The DOI matches its Crossref record; 54 of the 54 references it cites were found in a registry or an index; none of the 20 sources its claims cite is checked for support yet.
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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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesNone of the sources cited for this claim have been checked yet.
In the paper
“It is widely acknowledged that behavior plays a central role in the prevention and management of chronic disease.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > INTRODUCTION
What the sources say
- Not checked yetcites Mokdad, Marks, Stroup, & Gerberding, 2004
- Not checked yetcites Schroeder, 2007
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“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).”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
What the sources say
- Not checked yetcites Blumenthal, Babyak, Wei, O’Connor, Waugh, Eisenstein, Mark, Sherwood, et al., 2002
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“a 5% weight loss as a biomedical target (Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006)”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
What the sources say
- Not checked yetcites Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesNone of the sources cited for this claim have been checked yet.
In the paper
“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”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > INTRODUCTION
What the sources say
- Not checked yetcites Appel, Clark, Yeh, Wang, Coughlin, Daumit, Miller, Dalcin et al., 2011
- Not checked yetcites Appel, Champagne, Harsha, Cooper, Obarzanek, Elmer, Stevens, Vollmer, et al., 2003
- Not checked yetcites Knowler, Barrett-Connor, Fowler, Hamman, Lachin, Walker, Nathan, Diabetes Prevention Program Research Group, 2002
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“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)”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
What the sources say
- Not checked yetcites Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes? Checkable: unclear✓ Load-bearing: passes✓ Based: passesIn the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
What the sources say
- Not checked yetcites Kraemer, Mintz, Noda & Tinklenberg, 2006
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
- Probably not a substantial claim. 17
- It may state two separate claims as one. 9
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
What the sources say
- Not checked yetcites Davidson, Goldstein, Kaplan, Kaufmann, Knatterud, Orleans, Spring, Trudeau, & Whitlock, 2002
Strength:boosted· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The ORBIT model complements and extends these efforts in proposing a systematic, well-defined process by which the investigator can achieve these rigorous standards.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. The paper may give no reason why it holds.
In the paper
“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)”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
What the sources say
- Not checked yetcites Hamman, Wing, Edelstein, Lachin, Bray, Delahanty, Hoskin, Kriska, et al., 2006
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes? Checkable: unclear✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- 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.
None of the sources cited for this claim have been checked yet.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > INTRODUCTION
What the sources say
- Not checked yetcites Friedman, Furburg, & DeMets, 1998
- Not checked yetcites Lipsky & Sharp, 2001
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
In the paper
“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).”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
What the sources say
- Not checked yetcites deCharms, Maeda, Glover, Ludlow, Pauly, Soneji, Gabrieli, & Mackey, 2005
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. The paper may give no reason why it holds.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
What the sources say
- Not checked yetcites Handelsman, Mechanick, Blonde, Gruberger, Bloomgarden, Bray, Dagogo-Jack, Davidson, et al., 2011
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“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.””
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > Previous Efforts to Define a Process for Behavioral Intervention Development
What the sources say
- Not checked yetcites Coller (2008)
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“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”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > THE ORBIT MODEL FOR BEHAVIORAL TREATMENT DEVELOPMENT > The Process of Drug Development
What the sources say
- Not checked yetcites Friedman, Furburg, & DeMets, 1998
- Not checked yetcites Lipsky & Sharp, 2001
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence.
- 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?
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“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]
Experimental — accuracy not yet measuredIn the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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”
Citations
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Ecological momentary assessment
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Actual causes of death in the United States
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2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults
Jensen, M. D., Ryan, D. H., Apovian, C. M., Ard, J. D., Comuzzie, A. G., Donato, K. A., Hu, F. B., Hubbard, V. S., Jakicic, J. M., Kushner, R. F., et al. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.11.004 · Cited by 4,058
Single-Case Research Designs: Methods for Clinical and Applied Settings
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Planning health promotion programs an intervention mapping approach
Bartholomew, L. K., Parcel, G. S., Kok, G., & Gottlieb, N. (2006) · Cited by 2,038
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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
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Items 501–600 of 1,176
The Role of Virtual Reality in the Management of Irritable Bowel Syndrome
Suchak, K. K., Almario, C. V., Liran, O., Chernoff, R. A., & Spiegel, B. M. R. (2024) · Current Gastroenterology Reports · doi:10.1007/s11894-024-00940-w · Cited by 10
“Using the ORBIT Model for Developing Behavioral Treatments for Chronic Diseases framework, our Cedars-Sinai team developed a VR program that delivers CBT over an 8-week period to help patients manage their gut symptoms [67].”
MethodBaldwin, A. S., Zhu, H., Rochefort, C., Marks, E. G., Fullington, H. M., Rodriguez, S. A., Kassa, S., & Tiro, J. A. (2021) · Health Psychology · doi:10.1037/hea0001075 · Cited by 7
Lui, F., Chen, Z., Niu, Y., BREITBART, W. S., Gany, F. M., & Leng, J. C. F. (2024) · Asian American Journal of Psychology · doi:10.1037/aap0000318 · Cited by 7
Currie, C. C., Walburn, J., Hackett, K. L., McCabe, R., Sniehotta, F. F., O’Keeffe, S., Jong, N. B.-D., & Araújo‐Soares, V. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-818697-8.00177-1 · Cited by 7
Developing a narrative communication intervention in the context of HPV vaccination
Fleszar-Pavlović, S. E., & Cameron, L. (2024) · PEC Innovation · doi:10.1016/j.pecinn.2024.100272 · Cited by 7
“Firstly, it applies the ORBIT framework [45] for creating a CSM-guided narrative intervention to boost HPV vaccination.”
MethodWalsh, C., Miller, S. J., Smith, C. B., Prigerson, H. G., McFarland, D. C., Yarborough, S., Santos, C. D. L., Thomas, R., Czaja, S. J., RoyChoudhury, A., et al. (2023) · PEC Innovation · doi:10.1016/j.pecinn.2023.100245 · Cited by 7
“…by the Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral intervention development (Phase 1b: Refine), patients, caregivers, and experts working with patients with advanced cancer participated in semi-structured interviews to provide feedback about the PACT website [28].”
MethodNewsome, F. A., Cardel, M. I., Chi, X., Lee, A. M., Miller, D. R., Menon, S., Janicke, D. M., Gurka, M. J., Butryn, M. L., & Manasse, S. M. (2022) · Childhood Obesity · doi:10.1089/chi.2022.0116 · Cited by 7
“24 Formative work revealed differences in perceived barriers and facilitators among males and females, and a desire for sex stratified and tailored interventions.”
Tighe, C. A., Phares, A. D., Weiner, D. K., Beehler, G. P., VanSwearingen, J. M., Harvey, A. G., Hilgeman, M. M., Buysse, D. J., & Forman, D. E. (2024) · Behavioral Sleep Medicine · doi:10.1080/15402002.2024.2386602 · Cited by 5
“Following models of behavioral intervention development/adaptation and evaluation (Czajkowski et al., 2015; Onken et al., 2014), next steps may include a pilot randomized trial to assess feasibility of conducting a larger-scale efficacy study.”
Young, P. J., Wallsworth, C., Gosal, H., & Mackey, D. C. (2024) · Journal of Aging and Physical Activity · doi:10.1123/japa.2023-0290 · Cited by 8
Key milestones during 40 years of behavioral medicine at the National Institutes of Health
Czajkowski, S. M., Riley, W. T., Stoney, C. M., Klein, W. M. P., & Croyle, R. T. (2019) · Journal of Behavioral Medicine · doi:10.1007/s10865-018-9981-0 · Cited by 7
Self-citationStress, psychiatric disorders, and cardiovascular disease
Bacon, S. (2019) · BMJ · doi:10.1136/bmj.l1577 · Cited by 7
Bamonti, P. M., Rose, G. A., Park, S., Silberbogen, A. K., Moye, J. A., & Moy, M. L. (2024) · Annals of Behavioral Medicine · doi:10.1093/abm/kaae030 · Cited by 7
Geiss, C., Chavez, M., Oswald, L. B., Ketcher, D., Reblin, M., Bandera, E. V., Savard, J., Zhou, E. S., Fox, R. S., Jim, H., et al. (2022) · Annals of Behavioral Medicine · doi:10.1093/abm/kaac035 · Cited by 9
“Consistent with Phase I of the ORBIT Model for Developing Behavioral Treatments [18], qualitative research is critical to the success of developing culturally targeted interventions that may help reduce disparities.”
MethodShaw, A., Robert, R. S., Kresta, K., Andersen, C. R., Lewis, B., Maetzold, B., Valderrama, R., Cion, I., & Tewari, P. (2022) · Children · doi:10.3390/children9020186 · Cited by 7
“The foundation of this intervention (TEAM Me) was based on the Orbit Model for behavioral treatment development, wherein this quality improvement program and data serve as a Phase IIa, ‘Proof-of-Concept’ [12].”
MethodEconomic and Behavioral Economic Approaches to Behavior Change
Brown, P. M., Cameron, L. D., Wilkinson, M., & Taylor, D. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.042 · Cited by 7
Development and pilot test of a pregnancy decision making tool for women with physical disabilities
Kalpakjian, C. Z., Haapala, H. J., Ernst, S., Orians, B. R., Barber, M. L., Mulenga, L., Bolde, S., Kreschmer, J. M., Parten, R., Carlson, S. E., et al. (2022) · Health Services Research · doi:10.1111/1475-6773.14103 · Cited by 8
Epton, T., & Armitage, C. J. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.038 · Cited by 8
Dias, N., Boring, E., Johnson, L. A., Grossoehme, D. H., Murphy, S., & Friebert, S. E. (2021) · Death Studies · doi:10.1080/07481187.2021.1914239 · Cited by 7
“This finding addresses issues related to usability, a goal of ORBIT Phase 1a (Czajkowski et al., 2015).”
InfluentialHealth Psychology and Climate Change: Time to address humanity’s most existential crisisPreprint
Papies, E. K., Nielsen, K. S., & Soares, V. A. (2023) · doi:10.31234/osf.io/ujwk4 · Cited by 7
Locke, S., Falkenhain, K., Lowe, D. A., Lee, T., Singer, J., Weiss, E. J., & Little, J. P. (2020) · JMIR Research Protocols · doi:10.2196/19053 · Cited by 7
“Furthermore, a randomized efficacy trial with strict eligibility criteria is necessary and appropriate for the stage of research [38].”
BackgroundJuengst, S. B., Wright, B., Driver, S. J., Calhoun, S., Muir, A., Dart, G., Goldin, Y., Lengenfelder, J., & Bell, K. R. (2023) · Neurorehabilitation · doi:10.3233/nre-220129 · Cited by 8
Motivational Interviewing Interventions
Berman, A. H., Beckman, M., & Lindqvist, H. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.045 · Cited by 12
Smith-Ricketts, J., Beaumont, C. T., Fleming, J. K., Hornbuckle, L. M., & Strohacker, K. A. (2022) · Journal of Aging and Physical Activity · doi:10.1123/japa.2022-0064 · Cited by 5
Greenberg, J., Singh, T., Popok, P., Kulich, R. J., & Vranceanu, A. (2021) · International Journal of Behavioral Medicine · doi:10.1007/s12529-021-09971-3 · Cited by 5
Gudzune, K. A., Jerome, G. J., Dalcin, A., Gao, R., Mace, E., Fink, T., Minahan, E., Yuan, C. T., Xie, A., Goldsholl, S., et al. (2023) · Obesity Science & Practice · doi:10.1002/osp4.690 · Cited by 4
“Then, applying the Obesity ‐ Related Behavioral Intervention Trials (ORBIT) model of using treatment ‐ only design to rapidly evaluate a behavioral intervention, 32 this curriculum was preliminarily tested among persons with SMI to determine”
MethodLoughan, A. R., Lanoye, A. M., Willis, K. D., Ravyts, S. G., Fox, A. M., Zukas, A. M., & Kim, Y. (2023) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2023.101083 · Cited by 6
Wuerstl, K. R., Todd, K. R., Lawrason, S., Shwed, A., Holmes, B., & Gainforth, H. L. (2023) · Addictive Behaviors · doi:10.1016/j.addbeh.2023.107762 · Cited by 5
Flora, P. K., Lopez, P., Mina, D. S., Jones, J. M., Brawley, L. R., Sabiston, C. M., Ferguson, S. E., Obadia, M., & Auger, L. E. (2021) · Journal of Psychosocial Oncology · doi:10.1080/07347332.2021.1939474 · Cited by 6
“The ORBIT model is a systematic framework that guides behavioral treatment development for a broad array of chronic diseases.(27) This investigation is a Phase 1 b study, as classified by the ORBIT model, which aims to refine a treatment to promote efficiency by examining treatments relative to feasibility, acceptabil…”
MethodInfluentialConner, M. T., Williams, D. M., & Rhodes, R. E. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.034 · Cited by 6
Feasibility and Acceptability: Narrative Writing with Caregivers in Pediatric Critical Care
Grossoehme, D. H., Robinson, N., Aultman, J. M., Forbes, M. L., Gerak, L., & Friebert, S. E. (2022) · Journal of Palliative Medicine · doi:10.1089/jpm.2022.0207 · Cited by 6
Griffith, D. M., Pennings, J. S., & Jaeger, E. C. (2023) · American Journal of Men s Health · doi:10.1177/15579883231193235 · Cited by 8
“The primary goal of this pilot is to assess the logistical feasibility and acceptability of the effectiveness trial protocol for investigators and participants in preparation for a fully powered randomized controlled trial (Czajkowski et al., 2015; Freedland, 2020).”
Lévesque, A., Ogez, D., Gravel, V., Marcil, V., Curnier, D. Y., Rondeau, É., Sinnett, D., Péloquin, K., & Sultan, S. (2023) · Journal of Clinical Psychology in Medical Settings · doi:10.1007/s10880-023-09998-6 · Cited by 6
“Reach To assess reach, we followed the recommendations of Czajkowski et al., 2015 (Czajkowski et al., 2015) and calculated the enrollment ratio (i.e., ratio of enrolled families/eligible families) and the dropout rate (i.e., ratio of the number of families who did not complete the 4 individual…”
Lake, A. J., Bo, A., & Hadjiconstantinou, M. (2021) · Current Diabetes Reports · doi:10.1007/s11892-021-01432-1 · Cited by 6
Dugan, S. A., Lange‐Maia, B. S., Karavolos, K., Kazlauskaite, R., Hollings, C. S., Avery, E., Nackers, L. M., Lynch, E. B., Ventrelle, J., Normand, P. S., et al. (2016) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2016.07.002 · Cited by 8
Self-citationOrtega, A., & Cushing, C. C. (2024) · JMIR Formative Research · doi:10.2196/60171 · Cited by 5
“The Obesity-Related Behavioral Interventions Trials (ORBIT) model provides a sequence of phases for initially designing and later optimizing behavioral treatments [27].”
InfluentialCaru, M., Dandekar, S. C., Gordon, B. R., Conroy, D. E., Barb, E. D., Doerksen, S. E., Smink, G. M., McKeone, D. J., Shah, N. B., Greiner, R. J., et al. (2024) · Journal of Behavioral Medicine · doi:10.1007/s10865-024-00497-z · Cited by 8
“Guided by the ORBIT model for the development of behavioral interventions for chronic diseases [24], we determined that a Phase 1a study was the most appropriate.”
Kim, M., Patrick, K., Nebeker, C., Godino, J., Stein, S., Klasnja, P., Perski, O., Viglione, C., Coleman, A., & Hekler, E. B. (2022) · doi:10.31219/osf.io/8t5xy · Cited by 5
Vilardaga, R., Thrul, J., DeVito, A., Kendzor, D. E., Sabo, P. L., & Khafif, T. C. (2023) · Addiction Neuroscience · doi:10.1016/j.addicn.2023.100090 · Cited by 6
Kwok, G., Levonyan‐Radloff, K., Masterson, M., Ohman‐Strickland, P., Pawlish, K. S., Burger, S. S., Paddock, L. E., Palermo, T. M., Bouchard, E., Manne, S. L., et al. (2025) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsaf004 · Cited by 7
McVay, M. A., Yancy, W. S., Bennett, G. G., Levine, E. L., Jung, S., Jung, S., Anton, S., & Voils, C. I. (2019) · Translational Behavioral Medicine · doi:10.1093/tbm/ibz143 · Cited by 6
“A first step towards evaluating the mobilization tool is conducting a feasibility trial to determine the tool's acceptability, feasibility of a planned effectiveness trial protocol, and presence of a signal of an effect of the tool [18,19].”
BackgroundMethodKroshus, E., Hafferty, K. R., Garrett, K., Johnson, A. M., Webb, L., Bloom, A., Sullivan, E., Senturia, K., & Tandon, P. S. (2023) · BMC Public Health · doi:10.1186/s12889-023-15338-y · Cited by 6
“Guided by the Obesity-Related Behavioral Interventions Trials (ORBIT) Model, [11] we determined that a Phase 1a evaluation was most appropriate.”
BackgroundMethodInfluentialDouglas, S. M., Hawkins, G. M., Berlin, K. S., Crouter, S. E., Epstein, L. H., Thomas, J. G., & Raynor, H. A. (2020) · Contemporary Clinical Trials · doi:10.1016/j.cct.2020.106153 · Cited by 5
“The ORBIT model serves as a platform to guide the goal of translating basic behavior sciences into behavioral treatments aimed toward preventing or treating chronic illness [64].”
MethodDiaz, K. M., Murdock, M. E., Clark, A. W., Kumar, S., Jerez, V., Serafini, M. A., Xu, C., Boudreaux, B. D., Romero, E. K., Aguirre, J., et al. (2025) · BMC Public Health · doi:10.1186/s12889-025-22250-0 · Cited by 6
“Although a systematic framework for early phase development of behavioral interventions exists [25, 26], rigorous and methodical dose escalation experiments have largely not been conducted to elucidate efficacious and tolerated sedentary break doses.”
Forthun, L. F., Sajatovic, M., Levin, J. B., DelBello, M. P., Appling, D., Broadnax, M., Fuentes‐Casiano, E., Cooley, R., Blixen, C. E., & Modi, A. C. (2023) · JAACAP Open · doi:10.1016/j.jaacop.2023.04.001 · Cited by 7
“16 20 Managing BD is a complex process for anyone, but is particularly challenging for AYAs, and only some interventions exist that address adherence and self-management in AYAs with BD. 21 A successful evidence-based adherence intervention and self-management program for adults with BD called customized adherence enh…”
BackgroundMethodInfluentialJoyce, K. M., Rioux, C., MacKinnon, A., Katz, L. Y., Reynolds, K., Kelly, L. E., Klassen, T. P., Afifi, T. O., Mushquash, A. R., Clement, F. M., et al. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01260-y · Cited by 10
Self-citationPurkart, R., Aleksieva, P., Mellah, S., Leblond‐Baccichet, G., & Belleville, S. (2023) · Journal of Cognition · doi:10.5334/joc.323 · Cited by 7
Misserian, M., Wheelington, A., King, R., et al. (2024) · Journal of Translational Medicine · doi:10.1186/s12967-024-04953-x · Cited by 6
“Overall, TeenLYFT represents a promising approach to supporting adolescent MBS patients, building upon the foundation of the DPP/GLB while tailoring it to meet their specific needs and preferences [17].”
BackgroundInfluentialChevalier, L., Fine, E., Sharma, A., Zhou, E. S., & Recklitis, C. J. (2022) · Journal of Psychosocial Oncology · doi:10.1080/07347332.2022.2054750 · Cited by 5
Knol, L. L., Appel, S. J., Crowe-White, K. M., Brantley, C., Adewumi, O., & Senkus, K. E. (2021) · American Journal of Health Education · doi:10.1080/19325037.2021.1930615 · Cited by 6
“The Obesity-related Behavioral Intervention Trials (ORBIT) consortium recommends a process of defining, refining, and optimizing behavioral interventions prior to full efficacy (Phase 3) and effectiveness (Phase 4) trials.(37) This process was used in the development of Project MEE.”
MethodIt's About Time: Answering the Call for Greater Precision in Research and Practice
Rothman, A. J. (2019) · Applied Psychology Health and Well-Being · doi:10.1111/aphw.12158 · Cited by 4
Lui, F., Zhang, Q., Bao, G. C., Narang, B., Chen, R., Niu, Y., Leng, J. C. F., & BREITBART, W. S. (2025) · BMC Health Services Research · doi:10.1186/s12913-024-12124-3 · Cited by 7
Vickery, K. D., Gelberg, L., Hyson, A. R., Strother, E., Carter, J., Perez, O. O., Franco, M., Kavistan, S., Gust, S., Adair, E., et al. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1329138 · Cited by 7
Mobile Health Tobacco Cessation Interventions to Promote Health Equity: Current Perspectives
Battalio, S. L., Pfammatter, A. F., Kershaw, K. N., Hernandez, A., Conroy, D. E., & Spring, B. J. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2022.821049 · Cited by 6
“ObesityRelated Behavioral Intervention Trials (ORBIT) model, (53) the experimental medicine approach, (54) or the Medical Research Council (MRC) framework (55).”
MethodBuilding and strengthening physical activity identity: a theory-informed user-guide
Strachan, S. M., Kullman, S. M., & Rhodes, R. E. (2025) · Health Psychology Review · doi:10.1080/17437199.2025.2550359 · Cited by 9
“In developing such interventions, researchers are encouraged to follow established recommendations for behavioural intervention development (e.g., Czajkowski et al., 2015).”
Demers, C., Brochu, A., Higgins, J., & Gélinas, I. (2021) · Pediatric Blood & Cancer · doi:10.1002/pbc.29090 · Cited by 6
Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial)
Meyer, J. D., Kelly, S. J. E., Gidley, J. M., Lansing, J. E., Smith, S. L., Churchill, S. L., Thomas, E. B. K., Goldberg, S. B., Abercrombie, H. C., Murray, T. A., et al. (2024) · Trials · doi:10.1186/s13063-024-08495-x · Cited by 6
“This is a phase IIc preliminary testing trial within the ORBIT model for behavioral treatment development [21, 55].”
MethodNorweg, A. M., Hofferber, B., Maguire, S., Oh, C., Raveis, V. H., & Simon, N. M. (2023) · Respiratory Medicine · doi:10.1016/j.rmed.2023.107505 · Cited by 7
Make me more comfortable: effects of a hypnosis session on pain perception in chronic pain patients
Ogez, D., Landry, M., Caron-Trahan, R., Jusseaux, A.-E., Aubin, M., Véronneau, J., Fournier, V., Godin, N., Idrissi, M., Rainville, P., et al. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1362208 · Cited by 9
“Our approach to designing this program followed the ORBIT framework (Figure 1; Czajkowski et al., 2015).”
MethodNieves-Vázquez, C. I., Detrés-Marquéz, A. C., Torres-Reverón, A., Appleyard, C. B., Jesús, A. P. L.-D., Resto, I. N., López-Rodríguez, V., Echevarria, P. M. R., Castro, E., & Flores, I. (2023) · Frontiers in Global Women s Health · doi:10.3389/fgwh.2022.1058559 · Cited by 6
“for developing behavioral interventions for chronic diseases (43).”
BackgroundSANTOS, C. D. S., Garcia, B. C. C., de Souza, L. A. M., Gomes, M. F., Fernandes, B. S., Esteves, E. A., & Rocha‐Vieira, E. (2023) · Journal on Interactive Systems · doi:10.5753/jis.2023.3274 · Cited by 7
“Also, the person-centred approach recommends using qualitative and iterative research to explore and test intervention with the end-user before implementation (Ferdig 2009; Czajkowski et al. 2015; Yardley et al. 2015).”
MethodInfluentialDigitally characterizing the dynamics of multiple health behavior change.
Spring, B. J., Stump, T. K., Battalio, S. L., McFadden, H. G., Pfammatter, A. F., Alshurafa, N. I., & Hedeker, D. (2021) · Health Psychology · doi:10.1037/hea0001057 · Cited by 7
Simple Interventions for Pediatric Residents’ Moral Distress: A Randomized, Controlled Experiment
Layman, A. A. K., Callahan, K. P., Nathanson, P. G., Lechtenberg, L., Hill, D. L., & Feudtner, C. (2023) · PEDIATRICS · doi:10.1542/peds.2022-060269 · Cited by 8
Development of a Health Insurance Navigation Program for Long-Term Childhood Cancer Survivors
Warner, E. L., Perez, G. K., Waters, A. R., Berghuijs, K. M. V. T., Lopez, P. L. V., Foor, A., Ray, N., Donelan, K., Kuhlthau, K. A., Kirchhoff, A. C., et al. (2024) · Health Education & Behavior · doi:10.1177/10901981241275628 · Cited by 5
“ORBIT emphasizes pre-efficacy development and testing of an intervention through an iterative and flexible process with a focus on clinical outcomes (Czajkowski et al., 2015).”
Kepper, M. M., Walsh‐Bailey, C., Miller, Z. M., Zhao, M., Zucker, K., Gacad, A., Herrick, C., White, N. H., Brownson, R. C., & Foraker, R. E. (2024) · JMIR Formative Research · doi:10.2196/55731 · Cited by 5
“The use of behavioral theory in such tools is critical to effectively promote behavior change [23].”
BackgroundFreedland, K. E., Skala, J. A., Carney, R. M., Steinmeyer, B. C., & Rich, M. W. (2023) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2023.104585 · Cited by 5
Mancinelli, E., Gabrielli, S., & Salcuni, S. (2024) · JMIR Human Factors · doi:10.2196/50098 · Cited by 5
“In this regard, this study relied on the Obesity-Related Behavioral Intervention Trials model [33], which provides an iterative progressive framework guiding the development, testing, and refinement of the behavioral intervention.”
MethodHow long does it take to scale-up obesity prevention interventions?
Lee, K., Bauman, A. E., Wolfenden, L., Phongsavan, P., & Crane, M. A. (2024) · Preventive Medicine · doi:10.1016/j.ypmed.2024.108012 · Cited by 6
Pilot trial of a new self-directed psychological intervention for infertility-related distress
Poulter, M. M. L., Balsom, A. A., & Gordon, J. L. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01535-y · Cited by 8
“The development of this intervention used a methodical and evidence-based approach guided by the Medical Research Council [33] and Obesity-Related Behavioral Intervention Trials [34] models for behavioral intervention development.”
MethodSalinas, J. J., Valenzuela, R., Sheen, J., Carlyle, M., Gay, J. L., & Morales, A. E. V. (2020) · Journal of Health Psychology · doi:10.1177/1359105320977650 · Cited by 6
Gordon, J. L., Poulter, M. M. L., Balsom, A. A., & Campbell, T. S. (2023) · JMIR Research Protocols · doi:10.2196/52662 · Cited by 5
“…is designed to improve upon the limitations of current approaches, we have used a methodical and evidence-based framework in designing and refining our intervention, using the Medical Research Council [14] and National Institute of Health’s ORBIT Model [15] for trial design interventions as guides.”
MethodResponse to school-based interventions for overweight and obesity: A systematic scoping review
Arlinghaus, K. R., Cepni, A., Helbing, R. R., Goodman, L. P., Ledoux, T., & Johnston, C. A. (2022) · Clinical Obesity · doi:10.1111/cob.12557 · Cited by 5
“intervention research and is consistent with the ORBIT model which emphasizes the need for preliminary evidence that intervention outcomes are likely to have clinically meaningful outcomes before doing larger scale efficacy trials.(7) Similarly, understanding the proportion of participants who reach clinically meaning…”
ResultGrow Online: feasibility and proof of concept study
Chesnut, R. P., Czymoniewicz‐Klippel, M. T., DiNallo, J. M., & Perkins, D. F. (2019) · Journal of Children s Services · doi:10.1108/jcs-10-2018-0026 · Cited by 4
Davey, E., Bryant‐Waugh, R., Bennett, S. D., Micali, N., Baudinet, J., Clark-Stone, S., & Shafran, R. (2024) · PLoS ONE · doi:10.1371/journal.pone.0301606 · Cited by 5
“As formal sample size calculations are unnecessary for proof-of-concept studies [53], the number of children and young people recruited to receive the CBT guided self-help intervention is not pre-specified.”
BackgroundMethodInfluentialGuertler, D., Krause, K., Möhring, A., Bischof, G., Batra, A., Freyer‐Adam, J., Ulbricht, S., Rumpf, H., Wurm, S., Cuijpers, P. J., et al. (2023) · Journal of Affective Disorders · doi:10.1016/j.jad.2023.06.059 · Cited by 5
Massage therapy for hospital-based nurses: A proof-of-concept study
Hulett, J. M., Spotts, R. A., Narkthong, N., & Scott, S. D. (2024) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2024.101846 · Cited by 5
Changing Behavior Using Integrative Self-Control Theory
Hofmann, W., Dohle, S., & Diel, K. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.011 · Cited by 7
Substance and Behavioral Addictions Assessment Instruments
Grigsby, T. J. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.012 · Cited by 6
A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial
Litchman, M. L., Kwan, B. M., ZITTLEMAN, L. K., SIMONETTI, J. S., Iacob, E., Curcija, K., Neuberger, J., Latendress, G., & Oser, T. K. (2022) · JMIR Research Protocols · doi:10.2196/34255 · Cited by 6
Addressing Underserved Populations and Disparities in Behavior Change
Schüz, B., & Hooper, M. W. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.027 · Cited by 5
Sessford, J. D., Chan, K., Kaiser, A., Singh, H., Munce, S., Alavinia, M., & Musselman, K. E. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-065684 · Cited by 6
“This Phase 2a proof of concept study 42 will be conducted using a convergent mixed methods design, which is used when the quantitative and qualitative strands are independent from one another.”
MethodLin, Y. K., Aikens, J. E., de Zoysa, N., Hall, D., Funnell, M. M., Nwankwo, R. B., Kloss, K., DeJonckheere, M. J., Pop‐Busui, R., Piatt, G., et al. (2023) · JMIR Formative Research · doi:10.2196/50374 · Cited by 5
Matthews, L. T., Psaros, C., Mathenjwa, M., Mosery, N., Greener, L. R., Khidir, H., Hovey, J. R., Pratt, M. C., Harrison, A. D., Bennett, K. K., et al. (2022) · JMIR Formative Research · doi:10.2196/34262 · Cited by 6
“We used the ORBIT model for the development of behavioral interventions to frame this phase of the research as Phase Ib preliminary testing to refine the intervention [26].”
MethodLee, D., Erande, A. S., Christodoulou, G., & Malik, S. (2024) · Stress and Health · doi:10.1002/smi.3502 · Cited by 7
“Using the ORBIT model (Czajkowski et al. 2015), we would consider our intervention to be a Phase II preliminary testing phase as we translated an existing in‐person intervention, biofeedback, to a virtually‐ delivered intervention.”
Lin, Y. C., Hagen, R., Powers, B. D., Dineen, S. P., Milano, J., Hume, E., Sprow, O., Diaz-Carraway, S., Permuth, J. B., Deneve, J. L., et al. (2025) · JMIR Cancer · doi:10.2196/67108 · Cited by 6
“…model, the goal of the single-arm study was to identify potential technical issues with digital health delivery, assess the optimal length of intervention delivery, and gather participant feedback on acceptability to inform intervention refinement prior to larger testing in a randomized trial [23].”
Wittenborn, A. K., Subramaniam, S., Morgan, P. C., & Tseng, C. (2022) · Journal of Marital and Family Therapy · doi:10.1111/jmft.12586 · Cited by 4
“This article describes a proof‐of‐concept study examining the addition of VF to EFT supervision in a university training clinic (Czajkowski et al., 2015).”
BackgroundHawk, L. W., Murphy, T. F., Hartmann, K. E., Burnett, A., & Maguin, E. (2023) · Journal of Clinical and Translational Science · doi:10.1017/cts.2023.692 · Cited by 5
“…the field may benefit from considering stage models for behavioral treatment development, with an emphasis on identifying a set of common, short-term efficacy signals that can be used to evaluate and refine promising interventions [26], including outcomes that can be passively collected [27].”
BackgroundRobertson, M. C., Cox-Martin, E., Shegog, R., Markham, C. M., Fujimoto, K., Durand, C. P., Brewster, A. M., Lyons, E., Liao, Y., Flores, S. A., et al. (2022) · JMIR Cancer · doi:10.2196/31815 · Cited by 4
“This research corresponds to phase IIa: Proof-of-Concept of the Obesity-Related Behavioral Intervention Trials model for developing behavioral treatments [18].”
MethodCaron-Trahan, R., Jusseaux, A.-E., Aubin, M., Urbanowicz, R., Richebé, P., & Ogez, D. (2022) · EXPLORE · doi:10.1016/j.explore.2022.08.008 · Cited by 8
Pozzar, R. A., Wall, J. A., Tavormina, A., Thompson, E., Enzinger, A. C., Matulonis, U. A., Campos, S. M., Meyer, L. A., & Wright, A. A. (2023) · Gynecologic Oncology · doi:10.1016/j.ygyno.2023.12.013 · Cited by 7
Sangalli, L., Gilmore, G. R., Moreno‐Hay, I., Whitehurst, L. N., Alessandri‐Bonetti, A., & Boggero, I. A. (2025) · CRANIO® · doi:10.1080/08869634.2025.2476606 · Cited by 5
“Single-case designs investigating within-subject changes can be used to refine interventions prior to proceeding to efficacy trials [33,34].”
Practicing self-hypnosis to reduce chronic pain: A qualitative exploratory study of HYlaDO
Caron-Trahan, R., Jusseaux, A.-E., Aubin, M., Cardinal, É., Aramideh, J., Idrissi, M., Godin, N., Landry, M., Urbanowicz, R., Rainville, P., et al. (2023) · British Journal of Pain · doi:10.1177/20494637231200324 · Cited by 5
“14,15 This framework comprises four distinct phases.”
Psihogios, A. M., & Stiles‐Shields, C. (2024) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsae094 · Cited by 5
de Winckel, A. V., Zhang, L., Hendrickson, T. J., Lim, K. O., Mueller, B. A., Philippus, A. H., Monden, K. R., Oh, J., Huang, Q., Sertic, J. V. L., et al. (2023) · medRxiv · doi:10.1101/2023.02.11.23285808 · Cited by 6
Osuna, A., Sabini, K., Yamane, E., Flores, J. A., Pierce, N. E., Lemus-Valle, J., & Vernon, T. W. (2023) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-023-06100-9 · Cited by 5
Morrow, E. L., Nelson, L. A., Duff, M. C., & Mayberry, L. S. (2024) · JMIR Rehabilitation and Assistive Technologies · doi:10.2196/59630 · Cited by 9
“Now that we have determined the usability of the tool, the next steps will be evaluating longer-term engagement, examining the feasibility of different prompt schedules and content, and then establishing efficacy in accordance with the ORBIT model of behavioral intervention development [71,72].”
(2022) · doi:10.2196/44329 · Cited by 5
“The ORBIT model uses an iterative process and was chosen because the LEIFc intervention is behavioral in nature, in the early stage of development, and focused on prevention of a chronic disease [30].”
A Mindfulness-Based App Intervention for Pregnant Women: Protocol for a Pilot Feasibility Study
Rizzi, S., Poggianella, S., Pavesi, M. C., Gios, L., Bincoletto, G., Scolari, I., Paoli, C., Marroni, D., Tassinari, I., Baietti, B., et al. (2024) · JMIR Research Protocols · doi:10.2196/53890 · Cited by 4
“This study is positioned within the design and development cycle of the Obesity-Related Behavioral Intervention Trials model (specifically the Refine phase) [14].”
Method“Nurturing Parents”–Mindfulness-Based Parent Well-Being Group in Pediatric Cystic Fibrosis
Harris, S. A., Harris, P. R., Lenton, J., Warde, C., Gold, E., Gane, T., & Seddon, P. C. (2021) · Clinical Practice in Pediatric Psychology · doi:10.1037/cpp0000394 · Cited by 5
“…the lack of a control group and limited follow up mean interpretations must be made with caution; nevertheless this study meets the conditions of a Phase Ib design (Czajkowski et al., 2015) and the sample size is comparable with otherpublishedmixed-methodsfeasibilityresearch (Zhangetal.,2017).”
Influential(2022) · doi:10.1089/jayao.2021.0143 · Cited by 5
“24,25 For example, as sleep was iden-tified as the most common barrier, assessing each AYA’s sleep schedule and planning PT visits for times when that patient is typically awake (e.g., in the evenings) may increase adherence.”
Metadata
- 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
- 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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