BACKGROUND: Physical activity engagement following a cancer diagnosis is positively associated with survival, reduced risk of disease recurrence, and reduced cancer-specific and all-cause mortality. However, rates of physical activity engagement are low among individuals diagnosed with and being treated for breast cancer or prostate cancer.
OBJECTIVE: The purpose of this study was to describe the systematic process of developing an e-cycling intervention aimed at increasing physical activity among individuals living with prostate cancer or breast cancer and outline the key components to be implemented.
METHODS: The Medical Research Council guidance for developing complex interventions and the Behaviour Change Wheel were used to guide intervention development. Information was gathered from the literature and through discussions with end users to understand factors influencing e-cycling. These factors were mapped onto the Theoretical Domains Framework to identify potential mechanisms of action. Behavior change techniques were selected from theory and evidence to develop intervention content. Interested parties, including cycling instructors, end users, and behavior change experts, reviewed and refined the intervention.
RESULTS: Anticipated barriers and facilitators to e-cycling engagement were mapped onto 11 of the 14 domains of the Theoretical Domains Framework. A total of 23 behavior change techniques were selected to target these domains over 4 one-to-one e-cycling sessions delivered by trained cycling instructors in the community. Cycling instructors were provided a 3-hour classroom training session on delivering the intervention and a 3-hour practical session with feedback. The outcome of this work is a theory and evidence-informed intervention aimed at promoting e-cycling behavior among individuals being treated for breast cancer or prostate cancer, which is currently being implemented and evaluated.
CONCLUSIONS: Transparent intervention development and reporting of content is important for comprehensively examining intervention implementation. The implementation of this intervention package is currently being evaluated in a pilot randomized controlled trial. If the intervention is found to be effective and the content and delivery are acceptable, this intervention will form a basis for the development of e-cycling interventions in other survivors of cancer.
BACKGROUND: ISRCTN Registry ISRCTN39112034 https://www.isrctn.com/ISRCTN39112034; and IRSCTN Registry ISRCTN42852156; https://www.isrctn.com/ISRCTN42852156.

BACKGROUND: Behavior change techniques (BCTs) are considered as active components of implementation strategies, influencing determinants and, ultimately, implementation performance. In our previous Delphi study, experts formulated \'implementation hypotheses\', detailing how specific combinations of BCTs and strategies (referred to as BCT-strategy combinations) might influence determinants and guideline implementation within youth care. For example, educational meetings providing instructions on guideline use were hypothesized to enhance practitioners\' knowledge and, consequently, guideline implementation. However, these hypotheses have not been verified in practice yet.
METHODS: We conducted a cross-sectional study involving practitioners and management professionals from youth (health)care organizations. Using questionnaires, we obtained data on the presence of BCT-strategy combinations and their perceived influence on determinants and implementation performance. Chi-squared tests and regression analyses were employed to determine the influence of specific BCT-strategy combinations on determinants and implementation performance.
RESULTS: Our analyses included data from 104 practitioners and 34 management professionals. Most of the management professionals indicated that the BCT-strategy combinations positively influenced or had the potential to influence their implementation performance. At the practitioner level, half of the combinations were perceived to have a positive influence on determinants and implementation performance. Furthermore, practitioners who reported the absence of BCT-strategy combinations were more skeptical about their potential influence on determinants and implementation performance.
CONCLUSIONS: Several BCT-strategy combinations were perceived to improve or potentially improve implementation performance of both practitioners and management professionals. In the development and evaluation of implementation efforts, we advocate for clearly describing the implementation effort\'s objective and using frameworks that detail the BCTs inducing behavior change, the strategy employed, and the processes driving the observed changes. Understanding these interconnected processes is important in designing targeted, evidence-based behavior change interventions. This understanding optimizes resource allocation and contributes to the overall success of implementation efforts in youth care.

BACKGROUND: Adopting a healthy diet is one of the cornerstones of type 2 diabetes (T2D) management. Apps are increasingly used in diabetes self-management, but most studies to date have focused on assessing their impact in terms of weight loss or glycemic control, with limited evidence on the behavioral factors that influence app use to change dietary habits.
OBJECTIVE: The main objectives of this study were to assess the enablers and barriers to adopting a healthier diet using the Gro Health app in 2 patient groups with T2D (patients with recently diagnosed and long-standing T2D) and to identify behavior change techniques (BCTs) to enhance enablers and overcome barriers.
METHODS: Two semistructured qualitative interview studies were conducted; the first study took place between June and July 2021, with a sample of 8 patients with recently diagnosed (<12 mo) T2D, whereas the second study was conducted between May and June 2022 and included 15 patients with long-standing (>18 mo) T2D. In both studies, topic guides were informed by the Capability, Opportunity, Motivation, and Behavior model and the Theoretical Domains Framework. Transcripts were analyzed using a combined deductive framework and inductive thematic analysis approach. The Behavior Change Wheel framework was applied to identify appropriate BCTs that could be used in future iterations of apps for patients with diabetes. Themes were compared between the patient groups.
RESULTS: This study identified similarities and differences between patient groups in terms of enablers and barriers to adopting a healthier diet using the app. The main enablers for recently diagnosed patients included the acquired knowledge about T2D diets and skills to implement these, whereas the main barriers were the difficulty in deciding which app features to use and limited cooking skills. By contrast, for patients with long-standing T2D, the main enablers included knowledge validation provided by the app, along with app elements to help self-regulate food intake; the main barriers were the limited interest paid to the content provided or limited skills engaging with apps in general. Both groups reported more enablers than barriers to performing the target behavior when using the app. Consequently, BCTs were selected to address key barriers in both groups, such as simplifying the information hierarchy in the app interface, including tutorials demonstrating how to use the app features, and redesigning the landing page of the app to guide users toward these tutorials.
CONCLUSIONS: Patients with recently diagnosed and long-standing T2D encountered similar enablers but slightly different barriers when using an app to adopting a healthier diet. Consequently, the development of app-based approaches to adopt a healthier diet should account for these similarities and differences within patient segments to reduce barriers to performing the target behavior.

BACKGROUND: The worldwide prevalence of type 2 diabetes (T2D) has increased in the past decade, and it is projected to increase by 126% by 2045 in Africa. At the same time, mobile phone use has increased in Africa, providing a potential for innovative mobile health interventions to support diabetes care.
OBJECTIVE: This study aimed to apply the Behavior Change Wheel (BCW) framework to develop text messages to influence food literacy in adults with T2D in urban Kenya.
METHODS: The 8 steps of the BCW framework guided the development of text messages: (1) Define the problem in behavioral terms; (2) select target behaviors; (3) specify the target behaviors based on who needs to perform the behaviors, what needs to change, and when, where, how often, and with whom; (4) identify what needs to change; (5) identify intervention functions; (6) select policy categories; (7) select behavior change techniques (BCTs); and (8) select the mode of delivery. Recent exploratory studies in Kenya and other low- and middle-income countries provided information that was used to contextualize the intervention.
RESULTS: In step 1, the behavioral problem was defined as unhealthy dietary patterns among adults with T2D. In step 2, based on a qualitative study in the target population, the target behavior was selected to be evaluation of reliable sources of information, and selection and preparation of healthy food. In step 3, unhealthy dietary patterns were selected. In step 4, 10 domains of the Theoretical Domains Framework were identified, and in step 5, 5 intervention functions were linked to the domains and unhealthy dietary patterns were specified. In step 6, communication and regulations were identified as policy categories, while in step 7, 9 BCTs were selected from the Behavior Change Technique Taxonomy version 1. In step 8, the most suitable mode of delivery was determined to be mobile text messages. A total of 36 mobile text messages were developed based on the 9 BCTs.
CONCLUSIONS: This study shows the step-by-step application of the BCW framework to develop mobile text messages to influence food literacy in adults with T2D.
UNASSIGNED: RR1-10.2196/48271.

Around 14% of pregnancies globally are affected by gestational diabetes mellitus (GDM), making it one of the most common disorders experienced by women in pregnancy. While dietary, physical activity and supplement interventions have been implemented to prevent GDM, with varying levels of success, altering the gut microbiota through diet is a promising strategy for prevention. Several studies have demonstrated that women with GDM likely have a different gut microbiota to pregnant women without GDM, demonstrating that the gut microbiota may play a part in glycemic control and the development of GDM. To date, there have been no randomized controlled trials using diet to alter the gut microbiota in pregnancy with the aim of preventing GDM. Here, we present the study protocol for a single-blind randomized controlled trial which aims to determine the effectiveness of the Healthy Gut Diet on reducing the diagnosis of GDM in pregnant women with one or more risk factors. Consenting women will be randomized into either the Healthy Gut Diet intervention group or the usual care (control) group after 11 weeks gestation. The women in the intervention group will receive three telehealth counseling appointments with an Accredited Practicing Dietitian with the aim of educating and empowering these women to build a healthy gut microbiota through their diet. The intervention was co-designed with women who have lived experience of GDM and incorporates published behavior change techniques. The control group will receive the usual care and will also be shown a brief (3 min) video on general healthy eating in pregnancy. The primary outcome is the diagnosis of GDM at any stage of the pregnancy. Secondary outcomes include changes to gut microbiota composition and diversity; gestational weight gain; maternal and infant outcomes; management of GDM (where relevant); dietary quality and intake; physical activity; and depression scoring. We aim to recruit 120 women over 16 months. Recruitment commenced in January 2023. The trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001285741).

BACKGROUND: Being physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person\'s response to each specific intervention.
OBJECTIVE: This study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years.
METHODS: The intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the study components and attitudes and opinions toward personalized trials will be measured at the intervention\'s conclusion.
RESULTS: Pooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with study components and attitudes and opinions toward personalized trials).
CONCLUSIONS: Assessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials.
BACKGROUND: clinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313.
UNASSIGNED: RR1-10.2196/43418.

BACKGROUND: Evidence suggests that patients suffering from different mental disorders benefit from exercise programs combined with behavior change techniques. Based on this evidence, we have developed an exercise program (ImPuls) specifically designed to provide an additional treatment option in the outpatient mental health care system. The implementation of such complex programs into the outpatient context requires research that goes beyond the evaluation of effectiveness, and includes process evaluation. So far, process evaluation related to exercise interventions has rarely been conducted. As part of a current pragmatic randomized controlled trial evaluating ImPuls treatment effects, we are therefore carrying out comprehensive process evaluation according to the Medical Research Council (MRC) framework. The central aim of our process evaluation is to support the findings of the ongoing randomized controlled trial.
METHODS: The process evaluation follows a mixed-methods approach. We collect quantitative data via online-questionnaires from patients, exercise therapists, referring healthcare professionals and managers of outpatient rehabilitative and medical care facilities before, during, and after the intervention. In addition, documentation data as well as data from the ImPuls smartphone application are collected. Quantitative data is complemented by qualitative interviews with exercise therapists as well as a focus-group interview with managers. Treatment fidelity will be assessed through the rating of video-recorded sessions. Quantitative data analysis includes descriptive as well as mediation and moderation analyses. Qualitative data will be analyzed via qualitative content analysis.
CONCLUSIONS: The results of our process evaluation will complement the evaluation of effectiveness and cost-effectiveness and will, for example, provide important information about mechanisms of impact, structural prerequisites, or provider qualification that may support the decision-making process of health policy stakeholders. It might contribute to paving the way for exercise programs like ImPuls to be made successively available for patients with heterogeneous mental disorders in the German outpatient mental health care system.
BACKGROUND: The parent clinical study was registered in the German Clinical Trials Register (ID: DRKS00024152, registered 05/02/2021, https://drks.de/search/en/trial/DRKS00024152 ).

BACKGROUND: Adults of low socioeconomic position (SEP) are generally less physically active than those who are more socioeconomically advantaged, which increases their cardiovascular disease incidence risk. Moreover, individuals of low SEP are often less easily reached with physical activity (PA) interventions than individuals of higher SEP. Smartphone apps have been presented as a promising platform for delivering PA interventions to difficult-to-reach individuals of low SEP. Although PA apps are widely available, they are rarely based on health behavior theories and most predominantly offer generic PA advice. Consequently, it is unlikely that available apps are the most effective PA intervention tools.
OBJECTIVE: To respond to these areas for improvement, we developed SNapp, an app-based intervention encouraging adults of low SEP to increase PA by providing tailored coaching messages targeting walking behavior. This study aimed to describe SNapp\'s stepwise development and pilot evaluation process.
METHODS: We applied a stepwise approach: analyzing the health problem, developing a program framework, developing tailoring assessments, writing tailored messages, automating the tailoring process, and implementing and evaluating the program in a qualitative pilot study (11 participants).
RESULTS: SNapp consisted of several elements. First, an app was developed to collect step count and geolocation data using smartphone sensor functionalities. In addition, a survey measure was created to assess users\' behavior change technique (BCT) preferences. These 3 data types were used to tailor SNapp\'s coaching messages to stimulate walking. This allows SNapp to offer feedback on performance levels, contextually tailored prompts when users are near green spaces, and coaching content that aligns with individual BCT preferences. Finally, a server-based Python program that interacts with databases containing user data and tailored messages was built using Microsoft Azure to select and automatically send messages to users through Telegram messenger. Pilot study findings indicated that SNapp was rated positively, with participants reporting that its design, technical functioning, and message content were acceptable. Participants suggested additional functionalities that are worth considering for future updates.
CONCLUSIONS: SNapp is an app-based intervention that aims to promote walking in adults of low SEP by offering tailored coaching messages. Its development is theory based, and it is among the first to incorporate contextualized feedback and content tailored to individual BCT preferences. The effectiveness of SNapp will be evaluated in a 12-month real-life parallel cluster-randomized controlled trial.

While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of behavioral influences during recruitment is in tension with the ethical principle of respect for persons, as at least some of these influences could be used to manipulate potential participants. In this paper, we examine this tension by discussing two types of behavioral influences: one example involves physician recommendations, and the other involves framing of information to exploit cognitive biases. We argue that despite the apparent tension with ethical principles, influencing trial participants through behavior change strategies can be ethically acceptable. However, we argue that trialists have a positive obligation to analyze their recruitment strategies for behavioral influences and disclose these upfront to the research ethics committee. But we also acknowledge that since neither trialists nor ethics committees are presently well equipped to perform these analyses, additional resources and guidance are needed. We close by outlining a path toward the development of such guidance.

UNASSIGNED: Lung transplantation is an established treatment option for persons with advanced lung disease. After transplantation, lung function typically returns to near normal levels, however exercise capacity remains low due to chronic deconditioning, limited physical function, and inactive lifestyles which undermine the intended benefits of the highly selective, resource-intensive transplant procedure. Pulmonary rehabilitation is recommended to improve fitness and activity tolerance, however due to multiple barriers, lung transplant recipients either never participate, or fail to complete, pulmonary rehabilitation programs.
UNASSIGNED: To describe the design of Lung Transplant Go (LTGO), a trial modified for the remote environment based on recommendations to preserve trial integrity during COVID. The aims are to evaluate a behavioral exercise intervention to improve physical function, physical activity, and blood pressure control in lung transplant recipients conducted safely and effectively using a telerehabilitation (telerehab) platform, and to explore the role of potential mediators and moderators of the relationship between LTGO and outcomes.
UNASSIGNED: Single-site, 2-group randomized controlled trial with lung transplant recipients randomized 1:1 to either the LTGO intervention (a 2-phased, supervised, telerehab behavioral exercise program), or to enhanced usual care (activity tracking and monthly newsletters). All study activities, including intervention delivery, recruitment, consenting, assessment, and data collection, will be performed remotely.
UNASSIGNED: If efficacious, this fully scalable and replicable telerehab intervention could be efficiently translated to reach large numbers of lung recipients to improve and sustain self-management of exercise habits by overcoming barriers to participation in existing, in-person pulmonary rehabilitation programs.