Protocol for an intervention development and pilot implementation evaluation study of an e-health solution to improve newborn care quality and survival in two low-resource settings, Malawi and Zimbabwe: Neotree.

INTRODUCTION: Every year 2.4 million deaths occur worldwide in babies younger than 28 days. Approximately 70% of these deaths occur in low-resource settings because of failure to implement evidence-based interventions. Digital health technologies may offer an implementation solution. Since 2014, we have worked in Bangladesh, Malawi, Zimbabwe and the UK to develop and pilot Neotree: an android app with accompanying data visualisation, linkage and export. Its low-cost hardware and state-of-the-art software are used to improve bedside postnatal care and to provide insights into population health trends, to impact wider policy and practice. METHODS AND ANALYSIS: This is a mixed methods (1) intervention codevelopment and optimisation and (2) pilot implementation evaluation (including economic evaluation) study. Neotree will be implemented in two hospitals in Zimbabwe, and one in Malawi. Over the 2-year study period clinical and demographic newborn data will be collected via Neotree, in addition to behavioural science informed qualitative and quantitative implementation evaluation and measures of cost, newborn care quality and usability. Neotree clinical decision support algorithms will be optimised according to best available evidence and clinical validation studies. ETHICS AND DISSEMINATION: This is a Wellcome Trust funded project (215742_Z_19_Z). Research ethics approvals have been obtained: Malawi College of Medicine Research and Ethics Committee (P.01/20/2909; P.02/19/2613); UCL (17123/001, 6681/001, 5019/004); Medical Research Council Zimbabwe (MRCZ/A/2570), BRTI and JREC institutional review boards (AP155/2020; JREC/327/19), Sally Mugabe Hospital Ethics Committee (071119/64; 250418/48). Results will be disseminated via academic publications and public and policy engagement activities. In this study, the care for an estimated 15 000 babies across three sites will be impacted. TRIAL REGISTRATION NUMBER: NCT0512707; Pre-results.

Do automated digital health behaviour change interventions have a positive effect on self-efficacy? A systematic review and meta-analysis.

Self-efficacy is an important determinant of health behaviour. Digital interventions are a potentially acceptable and cost-effective way of delivering programmes of health behaviour change at scale. Whether behaviour change interventions work to increase self-efficacy in this context is unknown. This systematic review and meta-analysis sought to identify whether automated digital interventions are associated with positive changes in self-efficacy amongst non-clinical populations for five major health behaviours, and which BCTs are associated with that change. A systematic literature search identified 20 studies (n = 5624) that assessed changes in self-efficacy and were included in a random-effects meta-analysis. Interventions targeted: healthy eating (k = 4), physical activity (k = 9), sexual behaviour (k = 3) and smoking (k = 4). No interventions targeting alcohol use were identified. Overall, interventions had a small, positive effect on self-efficacy (g¯=0.190,CI[0.078;0.303]). The effect of interventions on self-efficacy did not differ as a function of health behaviour type (Q-between = 7.3704, p = .061, df = 3). Inclusion of the BCT 'information about social and environmental consequences' had a small, negative effect on self-efficacy (Δg¯=-0.297,Q=7.072,p=.008). Whilst this review indicates that digital interventions can be used to change self-efficacy, which techniques work best in this context is not clear.

Novel Digital Architecture of a "Low Carb Program" for Initiating and Maintaining Long-Term Sustainable Health-Promoting Behavior Change in Patients with Type 2 Diabetes.

Globally, the burden of noncommunicable diseases such as type 2 diabetes is crippling health care systems. Type 2 diabetes, a disease linked with obesity, affects 1 in every 30 people today and is expected to affect 1 in 10 people by 2030. Current provisions are struggling to manage the trajectory of type 2 diabetes prevalence. Offline, face-to-face education for patients with type 2 diabetes has shown to lack long-term impact or the capacity for widespread democratized adoption. Digitally delivered interventions have been developed for patients with type 2 diabetes, and the evidence shows that some interventions provide the capacity to support hyperpersonalization and real-time continuous support to patients, which can result in significant engagement and health outcomes. However, digital health app engagement is notoriously difficult to achieve. This paper reviews the digital behavior change architecture of the Low Carb Program and the application of health behavioral theory underpinning its development and use in scaling novel methods of engaging the population with type 2 diabetes and supporting long-term behavior change.

A Medication Adherence App for Children With Sickle Cell Disease: Qualitative Study.

BACKGROUND: Young people with sickle cell disease (SCD) often demonstrate low medication adherence and low motivation for effectively self-managing their condition. The growing sophistication of mobile phones and their popularity among young people render them a promising platform for increasing medication adherence. However, so far, few apps targeting SCD have been developed from research with the target population and underpinned with theory and evidence. OBJECTIVE: The aim of this study was to develop a theory-and-evidence-based medication adherence app to support children and adolescents with SCD. METHODS: The Behavior Change Wheel (BCW), a theoretically based intervention development framework, along with a review of the literature, 10 interviews with children and adolescents with SCD aged between 12 and 18 years, and consultation with experts informed app development. Thematic analysis of interviews provided relevant theoretical and evidence-based components to underpin the design and development of the app. RESULTS: Findings suggested that some patients had lapses in memory for taking their medication (capability); variation in beliefs toward the effectiveness of medication and confidence in self-managing their condition (motivation); a limited time to take medication; and barriers and enablers within the changing context of social support during the transition into adulthood (opportunity). Steps were taken to select the appropriate behavioral change components (involving behavior change techniques [BCTs] such as information on antecedents, prompts/cues; self-monitoring of the behavior; and social support) and translate them into app features designed to overcome these barriers to medication adherence. CONCLUSIONS: Patients with SCD have complex barriers to medication adherence necessitating the need for comprehensive models of behavior change to analyze the problem. Children and adolescents require an app that goes beyond simple medication reminders and takes into account the patient's beliefs, emotions, and environmental barriers to medication adherence.

Factors influencing application of behavioural science evidence by public health decision-makers and practitioners, and implications for practice.

The National Institute of Health and Care Excellence (NICE) in the UK recommends behavioural science evidence underpins public health improvement services. In practice, level of implementation varies. This study is the first to explore factors affecting use of behaviour-specific evidence by public health decision-makers and practitioners for design and delivery of health improvement services. Twenty semi-structured interviews were conducted, along with a review of the commissioning cycle with public health decision-makers and practitioners across a range of health improvement fields (e.g. weight management). Interviews were informed and analysed using the Theoretical Domains Framework (TDF). Limited comprehension of behaviour change, challenges identifying specific behaviour change strategies and translating research into practice were prevalent. Local authority processes encouraged uptake of evidence to justify solutions as opposed to evidence-driven decision-making. Some decision-makers perceived research evidence may stifle innovation and overwhelm practitioners. Potential facilitators of research use included: ensuring uptake and implementation of evidence is compulsory within commissioning and its potential to show value for money. A strong belief in local evidence and achieving outcomes were identified as barriers to research evidence uptake. Social and environmental challenges included cultural, political, and workload pressures and journal article accessibility. Embedding behavioural science systematically into public health practice requires changes throughout the public health system; from priorities set by national public health leaders to the way in which relevant evidence is disseminated. Framing factors affecting use of behavioural science evidence using the TDF is helpful for identifying the range of interventions and support needed to affect change.

Big hearts, small hands: a focus group study exploring parental food portion behaviours.

BACKGROUND: The development of healthy food portion sizes among families is deemed critical to childhood weight management; yet little is known about the interacting factors influencing parents' portion control behaviours. This study aimed to use two synergistic theoretical models of behaviour: the COM-B model (Capability, Opportunity, Motivation - Behaviour) and Theoretical Domains Framework (TDF) to identify a broad spectrum of theoretically derived influences on parents' portion control behaviours including examination of affective and habitual influences often excluded from prevailing theories of behaviour change. METHODS: Six focus groups exploring family weight management comprised of one with caseworkers (n = 4), four with parents of overweight children (n = 14) and one with parents of healthy weight children (n = 8). A thematic analysis was performed across the dataset where the TDF/COM-B were used as coding frameworks. RESULTS: To achieve the target behaviour, the behavioural analysis revealed the need for eliciting change in all three COM-B domains and nine associated TDF domains. Findings suggest parents' internal processes such as their emotional responses, habits and beliefs, along with social influences from partners and grandparents, and environmental influences relating to items such as household objects, interact to influence portion size behaviours within the home environment. CONCLUSION: This is the first study underpinned by COM-B/TDF frameworks applied to childhood weight management and provides new targets for intervention development and the opportunity for future research to explore the mediating and moderating effects of these variables on one another.

Understanding and Promoting Effective Engagement With Digital Behavior Change Interventions.

This paper is one in a series developed through a process of expert consensus to provide an overview of questions of current importance in research into engagement with digital behavior change interventions, identifying guidance based on research to date and priority topics for future research. The first part of this paper critically reflects on current approaches to conceptualizing and measuring engagement. Next, issues relevant to promoting effective engagement are discussed, including how best to tailor to individual needs and combine digital and human support. A key conclusion with regard to conceptualizing engagement is that it is important to understand the relationship between engagement with the digital intervention and the desired behavior change. This paper argues that it may be more valuable to establish and promote "effective engagement," rather than simply more engagement, with "effective engagement" defined empirically as sufficient engagement with the intervention to achieve intended outcomes. Appraisal of the value and limitations of methods of assessing different aspects of engagement highlights the need to identify valid and efficient combinations of measures to develop and test multidimensional models of engagement. The final section of the paper reflects on how interventions can be designed to fit the user and their specific needs and context. Despite many unresolved questions posed by novel and rapidly changing technologies, there is widespread consensus that successful intervention design demands a user-centered and iterative approach to development, using mixed methods and in-depth qualitative research to progressively refine the intervention to meet user requirements.

Targeting Parents for Childhood Weight Management: Development of a Theory-Driven and User-Centered Healthy Eating App.

BACKGROUND: The proliferation of health promotion apps along with mobile phones' array of features supporting health behavior change offers a new and innovative approach to childhood weight management. However, despite the critical role parents play in children's weight related behaviors, few industry-led apps aimed at childhood weight management target parents. Furthermore, industry-led apps have been shown to lack a basis in behavior change theory and evidence. Equally important remains the issue of how to maximize users' engagement with mobile health (mHealth) interventions where there is growing consensus that inputs from the commercial app industry and the target population should be an integral part of the development process. OBJECTIVE: The aim of this study is to systematically design and develop a theory and evidence-driven, user-centered healthy eating app targeting parents for childhood weight management, and clearly document this for the research and app development community. METHODS: The Behavior Change Wheel (BCW) framework, a theoretically-based approach for intervention development, along with a user-centered design (UCD) philosophy and collaboration with the commercial app industry, guided the development process. Current evidence, along with a series of 9 focus groups (total of 46 participants) comprised of family weight management case workers, parents with overweight and healthy weight children aged 5-11 years, and consultation with experts, provided data to inform the app development. Thematic analysis of focus groups helped to extract information related to relevant theoretical, user-centered, and technological components to underpin the design and development of the app. RESULTS: Inputs from parents and experts working in the area of childhood weight management helped to identify the main target behavior: to help parents provide appropriate food portion sizes for their children. To achieve this target behavior, the behavioral diagnosis revealed the need for eliciting change in parents' capability, motivation, and opportunity in 10-associated Theoretical Domains Framework (TDF) domains. Of the 9 possible intervention functions, 6 were selected to bring about this change which guided the selection of 21 behavior change techniques. Parents' preferences for healthy eating app features revolved around four main themes (app features, time saving and convenience, aesthetics, and gamification) whereupon a criterion was applied to guide the selection on which preferences should be integrated into the design of the app. Collaboration with the app company helped to build on users' preferences for elements of gamification such as points, quizzes, and levels to optimize user engagement. Feedback from parents on interactive mock-ups helped to inform the final development of the prototype app. CONCLUSIONS: Here, we fully explicate a systematic approach applied in the development of a family-oriented, healthy eating health promotion app grounded in theory and evidence, and balanced with users' preferences to help maximize its engagement with the target population.