Cited by 460Statistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesHealth Policy Implementation Science

The DOI matches its Crossref record; 87 of the 88 references it cites were found in a registry or an index; none of the 50 sources its claims cite is checked for support yet.

Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research

Open access

Almirall, Daniel, Nahum-Shani, Inbal, Sherwood, Nancy E., Murphy, Susan A.·2014·Translational Behavioral Medicine

DOI 10.1007/s13142-014-0265-0PMC PMC4167891

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Abstract

The management of many health disorders often entails a sequential, individualized approach whereby treatment is adapted and readapted over time in response to the specific needs and evolving status of the individual. Adaptive interventions provide one way to operationalize the strategies (e.g., continue, augment, switch, step-down) leading to individualized sequences of treatment. Often, a wide variety of critical questions must be answered when developing a high-quality adaptive intervention. Yet, there is often insufficient empirical evidence or theoretical basis to address these questions. The Sequential Multiple Assignment Randomized Trial (SMART)-a type of research design-was developed explicitly for the purpose of building optimal adaptive interventions by providing answers to such questions. Despite increasing popularity, SMARTs remain relatively new to intervention scientists. This manuscript provides an introduction to adaptive interventions and SMARTs. We discuss SMART design considerations, including common primary and secondary aims. For illustration, we discuss the development of an adaptive intervention for optimizing weight loss among adult individuals who are overweight.

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In the paper
“Therefore, assuming a within-person correlation of 0.50 in longitudinal weight, and a study drop-out rate of 10 %, a total sample size of at least N=122 (i.e., 61 in group A+B+C vs 61 in group D+E+F) would be needed in order to detect a medium effect size [58] (Cohen's d=0.5) with at least 85 % power and type-I error of 5 %.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [58] Forman EM, Hoffman KL, McGrath KB, et al. A comparison of acceptance- and control-based strategies for coping with food cravings: an analog study. Behav Res Ther. 2007; 45(10): 2372-2386. source
Strength:hedged· not yet calibratedn = 122
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In the paper
“Further, research suggests that it may be possible to identify such individuals early, i.e., during treatment [16].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [16] Nackers LM, Ross KM, Perri MG. The association between rate of initial weight loss and long-term success in obesity treatment: does slow and steady win the race? Int J Behav Med. 2010; 17(3): 161-167. source
Load-bearingStrength:hedged· not yet calibratedCausal:correlational· not yet calibrated
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In the paper
“Data analyses associated with the aim to develop a more deeply-tailored AI are akin to, but go beyond, standard moderator analysis [69][70][71][72].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
What the sources say
- Not checked yetcites [69][70][71]
Strength:plain· not yet calibratedCausal:correlational· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes
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
“Due to the cost of meal replacements (MR) and the cost and availability of trained ACT psychotherapists, it would not be feasible from a public health, costeffectiveness point of view, to provide all adult individuals who are overweight with IBT+MR or with ACT from the start.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
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- Rests on an assumption: Meal replacements and trained ACT psychotherapists are costly or limited in availability.

Show all 48 claims

It may state two separate claims as one. 20
Probably not a substantial claim. 34

None of the sources cited for this claim have been checked yet.
In the paper
“In addition, not all individuals will respond or adhere to the weight loss treatment to the same degree, have the same side effect profile (e.g., in the case of weight loss medications), or respond within the same time-frame, to any given treatment or package of treatments (between-persons heterogeneity; [5,6].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [5] Rock CL, Flatt SW, Sherwood NE, et al. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010; 304(16): 1803-1810. source
- Not checked yetcites [6] Jeffrey RW, Drewnowski A, Epstein LH, et al. Long-term maintenance of weight loss: current status. Health Psychol. 2000; 19(1): 5-16. source
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It may state two separate claims as one.
In the paper
“Once the mean outcome and standard error is estimated for each of the embedded AIs, it is possible to conduct a hypothesis test to compare any two (or more) of the embedded AIs, or identify the AI leading to the greatest estimated weight loss [63].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
What the sources say
- Not checked yetcites [63] Oetting AI, Levy JA, Weiss RD, et al. Statistical Methodology for a SMART Design in the development of adaptive treatment strategies. In: Shrout PE, Keyes KM, Ornstein K, eds. Causality and Psychopathology: Finding the Determinants of Disorders and their Cures. Arlington: American Psychiatric Publishing, Inc; 2011: 179-205.
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It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“For example, SMART has been used in oncology to develop medication algorithms to treat prostate cancer [36,52,53].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [36] Wang L, Rotnitzky A, Lin X, et al. Evaluation of viable dynamic treatment regimes in a sequentially randomized trial of advanced prostate cancer. J Am Stat Assoc. 2012; 107(498): 493-508. source
- Not checked yetcites [52] Thall P, Logothetis C, Pagliaro L, et al. Adaptive therapy for androgen-independent prostate cancer: a randomized selection trial of four regimens. J Natl Cancer Inst. 2007; 99(21): 1613-1622. source
- Not checked yetcites [53] Almirall D, Lizotte D, Murphy SA. SMART design issues and the consideration of opposing outcomes. J Am Stat Assoc. 2012; 107(498): 509-512. source
Strength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passes
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
“Despite the general success of interventions such as IBT (and others [7,[10][11][12][13][14]), a significant number of individuals do not lose a clinically significant amount of weight (for example, ≥7 % weight loss in a 26week period (~6 months) [15]) or meet their targeted goals for weight loss.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [7,[10][11][12][13][14]
- Not checked yetcites [15] Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002; 346: 393-403. source
Load-bearingStrength:plain· not yet calibrated
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It may state two separate claims as one.
In the paper
“In this example, the 5 lbs cutoff is based on previous research [16], which is corroborated by clinical experience, suggesting that weight loss of less than 5 lbs during the first 5 weeks of behavioral therapy treatment is associated with longer-term insufficient weight loss (<5-10 % of body weight at the end of 26 weeks), thereby indicating a need for subsequent (changes or”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > ADAPTIVE INTERVENTIONS
What the sources say
- Not checked yetcites [16] Nackers LM, Ross KM, Perri MG. The association between rate of initial weight loss and long-term success in obesity treatment: does slow and steady win the race? Int J Behav Med. 2010; 17(3): 161-167. source
Load-bearingStrength:hedged· not yet calibratedCausal:correlational· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
In the paper
“Lei et al. [23] describe the rationale and scientific questions addressed by four different SMART studies either recently completed or underway in autism, attention-deficit/hyperactivity disorder (ADHD), and for various substance use disorders.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [23] Lei H, Nahum-Shani I, Lynch K, et al. A “SMART” design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012; 8: 21-48. source
Strength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passes
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Developed explicitly for the purpose of building empirically supported adaptive interventions, they are meant to complement the use of theoretical models and expert clinical consensus for developing optimal adaptive interventions [21][22][23].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [21][22][23]
Load-bearingStrength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
In the paper
“A growing body of literature suggests that ACT may be useful for managing or losing weight [48][49][50].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > ADAPTIVE INTERVENTIONS
What the sources say
- Not checked yetcites [48][49][50]
Strength:hedged· not yet calibratedCausal:conditional· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passes
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Misconceptions about SMART also arise when the term “adaptive design” is used to describe SMARTs because the phrase is not sufficiently precise [81].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [81] The Methodology Center. are adaptive interventions Bayesian? Available at http://methodology.psu.edu/eresources/ask/sp11 . Accessibility verified December 31, 2013.
Strength:plain· not yet calibratedCausal:direct· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passes
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“is a data analysis method useful for optimizing the AI while exploring candidate tailoring variables [22].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > "Q-Learning
What the sources say
- Not checked yetcites [22] Nahum-Shani I, Qian M, Almirall D, et al. Q-Learning: a data analysis method for constructing adaptive interventions. Psychol Methods. 2013; 2012; 17(4): 478–94.
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Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“After these decisions were made, the investigators evaluated this adaptive intervention versus a standard behavioral weight loss intervention using a 2-arm RCT.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [44] Jakicic JM, Tate DF, Lang W, et al. Effect of a stepped-care intervention approach on weight loss in adults. JAMA. 2012; 307(24): 2617-2626. source
Load-bearingStrength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
Probably not a substantial claim.
None of the sources cited for this claim have been checked yet.
In the paper
“Different SMART designs are suitable for addressing different types of scientific questions [21,23].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [21] Nahum-Shani I, Qian M, Almirall D, et al. Experimental design and primary data analysis methods for comparing adaptive interventions. Psychol Methods. 2012; 17(4): 457-477. source
- Not checked yetcites [23] Lei H, Nahum-Shani I, Lynch K, et al. A “SMART” design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012; 8: 21-48. source
Strength:plain· not yet calibratedCausal:correlational· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passes
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In developing this AI prior to study, decisions were made (i) about the total number of decision stages, including when and how often they would occur (i.e., there was a step every 3 months over 18 months), (ii) to use one tailoring variable (i.e., weight loss), (iii) about the treatment options (i.e., group sessions, behavioral lessons, 1 vs 2 sessions of telephone counseling, individual sessions”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [44] Jakicic JM, Tate DF, Lang W, et al. Effect of a stepped-care intervention approach on weight loss in adults. JAMA. 2012; 307(24): 2617-2626. source
Strength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes
It may state two separate claims as one.
In the paper
“An alternative, potentially less conservative approach, is to calculate the sample size to contrast two (or more) embedded adaptive interventions by simulation experiment [78].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [78] Buyze J, Rompaye BV, Goetghebeur E. Designing a sequentially randomized study with adherence enhancing interventions for diabetic patients. Stat Med. 2010; 29: 1114-1126. source
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Probably not a substantial claim. The paper’s conclusions may not depend on it.

49 of 49

The paper relies on this without support.
Meal replacements are effective for weight loss partly because they remove the need to decide what food to prepare and the time and effort to prepare it, and they provide a clear method for portion control and reduced energy intake.
“MR is effective for weight loss, in part, because it alleviates the need for decision-making regarding what food(s) to prepare as well as the time and effort needed to prepare the food.It provides a clear and unambiguous method for obtaining portion control and accompanying reduction in energy intake.”
The paper relies on this without support.
Meal replacements and trained ACT psychotherapists are costly or limited in availability.
“Due to the cost of meal replacements (MR) and the cost and availability of trained ACT psychotherapists”
The paper relies on this without support.
ACT requires a time commitment from the individual that may be burdensome.
“Furthermore, ACT requires a time commitment on the part of the individual, which may be burdensome.”
The paper relies on this without support.
A subset of people may do well enough over time with IBT by itself.
“These perspectives are important since some proportion of individuals might benefit adequately in the longterm from IBT alone.”
The paper relies on this without support.
Creating a high-quality adaptive intervention usually demands answers to many critical questions, yet empirical evidence or theoretical grounding for those answers is frequently lacking.
“Often, a wide variety of critical questions must be answered when developing a highquality adaptive intervention.Yet, there is often insufficient empirical evidence or theoretical basis to address these questions.”
The paper relies on this without support.
Many behavioral intervention scientists are still unfamiliar with SMARTs.
“Despite their increasing popularity due to their real-world clinical appeal, and their fit in research aimed at developing high-quality adaptive interventions, SMARTs remain relatively new to many behavioral intervention scientists.”
The paper relies on this without support.
Most healthy dieting and weight-loss programs include IBT.
“IBT is incorporated in most healthy dieting and weight loss interventions.”
The paper relies on this without support.
Many investigators lack sufficient empirical evidence or theoretical basis to form a high-quality adaptive intervention.
“in many other cases investigators have insufficient empirical evidence or theoretical basis to form a high-quality adaptive intervention.”
The paper relies on this without support.
Investigators often face important open questions about optimal adaptive intervention design, such as the best first-stage treatment.
“investigators often confront important open questions such as “What is the best first-stage treatment?””

9 of 9

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Figure 3 caption identifies itself as the baseline-randomization design
Minor
The caption calls Figure 3 a variation of the design in Figure 3, with the duration decision moved from baseline to week 5. The body instead identifies Figure 2 as the baseline-randomization design and Figure 3 as its variation.

1 of 1

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Background
Acceptance and commitment therapy: model, processes and outcomes
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Background
Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia
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Method
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Lillis J, Hayes SC, Bunting K, et al. Teaching acceptance and mindfulness to improve the lives of the obese: a preliminary test of a theoretical model. Ann Behav Med. 2009; 37(1): 58-69. · DOI · Paper page

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Authors: Almirall, D., Nahum-Shani, I., Sherwood, N. E., & Murphy, S. A.
Affiliations: University of Michigan (US)
HealthPartners (US)
Corresponding author: Almirall, Daniel
ORCID: Almirall, Daniel
Nahum-Shani, Inbal
Sherwood, Nancy E.
Murphy, Susan A.
Venue: Translational Behavioral Medicine
Publisher: Oxford University Press (OUP)
Published: 2014-05-06
Volume: 4
Issue: 3
Pages: 260-274
ISSN: 1613-9860 (ISSN-L)
1869-6716
DOI: 10.1007/s13142-014-0265-0
PMC: PMC4167891
OpenAlex: W1986546901
Cited by: 453
References: 88
Citations by year: 2026: 35 · 2025: 50 · 2024: 49 · 2023: 37 · 2022: 49 · 2021: 44 · 2020: 45 · 2019: 47 · 2018: 26 · 2017: 27 · 2016: 30 · 2015: 11 · 2014: 2
FWCI: 24.67
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Translational Behavioral Medicine (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health
National Institute of Mental Health (RC4MH092722, R03MH097954)
National Institute on Drug Abuse (P50DA010075)
National Institute of Diabetes and Digestive and Kidney Diseases (P30DK050456, P30DK092924)
National Institute of Biomedical Imaging and Bioengineering (U54EB020404)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords: adaptive interventions, sequential multiple assignment randomized trial, smart design, weight loss, overweight adults, personalized treatment, intervention development

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Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research

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