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The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program: Protocol for Development, Evaluation, and Implementation.

ABSTRACT: BACKGROUND:Clustering of multiple lifestyle risk behaviors has been associated with a greater risk of noncommunicable diseases and mortality than one lifestyle risk behavior or no lifestyle risk behaviors. The National Board of Health and Welfare in Sweden reported in 2018 that it is important to provide additional support to individuals with multiple lifestyle risk behaviors, as risks from these behaviors are multiplicative rather than additive. However, the same report emphasized that there is a lack of knowledge regarding interventions that support changes to unhealthy lifestyle behaviors. OBJECTIVE:The MoBILE (Mobile health Multiple lifestyle Behavior Interventions across the LifEspan) research program has brought together two Swedish research groups supported by international collaborators. Through this collaboration, we aim to design and evaluate a number of novel and tailored mobile health (mHealth) multiple lifestyle behavior interventions across the life span of different health care populations. In addition, the MoBILE research program will extend ongoing research to include mHealth interventions for migrant pregnant women and children. METHODS:Each project within the MoBILE program will focus on a specific group: pregnant women, preschool children, high school and university students, and adults in primary and clinical care. All the projects will follow the same 4 phases: requirements, development, evaluation, and implementation. During the requirements phase, implementers and end users will aid the design of content and functionality of the interventions. In the development phase, findings from the first phase will be synthesized with expert domain knowledge and theoretical constructs to create interventions tailored to the target groups. The third phase, evaluation, will comprise randomized controlled trials conducted to estimate the effects of the interventions on multiple lifestyle risk behaviors (eg, alcohol, nutrition, physical activity, and smoking). The final phase will investigate how the interventions, if found effective, can be disseminated into different health care contexts. RESULTS:The research program commenced in 2019, and the first results will be available in 2020. Projects involving pregnant women, preschool children, and high school and university students will be completed in the first 3 years, with the remaining projects being planned for the program's final 3 years. CONCLUSIONS:The development of evidence-based digital tools is complex, as they should be guided by theoretical frameworks, and requires large interdisciplinary teams with competence in technology, behavioral science, and lifestyle-specific areas. Individual researchers or smaller research groups developing their own tools is not the way forward, as it means reinventing the wheel over and over again. The MoBILE research program therefore aims to join forces and learn from the past 10 years of mHealth research to maximize scientific outcomes, as well as the use of financial resources to expand the growing body of evidence for mHealth lifestyle behavior interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/14894.

SUBMITTER: Bendtsen M

PROVIDER: S-EPMC7199135 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program: Protocol for Development, Evaluation, and Implementation.

Bendtsen Marcus M Bendtsen Preben P Henriksson Hanna H Henriksson Pontus P Müssener Ulrika U Thomas Kristin K Löf Marie M

JMIR research protocols 20200420 4

<h4>Background</h4>Clustering of multiple lifestyle risk behaviors has been associated with a greater risk of noncommunicable diseases and mortality than one lifestyle risk behavior or no lifestyle risk behaviors. The National Board of Health and Welfare in Sweden reported in 2018 that it is important to provide additional support to individuals with multiple lifestyle risk behaviors, as risks from these behaviors are multiplicative rather than additive. However, the same report emphasized that ...[more]

PMID: 32310147

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Project description:BackgroundLifestyle medicine (LM) is the use of therapeutic lifestyle changes (including a whole-food, plant-predominant eating pattern; regular physical activity; restorative sleep; stress management; avoidance of risky substances; and positive social connection) to prevent and treat chronic illness. Despite growing evidence, LM is still not widely implemented in health care settings. Potential challenges to LM implementation include lack of clinician training, staffing concerns, and misalignment of LM services with fee-for-service reimbursement, but the full range of factors facilitating or obstructing its implementation and long-term success are not yet understood. To learn important lessons for success and failure, it is crucial to understand the experiences of different LM programs.ObjectiveThis study aims to describe in depth the protocol used to identify barriers and facilitators impacting the implementation of LM in health systems.MethodsThe study team comprises team members at the American College of Lifestyle Medicine (ACLM), including staff and researchers with expertise in public health, LM, and qualitative research. We recruited health systems that were members of the ACLM Health Systems Council. From among 15 self-nominating health systems, we selected 7 to represent a diversity of geographic location, type, size, expertise, funding, patients, and LM services. Partway through the study, we recruited 1 additional contrasting health system to serve as a negative case. For each case, we conducted in-depth interviews, document reviews, site visits (limited due to the COVID-19 pandemic), and study team debriefs. Interviews lasted 45-90 minutes and followed a semistructured interview guide, loosely based on the Consolidated Framework for Implementation Research (CFIR) model. We are constructing detailed case narrative reports for each health system that are subsequently used in cross-case analyses to develop a contextually rich and detailed understanding of various predetermined and emergent topics. Cross-case analyses will draw on a variety of methodologies, including in-depth case familiarization, inductive or deductive coding, and thematic analysis, to identify cross-cutting themes.ResultsThe study team has completed data collection for all 8 participating health systems, including 68 interviews and 1 site visit. We are currently drafting descriptive case narratives, which will be disseminated to participating health systems for member checking and shared broadly as applied vignettes. We are also conducting cross-case analyses to identify critical facilitators and barriers, explore clinician training strategies to facilitate LM implementation, and develop an explanatory model connecting practitioner adoption of LM and experiences of burnout.ConclusionsThis protocol paper offers real-world insights into research methods and practices to identify barriers and facilitators to the implementation of LM in health systems. Findings can advise LM implementation across various health system contexts. Methodological limitations and lessons learned can guide the execution of other studies with similar methodologies.International registered report identifier (irrid)DERR1-10.2196/51562.

Project description:BACKGROUND:Healthcare reform in the United States is encouraging Federally Qualified Health Centers and other primary-care practices to integrate treatment for addiction and other behavioral health conditions into their practices. The potential of mobile health technologies to manage addiction and comorbidities such as HIV in these settings is substantial but largely untested. This paper describes a protocol to evaluate the implementation of an E-Health integrated communication technology delivered via mobile phones, called Seva, into primary-care settings. Seva is an evidence-based system of addiction treatment and recovery support for patients and real-time caseload monitoring for clinicians. METHODS/DESIGN:Our implementation strategy uses three models of organizational change: the Program Planning Model to promote acceptance and sustainability, the NIATx quality improvement model to create a welcoming environment for change, and Rogers's diffusion of innovations research, which facilitates adaptations of innovations to maximize their adoption potential. We will implement Seva and conduct an intensive, mixed-methods assessment at three diverse Federally Qualified Healthcare Centers in the United States. Our non-concurrent multiple-baseline design includes three periods - pretest (ending in four months of implementation preparation), active Seva implementation, and maintenance - with implementation staggered at six-month intervals across sites. The first site will serve as a pilot clinic. We will track the timing of intervention elements and assess study outcomes within each dimension of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, including effects on clinicians, patients, and practices. Our mixed-methods approach will include quantitative (e.g., interrupted time-series analysis of treatment attendance, with clinics as the unit of analysis) and qualitative (e.g., staff interviews regarding adaptations to implementation protocol) methods, and assessment of implementation costs. DISCUSSION:If implementation is successful, the field will have a proven technology that helps Federally Qualified Health Centers and affiliated organizations provide addiction treatment and recovery support, as well as a proven strategy for implementing the technology. Seva also has the potential to improve core elements of addiction treatment, such as referral and treatment processes. A mobile technology for addiction treatment and accompanying implementation model could provide a cost-effective means to improve the lives of patients with drug and alcohol problems. TRIAL REGISTRATION:ClinicalTrials.gov (NCT01963234).

Project description:BACKGROUND:Unhealthy lifestyle behaviors such as insufficient physical activity, unhealthy diet, smoking, and harmful use of alcohol tend to cluster (ie, individuals may be at risk from more than one lifestyle behavior that can be established in early childhood and adolescence and track into adulthood). Previous research has underlined the potential of lifestyle interventions delivered via mobile phones. However, there is a need for deepened knowledge on how to design mobile health (mHealth) interventions taking end user views into consideration in order to optimize the overall usability of such interventions. Adolescents are early adopters of technology and frequent users of mobile phones, yet research on interventions that use mobile devices to deliver multiple lifestyle behavior changes targeting at-risk high school students is lacking. OBJECTIVE:This protocol describes a participatory design study with the aim of developing an mHealth lifestyle behavior intervention to promote healthy lifestyles among high school students. METHODS:Through an iterative process using participatory design, user requirements are investigated in terms of technical features and content. The procedures around the design and development of the intervention, including heuristic evaluations, focus group interviews, and usability tests, are described. RESULTS:Recruitment started in May 2019. Data collection, analysis, and scientific reporting from heuristic evaluations and usability tests are expected to be completed in November 2019. Focus group interviews were being undertaken with high school students from October through December, and full results are expected to be published in Spring 2020. A planned clinical trial will commence in Summer 2020. The study was funded by a grant from the Swedish Research Council for Health, Working Life, and Welfare. CONCLUSIONS:The study is expected to add knowledge on how to design an mHealth intervention taking end users' views into consideration in order to develop a novel, evidence-based, low-cost, and scalable intervention that high school students want to use in order to achieve a healthier lifestyle. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14588.

Project description:BackgroundImplementation of lifestyle interventions in patient care is a major challenge. Understanding factors that influence implementation is a first step in programs to enhance uptake of these interventions. A lifestyle-counseling intervention, Lively Legs, delivered by trained nurses, can effectively improve the lifestyle in patients with venous leg ulcers. The aim of this study was to identify factors that hindered or facilitated implementation of this intervention in outpatient dermatology clinics and in home care.MethodsA mixed-methods multiple case study in five purposefully selected healthcare settings in the Netherlands was conducted. Measurements to identify influencing factors before and after implementation of Lively Legs included interviews, focus groups, questionnaires, and nurses' registration. Analyses focused on qualitative data as the main data source. All data were compared across multiple cases to draw conclusions from the study as a whole.ResultsA total of 53 patients enrolled in the Lively Legs program, which was delivered by 12 trained nurses. Barriers for implementation were mainly organizational. It was difficult to effectively organize reaching and recruiting patients for the program, especially in home care. Main barriers were a lack of a standardized healthcare delivery process, insufficient nursing time, and a lack of motivated nurses to deliver the program. Facilitating factors were nurse-driven coordination of care and a standardized care process to tie Lively Legs into, as this resulted in better patient recruitment and better program implementation.ConclusionsThis study identified a range of factors influencing the implementation of a lifestyle-counseling program, mainly related to the organization of healthcare. Using a case study method proved valuable in obtaining insight into influencing factors for implementation. This study also shed light on a more general issue, which is that leg ulcer care is often fragmented, indicating that quality improvement is needed.

Project description:BackgroundThe Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) is a handwashing with soap and water treatment intervention program delivered by a health promoter bedside in a health facility and through home visits to diarrhea patients and their household members during the 7?days after admission to a health facility. In a randomized controlled trial among cholera patient households in Bangladesh, the 7-day CHoBI7 program resulted in a significant reduction in cholera among household members of cholera patients and sustained improvements in drinking water quality and handwashing with soap practices 12 months post-intervention. In an effort to take this intervention to scale across Bangladesh in partnership with the Bangladesh Ministry of Health and Family Welfare, this study evaluates the feasibility and acceptability of mobile health (mHealth) programs as a low-cost, scalable approach for CHoBI7 program delivery.MethodsFormative research for the development of the CHoBI7 mHealth intervention included 40 semi-structured interviews, 4 mHealth workshops, 2 group discussions, and a pilot study of 52 households to assess the feasibility and acceptability of the developed mHealth program. Thematic analysis of the interviews and group discussions was conducted by two individuals separately based on emergent themes, and then themes were compared and discussed.ResultsA theory- and evidence-based approach using qualitative research methods was implemented to design the CHoBI7 mHealth program. Semi-structured interviews with government stakeholders identified perceptions and preferences for scaling the CHoBI7 mHealth program. Group discussions and semi-structured interviews with diarrhea patients and their family members identified beneficiary perceptions of mHealth and preferences for CHoBI7 mHealth program delivery. mHealth workshops were conducted as an interactive approach to draft and refine mobile message content based on stakeholder preferences. The pilot findings indicate that the CHoBI7 mHealth program has high user acceptability and is feasible to deliver to diarrhea patients that present at health facilities for treatment in Bangladesh. Both text and voice messages were recommended for program delivery. Dr. Chobi, the sender of mHealth messages, was viewed as a credible source of information that could be shared with others.ConclusionThis study presents a theory- and evidence-based approach that can be implemented for the development of future water, sanitation, and hygiene mHealth programs in low-resource settings.

Project description:BackgroundThe adoption of a healthy lifestyle, including physical activity, a balanced diet, a moderate alcohol consumption and abstinence from smoking, are associated with large decreases in the incidence and mortality rates for the most common chronic diseases. That is why primary health care (PHC) services are trying, so far with less success than desirable, to promote healthy lifestyles among patients. The objective of this study is to design and model, under a participative collaboration framework between clinicians and researchers, interventions that are feasible and sustainable for the promotion of healthy lifestyles in PHC.Methods and designPhase I formative research and a quasi-experimental evaluation of the modelling and planning process will be undertaken in eight primary care centres (PCCs) of the Basque Health Service--OSAKIDETZA, of which four centres will be assigned for convenience to the Intervention Group (the others being Controls). Twelve structured study, discussion and consensus sessions supported by reviews of the literature and relevant documents, will be undertaken throughout 12 months. The first four sessions, including a descriptive strategic needs assessment, will lead to the prioritisation of a health promotion aim in each centre. In the remaining eight sessions, collaborative design of intervention strategies, on the basis of a planning process and pilot trials, will be carried out. The impact of the formative process on the practice of healthy lifestyle promotion, attitude towards health promotion and other factors associated with the optimisation of preventive clinical practice will be assessed, through pre- and post-programme evaluations and comparisons of the indicators measured in professionals from the centres assigned to the Intervention or Control Groups.DiscussionThere are four necessary factors for the outcome to be successful and result in important changes: (1) the commitment of professional and community partners who are involved; (2) their competence for change; (3) the active cooperation and participation of the interdisciplinary partners involved throughout the process of change; and (4) the availability of resources necessary to facilitate the change.

Project description:BackgroundStress-related disorders such as anxiety and depression are highly prevalent and cause a tremendous burden for affected individuals and society. In order to improve prevention strategies, knowledge regarding resilience mechanisms and ways to boost them is highly needed. In the Dynamic Modelling of Resilience - interventional multicenter study (DynaM-INT), we will conduct a large-scale feasibility and preliminary efficacy test for two mobile- and wearable-based just-in-time adaptive interventions (JITAIs), designed to target putative resilience mechanisms. Deep participant phenotyping at baseline serves to identify individual predictors for intervention success in terms of target engagement and stress resilience.MethodsDynaM-INT aims to recruit N = 250 healthy but vulnerable young adults in the transition phase between adolescence and adulthood (18-27 years) across five research sites (Berlin, Mainz, Nijmegen, Tel Aviv, and Warsaw). Participants are included if they report at least three negative burdensome past life events and show increased levels of internalizing symptoms while not being affected by any major mental disorder. Participants are characterized in a multimodal baseline phase, which includes neuropsychological tests, neuroimaging, bio-samples, sociodemographic and psychological questionnaires, a video-recorded interview, as well as ecological momentary assessments (EMA) and ecological physiological assessments (EPA). Subsequently, participants are randomly assigned to one of two ecological momentary interventions (EMIs), targeting either positive cognitive reappraisal or reward sensitivity. During the following intervention phase, participants' stress responses are tracked using EMA and EPA, and JITAIs are triggered if an individually calibrated stress threshold is crossed. In a three-month-long follow-up phase, parts of the baseline characterization phase are repeated. Throughout the entire study, stressor exposure and mental health are regularly monitored to calculate stressor reactivity as a proxy for outcome resilience. The online monitoring questionnaires and the repetition of the baseline questionnaires also serve to assess target engagement.DiscussionThe DynaM-INT study intends to advance the field of resilience research by feasibility-testing two new mechanistically targeted JITAIs that aim at increasing individual stress resilience and identifying predictors for successful intervention response. Determining these predictors is an important step toward future randomized controlled trials to establish the efficacy of these interventions.

Dataset Information

The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program: Protocol for Development, Evaluation, and Implementation.

Publications

The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program: Protocol for Development, Evaluation, and Implementation.

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