A control system model of capability-opportunity-motivation and behaviour (COM-B) framework for sedentary and physical activity behaviours.

Objective: Theoretical frameworks are essential for understanding behaviour change, yet their current use is inadequate to capture the complexity of human behaviour such as physical activity. Real-time and big data analytics can assist in the development of more testable and dynamic models of current theories. To transform current behavioural theories into more dynamic models, it is recommended that researchers adopt principles such as control systems engineering. In this article, we aim to describe a control system model of capability-opportunity-motivation and behaviour (COM-B) framework for reducing sedentary behaviour (SB) and increasing physical activity (PA) in adults. Methods: The COM-B model is explained in terms of control systems. Examples of effective behaviour change techniques (BCTs) (e.g. goal setting, problem-solving and social support) for reducing SB and increasing PA were mapped to the COM-B model for illustration. Result: A fluid analogy of the COM-B system is presented. Conclusions: The proposed integrated model will enable empirical testing of individual behaviour change components (i.e. BCTs) and contribute to the optimisation of digital behaviour change interventions.

Predicting Goal Attainment in Process-Oriented Behavioral Interventions Using a Data-Driven System Identification Approach.

Behavioral interventions (such as those developed to increase physical activity, achieve smoking cessation, or weight loss) can be represented as dynamic process systems incorporating a multitude of factors, ranging from cognitive (internal) to environmental (external) influences. This facilitates the application of system identification and control engineering methods to address questions such as: what drives individuals to improve health behaviors (such as engaging in physical activity)? In this paper, the goal is to efficiently estimate personalized, dynamic models which in turn will lead to control systems that can optimize this behavior. This problem is examined in system identification applied to the Just Walk study that aimed to increase walking behavior in sedentary adults. The paper presents a Discrete Simultaneous Perturbation Stochastic Approximation (DSPSA)-based modeling of the Goal Attainment construct estimated using AutoRegressive with eXogenous inputs (ARX) models. Feature selection of participants and ARX order selection is achieved through the DSPSA algorithm, which efficiently handles computationally expensive calculations. DSPSA can search over large sets of features as well as regressor structures in an informed, principled manner to model behavioral data within reasonable computational time. DSPSA estimation highlights the large individual variability in motivating factors among participants in Just Walk, thus emphasizing the importance of a personalized approach for optimized behavioral interventions.

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.

Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.

Advancing Understanding of Just-in-Time States for Supporting Physical Activity (Project JustWalk JITAI): Protocol for a System ID Study of Just-in-Time Adaptive Interventions.

BACKGROUND: Just-in-time adaptive interventions (JITAIs) are designed to provide support when individuals are receptive and can respond beneficially to the prompt. The notion of a just-in-time (JIT) state is critical for JITAIs. To date, JIT states have been formulated either in a largely data-driven way or based on theory alone. There is a need for an approach that enables rigorous theory testing and optimization of the JIT state concept. OBJECTIVE: The purpose of this system ID experiment was to investigate JIT states empirically and enable the empirical optimization of a JITAI intended to increase physical activity (steps/d). METHODS: We recruited physically inactive English-speaking adults aged ≥25 years who owned smartphones. Participants wore a Fitbit Versa 3 and used the study app for 270 days. The JustWalk JITAI project uses system ID methods to study JIT states. Specifically, provision of support systematically varied across different theoretically plausible operationalizations of JIT states to enable a more rigorous and systematic study of the concept. We experimentally varied 2 intervention components: notifications delivered up to 4 times per day designed to increase a person's steps within the next 3 hours and suggested daily step goals. Notifications to walk were experimentally provided across varied operationalizations of JIT states accounting for need (ie, whether daily step goals were previously met or not), opportunity (ie, whether the next 3 h were a time window during which a person had previously walked), and receptivity (ie, a person previously walked after receiving notifications). Suggested daily step goals varied systematically within a range related to a person's baseline level of steps per day (eg, 4000) until they met clinically meaningful targets (eg, averaging 8000 steps/d as the lower threshold across a cycle). A series of system ID estimation approaches will be used to analyze the data and obtain control-oriented dynamical models to study JIT states. The estimated models from all approaches will be contrasted, with the ultimate goal of guiding rigorous, replicable, empirical formulation and study of JIT states to inform a future JITAI. RESULTS: As is common in system ID, we conducted a series of simulation studies to formulate the experiment. The results of our simulation studies illustrated the plausibility of this approach for generating informative and unique data for studying JIT states. The study began enrolling participants in June 2022, with a final enrollment of 48 participants. Data collection concluded in April 2023. Upon completion of the analyses, the results of this study are expected to be submitted for publication in the fourth quarter of 2023. CONCLUSIONS: This study will be the first empirical investigation of JIT states that uses system ID methods to inform the optimization of a scalable JITAI for physical activity. TRIAL REGISTRATION: ClinicalTrials.gov NCT05273437; https://clinicaltrials.gov/ct2/show/NCT05273437. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52161.

System Identification and Hybrid Model Predictive Control in Personalized mHealth Interventions for Physical Activity.

The application of control systems principles in behavioral medicine includes developing interventions that can be individualized to promote healthy behaviors, such as sustained engagement in adequate levels of physical activity (PA). This paper presents the use of system identification and control engineering methods in the design of behavioral interventions through the novel formalism of a control-optimization trial (COT). The multiple stages of a COT, from experimental design in system identification through controller implementation, are illustrated using participant data from Just Walk, an intervention to promote walking behavior in sedentary adults. ARX models for individual participants are estimated using multiple estimation and validation data combinations, with the model leading to the best performance over a weighted norm being selected. This model serves as the internal model in a hybrid MPC controller formulated with three degree-of-freedom (3DoF) tuning that properly balances the requirements of physical activity interventions. Its performance in a realistic closed-loop setting is evaluated via simulation. These results serve as proof of concept for the COT approach, which is currently being evaluated with human participants in the clinical trial YourMove.

Idiographic Dynamic Modeling for Behavioral Interventions with Mixed Data Partitioning and Discrete Simultaneous Perturbation Stochastic Approximation.

This paper presents the use of discrete simultaneous perturbation stochastic approximation (DSPSA) as a routine method to efficiently determine features and parameters of idiographic (i.e. single subject) dynamic models for personalized behavioral interventions using various partitions of estimation and validation data. DSPSA is demonstrated as a valuable method to search over model features and regressor orders of AutoRegressive with eXogenous input estimated models using participant data from Just Walk (a behavioral intervention to promote physical activity in sedentary adults); results of DSPSA are compared to those of exhaustive search. In Just Walk, DSPSA efficiently and quickly estimates models of walking behavior, which can then be used to develop control systems to optimize the impacts of behavioral interventions. The use of DSPSA to evaluate models using various partitions of individual data into estimation and validation data sets also highlights data partitioning as an important feature of idiographic modeling that should be carefully considered.

Evaluating the Mental Health of Physician-Trainees Using an SMS Text Message-Based Assessment Tool: Longitudinal Pilot Study.

BACKGROUND: Physician burnout is a multibillion-dollar issue in the United States. Despite its prevalence, burnout is difficult to accurately measure. Institutions generally rely on periodic surveys that are subject to recall bias. SMS text message-based surveys or assessments have been used in health care and have the advantage of easy accessibility and high response rates. OBJECTIVE: In this pilot project, we evaluated the utility of and participant engagement with a simple, longitudinal, and SMS text message-based mental health assessment system for physician-trainees at the study institution. The goal of the SMS text message-based assessment system was to track stress, burnout, empathy, engagement, and work satisfaction levels faced by users in their normal working conditions. METHODS: Three SMS text message-based questions per week for 5 weeks were sent to each participant. All data received were deidentified. Additionally, each participant had a deidentified personal web page to follow their scores as well as the aggregated scores of all participants over time. A 13-question optional survey was sent at the conclusion of the study to evaluate the usability of the platform. Descriptive statistics were performed. RESULTS: In all, 81 participants were recruited and answered at least six (mean 14; median 14; range 6-16) questions for a total of 1113 responses. Overall, 10 (17%) out of 59 participants responded "Yes" to having experienced a traumatic experience during the study period. Only 3 participants ever answered being "Not at all satisfied" with their job. The highest number of responses indicating that participants were stressed or burnt out came on day 25 in the 34-day study period. There were mixed levels of concern for the privacy of responses. No substantial correlations were noted between responses and having experienced a traumatic experience during the study period. Furthermore, 12 participants responded to the optional feedback survey, and all either agreed or strongly agreed that the SMS text message-based assessment system was easy to use and the number of texts received was reasonable. None of the 12 respondents indicated that using the SMS text message-based assessment system caused stress. CONCLUSIONS: Responses demonstrated that SMS text message-based mental health assessments are potentially useful for recording physician-trainee mental health levels in real time with minimal burden, but further study of SMS text message-based mental health assessments should address limitations such as improving response rates and clarifying participants' sense of privacy when using the SMS text message-based assessment system. The findings of this pilot study can inform the development of institution-wide tools for assessing physician burnout and protecting physicians from occupational stress.

Nutrition-Related N-of-1 Studies Warrant Further Research to Provide Evidence for Dietitians to Practice Personalized (Precision) Medical Nutrition Therapy: A Systematic Review.

N-of-1 trials provide a higher level of evidence than randomized controlled trials for determining which treatment works best for an individual, and the design readily accommodates testing of personalized nutrition. The aim of this systematic review was to synthesize nutrition-related studies using an N-of-1 design. The inclusion criterion was adult participants; the intervention/exposure was any nutrient, food, beverage, or dietary pattern; the comparators were baseline values, a control condition untreated or placebo, or an alternate treatment, alongside any outcomes such as changes in diet, body weight, biochemical outcomes, symptoms, quality of life, or a disease outcome resulting from differences in nutritional conditions. The information sources used were Medline, Embase, Scopus, Cochrane Central, and PsychInfo. The quality of study reporting was assessed using the Consort Extension for N-of-1 trials (CENT) statement or the STrengthening Reporting of OBservational Studies in Epidemiology (STROBE) guidelines, as appropriate. From 211 articles screened, a total of 7 studies were included and were conducted in 5 countries with a total of 83 participants. The conditions studied included prediabetes, diabetes, irritable bowel syndrome, weight management, and investigation of the effect of diet in healthy people. The quality of reporting was mostly adequate, and dietary assessment quality varied from poor to good. The evidence base is small, but served to illustrate the main characteristics of N-of-1 study designs and considerations for moving research forward in the era of personalized medical nutrition therapy.

Development and Validation of Multivariable Prediction Algorithms to Estimate Future Walking Behavior in Adults: Retrospective Cohort Study.

BACKGROUND: Physical inactivity is associated with numerous health risks, including cancer, cardiovascular disease, type 2 diabetes, increased health care expenditure, and preventable, premature deaths. The majority of Americans fall short of clinical guideline goals (ie, 8000-10,000 steps per day). Behavior prediction algorithms could enable efficacious interventions to promote physical activity by facilitating delivery of nudges at appropriate times. OBJECTIVE: The aim of this paper is to develop and validate algorithms that predict walking (ie, >5 min) within the next 3 hours, predicted from the participants' previous 5 weeks' steps-per-minute data. METHODS: We conducted a retrospective, closed cohort, secondary analysis of a 6-week microrandomized trial of the HeartSteps mobile health physical-activity intervention conducted in 2015. The prediction performance of 6 algorithms was evaluated, as follows: logistic regression, radial-basis function support vector machine, eXtreme Gradient Boosting (XGBoost), multilayered perceptron (MLP), decision tree, and random forest. For the MLP, 90 random layer architectures were tested for optimization. Prior 5-week hourly walking data, including missingness, were used for predictors. Whether the participant walked during the next 3 hours was used as the outcome. K-fold cross-validation (K=10) was used for the internal validation. The primary outcome measures are classification accuracy, the Mathew correlation coefficient, sensitivity, and specificity. RESULTS: The total sample size included 6 weeks of data among 44 participants. Of the 44 participants, 31 (71%) were female, 26 (59%) were White, 36 (82%) had a college degree or more, and 15 (34%) were married. The mean age was 35.9 (SD 14.7) years. Participants (n=3, 7%) who did not have enough data (number of days <10) were excluded, resulting in 41 (93%) participants. MLP with optimized layer architecture showed the best performance in accuracy (82.0%, SD 1.1), whereas XGBoost (76.3%, SD 1.5), random forest (69.5%, SD 1.0), support vector machine (69.3%, SD 1.0), and decision tree (63.6%, SD 1.5) algorithms showed lower performance than logistic regression (77.2%, SD 1.2). MLP also showed superior overall performance to all other tried algorithms in Mathew correlation coefficient (0.643, SD 0.021), sensitivity (86.1%, SD 3.0), and specificity (77.8%, SD 3.3). CONCLUSIONS: Walking behavior prediction models were developed and validated. MLP showed the highest overall performance of all attempted algorithms. A random search for optimal layer structure is a promising approach for prediction engine development. Future studies can test the real-world application of this algorithm in a "smart" intervention for promoting physical activity.

Thinking Health-related Behaviors in a Climate Change Context: A Narrative Review.

BACKGROUND: Human activities have changed the environment so profoundly over the past two centuries that human-induced climate change is now posing serious health-related threats to current and future generations. Rapid action from all scientific fields, including behavioral medicine, is needed to contribute to both mitigation of, and adaption to, climate change. PURPOSE: This article aims to identify potential bi-directional associations between climate change impacts and health-related behaviors, as well as a set of key actions for the behavioral medicine community. METHODS: We synthesized the existing literature about (i) the impacts of rising temperatures, extreme weather events, air pollution, and rising sea level on individual behaviors (e.g., eating behaviors, physical activity, sleep, substance use, and preventive care) as well as the structural factors related to these behaviors (e.g., the food system); and (ii) the concurrent positive and negative roles that health-related behaviors can play in mitigation and adaptation to climate change. RESULTS: Based on this literature review, we propose a first conceptual model of climate change and health-related behavior feedback loops. Key actions are proposed, with particular consideration for health equity implications of future behavioral interventions. Actions to bridge the fields of behavioral medicine and climate sciences are also discussed. CONCLUSIONS: We contend that climate change is among the most urgent issues facing all scientists and should become a central priority for the behavioral medicine community.

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors.

Younger breast cancer survivors (YBCS) consistently report poorer quality of life (QOL) than older survivors. Increasing physical activity (PA) may improve QOL, but this has been understudied in YBCS. This single arm pilot study evaluated the feasibility and acceptability of a 3-month, peer-delivered, remote intervention to increase PA and improve QOL in YBCS. Data were collected from October 2019 - July 2020. Participants (n = 34, 43.1 ± 5.5 years old, 46 ± 34.4 months post-diagnosis, BMI = 30.2 ± 7.4 kg/m2) completed six video sessions with a trained peer mentor; self-monitored PA with a Fitbit activity tracker; and interacted with a private Fitbit Community for social support. At baseline, 3-and 6-months, participants completed QOL questionnaires and PA was measured through accelerometer (moderate-to-vigorous PA [MVPA]) and self-report (strength and flexibility). A parallel mixed-methods approach (qualitative interviews and quantitative satisfaction survey at 3-months) explored intervention feasibility and acceptability. One-way repeated-measures ANOVAs examined impacts on PA and QOL at 3-and 6-months. The intervention was feasible as evidenced by efficient recruitment, high retention, and adherence to intervention components. Remote delivery, working with a peer mentor, and using Fitbit tools were highly acceptable. From baseline to 3-months, participants increased time spent in objectively measured MVPA, strength, and flexibility exercises, and reported meaningful improvements to body image, fatigue, anxiety, and emotional support. A fully remote, peer-to-peer intervention is an acceptable and promising strategy to increase PA and improve QOL in YBCS. Refinements to the intervention and its delivery should be further assessed in future studies, toward the goal of disseminating an evidence-based, scalable intervention to the growing number of YBCS.Trial registration Prospectively registered as NCT04064892.

The core functions and forms paradigm throughout EPIS: designing and implementing an evidence-based practice with function fidelity.

There are numerous frameworks for implementing evidence-based practices (EBPs) in novel settings to achieve "fidelity." However, identifying appropriate referents for fidelity poses a challenge. The Core Functions and Forms paradigm offers a model that can inform adaptation decisions throughout all phases of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. We applied the Core Functions-Forms paradigm throughout the Exploration and Preparation phases of EPIS in the design of two EBPs targeting family protective factors among Latinos in San Diego, as well as describe plans for its use in Implementation and Sustainment. We employed a distinct approach for each intervention element to contrast adaptation decisions that prioritize adherence to either form or function fidelity. We describe our application of the functions-forms paradigm within the EPIS framework, focusing on the Preparation phase. We also provide functions-forms matrices that map out the relationship between individual intervention components (forms) and the essential processes (functions) by which components are theorized to exert their impact. This case study of how the core functions-forms framework can be mapped onto EPIS can support a conceptual shift from prioritizing form fidelity to also focusing on function fidelity. This might allow interventionists to target appropriate fidelity referents when adapting an EBP, rather than defaulting to maintaining fidelity to forms as described in the protocol. We see great promise for using this framework for guiding actions throughout all EPIS phases and informing future applications of this paradigm to foster more robust fidelity to function.

Enhanced Social Cognitive Theory Dynamic Modeling and Simulation Towards Improving the Estimation of "Just-In-Time" States.

Insufficient physical activity (PA) is commonplace in society, in spite of its significant impact on personal health and well-being. Improved interventions are clearly needed. One of the challenges faced in behavioral interventions is a lack of understanding of multi-timescale dynamics. In this paper we rely on a dynamical model of Social Cognitive Theory (SCT) to gain insights regarding a control-oriented experimental design for a behavioral intervention to improve PA. The intervention (Just Walk JITAI) is designed with the aim to better understand and estimate ideal times for intervention and support based on the concept of "just-in-time" states. An innovative input signal design strategy is used to study the just-in-time state dynamics through the use of decision rules based on conditions of need, opportunity and receptivity. Model simulations featuring within-day effects are used to assess input signal effectiveness. Scenarios for adherent and non-adherent participants are presented, with the proposed experimental design showing significant potential for reducing notification burden while providing informative data to support future system identification and control design efforts.

Model Personalization in Behavioral Interventions using Model-on-Demand Estimation and Discrete Simultaneous Perturbation Stochastic Approximation.

This paper presents the use of discrete Simultaneous Perturbation Stochastic Approximation (DSPSA) to optimize dynamical models meaningful for personalized interventions in behavioral medicine, with emphasis on physical activity. DSPSA is used to determine an optimal set of model features and parameter values which would otherwise be chosen either through exhaustive search or be specified a priori. The modeling technique examined in this study is Model-on-Demand (MoD) estimation, which synergistically manages local and global modeling, and represents an appealing alternative to traditional approaches such as ARX estimation. The combination of DSPSA and MoD in behavioral medicine can provide individualized models for participant-specific interventions. MoD estimation, enhanced with a DSPSA search, can be formulated to provide not only better explanatory information about a participant's physical behavior but also predictive power, providing greater insight into environmental and mental states that may be most conducive for participants to benefit from the actions of the intervention. A case study from data collected from a representative participant of the Just Walk intervention is presented in support of these conclusions.

Model Predictive Control Strategies for Optimized mHealth Interventions for Physical Activity.

Many individuals fail to engage in sufficient physical activity (PA), despite its well-known health benefits. This paper examines Model Predictive Control (MPC) as a means to deliver optimized, personalized behavioral interventions to improve PA, as reflected by the number of steps walked per day. Using a health behavior fluid analogy model representing Social Cognitive Theory, a series of diverse strategies are evaluated in simulated scenarios that provide insights into the most effective means for implementing MPC in PA behavioral interventions. The interplay of measurement, information, and decision is explored, with the results illustrating MPC's potential to deliver feasible, personalized, and user-friendly behavioral interventions, even under circumstances involving limited measurements. Our analysis demonstrates the effectiveness of sensibly formulated constrained MPC controllers for optimizing PA interventions, which is a preliminary though essential step to experimental evaluation of constrained MPC control strategies under real-life conditions.

[A decision framework for an adaptive behavioral intervention for physical activity using hybrid model predictive control: illustration with Just Walk]. / Un esquema de decisiones para intervenciones adaptativas comportamentales de actividad física basado en control predictivo por modelo híbrido: ilustración con Just Walk.

Physical inactivity is a major contributor to morbidity and mortality worldwide. Many current physical activity behavioral interventions have shown limited success addressing the problem from a long-term perspective that includes maintenance. This paper proposes the design of a decision algorithm for a mobile and wireless health (mHealth) adaptive intervention that is based on control engineering concepts. The design process relies on a behavioral dynamical model based on Social Cognitive Theory (SCT), with a controller formulation based on hybrid model predictive control (HMPC) being used to implement the decision scheme. The discrete and logical features of HMPC coincide naturally with the categorical nature of the intervention components and the logical decisions that are particular to an intervention for physical activity. The intervention incorporates an online controller reconfiguration mode that applies changes in the penalty weights to accomplish the transition between the behavioral initiation and maintenance training stages. Controller performance is illustrated using an ARX model estimated from system identification data of a representative participant for Just Walk, a physical activity intervention designed on the basis of control systems principles.

Enhancing Nutrition Care Through Real-Time, Sensor-Based Capture of Eating Occasions: A Scoping Review.

As food intake patterns become less structured, different methods of dietary assessment may be required to capture frequently omitted snacks, smaller meals, and the time of day when they are consumed. Incorporating sensors that passively and objectively detect eating behavior may assist in capturing these eating occasions into dietary assessment methods. The aim of this study was to identify and collate sensor-based technologies that are feasible for dietitians to use to assist with performing dietary assessments in real-world practice settings. A scoping review was conducted using the PRISMA extension for scoping reviews (PRISMA-ScR) framework. Studies were included if they were published between January 2016 and December 2021 and evaluated the performance of sensor-based devices for identifying and recording the time of food intake. Devices from included studies were further evaluated against a set of feasibility criteria to determine whether they could potentially be used to assist dietitians in conducting dietary assessments. The feasibility criteria were, in brief, consisting of an accuracy ≥80%; tested in settings where subjects were free to choose their own foods and activities; social acceptability and comfort; a long battery life; and a relatively rapid detection of an eating episode. Fifty-four studies describing 53 unique devices and 4 device combinations worn on the wrist (n = 18), head (n = 16), neck (n = 9), and other locations (n = 14) were included. Whilst none of the devices strictly met all feasibility criteria currently, continuous refinement and testing of device software and hardware are likely given the rapidly changing nature of this emerging field. The main reasons devices failed to meet the feasibility criteria were: an insufficient or lack of reporting on battery life (91%), the use of a limited number of foods and behaviors to evaluate device performance (63%), and the device being socially unacceptable or uncomfortable to wear for long durations (46%). Until sensor-based dietary assessment tools have been designed into more inconspicuous prototypes and are able to detect most food and beverage consumption throughout the day, their use will not be feasible for dietitians in practice settings.

Accuracy and Precision of Energy Expenditure, Heart Rate, and Steps Measured by Combined-Sensing Fitbits Against Reference Measures: Systematic Review and Meta-analysis.

BACKGROUND: Although it is widely recognized that physical activity is an important determinant of health, assessing this complex behavior is a considerable challenge. OBJECTIVE: The purpose of this systematic review and meta-analysis is to examine, quantify, and report the current state of evidence for the validity of energy expenditure, heart rate, and steps measured by recent combined-sensing Fitbits. METHODS: We conducted a systematic review and Bland-Altman meta-analysis of validation studies of combined-sensing Fitbits against reference measures of energy expenditure, heart rate, and steps. RESULTS: A total of 52 studies were included in the systematic review. Among the 52 studies, 41 (79%) were included in the meta-analysis, representing 203 individual comparisons between Fitbit devices and a criterion measure (ie, n=117, 57.6% for heart rate; n=49, 24.1% for energy expenditure; and n=37, 18.2% for steps). Overall, most authors of the included studies concluded that recent Fitbit models underestimate heart rate, energy expenditure, and steps compared with criterion measures. These independent conclusions aligned with the results of the pooled meta-analyses showing an average underestimation of -2.99 beats per minute (k comparison=74), -2.77 kcal per minute (k comparison=29), and -3.11 steps per minute (k comparison=19), respectively, of the Fitbit compared with the criterion measure (results obtained after removing the high risk of bias studies; population limit of agreements for heart rate, energy expenditure, and steps: -23.99 to 18.01, -12.75 to 7.41, and -13.07 to 6.86, respectively). CONCLUSIONS: Fitbit devices are likely to underestimate heart rate, energy expenditure, and steps. The estimation of these measurements varied by the quality of the study, age of the participants, type of activities, and the model of Fitbit. The qualitative conclusions of most studies aligned with the results of the meta-analysis. Although the expected level of accuracy might vary from one context to another, this underestimation can be acceptable, on average, for steps and heart rate. However, the measurement of energy expenditure may be inaccurate for some research purposes.