Applying the Non-adoption, Abandonment, Scale-up, Spread and Sustainability (NASSS) framework to evaluate automated evidence synthesis in health behaviour change.

Automated tools to speed up the process of evidence synthesis are increasingly apparent within health behaviour research. This brief review explores the potential of the Non-adoption, Abandonment, Scale-up, Spread and Sustainability framework for supporting automated evidence synthesis in health behaviour change by applying it to the ongoing Human Behaviour-Change Project, which aims to revolutionize evidence synthesis within behaviour change intervention research. To increase the relevance of NASSS for health behaviour change, we recommend i) terminology changes ('condition' to 'behaviour' and 'patient' to 'end user') and ii) that it is used prospectively address complexities iteratively. We draw conclusions about i) the need to specify the organizations that will use the technology, ii) identifying what to do if interdependencies fail and iii) even though we have focused on automated evidence synthesis, NASSS would arguably be beneficial for technology developments in health behaviour change more generally, particularly for invention development.

Physiotherapists' barriers and facilitators to the implementation of a behaviour change-informed exercise intervention to promote the adoption of regular exercise practice in patients at risk of recurrence of low back pain: a qualitative study.

BACKGROUND: Recurrences of low back pain (LBP) are frequent and associated with high levels of disability and medical costs. Regular exercise practice may be an effective strategy to prevent recurrences of LBP, however, the promotion of this behaviour by physiotherapists seems to be challenging. This study aims to explore physiotherapists' perceived barriers and facilitators to the implementation of a behaviour change-informed exercise intervention to promote the adoption of regular exercise practice by patients at risk of recurrence of low back pain. METHODS: Two focus groups with primary healthcare physiotherapists were conducted, based on a semi-structured interview schedule informed by the Behaviour Change Wheel, including the Capability, Opportunity, Motivation-Behaviour (COM-B) model and the Theoretical Domains Framework (TDF). All focus groups were held through videoconference, audio and video recorded and transcribed verbatim. A deductive content analysis, using a coding matrix based on the COM-B and TDF, was performed by two independent researchers. A third researcher was approached to settle disagreements. RESULTS: In total, 14 physiotherapists participated in the focus groups. The analysis revealed a total of 13 barriers (4 COM-B components and 7 TDF domains) and 23 facilitators (5 COM-B and 13 TDF) to physiotherapists' implementation of a behaviour change-informed exercise intervention. The most common barriers were the lack of skills and confidence to implement the proposed intervention. These were explained by the fact that it differs from the usual practice of most participants and requires the learning of new skills applied to their contexts. However, for those who had already implemented other similar interventions or whose rationale is aligned with the new intervention, there seemed to exist more positive determinants, such as potential benefits for physiotherapists and the profession, improvement of quality of care and willingness to change clinical practice. For others who did not previously succeed in implementing these types of interventions, more context-related barriers were mentioned, such as lack of time to implement the intervention, schedule incompatibilities and lack of material and human resources. CONCLUSIONS: This study identified modifiable barriers and facilitators to physiotherapists' implementation of a behaviour change-informed exercise intervention for patients at risk of recurrence of LBP in primary healthcare. The findings of this study will allow the systematic and theory-based development of a behaviour change-informed training programme, aimed at physiotherapists and supporting the successful implementation of the exercise intervention.

Are motivational and self-regulation factors associated with 12 months' weight regain prevention in the NoHoW study? An analysis of European adults.

PURPOSE: Preventing weight regain can only be achieved by sustained changes in energy balance-related behaviors that are associated with weight, such as diet and physical activity. Changes in motivation and self-regulatory skills can support long-term behavioral changes in the context of weight loss maintenance. We propose that experiencing a supportive climate care is associated with enhanced satisfaction of basic psychological needs, intrinsic goals, and autonomous motivation. These factors are expected to be associate with the utilization of self-regulation skills, leading to more sustained behavior changes and ultimately preventing weight regain. This hypothesis was tested in this ancillary analysis of the NoHoW trial, where the study arms were pooled and followed for 12 months. METHODS: The NoHoW was a three-center, large-scale weight regain prevention full factorial trial. In this longitudinal study, data were collected in adults who lost > 5% weight in the past year (N = 870, complete data only, 68.7% female, 44.10 ± 11.86 years, 84.47 ± 17.03 kg) during their participation in a 12-month digital behavior change intervention. Weight and validated measures of motivational- and self-regulatory skills-related variables were collected at baseline, six- and 12 months. Change variables were used in Mplus' path analytical models informed by NoHoW's logic model. RESULTS: The bivariate correlations confirmed key mediators' potential effect on weight outcomes in the expected causal direction. The primary analysis showed that a quarter of the variance (r2 = 23.5%) of weight regain prevention was achieved via the mechanisms of action predicted in the logic model. Specifically, our results show that supportive climate care is associated with needs satisfaction and intrinsic goal content leading to better weight regain prevention via improvements in self-regulatory skills and exercise-controlled motivation. The secondary analysis showed that more mechanisms of action are significant in participants who regained or maintained their weight. CONCLUSIONS: These results contribute to a better understanding of the mechanisms of action leading to behavior change in weight regain prevention. The most successful participants used only a few intrinsic motivation-related mechanisms of action, suggesting that habits may have been learned. While developing a digital behavior change intervention, researchers and practitioners should consider creating supportive climate care to improve needs satisfaction and intrinsic goal contents. TRIAL REGISTRATION: ISRCTN, ISRCTN88405328 , registered 12/22/2016.

Testing motivational and self-regulatory mechanisms of action on device-measured physical activity in the context of a weight loss maintenance digital intervention: A secondary analysis of the NoHoW trial.

BACKGROUND: To date, few digital behavior change interventions for weight loss maintenance focusing on long-term physical activity promotion have used a sound intervention design grounded on a logic model underpinned by behavior change theories. The current study is a secondary analysis of the weight loss maintenance NoHoW trial and investigated putative mediators of device-measured long-term physical activity levels (six to 12 months) in the context of a digital intervention. METHODS: A subsample of 766 participants (Age = 46.2 ± 11.4 years; 69.1% female; original NoHoW sample: 1627 participants) completed all questionnaires on motivational and self-regulatory variables and had all device-measured physical activity data available for zero, six and 12 months. We examined the direct and indirect effects of Virtual Care Climate on post intervention changes in moderate-to-vigorous physical activity and number of steps (six to 12 months) through changes in the theory-driven motivational and self-regulatory mechanisms of action during the intervention period (zero to six months), as conceptualized in the logic model. RESULTS: Model 1 tested the mediation processes on Steps and presented a poor fit to the data. Model 2 tested mediation processes on moderate-to-vigorous physical activity and presented poor fit to the data. Simplified models were also tested considering the autonomous motivation and the controlled motivation variables independently. These changes yielded good results and both models presented very good fit to the data for both outcome variables. Percentage of explained variance was negligible for all models. No direct or indirect effects were found from Virtual Care Climate to long term change in outcomes. Indirect effects occurred only between the sequential paths of the theory-driven mediators. CONCLUSION: This was one of the first attempts to test a serial mediation model considering psychological mechanisms of change and device-measured physical activity in a 12-month longitudinal trial. The model explained a small proportion of variance in post intervention changes in physical activity. We found different pathways of influence on theory-driven motivational and self-regulatory mechanisms but limited evidence that these constructs impacted on actual behavior change. New approaches to test these relationships are needed. Challenges and several alternatives are discussed. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN88405328. Registered December 16, 2016, https://www.isrctn.com/ISRCTN88405328.

The Behaviour Change Technique Ontology: Transforming the Behaviour Change Technique Taxonomy v1.

Background: The Behaviour Change Technique Taxonomy v1 (BCTTv1) specifies the potentially active content of behaviour change interventions. Evaluation of BCTTv1 showed the need to extend it into a formal ontology, improve its labels and definitions, add BCTs and subdivide existing BCTs. We aimed to develop a Behaviour Change Technique Ontology (BCTO) that would meet these needs. Methods: The BCTO was developed by: (1) collating and synthesising feedback from multiple sources; (2) extracting information from published studies and classification systems; (3) multiple iterations of reviewing and refining entities, and their labels, definitions and relationships; (4) refining the ontology via expert stakeholder review of its comprehensiveness and clarity; (5) testing whether researchers could reliably apply the ontology to identify BCTs in intervention reports; and (6) making it available online and creating a machine-readable version. Results: Initially there were 282 proposed changes to BCTTv1. Following first-round review, 19 BCTs were split into two or more BCTs, 27 new BCTs were added and 26 BCTs were moved into a different group, giving 161 BCTs hierarchically organised into 12 logically defined higher-level groups in up to five hierarchical levels. Following expert stakeholder review, the refined ontology had 247 BCTs hierarchically organised into 20 higher-level groups. Independent annotations of intervention evaluation reports by researchers familiar and unfamiliar with the ontology resulted in good levels of inter-rater reliability (0.82 and 0.79, respectively). Following revision informed by this exercise, 34 BCTs were added, resulting in a final version of the BCTO containing 281 BCTs organised into 20 higher-level groups over five hierarchical levels. Discussion: The BCT Ontology provides a standard terminology and comprehensive classification system for the content of behaviour change interventions that can be reliably used to describe interventions.

Clustering of Health Behaviors in Canadians: A Multiple Behavior Analysis of Data from the Canadian Longitudinal Study on Aging.

BACKGROUND: Health behaviors such as physical inactivity, unhealthy eating, smoking tobacco, and alcohol use are each leading risk factors for non-communicable chronic disease. Better understanding which behaviors tend to co-occur (i.e., cluster together) and co-vary (i.e., are correlated) may provide novel opportunities to develop more comprehensive interventions to promote multiple health behavior change. However, whether co-occurrence or co-variation-based approaches are better suited for this task remains relatively unknown. PURPOSE: To compare the utility of co-occurrence vs. co-variation-based approaches for understanding the interconnectedness between multiple health-impacting behaviors. METHODS: Using baseline and follow-up data (N = 40,268) from the Canadian Longitudinal Study of Aging, we examined the co-occurrence and co-variation of health behaviors. We used cluster analysis to group individuals based on their behavioral tendencies across multiple behaviors and to examine how these clusters are associated with demographic characteristics and health indicators. We compared outputs from cluster analysis to behavioral correlations and compared regression analyses of clusters and individual behaviors predicting future health outcomes. RESULTS: Seven clusters were identified, with clusters differentiated by six of the seven health behaviors included in the analysis. Sociodemographic characteristics varied across several clusters. Correlations between behaviors were generally small. In regression analyses individual behaviors accounted for more variance in health outcomes than clusters. CONCLUSIONS: Co-occurrence-based approaches may be more suitable for identifying sub-groups for intervention targeting while co-variation approaches are more suitable for building an understanding of the relationships between health behaviors.

Health behaviors such as physical inactivity, unhealthy eating, smoking tobacco, and alcohol use are each leading risk factors for non-communicable chronic disease. A better understanding of which behavioral combinations people engage in, and which behaviors are associated with each other, may provide new insights to support the development of interventions to promote multiple health behavior change. Using data with two time points (N = 40,268) from the Canadian Longitudinal Study of Aging, we grouped people into clusters based on their health behaviors and examined how these clusters are associated with demographic characteristics and health indicators. Seven clusters were identified with sociodemographic patterns evident across several clusters. Correlations between behaviors were generally small. We compared whether individual health behaviors, or groupings of people based on their health behaviors, were better predictors of future health outcomes. Individual behaviors were slightly better predictors of future health outcomes than clusters.

Content and quality of physical activity ontologies: a systematic review.

INTRODUCTION: Ontologies are a formal way to represent knowledge in a particular field and have the potential to transform the field of health promotion and digital interventions. However, few researchers in physical activity (PA) are familiar with ontologies, and the field can be difficult to navigate. This systematic review aims to (1) identify ontologies in the field of PA, (2) assess their content and (3) assess their quality. METHODS: Databases were searched for ontologies on PA. Ontologies were included if they described PA or sedentary behavior, and were available in English language. We coded whether ontologies covered the user profile, activity, or context domain. For the assessment of quality, we used 12 criteria informed by the Open Biological and Biomedical Ontology (OBO) Foundry principles of good ontology practice. RESULTS: Twenty-eight ontologies met the inclusion criteria. All ontologies covered PA, and 19 included information on the user profile. Context was covered by 17 ontologies (physical context, n = 12; temporal context, n = 14; social context: n = 5). Ontologies met an average of 4.3 out of 12 quality criteria. No ontology met all quality criteria. DISCUSSION: This review did not identify a single comprehensive ontology of PA that allowed reuse. Nonetheless, several ontologies may serve as a good starting point for the promotion of PA. We provide several recommendations about the identification, evaluation, and adaptation of ontologies for their further development and use.

Motivational and self-efficacy reciprocal effects during a 12-month' weight regain prevention program.

OBJECTIVE: Weight regain prevention is a critical public health challenge. Digital behaviour change interventions provide a scalable platform for applying and testing behaviour change theories in this challenging context. This study's goal was to analyse reciprocal effects between psychosocial variables (i.e., needs satisfaction, eating regulation, self-efficacy) and weight over 12 months using data from a large sample of participants engaged in a weight regain prevention trial. METHODS: The NoHoW study is a three-centre, large-scale weight regain prevention trial. Adults who lost >5% of their weight in the past year (N = 1627, 68.7% female, 44.10 ± 11.86 years, 84.47 ± 17.03 kg) participated in a 12-month' digital behaviour change-based intervention. Weight and validated measures of basic psychological needs satisfaction, eating regulation and self-efficacy were collected at baseline, six- and 12 months. Correlational, latent growth models and cross-lagged analysis were used to identify potential reciprocal effects. RESULTS: Baseline higher scores of needs satisfaction and self-efficacy were associated with six- and 12-month' weight loss. Baseline weight was linked to all psychosocial variables at six months, and six-months weight was associated with needs satisfaction and self-efficacy at 12 months. During the 12 months, increases in eating regulation, needs satisfaction and self-efficacy were associated with weight loss over the same period, and reciprocal effects were observed between the variables, suggesting the existence of Weight Management Cycles. CONCLUSIONS: While further studies are needed, during long-term weight regain prevention, weight decrease, needs satisfaction and self-efficacy may lead to Weight Management Cycles, which, if recurrent, may provide sustained prevention of weight regain.

A Web-Based Self-help Intervention for Coping With the Loss of a Partner: Protocol for Randomized Controlled Trials in 3 Countries.

BACKGROUND: The death of a partner is a critical life event in later life, which requires grief work as well as the development of a new perspective for the future. Cognitive behavioral web-based self-help interventions for coping with prolonged grief have established their efficacy in decreasing symptoms of grief, depression, and loneliness. However, no study has tested the efficacy for reducing grief after losses occurring less than 6 months ago and the role of self-tailoring of the content. OBJECTIVE: This study aims to evaluate the clinical efficacy and acceptance of a web-based self-help intervention to support the grief process of older adults who have lost their partner. It will compare the outcomes, adherence, and working alliance in a standardized format with those in a self-tailored delivery format and investigate the effects of age, time since loss, and severity of grief at baseline as predictors. Focus groups to understand user experience and a cost-effectiveness analysis will complement the study. METHODS: The study includes 3 different randomized control trials. The trial in Switzerland comprises a waitlist control group and 2 active arms consisting of 2 delivery formats, standardized and self-tailored. In the Netherlands and in Portugal, the trials follow a 2-arm design that will be, respectively, complemented with focus groups on technology acceptance and cost-effectiveness analysis. The main target group will consist of adults aged >60 years from the general population in Switzerland (n≥85), the Netherlands (n≥40), and Portugal (n≥80) who lost their partner and seek help for coping with grief symptoms, psychological distress, and adaptation problems in daily life. The trials will test the intervention's clinical efficacy for reducing grief (primary outcome) and depression symptoms and loneliness (secondary outcomes) after the intervention. Measurements will take place at baseline (week 0), after the intervention (week 10), and at follow-up (week 20). RESULTS: The trials started in March 2022 and are expected to end in December 2022 or when the needed sample size is achieved. The first results are expected by January 2023. CONCLUSIONS: The trials will provide insights into the efficacy and acceptance of a web-based self-help intervention among older adults who have recently lost a partner. Results will extend the knowledge on the role of self-tailoring, working alliance, and satisfaction in the effects of the intervention. Finally, the study will suggest adaptations to improve the acceptance of web-based self-help interventions for older mourners and explore the cost-effectiveness of this intervention. Limitations include a self-selective sample and the lack of cross-cultural comparisons. TRIAL REGISTRATION: Switzerland: ClinicalTrials.gov NCT05280041; https://clinicaltrials.gov/ct2/show/NCT05280041; Portugal: ClinicalTrials.gov NCT05156346; https://clinicaltrials.gov/ct2/show/NCT05156346. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37827.

What goes on in digital behaviour change interventions for weight loss maintenance targeting physical activity: A scoping review.

Objective: To identify the core components of digital behaviour change interventions for weight loss maintenance targeting physical activity, in terms of: (i) behaviour change techniques, (ii) mechanisms of action, (iii) modes of delivery, (iv) dose and (v) tailoring/personalization. In addition, the links between these components were investigated. Methods: A literature search was performed in five electronic databases: PubMed, Embase, CINHAL, PsycINFO and Web of Science. Two reviewers independently screened the identified articles and extracted data related with the study characteristics and behaviour change techniques, mechanism of action, mode of delivery, dose, and tailoring, using standardized classifications whenever available (e.g. behaviour change techniques taxonomy). Results: Seventeen articles reporting 11 original studies were selected. Two studies were protocols, 9 studies presented results for weight change and all but one showed no significant differences between the intervention and control groups. Eight studies (73%) provided adequate information on behaviour change techniques. Five studies (45%) provided partial information about how the behaviour change techniques were linked to mechanisms of action, and only one study (0.9%) described these links for all the techniques. Around half of the studies reported the modes through which behaviour change techniques were delivered. Descriptions of dose were present in most studies, but with minimal information. The use of tailoring or personalization approaches was mentioned in eight studies (73%), but descriptions of what was tailored and how were minimal. Conclusions: The compilation of information regarding intervention components was difficult due to the lack of information and systematization in reporting across papers. This is particularly true for the reporting of the links between behaviour change techniques and the other core intervention components. This information is crucial to help us understand in the context of behaviour change interventions what works or does not work, how it works and why.

Evaluation of the Immediate Effects of Web-Based Intervention Modules for Goals, Planning, and Coping Planning on Physical Activity: Secondary Analysis of a Randomized Controlled Trial on Weight Loss Maintenance.

BACKGROUND: The use of digital interventions can be accurately monitored via log files. However, monitoring engagement with intervention goals or enactment of the actual behaviors targeted by the intervention is more difficult and is usually evaluated based on pre-post measurements in a controlled trial. OBJECTIVE: The objective of this paper is to evaluate if engaging with 2 digital intervention modules focusing on (1) physical activity goals and action plans and (2) coping with barriers has immediate effects on the actual physical activity behavior. METHODS: The NoHoW Toolkit (TK), a digital intervention developed to support long-term weight loss maintenance, was evaluated in a 2 x 2 factorial randomized controlled trial. The TK contained various modules based on behavioral self-regulation and motivation theories, as well as contextual emotion regulation approaches, and involved continuous tracking of weight and physical activity through connected commercial devices (Fitbit Aria and Charge 2). Of the 4 trial arms, 2 had access to 2 modules directly targeting physical activity: a module for goal setting and action planning (Goal) and a module for identifying barriers and coping planning (Barriers). Module visits and completion were determined based on TK log files and time spent in the module web page. Seven physical activity metrics (steps; activity; energy expenditure; fairly active, very active and total active minutes; and distance) were compared before and after visiting and completing the modules to examine whether the modules had immediate or sustained effects on physical activity. Immediate effect was determined based on 7-day windows before and after the visit, and sustained effects were evaluated for 1 to 8 weeks after module completion. RESULTS: Out of the 811 participants, 498 (61.4%) visited the Goal module and 406 (50.1%) visited the Barriers module. The Barriers module had an immediate effect on very active and total active minutes (very active minutes: before median 24.2, IQR 10.4-43.0 vs after median 24.9, IQR 10.0-46.3; P=.047; total active minutes: before median 45.1, IQR 22.9-74.9 vs after median 46.9, IQR 22.4-78.4; P=.03). The differences were larger when only completed Barriers modules were considered. The Barriers module completion was also associated with sustained effects in fairly active and total active minutes for most of the 8 weeks following module completion and for 3 weeks in very active minutes. CONCLUSIONS: The Barriers module had small, significant, immediate, and sustained effects on active minutes measured by a wrist-worn activity tracker. Future interventions should pay attention to assessing barriers and planning coping mechanisms to overcome them. TRIAL REGISTRATION: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328.

Changing healthcare professionals' non-reflective processes to improve the quality of care.

RATIONALE: Translating research evidence into clinical practice to improve care involves healthcare professionals adopting new behaviours and changing or stopping their existing behaviours. However, changing healthcare professional behaviour can be difficult, particularly when it involves changing repetitive, ingrained ways of providing care. There is an increasing focus on understanding healthcare professional behaviour in terms of non-reflective processes, such as habits and routines, in addition to the more often studied deliberative processes. Theories of habit and routine provide two complementary lenses for understanding healthcare professional behaviour, although to date, each perspective has only been applied in isolation. OBJECTIVES: To combine theories of habit and routine to generate a broader understanding of healthcare professional behaviour and how it might be changed. METHODS: Sixteen experts met for a two-day multidisciplinary workshop on how to advance implementation science by developing greater understanding of non-reflective processes. RESULTS: From a psychological perspective 'habit' is understood as a process that maintains ingrained behaviour through a learned link between contextual cues and behaviours that have become associated with those cues. Theories of habit are useful for understanding the individual's role in developing and maintaining specific ways of working. Theories of routine add to this perspective by describing how clinical practices are formed, adapted, reinforced and discontinued in and through interactions with colleagues, systems and organisational procedures. We suggest a selection of theory-based strategies to advance understanding of healthcare professionals' habits and routines and how to change them. CONCLUSION: Combining theories of habit and routines has the potential to advance implementation science by providing a fuller understanding of the range of factors, operating at multiple levels of analysis, which can impact on the behaviours of healthcare professionals, and so quality of care provision.

Locus Coeruleus Shows a Spatial Pattern of Structural Disintegration in Parkinson's Disease.

BACKGROUND: Parkinson's disease (PD) causes a loss of neuromelanin-positive, noradrenergic neurons in the locus coeruleus (LC), which has been implicated in nonmotor dysfunction. OBJECTIVES: We used "neuromelanin sensitive" magnetic resonance imaging (MRI) to localize structural disintegration in the LC and its association with nonmotor dysfunction in PD. METHODS: A total of 42 patients with PD and 24 age-matched healthy volunteers underwent magnetization transfer weighted (MTw) MRI of the LC. The contrast-to-noise ratio of the MTw signal (CNRMTw ) was used as an index of structural LC integrity. We performed slicewise and voxelwise analyses to map spatial patterns of structural disintegration, complemented by principal component analysis (PCA). We also tested for correlations between regional CNRMTw and severity of nonmotor symptoms. RESULTS: Mean CNRMTw of the right LC was reduced in patients relative to controls. Voxelwise and slicewise analyses showed that the attenuation of CNRMTw was confined to the right mid-caudal LC and linked regional CNRMTw to nonmotor symptoms. CNRMTw attenuation in the left mid-caudal LC was associated with the orthostatic drop in systolic blood pressure, whereas CNRMTw attenuation in the caudal most portion of right LC correlated with apathy ratings. PCA identified a bilateral component that was more weakly expressed in patients. This component was characterized by a gradient in CNRMTw along the rostro-caudal and dorso-ventral axes of the nucleus. The individual expression score of this component reflected the overall severity of nonmotor symptoms. CONCLUSION: A spatially heterogeneous disintegration of LC in PD may determine the individual expression of specific nonmotor symptoms such as orthostatic dysregulation or apathy. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson Movement Disorder Society.

Users' Experiences With the NoHoW Web-Based Toolkit With Weight and Activity Tracking in Weight Loss Maintenance: Long-term Randomized Controlled Trial.

BACKGROUND: Digital behavior change interventions (DBCIs) offer a promising channel for providing health promotion services. However, user experience largely determines whether they are used, which is a precondition for effectiveness. OBJECTIVE: The primary aim of this study is to evaluate user experiences with the NoHoW Toolkit (TK)-a DBCI that targets weight loss maintenance-over a 12-month period by using a mixed methods approach and to identify the main strengths and weaknesses of the TK and the external factors affecting its adoption. The secondary aim is to objectively describe the measured use of the TK and its association with user experience. METHODS: An 18-month, 2×2 factorial randomized controlled trial was conducted. The trial included 3 intervention arms receiving an 18-week active intervention and a control arm. The user experience of the TK was assessed quantitatively through electronic questionnaires after 1, 3, 6, and 12 months of use. The questionnaires also included open-ended items that were thematically analyzed. Focus group interviews were conducted after 6 months of use and thematically analyzed to gain deeper insight into the user experience. Log files of the TK were used to evaluate the number of visits to the TK, the total duration of time spent in the TK, and information on intervention completion. RESULTS: The usability level of the TK was rated as satisfactory. User acceptance was rated as modest; this declined during the trial in all the arms, as did the objectively measured use of the TK. The most appreciated features were weekly emails, graphs, goal setting, and interactive exercises. The following 4 themes were identified in the qualitative data: engagement with features, decline in use, external factors affecting user experience, and suggestions for improvements. CONCLUSIONS: The long-term user experience of the TK highlighted the need to optimize the technical functioning, appearance, and content of the DBCI before and during the trial, similar to how a commercial app would be optimized. In a trial setting, the users should be made aware of how to use the intervention and what its requirements are, especially when there is more intensive intervention content. TRIAL REGISTRATION: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-029425.

Behaviour change techniques taxonomy v1: Feedback to inform the development of an ontology.

Background: To build cumulative evidence about what works in behaviour change interventions, efforts have been made to develop classification systems for specifying the content of interventions. The Behaviour Change Techniques (BCT) Taxonomy v1 (BCTTv1) is one of the most widely used classifications of behaviour change techniques across a variety of behaviours. The BCTTv1 was intentionally named version 1 to allow for further revisions to the taxonomy. This study aimed to gather data to improve the BCTTv1 and provide recommendations for developing it into a more elaborated knowledge structure, an ontology.  Methods: Feedback from users of BCTTv1 about limitations and proposed improvements was collected through the BCT website, user survey, researchers and experts involved in the Human Behaviour-Change Project, and a consultation. In addition, relevant published research reports and other classification systems of BCTs were analysed. These data were synthesised to produce recommendations to inform the development of an ontology of BCTs. Results: A total of 282 comments from six sources were reviewed and synthesised into four categories of suggestions: additional BCTs, amendments to labels and definitions of specific BCTs, amendments to the groupings, and general improvements. Feedback suggested some lack of clarity regarding understanding and identifying techniques from labels, definitions, and examples; distinctions and relations between BCTs; and knowing what they would look like in practice. Three recommendations to improve the BCTTv1 resulted from this analysis: to review the label and definition of each BCT, the 16 groupings of BCTs, and the examples illustrating BCTs. Conclusions : This review of feedback about BCTTv1 identified the need to improve the precision and knowledge structure of the current taxonomy. A BCT ontology would enable the specification of relationships between BCTs, more precise definitions, and allow better interoperability with other ontologies. This ontology will be developed as part of the Human Behaviour-Change Project.

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study.

BACKGROUND: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union's Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention. OBJECTIVE: This paper aims to describe the development of the NoHoW Toolkit, focusing on the logic models, content, and specifications, as well as the results from user testing. METHODS: The toolkit was developed by using a systematic approach, which included the development of the theory-based logic models, the selection of behavior change techniques, the translation of these techniques into a web-based app (NoHoW Toolkit components), technical development, and the user evaluation and refinement of the toolkit. RESULTS: The toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers) and modules that targeted weight, physical activity, and dietary behaviors. The final toolkit comprised 34 sessions that were distributed through 15 modules and provided active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full toolkit (15 modules; 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Furthermore, the toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood, and sleep. CONCLUSIONS: A systematic approach to the development of digital solutions based on theory, evidence, and user testing may significantly contribute to the advancement of the science of behavior change and improve current solutions for sustained weight management. Testing the toolkit by using a 2×2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance.

Keep on running - a randomized controlled trial to test a digital evidence-based intervention for sustained adoption of recreational running: rationale, design and pilot feasibility study.

BACKGROUND: This paper describes the rationale, intervention development, study design and results from the pilot feasibility study of the Keep On Running (KOR) trial. KOR aims to test a web-based brief theory-based intervention, targeting maintenance of recreational running behavior over time (i.e. relapse preventing). METHODS: Intervention development was based both on Self-Determination Theory and on Self-Regulation Theory. As part of it, a pilot study was implemented (n=18) to measure intervention adherence and participant satisfaction in order to establish the feasibility and acceptability of the intervention toolkit. Furthermore, this pilot study was also used to test the feasibility and acceptability of the questionnaires selected to be part of the later RCT. RESULTS: Pilot intervention acceptability was good, but overall adherence was low. Features such as feedback and social sharing should be added to the toolkit. The main trial should lessen questionnaire length and include data from usual monitoring gadgets and apps (APIs). The protocol of the RCT was adjusted to test the efficacy of the refined final version of the intervention, and the RCT that will test it, contributing to the understanding of recreational running sustainability, allowing the optimization of future interventions aimed at physical activity promotion.

Evidence-Based Digital Tools for Weight Loss Maintenance: The NoHoW Project.

BACKGROUND: Effective interventions and commercial programmes for weight loss (WL) are widely available, but most people regain weight. Few effective WL maintenance (WLM) solutions exist. The most promising evidence-based behaviour change techniques for WLM are self-monitoring, goal setting, action planning and control, building self-efficacy, and techniques that promote autonomous motivation (e.g., provide choice). Stress management and emotion regulation techniques show potential for prevention of relapse and weight regain. Digital technologies (including networked-wireless tracking technologies, online tools and smartphone apps, multimedia resources, and internet-based support) offer attractive tools for teaching and supporting long-term behaviour change techniques. However, many digital offerings for weight management tend not to include evidence-based content and the evidence base is still limited. The Project: First, the project examined why, when, and how many European citizens make WL and WLM attempts and how successful they are. Second, the project employed the most up-to-date behavioural science research to develop a digital toolkit for WLM based on 2 key conditions, i.e., self-management (self-regulation and motivation) of behaviour and self-management of emotional responses for WLM. Then, the NoHoW trial tested the efficacy of this digital toolkit in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial BMI ≥25). The primary outcome was change in weight (kg) at 12 months from baseline. Secondary outcomes included biological, psychological, and behavioural moderators and mediators of long-term energy balance (EB) behaviours, and user experience, acceptability, and cost-effectiveness. IMPACT: The project will directly feed results from studies on European consumer behaviour, design and evaluation of digital toolkits self-management of EB behaviours into development of new products and services for WLM and digital health. The project has developed a framework and digital architecture for interventions in the context of EB tracking and will generate results that will help inform the next generation of personalised interventions for effective self-management of weight and health.

The H2020 "NoHoW Project": A Position Statement on Behavioural Approaches to Longer-Term Weight Management.

There is substantial evidence documenting the effects of behavioural interventions on weight loss (WL). However, behavioural approaches to initial WL are followed by some degree of longer-term weight regain, and large trials focusing on evidence-based approaches to weight loss maintenance (WLM) have generally only demonstrated small beneficial effects. The current state-of-the-art in behavioural interventions for WL and WLM raises questions of (i) how we define the relationship between WL and WLM, (ii) how energy balance (EB) systems respond to WL and influence behaviours that primarily drive weight regain, (iii) how intervention content, mode of delivery and intensity should be targeted to keep weight off, (iv) which mechanisms of action in complex interventions may prevent weight regain and (v) how to design studies and interventions to maximise effective longer-term weight management. In considering these issues a writing team within the NoHoW Consortium was convened to elaborate a position statement, and behaviour change and obesity experts were invited to discuss these positions and to refine them. At present the evidence suggests that developing the skills to self-manage EB behaviours leads to more effective WLM. However, the effects of behaviour change interventions for WL and WLM are still relatively modest and our understanding of the factors that disrupt and undermine self-management of eating and physical activity is limited. These factors include physiological resistance to weight loss, gradual compensatory changes in eating and physical activity and reactive processes related to stress, emotions, rewards and desires that meet psychological needs. Better matching of evidence-based intervention content to quantitatively tracked EB behaviours and the specific needs of individuals may improve outcomes. Improving objective longitudinal tracking of energy intake and energy expenditure over time would provide a quantitative framework in which to understand the dynamics of behaviour change, mechanisms of action of behaviour change interventions and user engagement with intervention components to potentially improve weight management intervention design and evaluation.