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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Claims the paper makes
21 Own interpretation · 15 Not checked yet
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
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None 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
boostedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In 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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In 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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a 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
“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
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None 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
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a 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
“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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a 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
“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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- 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
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably 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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a 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
“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
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It 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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It 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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a 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
“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
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably 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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably 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.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ 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
“Intervention Mapping (Bartholomew, Parcel, Kok, Gottlieb & Fernandez, 2011)”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > References
“4. Bartholomew L Parcel G Kok G Gottlieb G 2011 Planning health promotion programs: Intervention mapping San Francisco Jossey-Bass”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > SUMMARY AND CONCLUSIONS
“Davidson, Goldstein, Kaplan, Kaufmann, Knatterud, Orleans, Spring, Trudeau, & Whitlock, 2002”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > References
“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?”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ 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
“Office of Behavioral and Social Sciences Research, 2010”
§ From Ideas to Efficacy: The ORBIT Model for Developing Behavioral Treatments for Chronic Diseases > References
“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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Items 801–900 of 1,176
James, M. E., Cairney, J., Odorico, N., Finlay-Watson, T., & Arbour‐Nicitopoulos, K. P. (2023) · Journal of Motor Learning and Development · doi:10.1123/jmld.2023-0016 · Cited by 2
Azizoddin, D. R., DeForge, S. M., Zhao, J., Chen, M., SMITH, K. G. V., Schreiber, K. L., Edwards, R. R., Allsop, M. J., Baltazar, A. R., Nipp, R. D., et al. (2025) · JCO Clinical Cancer Informatics · doi:10.1200/cci-25-00228 · Cited by 3
Downs, D. S., Pauley, A. M., Rivera, D. E., Savage, J. S., Moore, A. M., Shao, D., Chow, S., Lagoa, C. M., Pauli, J. M., Khan, O., et al. (2025) · JMIR Research Protocols · doi:10.2196/66637 · Cited by 2
“Our translational science framework [47-50] guided by the Quality Implementation Framework [49] and Quality Implementation Tool [50] aligns with the paradigm shift in the literature to prospectively examine implementation markers (eg, subject acceptability, dosage exposure, and staff burden) from…”
Campos, B. A., Cummins, E., Sonnay, Y., Brindle, M. E., & Cauley, C. E. (2024) · JMIR Research Protocols · doi:10.2196/59067 · Cited by 3
“We will conduct interviews and focus groups until thematic saturation is reached, with an initial estimate of 24 participants across 4 focus groups needed based on past studies and practical limitations of available clinicians [19,20].”
MethodBogetz, J. F., Ayala, E. M., Anderson, J., Morris, L., Barton, K. S., Bradford, M. C., Zhou, C., Yi‐Frazier, J. P., Watson, R. S., & Rosenberg, A. R. (2025) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2025.101455 · Cited by 2
“We will perform a single-site, phase II randomized controlled clinical trial of a psychosocial behavioral health photo-narrative intervention to assess feasibility and acceptability among parents of children with SNI and their PICU clinicians at a single academic quaternary pediatric center [29].”
Perzow, S. E. D., Hu, J., Bristol, M., Ruzicka, E. B., Clementi, M. A., Handing, E. P., Vargas, E., Gutierrez‐Colina, A. M., Gulley, L. D., & Shomaker, L. B. (2025) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsaf049 · Cited by 2
“In particular, community-engaged tailoring of depression interventions for young people with physical health conditions may be more efficacious than a generalized approach, as the former ensures that learned skills are most relevant to patients’ distinct needs and contexts (Czajkowski et al., 2015).”
Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial
Bice, B., Michaud, A. L., McCormick, K. G., Miklos, E. M., Descombes, I. D., Medeiros-Nancarrow, C., Zhou, E. S., & Recklitis, C. J. (2024) · JMIR Research Protocols · doi:10.2196/60762 · Cited by 2
“Although originally developed by obesity researchers, the ORBIT model has been adapted for the development and early testing of behavioral interventions of all kinds [31-33].”
Bouncing Back Better: development of a family intervention program after young child burn injury
Asefnia, N., Mun, A. H., & Tully, C. (2025) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsaf027 · Cited by 2
Development of the Intervention Protocol for the Study of Creative Arts Among Children With Cancer
Raybin, J. L., Way, F., Montgomery, K. E., et al. (2025) · Journal of Pediatric Hematology/Oncology Nursing · doi:10.1177/27527530251369748 · Cited by 1
“The ORBIT (Obesity-Related Intervention Trials) model for the study of behavioral interventions proscribes the study phases similar to pharmaceutical studies (Czajkowski et al., 2015).”
Conley, C. C., Addington, E. L., Velazquez-Sosa, M. A., Mossman, B., Glenn, L. K., Drakeford, S., Guerra, R., Isaacs, C. J., Chitalia, A., Gallagher, C., et al. (2025) · JMIR Formative Research · doi:10.2196/77636 · Cited by 1
“Following best practices for the development of behavioral interventions [38], we conducted a single-arm pilot study (see Checklist 1 for CONSORT [Consolidated Standards of Reporting Trials] checklist for reporting a pilot or feasibility trial [39]).”
Michaud, A. L., Bice, B., Miklos, E. M., McCormick, K., Medeiros-Nancarrow, C., Zhou, E. S., & Recklitis, C. J. (2023) · JMIR Research Protocols · doi:10.2196/52315 · Cited by 1
“As recommended in the ORBIT model for development and testing of novel behavioral interventions [42-44], this trial will provide the first empirical evidence evaluating the efficacy of STEP-YA.”
MethodChoquette, E. M., Forthman, K. L., Kirlić, N., Stewart, J. L., Cannon, M. J., Akeman, E., McMillan, N., Mesker, M., Tarrasch, M., Kuplicki, R., et al. (2022) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1390199 · Cited by 3
Monteiro, A., Moore, J. B., Aikens, R. C., Duckworth, A. L., Gross, J. J., Schwartz, D., Baiocchi, M., Prochaska, J. J., & Oppezzo, M. (2025) · JMIR Research Protocols · doi:10.2196/64455 · Cited by 2
“If successful, these data will inform the development of and provide estimates needed for the implementation of a phase III efficacy trial [70].”
Preliminary Evaluation of a Core Knowledge Test for Certification of Health Care Chaplains
(2020) · doi:10.1080/08854726.2020.1847864 · Cited by 1
“Although this was not a research process in its classic form, being guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model designed to inform research development seemed a useful discipline (Czajkowski et al., 2015).”
MethodOluwoye, O., Puzia, M., Stokes, B., Fraser, E. R., Stokes, S., Siddiqi, K. A., & Roll, J. M. (2025) · Early Intervention in Psychiatry · doi:10.1111/eip.70037 · Cited by 1
“…the ORBIT (Obesity-Related Behavioural Intervention Trials) model, which provides a bi-directional framework to develop and iteratively refine behavioural treatments during the early and pre-efficacy stages and when to progress to additional testing of the intervention (Czajkowski et al. 2015).”
Luberto, C. M., Crute, S., Wang, A., Li, R., Yeh, G. Y., Huffman, J. C., Celano, C. M., Victorson, D. E., Hoeppner, B. B., & Park, E. R. (2024) · Global Advances in Integrative Medicine and Health · doi:10.1177/27536130241288213 · Cited by 1
Hayes, L., LaRosa, K. N., Marsac, M. L., Moorman, S., & Mayes, S. (2025) · Clinical Practice in Pediatric Psychology · doi:10.1177/21694826251341311 · Cited by 1
Joyce, K. M., Rioux, C., MacKinnon, A., Katz, L., Reynolds, K., Kelly, L. E., Klassen, T. P., Afifi, T. O., Mushquash, A. R., Clement, F. M., et al. (2022) · PsyArXiv (OSF Preprints) · doi:10.31234/osf.io/czt8h · Cited by 1
Self-citationLupini, F., Hilliard, M. E., Thurston, I. B., Jaser, S. S., Carreon, S. A., Gutierrez‐Colina, A. M., Streisand, R. M., Berlin, K. S., & Mackey, E. R. (2025) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsaf069 · Cited by 1
Christie, A. J., Bolden, C., Park, E. R., Yeh, G. Y., O’Cleirigh, C. M., Lee, H., Peppercorn, J. M., Wagner, L. I., Henley, E., Traeger, L. N., et al. (2025) · Global Advances in Integrative Medicine and Health · doi:10.1177/27536130251407685 · Cited by 1
Baldwin, A. S., Lamb, C. L., Geary, B. A., Mitchell, A. D., Kouros, C. D., Levens, S. M., & Martin, L. E. (2022) · JMIR Research Protocols · doi:10.2196/40908 · Cited by 3
“Trials (ORBIT) model [20], and Science of Behavior Change [21].”
MethodSidani, S., & Braden, C. J. (2021) · Wiley eBooks · doi:10.1002/9781119610113.ch4 · Cited by 1
Loughan, A. R., Braun, S. E., Lanoye, A. M., Davies, A., Kleva, C. S., Fox, A. M., & Zarrella, G. V. (2025) · Neuro-Oncology Practice · doi:10.1093/nop/npaf038 · Cited by 1
James, S., Clingan, C. L., Adesanya, I. A., Zhu, S., Francis, M. E., Rosenblatt, P. Y., Molitoris, J. K., Deighton, D. C., Winder, A. T., Desrochers, P. C., et al. (2026) · Journal of Cancer Survivorship · doi:10.1007/s11764-025-01946-7 · Cited by 1
Measurement, Prevention, and Treatment of Exercise Addiction
Hausenblas, H. A., Mann, D. T. Y., & Downs, D. S. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.036 · Cited by 2
Tappan, R. S., Ettinger, J. R., Mahon, D., Mroz, S. E., Hall, W., Maajid, E., Stratton, C., Zynda, D. T., Conroy, D. E., & Danilovich, M. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01397-w · Cited by 1
“This process focuses on defining and refining theory-based intervention content and methods based on stakeholder feedback [18].”
The Future of Behavioral Randomized Clinical Trials
Powell, L. H., Kaufmann, P. G., & Freedland, K. E. (2021) · Springer eBooks · doi:10.1007/978-3-030-39330-4_11 · Cited by 1
Self-citationKroshus, E., Moore, A., Steiner, M. K., Nieto, C., McCleery, J., Turner, K., Garrett, K., & Tandon, P. S. (2024) · Journal of School Health · doi:10.1111/josh.13479 · Cited by 2
Deslippe, A. L., Bergeron, C., Wu, O. Y., & Cohen, T. R. (2025) · Nutrients · doi:10.3390/nu17040685 · Cited by 2
“This specific study is a part of the foundational ‘basic behavioural science’ phase [26] that seeks to understand the key issues and differences in athletes’ and non-athletes eating habits and experiences surrounding food.”
Seferian, E. G., Berdahl, C. T., Coleman, B. L., Leang, D. W., Cohen, T., Qureshi, N., McCleskey, S. G., Kaiser, K., Grissinger, M. C., Kanji, F. F., et al. (2026) · Journal of Patient Safety · doi:10.1097/pts.0000000000001451 · Cited by 1
Smith, A. N., Higgins, L. Q., & Higgins, S. (2022) · International journal of exercise science · doi:10.70252/vgpi4392 · Cited by 1
Friends, Family, and Food: Development of a Food Allergy Intervention, F3-App, for Children
Jandasek, B. N., Kopel, S. J., Esteban, C. A., Rudders, S. A., Spitalnick, J. S., Larsen, M. A., Cushman, G. K., & McQuaid, E. L. (2024) · Clinical Practice in Pediatric Psychology · doi:10.1037/cpp0000513 · Cited by 1
“These study fi ndings support progression to the next phase of behavioral intervention development: pilot testing of the F3-App using a randomized design (Czajkowski et al., 2015).”
Protection of Random Assignment
Powell, L. H., Kaufmann, P. G., & Freedland, K. E. (2021) · Springer eBooks · doi:10.1007/978-3-030-39330-4_8 · Cited by 1
Self-citationHarden, S. M., Brow, K., Zoellner, J., & Armbruster, S. D. (2024) · Translational Behavioral Medicine · doi:10.1093/tbm/ibae030 · Cited by 2
SANTOS, C. D. S., de Souza, L. A. M., Gomes, M. F., Garcia, B. C. C., Esteves, E. A., & Rocha‐Vieira, E. (2021) · Simpósio Brasileiro de Jogos e Entretenimento Digital (SBGames) · doi:10.5753/sbgames_estendido.2021.19738 · Cited by 1
Giusto, A. M., Jaguga, F., Aburi, D., Korir, M., Maina, W., Rono, W., & Greenlee, M. (2025) · PLoS ONE · doi:10.1371/journal.pone.0325902 · Cited by 1
“Building on these promising results, this protocol describes a pilot hybrid type 1 effectiveness-implementation study using a randomized waitlist-control design [28,29].”
Are the Risk of Generalizability Biases Generalizable? A Meta-Epidemiological StudyPreprint
von Klinggraeff, L., Pfledderer, C. D., Burkart, S. A., Ramey, K. T., Smith, M. T., McLain, A. C., Armstrong, B., Weaver, R. G., Okely, A. D., Lubans, D. R., et al. (2024) · Research Square · doi:10.21203/rs.3.rs-3897976/v1 · Cited by 1
Richardson, M., Kleinstäuber, M., & Wong, D. K. (2025) · Movement Disorders · doi:10.1002/mds.30195 · Cited by 1
“On the basis of those positive preliminary fi ndings, the protocol for this phase IIb pilot randomized controlled trial (RCT) was developed to test the following hypotheses 16,18 : 1.”
Jimenez-Garcia, J. A., Rodas, A. G., & DeMont, R. G. (2024) · Research Quarterly for Exercise and Sport · doi:10.1080/02701367.2024.2343361 · Cited by 2
“Evaluating the intervention safety, determining the ideal dose response, and obtaining preliminary effectiveness evidence are also crucial steps in planning future studies (Czajkowski et al., 2015; Orsmond & Cohn, 2015).”
Sauvé, G., Corbière, M., Raucher-Chéné, D., Hotte-Meunier, A., & Lepage, M. (2024) · Journal of Psychosocial Rehabilitation and Mental Health · doi:10.1007/s40737-024-00439-7 · Cited by 1
“SCEDs are well suited for establishing feasibility and acceptability of novel interventions, as they represent smaller scale studies that can be used in preparation for future randomised controlled trials (Czajkowski et al., 2015; Eldridge et al., 2016).”
Veldheer, S., Scartozzi, C., Watt, B., Thomas, O. W., Hrabovsky, S., & Sciamanna, C. (2025) · Journal of Nutrition Education and Behavior · doi:10.1016/j.jneb.2025.03.014 · Cited by 1
Feasibility and Acceptability of a Narrative Medicine Intervention in a Burn Center
Grossoehme, D. H., Robinson, N., Khandelwal, A., Lou, R. B., Richner, G. J., McNinch, N. L., & Friebert, S. E. (2025) · Journal of Burn Care & Research · doi:10.1093/jbcr/iraf115 · Cited by 1
Gallagher, J. B., Bayman, E. O., Cadmus‐Bertram, L., et al. (2025) · Health Science Reports · doi:10.1002/hsr2.70485 · Cited by 1
“The Obesity ‐ Related Behavior Intervention Trials (ORBIT) model [10] was developed to develop behavioral interventions efficiently, effectively, and targeted to the needs of specific populations, and uses similar terminology to testing new pharmaceutics.”
Passionate Love Addiction: An Evolutionary Survival Mechanism That Can Go Terribly Wrong
Bolshakova, M., Fisher, H. E., Aubin, H., & Sussman, S. Y. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.026 · Cited by 2
Sussman, S. Y. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.003 · Cited by 1
Short, N. A., Deguzman-Lucero, R. M., Weese, R., Chisam, N., Black, J., Serrano, K., & McLean, S. A. (2026) · JMIR Formative Research · doi:10.2196/86612 · Cited by 1
“The ORBIT model of behavioral intervention development offers a systematic framework to guide the development and testing of promising behavioral interventions to prevent chronic diseases [21].”
InfluentialMindfulness-Based Intervention for Adolescents With Type 1 Diabetes: A Case Series
Lupini, F., Moore, H. R., Basch, M. C., Vagadori, J., Cooke, F., Kelly, K. P., Streisand, R. M., Shomaker, L. B., Dagnachew, M., Cooper, D. K., et al. (2025) · Clinical Practice in Pediatric Psychology · doi:10.1177/21694826251319328 · Cited by 2
“This explanation would be consistent with multiple theoretical frameworks for intervention tailoring (e.g., ORBIT; Czajkowski et al., 2015), which postulate that tailoring interventions for speci fi c populations is critical, rather than taking a one size fi ts all approach.”
Asiimwe, S. B., Kekibiina, A., Woolf‐King, S. E., Fatch, R., Emenyonu, N. I., & Hahn, J. A. (2024) · AIDS and Behavior · doi:10.1007/s10461-024-04377-0 · Cited by 1
“These observations highlight potential reasons why trials of SBI in SSA may or may not demonstrate efficacy [31].”
InfluentialAlaofè, H., Okechukwu, A., Hounkpatin, W. A., Oguegbu, A., Jackson, K., Bedrick, E. J., & Ehiri, J. E. (2026) · Frontiers in Nutrition · doi:10.3389/fnut.2026.1688980 · Cited by 2
“…emphasizes progressive refinement of intervention components to establish feasibility, acceptability, and cultural Summary of the ORBIT model [26, 27] applied to the development of ‘Objectif Santé Diabète Bénin’ (OSanDiaBé) program for T2D in Africa, enabling progress and refinement based on new…”
Zein, A. E., Ellison, K. M., Clina, J. G., Reynolds, C., Cohen, C. W., Hill, J. O., Dutton, G. R., Mehta, T. S., & Sayer, R. D. (2025) · Pilot and Feasibility Studies · doi:10.1186/s40814-025-01618-4 · Cited by 1
“Following established frameworks such as the ORBIT Model [35] and the NIH Stage Model [36], future efforts will focus on refining and enhancing the implementation of adaptive intervention packages under investigation to ensure greater alignment with clinical practice.”
Evans, S. W., Brockstein, H. J., Allan, D. M., Girton, S. L., Owens, J. S., & Everly, E. L. (2022) · Frontiers in Education · doi:10.3389/feduc.2022.983392 · Cited by 1
Guertler, D., Baumann, S., Möhring, A., Krause, K., Freyer‐Adam, J., Ulbricht, S., Bischof, G., Batra, A., Rumpf, H., Wurm, S., et al. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.04.095 · Cited by 2
Chevalier, L., Michaud, A. L., Mahler, H. I. M., Fine, E., & Recklitis, C. J. (2023) · Journal of Cancer Survivorship · doi:10.1007/s11764-023-01478-y · Cited by 1
“Consistent with phase IIb of the ORBIT model [53], this report evaluates the ability of SunSmart Information to produce clinically significant improvement in SP compared to a control condition.”
InfluentialSalmani, B., Hiemstra, M. S., Harry Prapavessis, A., Vanderloo, L. M., & Mitchell, M. (2026) · JMIR Formative Research · doi:10.2196/85484 · Cited by 3
“This preparatory study was guided by the Obesity-Related Behavioral Intervention Trial (ORBIT) model [27], a structured framework that supports the systematic development and evaluation of behavioral interventions.”
Braun, S. E., Mladen, S. N., Luberto, C. M., & Kinser, P. A. (2022) · Integrative Medicine Reports · doi:10.1089/imr.2021.0012 · Cited by 1
“Investigation of clinically significant change in relevant outcomes is an important achievement to establish before conducting larger scale RCTs.27 Analyses at the individual level could provide more nuanced information regarding the effects of MIHP, without which important subtleties regarding subgroups of participan…”
Background(2023) · doi:10.1016/j.pecinn.2023.100165 · Cited by 1
“phase 1a study within the ORBIT model [5], we provide early support for a clinically-significant question—specifically, insight into patient reactions and preferences, which can aid providers with informing patients about reclassification.”
BackgroundMethodWatkins, J. M., Brunnemer, J. E., Heeter, K. N., et al. (2024) · Research Square · doi:10.21203/rs.3.rs-3837825/v1 · Cited by 1
Williams, T. S., Taylor, M., Green, R. R., Lyon, R. E., Bondi, B. C., & Désiré, N. (2025) · Archives of Clinical Neuropsychology · doi:10.1093/arclin/acaf061 · Cited by 1
Stevens, C. J., Bobak, C. A., Morrissette, K. J., Thompson, R. C., Lyons, K. D., Wallace, G. M., Emerson, A. J., Conroy, D. E., Williams, D. M., Chamberlin, M. D., et al. (2025) · Psycho-Oncology · doi:10.1002/pon.70225 · Cited by 1
“[16, 17] For this work, the end goal is an effective, highly implementable strategy to promote physical activity among inactive breast cancer survivors as part of routine follow‐up care.”
InfluentialFladeboe, K., O’Daffer, A., Engelberg, R. A., Salsman, J. M., Merluzzi, T. V., Baker, K. S., Yi‐Frazier, J. P., & Rosenberg, A. R. (2025) · Annals of Behavioral Medicine · doi:10.1093/abm/kaaf012 · Cited by 1
Coleman, J. N., Lachman, S. E., Arthur, S. S., Stalls, J. M., Choi, Y., Zerubavel, N., Davidson, B. A., Reese, J. B., & Shelby, R. A. (2024) · Women s Reproductive Health · doi:10.1080/23293691.2024.2426155 · Cited by 1
McGoron, L., O'Neal, T., Savastano, G. E., Roberts, K. L., Richardson, P. A., & Bocknek, E. L. (2022) · Clinical Practice in Pediatric Psychology · doi:10.1037/cpp0000441 · Cited by 1
“Additionally,the programcouldbefurtherenhancedbygathering qualitativeinputfrommothers(arecommended stepininterventiondevelopment,e.g.,Czajkowski etal.,2015).”
Azizoddin, D. R., Hassett, M. J., Anderson, K.-A. S., Kessler, D., Wright, A. A., Gorra, M., Kematick, B. S., Chua, I. S., Brandoff, D. E., Lally, K. M., et al. (2025) · JMIR Cancer · doi:10.2196/79942 · Cited by 1
“The study also identified several opportunities to further optimize the intervention [49], which we are implementing.”
Madva, E. N., Huffman, J. C., Castillo, C., Harnedy, L. E., Franklin, T., Song, M., Murray, H. B., Healy, B. C., Staller, K. D., Bartels, S., et al. (2025) · Neurogastroenterology & Motility · doi:10.1111/nmo.70146 · Cited by 1
Watkins, J. M., Goss, J. M., Kercher, V. M. M., Coble, C. J., Werner, N. E., Weaver, R. G., & Kercher, K. A. (2025) · Pilot and Feasibility Studies · doi:10.1186/s40814-025-01695-5 · Cited by 2
“The study’s foundation rests on three key theoretical elements: the Basic Psychological Needs mini-theory within self-determination theory (SDT) [41], the biopsychosocial model [42], and Obesity-Related Behavioral Intervention Trials (ORBIT) model [43].”
The Future of Non-pharmacological Interventions
Ninot, G. (2020) · Springer eBooks · doi:10.1007/978-3-030-60971-9_9 · Cited by 1
Commentary: moving forward with mixed methods
Monarque, M., & Desjardins, L. (2025) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsaf083 · Cited by 1
Sears, C. S., Santos‐Iglesias, P., Millman, R. D., Jacox, N., Wiebe, E. M., & Walker, L. M. (2022) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2022.102236 · Cited by 1
Wilson, D. K., Quattlebaum, M. J., Sweeney, A. M., Simmons, T., Kipp, C., White, T., Wood, V., Horn, M. L. V., & Martin, P. P. (2025) · Annals of Behavioral Medicine · doi:10.1093/abm/kaaf034 · Cited by 2
Cardiac rehabilitation: One size does not fit all
(2023) · doi:10.1016/j.ijcard.2023.03.020 · Cited by 1
Ferrara, P.-M. M., Schaltegger, E. T., Beaumont, C. T., & Strohacker, K. A. (2020) · International journal of exercise science · doi:10.70252/vajb1586 · Cited by 1
“This is in line with the ORBIT Model (7) regarding flexible, iterative processes to designing novel behavioral interventions without expending valuable resources with premature large-scale control trials.”
BackgroundMethodInfluentialAdolescent Drug Misuse Prevention: Challenges in School-Based Programming
Scheier, L. M. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108632591.021 · Cited by 1
Thapar, S., Quesada, D., & Knaüper, B. (2025) · JMIR Formative Research · doi:10.2196/69532 · Cited by 2
“Aligned with the Obesity-Related Behavioral Intervention Trials model for designing behavioral interventions, further data will need to be obtained through a proof-of-concept study, pilot testing, and then a feasibility pilot in preparation for an efficacy trial [120].”
(2025) · doi:10.1093/jpepsy/jsaf092 · Cited by 1
“Following the ORBIT model for refinement and evaluation of novel behavioral interventions (Czajkowski et al., 2015), we conducted a single-arm, proof-of-concept pilot study in children receiving maintenance therapy for ALL.”
Maw, A., Profeit, M. C., Benson, A. J., McGuire, C. S., Saizew, K., Murata, A., Erickson, K. T., Côté, J., Wolff, M., Ladd, B., et al. (2025) · International Sport Coaching Journal · doi:10.1123/iscj.2024-0069 · Cited by 1
Braun, A. C., Hosseininasab, D., Corcoran, S., Godsey, T. J., Lucas, E. A., McCann, M. H., Koehler, G., & Emerson, S. R. (2025) · Nutrition and Health · doi:10.1177/02601060251375130 · Cited by 1
“This pilot study is a 27-month, randomized, controlled, three-arm factorial trial (Czajkowski et al., 2015) designed to determine if a novel intervention focused on dietary fi ber facilitates weight loss, improvements in eating-related behavior and cognition, and improvements in metabolic markers of…”
Carter, E. J., Zavez, K., Schramm, C. A., Zolla, M. M., Baron, K., & Banach, D. B. (2024) · Infection Control and Hospital Epidemiology · doi:10.1017/ice.2024.119 · Cited by 2
Coleman, J. N., Arthur, S. S., Lachman, S. E., Choi, Y., Zerubavel, N., Davidson, B. A., Reese, J. B., & Shelby, R. A. (2024) · Women s Reproductive Health · doi:10.1080/23293691.2024.2363820 · Cited by 1
Chaplin, A. M. L., Wordsworth, J., Prohens, L., Obrador‐Hevia, A., Morales, M. G., Ricci‐Cabello, I., Sesé, A., & Romaguera, D. (2025) · PLoS ONE · doi:10.1371/journal.pone.0323671 · Cited by 2
“This study will be based on the ORBIT model [49] for developing behavioral treatments for chronic diseases as well as on the Medical Research Council guidance [50] for evaluating complex interventions.”
Starikovsky, J., Solk, P., Desai, R. M., Reading, J. M., Hasanaj, K., Wang, S. D., Carden, L. B., Wolter, M., Hickey, B., Lee, J. J., et al. (2025) · Supportive Care in Cancer · doi:10.1007/s00520-024-09099-6 · Cited by 1
“Guidelines for behavioral intervention development (ORBIT model) recommend intervention pilot testing to refine interventions and achieve optimal treatment outcomes [24].”
Ibrahim, A. H., Beaumont, C. T., John, J. M., Blanton, J. E., Coe, D. P., & Strohacker, K. A. (2026) · Psychology of sport and exercise · doi:10.1016/j.psychsport.2026.103093 · Cited by 1
Hilliard, M. E., Levy, W. L., Weinstock, R. S., Hood, K. K., Trief, P. M., DeSalvo, D. J., Rojas, Y., Holland, K., Schneider‐Utaka, A. K., ALAMARIE, S. A., et al. (2025) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2025.101491 · Cited by 1
“Non-randomized designs are appropriate for initial pilot studies primarily designed to explore a new intervention ’ s feasibility and acceptability, prior to fully powered efficacy trials [38 – 40].”
Loughan, A. R., Lanoye, A. M., Willis, K. D., Braun, S. E., Davies, A., Rodin, G., Thacker, L. R., Fox, A. M., Kleva, C. S., Zarrella, G. V., et al. (2024) · Neuro-Oncology Practice · doi:10.1093/nop/npae097 · Cited by 1
Springer, J., Steinbrink, G. M., Tetmeyer, L. L., Mellen, K., Marcussen, B. L., Bond, D. S., Wu, Y., & Carr, L. J. (2026) · Journal of Behavioral Medicine · doi:10.1007/s10865-026-00647-5 · Cited by 1
“Using the Obesity-Related Behavioral Intervention Trials (ORBIT) model (Czajkowski, 2015), we employed a type IIa “proof-of-concept” study, designed to determine whether the intervention can improve targeted outcomes.”
Gyurcsik, N. C., Tupper, S. M., Brittain, D. R., Brawley, L. R., Cary, M. A., Ratcliffe-Smith, D., Blouin, J. E., Marchant, M. G., Sessford, J. D., Hellsten, L.-A. M., et al. (2020) · Scandinavian Journal of Pain · doi:10.1515/sjpain-2020-0089 · Cited by 1
“Based on the ORBIT model for early pre-efficacy phases of development and testing of new behavioral treatments, the present Phase IIa proof-of-concept study was conducted.”
BackgroundMethodInfluential
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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