M. R., Lopez, K. N., Marino, B. S., Neely, T., et al. (2021) · Cardiology in the Young · doi:10.1017/s1047951121002134 · Cited by 56 · see citing works
Lim, K., Chan, S., Lim, S. L., Tai, B. C., Tsai, C., Wong, S. R., Ang, S. M., Yew, T. W., Tai, E. S., & Yong, E. (2021) · JMIR mhealth and uhealth · doi:10.2196/22147 · Cited by 43 · see citing works
“The nBuddy app is locally developed and was based on the Obesity-Related Behavioral Intervention Trials model for developing behavioral treatments for chronic disease [24].”
MethodDeveloping a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study
Ong, J. C., Dawson, S. C., Mundt, J. M., & Moore, C. (2020) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.8750 · Cited by 52 · see citing works
“Consistent with phase 1b of the staged development of behavioral therapies, 19,21 the aims for this study were to (1) gather feasibility data on preliminary ef fi cacy on depressive symptoms and treatment effects on related psychosocial domains and (2) evaluate methodologic considerations using…”
Consolidated guidance for behavioral intervention pilot and feasibility studies
Pfledderer, C. D., von Klinggraeff, L., Burkart, S. A., Bandeira, A. D. S., Lubans, D. R., Jago, R., Okely, A. D., van Sluijs, E. M. F., Ioannidis, J. P. A., Thrasher, J. F., et al. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01485-5 · Cited by 65 · see citing works
“This implies researchers who conduct PFS intend to continue to refine and optimize an intervention for maximal impact along a translational science continuum [117–119].”
BackgroundFroome, H. M., Townson, C., Rhodes, S., Franco‐Arellano, B., LeSage, A., Savaglio, R., Brown, J. M., Hughes, J. M., Kapralos, B., & Arcand, J. (2020) · Nutrients · doi:10.3390/nu12113413 · Cited by 51 · see citing works
Behavioral Research in Cancer Prevention and Control: Emerging Challenges and Opportunities
Klein, W. M. P., O’Connell, M. E., Bloch, M., Czajkowski, S. M., Green, P. A., Han, P. K. J., Moser, R. P., Nebeling, L. C., & Vanderpool, R. C. (2021) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djab139 · Cited by 52 · see citing works
“These models include the experimental medicine approach espoused by the National Institutes of Health’s Science of Behavior Change initiative (128), the Obesity-Related Behavioral Intervention Trials model (129), and the Stage Model of Treatment Development”
Self-citationWarner, L. M., & French, D. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.032 · Cited by 53 · see citing works
Changing Behavior Using Ecological Models
Salmon, J., Hesketh, K. D., Arundell, L., Downing, K. L., & Biddle, S. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.017 · Cited by 51 · see citing works
Reed, D. D., Naudé, G. P., Gelino, B. W., & Amlung, M. T. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.011 · Cited by 48 · see citing works
Elbers, S., van Gessel, C., Renes, R. J., van der Lugt, R., Wittink, H., & Hermsen, S. (2021) · Journal of Medical Internet Research · doi:10.2196/18462 · Cited by 47 · see citing works
“Only a fraction of intervention development projects is able to bridge the translational gap from scientific research to clinical practice [1-4].”
BackgroundThe impact of humanistic coach training on youth athletes’ development through sport
Falcão, W. R., Bloom, G. A., & Sabiston, C. M. (2020) · International Journal of Sports Science & Coaching · doi:10.1177/1747954120933975 · Cited by 48 · see citing works
“Proof-of-concept are small-scale studies that provide a cost-effective way to determine if a treatment can benefit a target population prior to costly large randomized trials.(42) Differences in athletes’ reporting of competence, confidence, connection, and Falc~ao et al.”
BackgroundLamothe, M., McDuff, P., Pastore, Y. D., Duval, M., & Sultan, S. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-018421 · Cited by 45 · see citing works
The Prevention and Treatment of Gambling Disorders: Some Art, Some Science
Derevensky, J. L. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.024 · Cited by 45 · see citing works
Neurobiological Foundations of Behavioral Addictions
Vaccaro, A. G., & Potenza, M. N. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.016 · Cited by 45 · see citing works
Self-Compassion and the Self-Regulation of Exercise: Reactions to Recalled Exercise Setbacks
Semenchuk, B. N., Strachan, S. M., & Fortier, M. (2018) · Journal of Sport and Exercise Psychology · doi:10.1123/jsep.2017-0242 · Cited by 46 · see citing works
“This cross-sectional test of selfcompassionate reactions to an exercise setback is an appropriate test of proof-of-concept (Czajkowski et al., 2015) at this early stage of research.”
BackgroundChanging Behavior Using Self-Determination Theory
Hagger, M. S., Hankonen, N. E., Chatzisarantis, N. L. D., & Ryan, R. M. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.008 · Cited by 49 · see citing works
Considering the Overlap and Nonoverlap of Compulsivity, Impulsivity, and Addiction
Blum, A. W., & Grant, J. E. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.038 · Cited by 44 · see citing works
Tanning as an Addiction: The State of the Research and Implications for Intervention
Miller, K. A., & Mays, D. M. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.037 · Cited by 43 · see citing works
Schulte, E. M., Schiestl, E. T., & Gearhardt, A. N. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.035 · Cited by 43 · see citing works
Sensitization of Incentive Salience and the Transition to Addiction
Warlow, S. M., Baumgartner, H. M., Freeland, C. M., Naffziger, E. E., Olney, J. J., Berridge, K. C., & Robinson, M. J. F. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.006 · Cited by 45 · see citing works
Fedele, D. A., McConville, A., Thomas, J. G., McQuaid, E. L., Janicke, D. M., Turner, E. M., Moon, J., & Abu‐Hasan, M. (2017) · Contemporary Clinical Trials · doi:10.1016/j.cct.2017.09.007 · Cited by 43 · see citing works
Mindfulness-Based Interventions Applied to Addiction Treatments
Kechter, A., & Black, D. S. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.040 · Cited by 43 · see citing works
Neurobiology of Substance Addictions
Christie, N. C., & Bechara, A. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.015 · Cited by 44 · see citing works
Multiple Memory Systems, Addiction, and Health Habits: New Routes for Translational Science
Stacy, A. W., Pike, J. R., & Lee, A. Y. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.017 · Cited by 43 · see citing works
Prevention and Treatment of Compulsive Buying Disorder
Galimov, A., & Black, D. W. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.027 · Cited by 42 · see citing works
Feedback Models for Gambling Control: The Use and Efficacy of Online Responsible Gambling Tools
Griffiths, M. D. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.034 · Cited by 42 · see citing works
Prevention and Treatment of “Food Addiction”
Davis, C., & Mason, A. E. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.023 · Cited by 42 · see citing works
Behavioral Economics and Addictive Disorders
Jarmolowicz, D. P., & Schneider, T. D. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.005 · Cited by 42 · see citing works
Training cognitive control to reduce emotional vulnerability in breast cancer
Swainston, J., & Derakshan, N. (2018) · Psycho-Oncology · doi:10.1002/pon.4727 · Cited by 42 · see citing works
Human Neurobiological Approaches to Hedonically Motivated Behaviors
Burger, K. S., Shearrer, G. E., & Sadler, J. R. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.009 · Cited by 42 · see citing works
Blum, K., Roy, A. K., Podesta, A., Modestino, E. J., Steinberg, B., Gondré-Lewis, M. C., Baron, D. A., Thanos, P. K., Lott, L., Badgaiyan, S., et al. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.031 · Cited by 42 · see citing works
Effect of Morning and Evening Exercise on Energy Balance: A Pilot Study
Creasy, S. A., Wayland, L. T., Panter, S. L., Purcell, S. A., Rosenberg, R. C., Willis, E. A., Shiferaw, B. A., Grau, L., Breit, M. J., Bessesen, D. H., et al. (2022) · Nutrients · doi:10.3390/nu14040816 · Cited by 44 · see citing works
Determining sample size for pilot trials: a tutorial
Ying, X., Freedland, K. E., Powell, L. H., Stuart, E. A., Ehrhardt, S., & Mayo‐Wilson, E. (2025) · BMJ · doi:10.1136/bmj-2024-083405 · Cited by 55 · see citing works
Self-citation
- 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)
- ORCID
- Venue
- Health Psychology
- Published
- 2015-10
- Volume
- 34
- Issue
- 10
- Pages
- 971-982
- ISSN
- 0278-6133 (ISSN-L)
- 1930-7810
- PMC
- PMC4522392
- 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
- hybrid
- doi.org
- 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
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