Preben Bendtsen

Background: Extant digital multiple health behavior change interventions have shown promise in various populations; however, evidence for a broader approach among the general population is lacking. Moreover, existing interventions often contain several components but are typically assessed as a whole, meaning it remains unclear to what extent individual components contribute to intervention effects and how they may interact to influence health outcomes. Objective: This study estimates the effects of 6 components of a digital health behavior change intervention on alcohol, diet, physical activity, and smoking outcomes among individuals searching for help online. Methods: A double-blind randomized factorial trial design with 6 two-level factors was used. Adults from the general public in Sweden who were seeking help to change their behaviors were recruited through web searches and social media. Participants were eligible if they were 18 years or older and had at least one health behavior classified as unhealthy. Effects of 6 components were estimated: screening/feedback, goal-setting/planning, motivation, skills/know-how, mindfulness, and self-authored SMS text messages. Primary outcomes were weekly alcohol consumption and frequency of heavy episodic drinking, average daily fruit and vegetable consumption, weekly moderate-to-vigorous physical activity, and 4-week point-prevalence smoking. Results: A total of 5419 individuals were randomized. Overall, the screening/feedback component was the most effective for changing health behaviors, along with goal-setting/planning and motivation to change. In particular, there was evidence that screening/feedback increased average daily portions of fruit and vegetables at 2 months (mean difference 0.17, compatibility interval [CoI] 0.09-0.25, probability of effect [POE] >99.9%) and at 4 months (mean difference 0.13, CoI 0.04-0.21, POE 99.9%) and reduced the frequency of heavy episodic drinking at 4 months (incidence rate ratio 0.91, CoI 0.81-1.03, POE 94.2%). Components also interacted to further improve health outcomes, most notably the combination of screening/feedback with motivation to change, which further increased fruit and vegetable consumption (2 months: mean difference 0.20, CoI 0.09-0.30, POE >99.9%; 4 months: mean difference 0.17, CoI 0.05-0.29, POE 99.8%). Conclusions: The results from this study contribute to the development of more effective interventions by providing novel insights into the effects of individual and pairwise components of complex digital health behavior change interventions. Trial Registration: ISRCTN Registry ISRCTN16420548; http://www.isrctn.com/ISRCTN16420548 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2022-061024

Background: Digital interventions have shown promise in supporting healthy behaviors among university students; however, few interventions support simultaneous change across multiple health behaviors. Moreover, behavioral interventions are typically evaluated as a whole, making it challenging to disentangle the contribution of individual components to the overall effects. Objective: This study estimated the effects of the components of a digital behavior intervention on alcohol, diet, physical activity, and smoking outcomes among university students in Sweden. Methods: A double-blind randomized factorial trial with 6 two-level factors was conducted. University students in Sweden were proactively recruited through student health care centers and social media. Participants were eligible if they were aged 18 years or older and had at least one health behavior classified as unhealthy. The effects of 6 components were estimated: screening and feedback; goal-setting and planning; motivation; skills and know-how; mindfulness; and self-authored SMS text messages. Primary outcomes were weekly alcohol consumption and frequency of heavy episodic drinking, average daily fruit and vegetable consumption, weekly sugary drink consumption, weekly moderate-to-vigorous physical activity (MVPA), and 4-week point prevalence of smoking. Results: A total of 1704 students were randomized. The effectiveness of individual and pairwise components was estimated using available data from 1118 (65.61%) participants at 2 months and 874 (51.29%) at 4 months, with sensitivity analyses conducted using imputed missing data. Most consistently, the evidence indicated that screening and feedback affected fruit and vegetable consumption (2-month mean difference 0.11, compatibility interval [CoI] –0.02 to 0.24; probability of effect [POE] 94.7% and 4-month mean difference 0.12, CoI –0.03 to 0.26; POE 94.4%), as did skills and know-how (2-month mean difference 0.19, CoI 0.06-0.33; POE 99.8% and 4-month mean difference 0.14, CoI 0.01-0.28; POE 96.9%). The combination of these 2 components was even more effective (2-month mean difference 0.30, CoI 0.11-0.48; POE 99.9% and 4-month mean difference 0.26, CoI 0.05-0.46; POE 99.4%). The motivation and mindfulness components, both individually and in combination, increased MVPA at 2 months (combined mean difference 78.0, CoI 28.3-128.2; POE 99.9%); however, this effect was not observed at 4 months. Combining screening and feedback with skills and know-how increased MVPA at 4 months (mean difference 60.1, CoI 3.6-116.5; POE 98.2%). Heavy episodic drinking was reduced at 2 months by screening and feedback (incidence rate ratio 0.87, CoI 0.74-1.02; POE 95.2%), and the effect was greater when combined with goal-setting and mindfulness. There was some evidence that the motivation component was harmful with respect to heavy episodic drinking and that self-authored SMS text messages were harmful with respect to sugary drink consumption. Conclusions: We dismantled a complex digital multiple behavior intervention and examined it using a factorial design to provide novel insights into the effectiveness of the intervention’s different components. Both marginal and synergistic effects were observed across multiple behaviors, providing evidence regarding which components are most promising in complex interventions. These findings should be considered in light of the risk of bias introduced by attrition to follow-up, which was high in this effectiveness trial with low barriers to participation. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN23310640; https://www.isrctn.com/ISRCTN23310640 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-051044

Background: Smoking is a leading cause of mortality and morbidity worldwide. Efforts to reduce smoking prevalence have used SMS text message–based interventions, which typically send participants a series of short, informational, motivational, and practical messages over a set period. Evidence highlights the efficacy of using this approach to support smoking cessation, with such trials typically reporting the average treatment effects, in which causal inference is made regarding the average effect of a treatment on a heterogeneous sample. Nonetheless, using this approach to assessing treatment effects means we are unable to account for individual factors that impact the effectiveness of a treatment on outcomes, such as age, gender, and genetics. Objective: This study aimed to estimate the individualized effects of an SMS text message–based smoking cessation intervention to ascertain which individuals benefited the most and least during an effectiveness trial. Methods: Data from a randomized controlled trial including 1012 adults from the Swedish general population were used. The trial assessed the effects of an SMS text message–based intervention, NEXit (Nicotine Exit), that aimed to change behavior by increasing the importance of change, boosting knowledge on how to change, and instilling confidence for change. Outcomes assessed in the trial were prolonged abstinence and point prevalence of smoking cessation. Individualized treatment effects were modeled using baseline factors (demographics, psychosocial variables, and past behavior) to study who benefited the most and least from the intervention. Results: For prolonged abstinence, there was evidence of heterogeneous effects, with those benefiting the most from NEXit being older adults, female participants, individuals with high confidence in their ability to quit, and those who believed that quitting was important. For point prevalence abstinence, older individuals and those reporting high confidence in the ability to quit, the importance of quitting, and knowledge for change benefited the most. For both outcomes, individuals who reported smoking for a longer duration and smoking more at baseline benefited less. Conclusions: The results demonstrate how individuals respond differently to an SMS text message–based smoking cessation intervention. This provides an insight into who benefits the most and least from the intervention in terms of demographics, baseline characteristics, and behaviors. The study highlights which individuals need to be specifically targeted and/or have content developed to suit their individual needs to further reduce the prevalence of smoking.

BACKGROUND Extant digital multiple health behavior change interventions have shown promise in various populations; however, evidence for a broader approach among the general population is lacking. Moreover, existing interventions often contain several components but are typically assessed as a whole, meaning it remains unclear to what extent individual components contribute to intervention effects and how they may interact to influence health outcomes. OBJECTIVE This study estimates the effects of 6 components of a digital health behavior change intervention on alcohol, diet, physical activity, and smoking outcomes among individuals searching for help online. METHODS A double-blind randomized factorial trial design with 6 two-level factors was used. Adults from the general public in Sweden who were seeking help to change their behaviors were recruited through web searches and social media. Participants were eligible if they were 18 years or older and had at least one health behavior classified as unhealthy. Effects of 6 components were estimated: screening/feedback, goal-setting/planning, motivation, skills/know-how, mindfulness, and self-authored SMS text messages. Primary outcomes were weekly alcohol consumption and frequency of heavy episodic drinking, average daily fruit and vegetable consumption, weekly moderate-to-vigorous physical activity, and 4-week point-prevalence smoking. RESULTS A total of 5419 individuals were randomized. Overall, the screening/feedback component was the most effective for changing health behaviors, along with goal-setting/planning and motivation to change. In particular, there was evidence that screening/feedback increased average daily portions of fruit and vegetables at 2 months (mean difference 0.17, compatibility interval [CoI] 0.09-0.25, probability of effect [POE] >99.9%) and at 4 months (mean difference 0.13, CoI 0.04-0.21, POE 99.9%) and reduced the frequency of heavy episodic drinking at 4 months (incidence rate ratio 0.91, CoI 0.81-1.03, POE 94.2%). Components also interacted to further improve health outcomes, most notably the combination of screening/feedback with motivation to change, which further increased fruit and vegetable consumption (2 months: mean difference 0.20, CoI 0.09-0.30, POE >99.9%; 4 months: mean difference 0.17, CoI 0.05-0.29, POE 99.8%). CONCLUSIONS The results from this study contribute to the development of more effective interventions by providing novel insights into the effects of individual and pairwise components of complex digital health behavior change interventions. CLINICALTRIAL ISRCTN Registry ISRCTN16420548; http://www.isrctn.com/ISRCTN16420548 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2022-061024

BACKGROUND Digital interventions have shown promise in supporting healthy behaviors among university students; however, few interventions support simultaneous change across multiple health behaviors. Moreover, behavioral interventions are typically evaluated as a whole, making it challenging to disentangle the contribution of individual components to the overall effects. OBJECTIVE This study estimated the effects of the components of a digital behavior intervention on alcohol, diet, physical activity, and smoking outcomes among university students in Sweden. METHODS A double-blind randomized factorial trial with 6 two-level factors was conducted. University students in Sweden were proactively recruited through student health care centers and social media. Participants were eligible if they were aged 18 years or older and had at least one health behavior classified as unhealthy. The effects of 6 components were estimated: screening and feedback; goal-setting and planning; motivation; skills and know-how; mindfulness; and self-authored SMS text messages. Primary outcomes were weekly alcohol consumption and frequency of heavy episodic drinking, average daily fruit and vegetable consumption, weekly sugary drink consumption, weekly moderate-to-vigorous physical activity (MVPA), and 4-week point prevalence of smoking. RESULTS A total of 1704 students were randomized. The effectiveness of individual and pairwise components was estimated using available data from 1118 (65.61%) participants at 2 months and 874 (51.29%) at 4 months, with sensitivity analyses conducted using imputed missing data. Most consistently, the evidence indicated that screening and feedback affected fruit and vegetable consumption (2-month mean difference 0.11, compatibility interval [CoI] –0.02 to 0.24; probability of effect [POE] 94.7% and 4-month mean difference 0.12, CoI –0.03 to 0.26; POE 94.4%), as did skills and know-how (2-month mean difference 0.19, CoI 0.06-0.33; POE 99.8% and 4-month mean difference 0.14, CoI 0.01-0.28; POE 96.9%). The combination of these 2 components was even more effective (2-month mean difference 0.30, CoI 0.11-0.48; POE 99.9% and 4-month mean difference 0.26, CoI 0.05-0.46; POE 99.4%). The motivation and mindfulness components, both individually and in combination, increased MVPA at 2 months (combined mean difference 78.0, CoI 28.3-128.2; POE 99.9%); however, this effect was not observed at 4 months. Combining screening and feedback with skills and know-how increased MVPA at 4 months (mean difference 60.1, CoI 3.6-116.5; POE 98.2%). Heavy episodic drinking was reduced at 2 months by screening and feedback (incidence rate ratio 0.87, CoI 0.74-1.02; POE 95.2%), and the effect was greater when combined with goal-setting and mindfulness. There was some evidence that the motivation component was harmful with respect to heavy episodic drinking and that self-authored SMS text messages were harmful with respect to sugary drink consumption. CONCLUSIONS We dismantled a complex digital multiple behavior intervention and examined it using a factorial design to provide novel insights into the effectiveness of the intervention’s different components. Both marginal and synergistic effects were observed across multiple behaviors, providing evidence regarding which components are most promising in complex interventions. These findings should be considered in light of the risk of bias introduced by attrition to follow-up, which was high in this effectiveness trial with low barriers to participation. CLINICALTRIAL International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN23310640; https://www.isrctn.com/ISRCTN23310640 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2021-051044

Background: The prevalence of daily or occasional smoking among high school students in Sweden was approximately 20% in 2019, which is problematic since lifestyle behaviors are established in adolescence and track into adulthood. The Nicotine Exit (NEXit) Junior trial was conducted in response to a lack of evidence for the effects of text message smoking cessation interventions among high school students in Sweden. Objective: The aim of this study was to estimate the 3- and 6-month effects of a text messaging intervention among high school students in Sweden on smoking cessation outcomes. Methods: A 2-arm, single-blind randomized controlled trial was employed to estimate the effects of the intervention on smoking cessation in comparison to treatment as usual. Participants were recruited from high schools in Sweden using advertising and promotion by school staff from January 10, 2018, to January 10, 2019. Weekly or daily smokers who were willing to make a quit attempt were eligible for inclusion. Prolonged abstinence and point prevalence of smoking cessation were measured at 3 and 6 months after randomization. Results: Complete case analysis was possible on 57.9% (310/535) of the participants at 6 months, with no observed statistically significant effect on 5-month prolonged abstinence (odds ratio [OR] 1.27, 95% CI 0.73-2.20; P=.39) or 4-week smoking cessation (OR 1.42; 95% CI 0.83-2.46; P=.20). Sensitivity analyses using imputation yielded similar findings. Unplanned Bayesian analyses showed that the effects of the intervention were in the anticipated direction. The findings were limited by the risk of bias induced by high attrition (42.1%). The trial recruited high school students in a pragmatic setting and included both weekly and daily smokers; thus, generalization to the target population is more direct compared with findings obtained under more strict study procedures. Conclusions: Higher than expected attrition rates to follow-up 6 months after randomization led to null hypothesis tests being underpowered; however, unplanned Bayesian analyses found that the effects of the intervention were in the anticipated direction. Future trials of smoking cessation interventions targeting high school students should aim to prepare strategies for increasing retention to mid- and long-term follow-up. Trial Registration: IRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-3028-2

Background: The use of e-visits in health care is progressing rapidly worldwide. To date, studies on the advantages and disadvantages of e-consultations in the form of chat services for all inquiries in primary care have focused on the perspective of health care professionals (HCPs) rather than those of end users (patients). Objective: This study aims to explore patients’ experiences using a chat-based and automated medical history–taking service in regular, tax-based, not-for-profit primary care in Sweden. Methods: Overall, 25 individual interviews were conducted with patients in the catchment areas of 5 primary care centers (PCCs) in Sweden that tested a chat-based and automated medical history–taking service for all types of patient inquiries. The semistructured interviews were transcribed verbatim before content analysis using inductive and deductive strategies, the latter including an unconstrained matrix of human, organization, and technology perspectives. Results: The service provided an easily managed way for patients to make written contact with HCPs, which was considered beneficial for some patients and issues but less suitable for others (acute or more complex cases). The automated medical history–taking service was perceived as having potential but still derived from what HCPs need to know and how they address and communicate health and health care issues. Technical skills were not considered as necessary for a mobile phone chat as for handling a computer; however, patients still expressed concern for people with less digital literacy. The opportunity to take one’s time and reflect on one’s situation before answering questions from the HCPs was found to reduce stress and prevent errors, and patients speculated that it might be the same for the HCPs on the other end of the system. Patients appreciated the ability to have a conversation from almost anywhere, even from places not suitable for telephone calls. The asynchronicity of the chat service allowed the patients to take more control of the conversation and initiate a chat at any time at their own convenience; however, it could also lead to lengthy conversations where a single issue in the worst cases could take days to close. The opportunity to upload photographs made some visits to the PCC redundant, which would otherwise have been necessary if the ordinary telephone service had been used, saving patients both time and money. Conclusions: Patients generally had a positive attitude toward e-visits in primary care and were generally pleased with the prospects of the digital tool tested, somewhat more with the actual chat than with the automated history-taking system preceding the chat. Although patients expect their PCC to offer a range of different means of communication, the human, organization, and technology analysis revealed a need for more extensive (end) user experience design in the further development of the chat service.

BACKGROUND The prevalence of daily or occasional smoking among high school students in Sweden was approximately 20% in 2019, which is problematic since lifestyle behaviors are established in adolescence and track into adulthood. The Nicotine Exit (NEXit) Junior trial was conducted in response to a lack of evidence for the effects of text message smoking cessation interventions among high school students in Sweden. OBJECTIVE The aim of this study was to estimate the 3- and 6-month effects of a text messaging intervention among high school students in Sweden on smoking cessation outcomes. METHODS A 2-arm, single-blind randomized controlled trial was employed to estimate the effects of the intervention on smoking cessation in comparison to treatment as usual. Participants were recruited from high schools in Sweden using advertising and promotion by school staff from January 10, 2018, to January 10, 2019. Weekly or daily smokers who were willing to make a quit attempt were eligible for inclusion. Prolonged abstinence and point prevalence of smoking cessation were measured at 3 and 6 months after randomization. RESULTS Complete case analysis was possible on 57.9% (310/535) of the participants at 6 months, with no observed statistically significant effect on 5-month prolonged abstinence (odds ratio [OR] 1.27, 95% CI 0.73-2.20; P=.39) or 4-week smoking cessation (OR 1.42; 95% CI 0.83-2.46; P=.20). Sensitivity analyses using imputation yielded similar findings. Unplanned Bayesian analyses showed that the effects of the intervention were in the anticipated direction. The findings were limited by the risk of bias induced by high attrition (42.1%). The trial recruited high school students in a pragmatic setting and included both weekly and daily smokers; thus, generalization to the target population is more direct compared with findings obtained under more strict study procedures. CONCLUSIONS Higher than expected attrition rates to follow-up 6 months after randomization led to null hypothesis tests being underpowered; however, unplanned Bayesian analyses found that the effects of the intervention were in the anticipated direction. Future trials of smoking cessation interventions targeting high school students should aim to prepare strategies for increasing retention to mid- and long-term follow-up. CLINICALTRIAL IRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-3028-2

BACKGROUND The use of e-visits in health care is progressing rapidly worldwide. To date, studies on the advantages and disadvantages of e-consultations in the form of chat services for all inquiries in primary care have focused on the perspective of health care professionals (HCPs) rather than those of end users (patients). OBJECTIVE This study aims to explore patients’ experiences using a chat-based and automated medical history–taking service in regular, tax-based, not-for-profit primary care in Sweden. METHODS Overall, 25 individual interviews were conducted with patients in the catchment areas of 5 primary care centers (PCCs) in Sweden that tested a chat-based and automated medical history–taking service for all types of patient inquiries. The semistructured interviews were transcribed verbatim before content analysis using inductive and deductive strategies, the latter including an unconstrained matrix of human, organization, and technology perspectives. RESULTS The service provided an easily managed way for patients to make written contact with HCPs, which was considered beneficial for some patients and issues but less suitable for others (acute or more complex cases). The automated medical history–taking service was perceived as having potential but still derived from what HCPs need to know and how they address and communicate health and health care issues. Technical skills were not considered as necessary for a mobile phone chat as for handling a computer; however, patients still expressed concern for people with less digital literacy. The opportunity to take one’s time and reflect on one’s situation before answering questions from the HCPs was found to reduce stress and prevent errors, and patients speculated that it might be the same for the HCPs on the other end of the system. Patients appreciated the ability to have a conversation from almost anywhere, even from places not suitable for telephone calls. The asynchronicity of the chat service allowed the patients to take more control of the conversation and initiate a chat at any time at their own convenience; however, it could also lead to lengthy conversations where a single issue in the worst cases could take days to close. The opportunity to upload photographs made some visits to the PCC redundant, which would otherwise have been necessary if the ordinary telephone service had been used, saving patients both time and money. CONCLUSIONS Patients generally had a positive attitude toward e-visits in primary care and were generally pleased with the prospects of the digital tool tested, somewhat more with the actual chat than with the automated history-taking system preceding the chat. Although patients expect their PCC to offer a range of different means of communication, the human, organization, and technology analysis revealed a need for more extensive (end) user experience design in the further development of the chat service. CLINICALTRIAL