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

Objectives: The term 'research participation effects' (RPEs) is intended to capture features and artifacts of study design that may affect measured outcomes in ways that introduce bias into research findings, impacting inference and outcome validity. This systematic review aims to identify which RPEs have been studied in the context of alcohol research and provide an overview of estimates of RPEs on self-reported alcohol consumption.

Study Design and Setting: This systematic review summarizes the available evidence on RPEs in alcohol research.

Results: Twenty-seven reports were included in the review. The reports included randomized controlled trials (RCTs), studies-within-a-trial, between-subjects experiments, and qualitative investigations. A range of RPEs were addressed as follows: assessment reactivity (N = 15), being randomized to a waiting list control group (N = 3), the impact of obtaining informed consent (N = 2), experimentally induced social desirability (N = 3), and the Hawthorne effect, either specifically by name (N = 2, one quantitative, one qualitative) or described as general RPE presence (N = 2). The literature provided proportionally stronger evidence in favor of assessment reactivity and waiting list designs affecting alcohol outcomes, contrary to obtaining informed consent or inducing social desirability.

Conclusion: Variation in study quality, terminology, and outcome measures hinder comprehensive understanding and discussion of RPEs at present. Improved knowledge of RPEs and their potential long-term consequences in alcohol research, including a unified lexicon, would enhance trial design and improve the certainty of evidence in alcohol research.

Background: Digital interventions are effective in promoting healthy behaviors and are recognized as one of many strategies for achieving healthier populations. These interventions often include goal-setting, but the practical application and fidelity of goal setting, especially when targeting multiple health behaviors, remain underexplored. In a factorial randomized trial, we included goal-setting as one of six behavior change components in the digital intervention "Buddy," targeting university and college students' alcohol, diet, physical activity, and smoking behaviors. However, we found no strong and consistent evidence of an effect of goal-setting alone on any of the outcomes, highlighting the need to investigate how participants used this component.

Objective: This case study of Buddy aimed to gain insight into participants' interactions with the goal-setting component. Specific objectives were to identify the characteristics of participants who used this component and to analyze participants' self-authored content.

Methods: This study combined fidelity and effectiveness findings and involved 1704 participants from 18 universities and colleges in Sweden. Self-authored goals and challenges were analyzed using summative content analysis. Logistic and negative binomial regression analyses were conducted to estimate the odds of setting a goal, selecting or self-authoring a challenge, to estimate the odds of setting a goal with respect to a specific behavior, and to estimate the frequency of selecting or self-authoring different behavioral challenges.

Results: Of the 850 participants given access to the goal setting and challenges component, 427 (50%) set at least one goal and 403 (47%) selected or self-authored at least one challenge. A total of 607 goals were set, with most participants setting one goal (336/427, 79%). Goals primarily targeted physical activity (n=302), dietary behavior (n=140), and multiple health behaviors (n=53), typically combining physical activity with diet, alcohol, smoking, or sleep. Other goals included study performance, mental health, sleep, and mobile phone use (n=73). Fewer goals concerned alcohol (n=19) or tobacco (n=17). Participants selected 1506 challenges from 41 premade challenges, with dietary behavior challenges being most popular (667/1506, 44%). An additional 170 challenges were self-authored. Participants’ baseline characteristics were associated with the odds of setting goals targeting specific behaviors and the frequency of selecting or self-authoring challenges targeting specific behaviors.

Conclusions: Our analyses suggest that, while goal-setting is theoretically grounded, and participants used Buddy in ways that suited their personal needs, this did not translate to measurable behavior change in the study population. The self-authored content showed how participants used the component and provided insights into how they articulate behavior change in terms of personal goals, challenges, strategies for action, motivation plans, and rewards. Future research should explore the conditions under which goal-setting may be more or less effective, to better understand its nuances and potential benefits.

Trial Registration: The UK's Clinical Study Registry ISRCTN23310640; https://www.isrctn.com/ISRCTN23310640

BackgroundThe corticosteroid-sparing effects of ileocaecal resection have not been thoroughly investigated in a population-based cohort. AimTo investigate systemic corticosteroid use before and after primary ileocaecal resection in patients with Crohn's disease. MethodsThrough nationwide registries, we identified 1565 patients with Crohn's disease undergoing primary ileocaecal resection in Sweden 2006-2019. We stratified patients according to mean annual systemic corticosteroid (prednisolone equivalents) use in the last 5 years before surgery and compared Crohn's disease treatment after surgery. ResultsSome 19% (290/1565) of the patients had a mean annual corticosteroid use of >= 1000 mg up to 5 years pre-operatively, of whom 33% (97/290) had >= 2000 mg. Mean annual pre-operative CS use did not decrease during the study period (p = 0.35). Compared with patients with < 1000 mg/year pre-operative steroid use, patients with >= 1000 mg/year had more frequent previous bowel surgery (10% vs. 16%), exposure to biologics (29% vs. 38%), and immunomodulators (56% vs. 83%). Patients with a pre-operative mean annual corticosteroid use of >= 1000 mg had a mean annual reduction in corticosteroid use of 1354 mg after ileocaecal resection (1847 mg pre-operative versus 493 mg post-operative). During follow-up (median 6.8 years), exposure to biologics was similar among patients with different levels of pre-operative corticosteroid use. ConclusionOur results suggest a significant corticosteroid-sparing effect of ileocaecal resection in Crohn's disease patients with high pre-operative use, indicating a beneficial outcome of earlier surgical intervention. Despite increasing use of biologics, pre-operative corticosteroid use was consistent over the study period.

ObjectiveTo estimate the effects of an interactive web-based support system via mobile phone on preference-based patient participation in patients with hypertension treated in primary care (compared with standard hypertensive care only).DesignA parallel group, non-blinded, randomized controlled trial, conducted October 2018-February 2021. Besides standard hypertensive care, the intervention group received eight weeks of support via mobile phone to facilitate self-monitoring and self-management, tentatively providing for augmented patient engagement.Setting31 primary healthcare centers in Sweden.Subjects949 patients treated for hypertension.Main outcome measuresThe effects on preference-based patient participation, that is, the match between a patient's preferences for and experiences of patient participation in their health and healthcare. This was measured with the 4Ps (Patient Preferences for Patient Participation) tool at baseline, after 8 weeks, and at 12 months. Data were registered electronically and analyzed with multilevel ordinal regression.ResultsAt baseline, 43-51% had a complete match between their preferences for and experiences of patient participation. There was an indication of a positive effect by a higher match for 'managing treatment myself' at 8-weeks in the intervention group. Such preference-based participation in their health and healthcare was reversed at 12 months, and no further effects of the intervention on preference-based patient participation persisted after 12 months.ConclusionThe interactive web-based support system via mobile phone had a wavering effect on preference-based patient participation. There is a prevailing need to better understand how person-centered patient participation can be facilitated in primary care. Although patient participation is essential when having a long-term condition, interventions optimizing individuals' engagement have not been fully identified.About half of the patients with hypertension in this study did not experience participation in the manner and extent they preferred.A web-based support system via mobile phone improved some aspects of patient participation in the short- but not long term.Strategies to better identify patients' preferences for patient participation are needed, to evaluate and improve the outcome of care.

ObjectiveThe objective of this study was to examine the chronic effects of a 20-week exercise training program on device-assessed sleep and sleep-disordered breathing; and to determine whether participating in a session of the exercise program had effects on device-assessed sleep the subsequent night in children with overweight/obesity.MethodsA randomized clinical trial was conducted from November 2014 to June 2016. A total of 109 children (age 8-11 years) with overweight/obesity were randomized into an exercise training or control group. The exercise program included aerobic and resistance training 3 to 5 days/week. The control group participants continued their usual lifestyle. Device-assessed sleep outcomes were measured using wrist-worn actigraphy at baseline, in the middle of the exercise program (10th week), and at postintervention for seven consecutive days (24 h/day), and sleep-disordered breathing was measured via the Pediatric Sleep Questionnaire.ResultsThe exercise training program had a statistically significant effect on wake after sleep onset time (-10.8 min/day, -0.5 SDs, p = 0.040). No other chronic or acute effects (i.e., the subsequent night of attending a session of the exercise training program) were observed on the remaining sleep outcomes.ConclusionsA 20-week exercise training program reduced wake after sleep onset time in children with overweight/obesity. Future randomized trials that include a sample of children with poor sleep health at baseline are needed to better appreciate the role of exercise in sleep health.

Aim Intervention design may be improved through evaluating the feedback from those who have been exposed to such interventions. As such, here the perspectives of the intervention group from a recent randomized control trial investigating the effectiveness of a digital alcohol intervention, in terms of perceived suitability and usefulness of the support tool they engaged with, were investigated.Methods Respondents (N=475; 45% of the intervention group) answered five quantitative questions addressing user experience, completed the 10-item System Useability Scale, and were offered the opportunity to write free-text feedback. Quantitative measures were analysed using ordinal and linear regression with baseline characteristics as predictors, and free-text responses were evaluated using content analysis.Results Overall, respondents were positive towards the intervention in terms of it fitting their needs, the usefulness of the tools included, and the usefulness of text message content. The intervention was perceived as more helpful by respondents with lower total weekly alcohol consumption, higher self-reported confidence in their ability to reduce their drinking, and the perceived importance there of, at baseline. The free-text comments revealed the value of reminders as prompts to reflect on ones own drinking behaviour. Nonetheless, criticisms of the intervention were voiced, primarily highlighting the repetitive nature of the reminders and the lack of individuation in advice. Some also feltlike the intervention was impersonal and targeted only a specific drinking pattern.Conclusions Experiences of the intervention group in this trial were generally positive, though there may be demand for more individualised, targeted intervention design. Short Summary: Perspectives from participants in a recent parallel group randomized effectiveness trial of a digital alcohol intervention are investigated. Experiences were generally positive, and the efficacy of the behavioural change mechanisms underpinning the intervention design are supported. Nonetheless, more individualized, targeted intervention design may be beneficial in the future.

Hematologic abnormalities are common manifestations of SLE, although neutropenia is observed less frequently and is not included in the classification criteria. Nonetheless, neutropenia is a risk factor for infections, especially those caused by bacteria or fungi. We aimed to evaluate the impact of neutropenia in SLE through a systematic investigation of all infections in a large cohort of well-characterized patients, focusing on neutropenia, lymphopenia, and hypocomplementemia. Longitudinal clinical and laboratory parameters obtained at visits to the Rheumatology Unit, Link & ouml;ping University Hospital, and linked data on all forms of healthcare utilization for all the subjects included in our regional SLE register during 2008-2022 were assessed. Data regarding confirmed infections were retrieved from the medical records. Overall, 333 patients were included and monitored during 3,088 visits to a rheumatologist during the study period. In total, 918 infections were identified, and 94 occasions of neutropenia (ANC < 1.5 x 10(9)/L) were detected in 40 subjects (12%). Thirty neutropenic episodes in 15 patients occurred in association with infections, of which 13 (43%) required in-hospital care, 4 (13%) needed intensive care, and 1 (3%) resulted in death. Bayesian analysis showed that patients with >= 1 occasion of neutropenia were more likely to experience one or more infections (OR = 2.05; probability of association [POA] = 96%). Both invasiveness (OR = 7.08; POA = 98%) and severity (OR = 2.85; POA = 96%) of the infections were significantly associated with the present neutropenia. Infections are common among Swedish SLE patients, 12% of whom show neutropenia over time. Importantly, neutropenia is linked to both the invasiveness and severity of infections. Awareness of the risks of severe infections in neutropenic patients is crucial to tailor therapies to prevent severe illness and death.

Introduction Unhealthy lifestyle behaviors such as unhealthy diets, low physical activity levels, smoking, and harmful alcohol consumption are common in student populations, which constitute a large group of young adults. As unhealthy lifestyle behaviors are associated with future disease and premature mortality, most commonly from cardiovascular disease and cancers, it is from a public health perspective important to understand such behaviors in young adult populations. The objective of this study was to investigate university students experiences of health, health-related behaviors, and the barriers and facilitators for behavior change in terms of health promotion in everyday life. Materials and methods This qualitative study was conducted at a middle-sized university in Sweden. Students represented different faculties and were recruited via non-probability convenience sampling using means such as the snowball technique and social media. The 21 interviews with 24 students, individually or in groups, were transcribed verbatim prior to a qualitative analysis inspired by phenomenological hermeneutics. Results Our interviews showed that university student life is associated with new health-related challenges, for example study-related stress and procrastination implies a lack of energy to engage in healthy routines such as physical activity, and a limited budget affects food choices. While adapting to a new context, students explore personal strategies such as taking on changes in manageable steps, seeking social support, and avoiding disturbances to maintaining health and quality of life. Conclusions Experiences of health while becoming and being a university student can be described as a transition-a balancing act of walking a slack line-during which students seek to manage a healthy balance. In the past, interventions have to some extent been designed to address university students behaviors; however, our study aids an understanding of their needs. Future interventions should highlight the transitions they are experiencing and the challenges of student life.

Reducing research waste and protecting research participants from unnecessary harm should be top priorities for researchers studying interventions. However, the traditional use of fixed sample sizes exposes trials to risks of under- and overrecruitment by requiring that effect sizes be determined a priori. One mitigating approach is to adopt a Bayesian sequential design, which enables evaluation of the available evidence continuously over the trial period to decide when to stop recruitment. Target criteria are defined, which encode researchers’ intentions for what is considered findings of interest, and the trial is stopped once the scientific question is sufficiently addressed. In this tutorial, we revisit a trial of a digital alcohol intervention that used a fixed sample size of 2129 participants. We show that had a Bayesian sequential design been used, the trial could have ended after collecting data from approximately 300 participants. This would have meant exposing far fewer individuals to trial procedures, including being allocated to the waiting list control condition, and the evidence from the trial could have been made public sooner.