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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.

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.

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.

BackgroundJust-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. ObjectiveThe 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). MethodsWe 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. ResultsAs 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. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05273437; https://clinicaltrials.gov/ct2/show/NCT05273437 International Registered Report Identifier (IRRID)DERR1-10.2196/52161

La inactividad física es uno de los principales factores que contribuyen a la morbilidad y la mortalidad en todo el mundo. Muchas intervenciones comportamentales de actividad física en la actualidad han mostrado un éxito limitado al abordar el problema desde una perspectiva a largo plazo que incluye el mantenimiento. Este artículo propone el diseño de un algoritmo de decisión para una intervención adaptativa de salud móvil e inalámbrica (mHealth) que se basa en conceptos de ingeniería de control. El proceso de diseño se basa en un modelo dinámico que representa el comportamiento basada en la Teoría Cognitiva Social (TCS), con una formulación de controlador fundamentada en el control predictivo por modelo híbrido (HMPC por sus siglas en inglés) la cual se utiliza para implementar el esquema de decisión. Las características discretas y lógicas del HMPC coinciden naturalmente con la naturaleza categórica de los componentes de la intervención y las decisiones lógicas que son propias de una intervención para actividad física. La intervención incorpora un modo de reconfiguración del controlador en línea que aplica cambios en los pesos de penalización para lograr la transición entre las etapas de entrenamiento de iniciación comportamental y mantenimiento. Resultados de simulación se presentan para ilustrar el desempeño del controlador utilizando un modelo ARX estimado de datos de un participante representativo de Just Walk, una intervención de actividad física diseñada usando principios de sistemas de control.

Abstract Background Excess weight gain in young adulthood is associated with future weight gain and increased risk of chronic disease. Although multimodal, technology-based weight-loss interventions have the potential to promote weight loss among young adults, many interventions have limited personalization, and few have been deployed and evaluated for longer than a year. We aim to assess the effects of a highly personalized, 2-year intervention that uses popular mobile and social technologies to promote weight loss among young adults. Methods The Social Mobile Approaches to Reducing Weight (SMART) 2.0 Study is a 24-month parallel-group randomized controlled trial that will include 642 overweight or obese participants, aged 18–35 years, from universities and community colleges in San Diego, CA. All participants receive a wearable activity tracker, connected scale, and corresponding app. Participants randomized to one intervention group receive evidence-based information about weight loss and behavior change techniques via personalized daily text messaging (i.e., SMS/MMS), posts on social media platforms, and online groups. Participants in a second intervention group receive the aforementioned elements in addition to brief, technology-mediated health coaching. Participants in the control group receive a wearable activity tracker, connected scale, and corresponding app alone. The primary outcome is objectively measured weight in kilograms over 24 months. Secondary outcomes include anthropometric measurements; physiological measures; physical activity, diet, sleep, and psychosocial measures; and engagement with intervention modalities. Outcomes are assessed at baseline and 6, 12, 18, and 24 months. Differences between the randomized groups will be analyzed using a mixed model of repeated measures and will be based on the intent-to-treat principle. Discussion We hypothesize that both SMART 2.0 intervention groups will significantly improve weight loss compared to the control group, and the group receiving health coaching will experience the greatest improvement. We further hypothesize that differences in secondary outcomes will favor the intervention groups. There is a critical need to advance understanding of the effectiveness of multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults. Our findings should inform the implementation of low-cost and scalable interventions for weight loss and risk-reducing health behaviors. Trial registration ClinicalTrials.gov NCT03907462 . Registered on April 9, 2019

BackgroundPhysical 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. ObjectiveThe 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. MethodsWe 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. ResultsThe 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

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.

This paper presents the Experiment in a Box (XB) framework to support interactive technology design for building health skills. The XB provides a suite of experiments—time-limited, loosely structured evaluations of health heuristics for a user-as-experimenter to select from and then test in order to determine that heuristic’s efficacy, and to explore how it might be incorporated into the person’s life and when necessary, to support their health and wellbeing. The approach leverages self-determination theory to support user autonomy and competence to build actionable, personal health knowledge skills and practice (KSP). In the three studies of XB presented, we show that with even the short engagement of an XB experiment, participants develop health practices from the interventions that are still in use long after the intervention is finished. To situate the XB approach relative to other work around health practices in HCI in particular, we contribute two design continua for this design space: insourcing to outsourcing and habits to heuristics. From this analysis, we demonstrate that XB is situated in a largely under-explored area for interactive health interventions: the insourcing and heuristic oriented area of the design space. Overall, the work offers a new scaffolding, the XB Framework, to instantiate time-limited interactive technology interventions to support building KSP that can thrive in that person, significantly both post-interventions, and independent of that technology.

Despite the positive health effect of physical activity, one third of the world's population is estimated to be insufficiently active. Prior research has mainly investigated physical activity on an aggregate level over short periods of time, e.g., during 3 to 7 days at baseline and a few months later, post-intervention. To develop effective interventions, we need a better understanding of the temporal dynamics of physical activity. We proposed here an approach to studying walking behavior at "high-resolution" and by capturing the idiographic and day-to-day changes in walking behavior. We analyzed daily step count among 151 young adults with overweight or obesity who had worn an accelerometer for an average of 226 days (~25,000 observations). We then used a recursive partitioning algorithm to characterize patterns of change, here sudden behavioral gains and losses, over the course of the study. These behavioral gains or losses were defined as a 30% increase or reduction in steps relative to each participants' median level of steps lasting at least 7 days. After the identification of gains and losses, fluctuation intensity in steps from each participant's individual time series was computed with a dynamic complexity algorithm to identify potential early warning signals of sudden gains or losses. Results revealed that walking behavior change exhibits discontinuous changes that can be described as sudden gains and losses. On average, participants experienced six sudden gains or losses over the study. We also observed a significant and positive association between critical fluctuations in walking behavior, a form of early warning signals, and the subsequent occurrence of sudden behavioral losses in the next days. Altogether, this study suggests that walking behavior could be well understood under a dynamic paradigm. Results also provide support for the development of "just-in-time adaptive" behavioral interventions based on the detection of early warning signals for sudden behavioral losses.

Although group-level evidence supports the use of behavioral interventions to enhance cognitive and emotional well-being, different interventions may be more acceptable or effective for different people. N-of-1 trials are single-patient crossover trials designed to estimate treatment effectiveness in a single patient. We designed a mobile health (mHealth) supported N-of-1 trial platform permitting US adult volunteers to conduct their own 30-day self-experiments testing a behavioral intervention of their choice (deep breathing/meditation, gratitude journaling, physical activity, or helpful acts) on daily measurements of stress, focus, and happiness. We assessed uptake of the study, perceived usability of the N-of-1 trial system, and influence of results (both reported and perceived) on enthusiasm for the chosen intervention (defined as perceived helpfulness of the chosen intervention and intent to continue performing the intervention in the future). Following a social media and public radio campaign, 447 adults enrolled in the study and 259 completed the post-study survey. Most were highly educated. Perceived system usability was high (mean scale score 4.35/5.0, SD 0.57). Enthusiasm for the chosen intervention was greater among those with higher pre-study expectations that the activity would be beneficial for them (p < 0.001), those who obtained more positive N-of-1 results (as directly reported to participants) (p < 0.001), and those who interpreted their N-of-1 study results more positively (p < 0.001). However, reported results did not significantly influence enthusiasm after controlling for participants' interpretations. The interaction between pre-study expectation of benefit and N-of-1 results interpretation was significant (p < 0.001), such that those with the lowest starting pre-study expectations reported greater intervention enthusiasm when provided with results they interpreted as positive. We conclude that N-of-1 behavioral trials can be appealing to a broad albeit highly educated and mostly female audience, that usability was acceptable, and that N-of-1 behavioral trials may have the greatest utility among those most skeptical of the intervention to begin with.

Summary: Background: Smartphone apps might enable interventions to increase physical activity, but few randomised trials testing this hypothesis have been done. The MyHeart Counts Cardiovascular Health Study is a longitudinal smartphone-based study with the aim of elucidating the determinants of cardiovascular health. We aimed to investigate the effect of four different physical activity coaching interventions on daily step count in a substudy of the MyHeart Counts Study. Methods: In this randomised, controlled crossover trial, we recruited adults (aged ≥18 years) in the USA with access to an iPhone smartphone (Apple, Cupertino, CA, USA; version 5S or newer) who had downloaded the MyHeart Counts app (version 2.0). After completion of a 1 week baseline period of interaction with the MyHeart Counts app, participants were randomly assigned to receive one of 24 permutations (four combinations of four 7 day interventions) in a crossover design using a random number generator built into the app. Interventions consisted of either daily prompts to complete 10 000 steps, hourly prompts to stand following 1 h of sitting, instructions to read the guidelines from the American Heart Association website, or e-coaching based upon the individual's personal activity patterns from the baseline week of data collection. Participants completed the trial in a free-living setting. Due to the nature of the interventions, participants could not be masked from the intervention. Investigators were not masked to intervention allocation. The primary outcome was change in mean daily step count from baseline for each of the four interventions, assessed in the modified intention-to-treat analysis set, which included all participants who had completed 7 days of baseline monitoring and at least 1 day of one of the four interventions. This trial is registered with ClinicalTrials.gov, NCT03090321. Findings: Between Dec 12, 2016, and June 6, 2018, 2783 participants consented to enrol in the coaching study, of whom 1075 completed 7 days of baseline monitoring and at least 1 day of one of the four interventions and thus were included in the modified intention-to-treat analysis set. 493 individuals completed the full set of assigned interventions. All four interventions significantly increased mean daily step count from baseline (mean daily step count 2914 [SE 74]): mean step count increased by 319 steps (75) for participants in the American Heart Association website prompt group (p