OBJECTIVE:Do post-program motivational regulations mediate the intervention effect of the SDT-based European Fans in Training (EuroFIT) program on self-esteem, well-being and vitality at 12-months follow-up? METHODS:A causal mediation analysis of data from the randomised controlled trial of the EuroFIT program that recruited 1113 overweight, male football fans in England, Norway, Portugal and the Netherlands. RESULTS:We found evidence of indirect effects of autonomous motivation on vitality (b=.487, 95% CI: .229, .767, p<.001) well-being (b=.063, 95% CI: .003, .131, p=.038) and self-esteem (b=.491, 95% CI: .278, .701, p<.001), but not controlled motivation, at 12-months follow-up in the EuroFIT trial. We also found that reductions in amotivation at post-program partly explained positive increases across outcomes at 12-months follow-up. When controlling for increases in outcome variables at post-program, only the mediating effect of autonomous motivation on self-esteem remained significant, whereas the indirect pathway through reductions in amotivation remained significant for all outcomes. None of the indirect effects were robust to potential mediator-outcome confounding. CONCLUSION:EuroFIT program produced small-to-moderate improvements in vitality, well-being, and self-esteem at 12-month follow-up that were partly explained by post-program increases in autonomous motivation and reductions in amotivation. All indirect effects estimates were sensitive to potential mediator-outcome confounding.

Objective: Gender-sensitive approaches to increasing men's physical activity (PA) through sports settings have shown promise across cultural contexts. We examined changes to men's walking and the contribution of walking towards self-reported PA after participating in the men-only European Fans in Training (EuroFIT) programme before exploring men's experiences of sustaining walking to explain the quantitative findings. Design: A sequential mixed-methods design was used to collect self-reported PA questionnaire data as part of a randomised controlled trial at baseline, post-programme and 12-month follow-up, together with focus groups with participants. Setting: EuroFIT was delivered by football club/community coaches to overweight fans in football clubs across England, the Netherlands, Portugal and Norway. Results: Linear regression modelling demonstrated that self-reported walking was significantly higher at both post-programme (426 metabolic equivalents [METs], 95% confidence interval [CI]: 287-565, p < .001) and at 12-month follow-up (343 METs, 95% CI: 205-482, p < .001) in all countries in favour of the intervention group, despite a large decline in Norway from post-programme to follow-up. The contribution of walking towards total PA did not change after participating in EuroFIT. Qualitative analysis indicated that most men were positive about walking and had embodied learning from the EuroFIT programme, but also that some men also considered walking a transitional activity towards other more intensive forms of PA. Conclusion: EuroFIT succeeded in helping overweight, male football fans increase walking as part of their self-reported total PA. Although the percentage of walking in relation to total PA remained the same for participants in both groups, EuroFIT helped men to integrate walking into their daily lives.

BACKGROUND:Evidence supporting Self-Determination Theory (SDT) utility in facilitating and explaining physical activity (PA) behavior change and maintenance is robust and rapidly increasing. This paper aims to describe how SDT was used to develop the European Fans in Training program, and its adequacy, concerning the critical mechanisms theoretically provided, to predict objectively measured PA and sedentary behaviors. METHODS:European Fans in Training was a gender-sensitized, healthy lifestyle program that successfully attracted men and supported them in making changes in their PA and diet. This study analyzes self-reported psychometric and objectively measured PA data from the European Fans in Training intervention group of 560 overweight men aged 30-65 from 4 countries (The Netherlands, Norway, Portugal, and the United Kingdom). RESULTS:The motivational mediation sequence predicted by SDT showed an acceptable to excellent fit for the data: χ2 = 200.204; df = 87; P = .000; comparative fit index = .956; Tucker-Lewis Index = .933; root mean square error approximation = .050 (90% CI, .041 to .059); standardized root mean square residual = .056. Perceived need support by coaches was positively related to greater need satisfaction, which led to higher levels of self-determination and an increase in steps, lifestyle PA, and sit-to-stand transitions. Perceived need-thwarting behaviors were negatively associated with need satisfaction and indirectly with self-determination. CONCLUSIONS:Results confirm that interventions can create conditions for individuals to experience psychological need satisfaction, self-determined motivation, and PA-related health behavior change. These findings provide further support to the utility and acceptability of SDT among policymakers and practitioners wishing to promote PA in previously sedentary adults.

Background Given the elevated prevalence and impact of overweight and the potential risk of non-communicable diseases among women of Somali background in high-income countries and recognising the potential positive impact of physical activity (PA) on these health conditions, it becomes imperative to focus on understanding the PA behaviour of this specific population. The objectives of this paper were twofold: firstly, to provide a comprehensive description of both objectively and subjectively measured PA level and sedentary time in a group of overweight women of Somali background in Norway, and secondly, to assess the effectiveness of a tailored, culturally sensitive, and community-based intervention in enhancing PA levels and reducing sedentary time. Methods 169 overweight women of Somali background in Norway were randomised by borough to either a lifestyle programme or a comparison group. The programme consisted of two sessions per week for 12 weeks, combining classroom discussion with graded group-based PA activity led by coaches, followed by monthly sessions over nine months. PA was measured objectively using the ActivPAL monitor and subjectively using the international PA questionnaire short form (IPAQ). Results The women took on average 6804 (SD = 3286) steps per day and were sedentary for 9.1 hours (SD = 3) per day at baseline. There were no differences between groups on any objectively measured PA variable at any timepoint. There were significant differences on vigorous intensity PA and total PA at the 12-month measurement session between the two groups using the IPAQ. Conclusion Despite observing initially low PA levels and high sedentary time at baseline and thus a considerable potential for intervention, the intervention failed in attaining an increase in objectively measured PA or reduction in sedentary time compared to the control condition. However, self-reported measures indicated success in these aspects. The potential threats to the programme's reliability and validity include contamination, low attendance rates, and high drop-out rates possible due to the COVID-19 pandemic. These challenges underscore the complexity of interventions in this demographic, emphasising the need for further exploration and refinement of study methodologies to effectively enhance PA levels and reduce sedentary time in immigrant women living in high-income countries. Trial registration : clinicaltrials.gov NCT04578067. Keywords : Immigrant Somali women, Lifestyle programme, Overweight, Physical activity, Sedentary time, ActivPAL

The European Fans in Training (EuroFIT) program integrated need-supportive motivational strategies from Self-Determination Theory (SDT) in the design of a healthy lifestyle program delivered to overweight or obese male football fans (n=1113; mean age of 45.9 [SD=9.0] years old and BMI of 33.2 kg/m2 [SD=4.6]) in professional football club settings in the UK, Portugal, Norway and the Netherlands. With a critical realist approach, we developed a structured thematic framework analysis based on Self-Determination Theory (SDT) to investigate the process of change in men who participated in the EuroFIT randomized controlled trial (RCT). We examined whether men’s experiences of the social context of EuroFIT, and whether their engagement with the program’s motivational strategies supported or frustrated their basic psychological needs while attempting to change their lifestyle behaviours. We found that men in all countries perceived the social contexts of the EuroFIT program as mostly needs-supportive, and that they found engagement with most of the program components helpful in supporting their psychological needs when initiating health behaviour changes. However, some of the program elements in the EuroFIT program were perceived as needs-frustrating by some participants and need-supportive by others. Implications for the use of need-supportive motivational strategies in designing future lifestyle interventions in sport settings to promote health behaviour change among male football fans are discussed.

Background: Women of Somali background in Norway have a high prevalence of overweight and obesity, compared with women in the general Norwegian population. For lifestyle interventions to be applicable for immigrants to Norway, it is important to culturally tailor interventions in collaboration with relevant communities. The primary outcome was a difference in weight change between the intervention and control groups. Methods: In this interventional study, Somali women living in one borough of Oslo Municipality in Norway with body mass index (BMI) ≥27.0 kg.m-2 received a co-created, culturally tailored 12-month weight loss intervention consisting of 24 interactive sessions during the first three months, and monthly sessions for the next nine months, compared to a control group. Both groups were measured at baseline and 12 months. Results: A total of 169 participants were recruited, and 101 participants completed the follow-up. After multiple imputation, the mean difference in weight change adjusted for baseline weight, age, education, employment, marital status, number of children in the household and length of Norwegian residency was -1.6 kg (95 % CI -3.57, 0.43, p = 0.12) in the intervention compared to the control group. Conclusion: This culturally tailored intervention study demonstrated a modest non-significant effect on weight change after 12 months, possibly due to the short intervention duration and COVID-19. Further studies of a longer duration and considering the provision of childcare are needed to understand whether this approach can be transferred to other immigrant groups and genders.Trial registration: The study was registered at clinicaltrials.gov NCT04578067, 2020-09-29.

OBJECTIVE:Physical exercise can improve neurocognition in individuals with schizophrenia, presumably by facilitating neuroplasticity. There is, however, large inter-individual variation in response. The brain-derived neurotrophic factor (BDNF) has been proposed to mediate these effects. The current aim was to investigate the sparsely studied relationship between peripheral resting BDNF and neurocognitive response to physical exercise in individuals with schizophrenia. METHOD:The current study reports secondary analyses of data from a randomized controlled trial (RCT), ClinicalTrials.gov number 02205684, recently reported according to the CONSORT guidelines. Eighty-two individuals with schizophrenia (mean age 37 ± 14 years old, 61% men) were randomly allocated to high-intensity interval training (HIIT) or a comparison group performing low-intensity active video gaming (AVG). Both interventions consisted of 2 sessions/week for 12 weeks. In previously published primary RCT analyses, HIIT and AVG showed comparable small to moderate improvements in neurocognition. We now address the inter-individual variability in neurocognitive response. We apply mediation and moderation analyses for repeated measures designs (MEMORE) and mixed effects models. RESULTS:Baseline neurocognition was not significantly correlated with baseline levels of mature BDNF (baseline-mBDNF) or the precursor proBDNF. Nonetheless, baseline-mBDNF, but not baseline proBDNF, moderated the effect of exercise on neurocognition (p = 0.025) and explained 7% of the variance. The neurocognitive improvement increased with increasing baseline-mBDNF values. The moderating effect of baseline-mBDNF remained significant in a more complex model adding the moderating effects of exercise mode, sex, age, duration of illness and baseline VO2max on the outcome (neurocognition). Mean baseline-mBDNF significantly decreased from baseline to post-intervention (p = 0.036), regardless of exercise mode, differing by sex and associated with improved VO2max but not with change in neurocognition. A mediating role of mBDNF on the effect of physical exercise on neurocognition was not supported. Values of proBDNF mainly remained stable from baseline to post-intervention. CONCLUSION:We found that baseline-mBDNF moderated the effect of physical exercise on neurocognition in individuals with schizophrenia and explained a small part of the inter-individual variation in neurocognitive response. Mean mBDNF decreased from baseline to post-intervention, regardless of exercise mode. A mediating role of mBDNF on the effect of exercise on neurocognition was not supported. The inter-individual variation in neurocognitive response and the complex role of peripheral BDNF in physical exercise is still to be elucidated.

BackgroundIn individuals with schizophrenia, inflammation is associated with depression, somatic comorbidity and reduced quality of life. Physical exercise is known to reduce inflammation in other populations, but we have only limited knowledge in the field of schizophrenia. We assessed inflammatory markers in plasma samples from individuals with schizophrenia participating in an exercise intervention randomized controlled trial. We hypothesized that (i) physical exercise would reduce levels of inflammatory markers and (ii) elevated inflammatory status at baseline would be associated with improvement in cardiorespiratory fitness (CRF) following intervention. MethodEighty-two individuals with schizophrenia were randomized to a 12-week intervention of either high-intensity interval training (HIIT, n = 43) or active video gaming (AVG, n = 39). Participants were assessed at baseline, post intervention and four months later. The associations between exercise and the inflammatory markers soluble urokinase plasminogen activator receptor, c-reactive protein, tumor necrosis factor (TNF), soluble TNF receptor 1 and interleukin 6 (IL-6) were estimated using linear mixed effect models for repeated measures. For estimating associations between baseline inflammation and change in CRF, we used linear regression models. ResultsOur main findings were (i) TNF and IL-6 increased during the intervention period for both groups. Other inflammatory markers did not change during the exercise intervention period; (ii) baseline inflammatory status did not influence change in CRF during intervention, except for a positive association between baseline IL-6 levels and improvements of CRF to post intervention for both groups. ConclusionIn our study, HIIT and AVG for 12-weeks had no reducing effect on inflammatory markers. Patients with high baseline IL-6 levels had a positive change in CRF during intervention. In order to increase our knowledge regarding association between inflammatory markers and exercise in individuals with schizophrenia, larger studies with more frequent and longer exercise bout duration are warranted.

Background A randomised trial of European Fans in Training (EuroFIT), a 12-week healthy lifestyle program delivered in 15 professional football clubs in the Netherlands, Norway, Portugal, and the United Kingdom, successfully increased physical activity and improved diet but did not reduce sedentary time. To guide future implementation, this paper investigates how those effects were achieved. We ask: 1) how was EuroFIT implemented? 2) what were the processes through which outcomes were achieved? Methods We analysed qualitative data implementation notes, observations of 29 of 180 weekly EuroFIT deliveries, semi-structured interviews with 16 coaches and 15 club representatives, and 30 focus group discussions with participants (15 post-program and 15 after 12 months). We descriptively analysed quantitative data on recruitment, attendance at sessions and logs of use of the technologies and survey data on the views of participants at baseline, post program and after 12 months. We used a triangulation protocol to investigate agreement between data from difference sources, organised around meeting 15 objectives within the two research questions. Results We successfully recruited clubs, coaches and men to EuroFIT though the draw of the football club seemed stronger in the UK and Portugal. Advertising that emphasized getting fitter, club-based deliveries, and not ‘standing out’ worked and attendance and fidelity were good, so that coaches in all countries were able to deliver EuroFIT flexibly as intended. Coaches in all 15 clubs facilitated the use of behaviour change techniques and interaction between men, which together enhanced motivation. Participants found it harder to change sedentary time than physical activity and diet. Fitting changes into daily routines, planning for setbacks and recognising the personal benefit of behaviour change were important to maintain changes. Bespoke technologies were valued, but technological hitches frustrated participants. Conclusion EuroFIT was delivered as planned by trained club coaches working flexibly in all countries. It worked as expected to attract men and support initiation and maintenance of changes in physical activity and diet but the use of bespoke, unstable, technologies was frustrating. Future deliveries should eliminate the focus on sedentary time and should use only proven technologies to support self-monitoring and social interaction. Trial registration ISRCTN81935608, registered 16/06/2015.

This paper investigated facilitators and barriers to implementing the European Football Fans in Training program (EuroFIT) in professional sports clubs in England, the Netherlands, Norway, and Portugal. We analyzed qualitative data collected at clubs that delivered EuroFIT, based on semi-structured interviews with coordinating staff (n = 15), coaches (n = 16), and focus group interviews with participants (n = 108), as well as data from clubs that considered delivering EuroFIT in the future, based on interviews with staff (n = 7) and stakeholders (n = 8). Facilitators for implementation related to the content and structure of the program, its evidence-base, and the context for delivery in the football stadia. Financial and human resources were both facilitators and barriers. Further barriers were mostly practical, relating to human resources and infrastructure. Major differences between countries related to experience and commitment to running community projects, and differences in infrastructure, financing, and human resources. Professional football clubs’ ability to support health promotion efforts depended on their ethos and the financial and human resources available to them. Overall, the EuroFIT program was well received by clubs, coaches, participants, and stakeholders, which was reflected by the many facilitators supporting sustained implementation. For sustainable implementation, it is crucial that clubs and their stakeholders engage fully with the EuroFIT program and understand that for an adequate program delivery their views (ethos) and ways of working influence the implementation and thereby the effectiveness of EuroFIT. An important prerequisite for future roll out of EuroFIT would be a strong EuroFIT delivery partner organization to ensure financial and human resources while overseeing and guiding the quality of delivery in clubs.

Aims To prevent type 2 diabetes mellitus (T2D) and reduce the risk of complications, early identification of people at risk of developing T2D, preferably through simple diabetes risk scores, is essential. The aim of this study was to create a risk score for identifying subjects with undiagnosed prediabetes or T2D among Saharawi refugees in Algeria and compare the performance of this score to the Finnish diabetes risk score (FINDRISC). Methods A cross-sectional survey was carried out in five Saharawi refugee camps in Algeria in 2014. A total of 180 women and 175 men were included. HbA1c and cut-offs proposed by the American Diabetes Association (ADA) were used to define cases. Variables to include in the risk score were determined by backwards elimination in logistic regression. Simplified scores were created based on beta coefficients from the multivariable model after internal validation with bootstrapping and shrinkage. The empirical cut-off value for the simplified score and FINDRISC was determined by Area Under the Receiver Operating Curve (AUROC) analysis. Results Variables included in the final risk score were age, body mass index (BMI), and waist circumference. The area under the curve (AUC) (C.I) was 0.82 (0.76, 0.88). The sensitivity, specificity, and positive and negative predictive values were 89, 65, 28, and 97%, respectively. AUC and sensitivity were slightly higher and specificity somewhat lower than for FINDRISC. Conclusions The risk score developed is a helpful tool to decide who should be screened for prediabetes or T2D by blood sample analysis. The performance of the risk score was adequate based on internal validation with bootstrap analyses, but should be confirmed in external validation studies.

IntroductionHigh-intensity interval training (HIIT) may improve cardiorespiratory fitness (CRF) and mental health. The current observer-blinded RCT investigates the sparsely studied efficiency of HIIT in reducing psychotic and non-psychotic symptoms in schizophrenia and complements previous studies by investigating whether symptom reduction following HIIT is associated with, putatively partly mediated by, increased VO2max.MethodsParticipants (outpatients meeting diagnostic criteria for schizophrenia) were randomized to HIIT (n = 43) or a comparison group performing low-intensity active video gaming (AVG) to control for social interaction (n = 39). Both interventions consisted of two supervised sessions/week for 12 weeks and a 4 months follow-up. Effects on overall symptoms and symptom domains [PANSS (0–6 scale), five-factor model] were estimated using mixed-effects models (intention-to-treat, n = 82). Underlying mechanisms were analyzed using moderated mediation analyses (n = 66). We anticipated that HIIT would reduce overall symptoms, particularly depressive symptoms, more than AVG, and symptom reduction would be associated with, putatively mediated through, improved VO2max.ResultsDepressive symptoms (baseline score 3.97, 95% CI: 3.41, 4.52), were −1.03 points more reduced in HIIT than AVG at post-intervention (95% CI: −1.71, −0.35, p = 0.003), corresponding to a small to moderate effect size (d = 0.37) and persisting at follow-up. There was a small reduction in overall symptoms, but no significant between-group differences were observed. Change in VO2max correlated negatively with the change in depressive symptoms. Mediation analysis showed a significant effect of change in VO2max on change in depressive symptoms within HIIT. The total effect was moderated by group, and depressive symptoms were more reduced in HIIT. Direct effects, not mediated through VO2max, were non-significant. Indirect effects, mediated through VO2max, were non-significant, but the moderated mediation test indicated a non-significant trend of 0.4 points (95% CI: −1.188, 0.087) and a larger reduction in depressive symptoms through VO2max in HIIT.ConclusionHIIT reduced depressive symptoms more than AVG, which persisted at follow-up. HIIT may serve as a complementing treatment option targeting these symptoms in individuals with schizophrenia, even before they reach clinical depression. Depressive symptoms are important to prevent, stabilize, and treat due to their negative implications for psychological wellbeing and long-term functional outcome. Reduction in depressive symptoms was associated with improved VO2max, and non-significant trends in the data supported that improved VO2max may be part of the complex mechanisms underlying the anti-depressive effect of HIIT.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT02205684].

Background: The Sahrawi people fled their homes in 1975 as the conflict in Western Sahara escalated and settled down near Tindouf, Algeria, where they still live. High prevalence of overweight and obesity and type 2 diabetes had been found in this protracted refugee setting. Scaling up national policy efforts to promote physical activity (PA) is critical to reducing the prevalence of noncommunicable diseases (NCDs) in the near future. One possible barrier to the inclusion of PA in NCD prevention strategies is the lack of research on PA level, which may reduce political support and policy development for PA. Thus, the aim of this study was to investigate the PA level among adults living in Sahrawi refugee camps and socioeconomic factors associated with PA.Methods: A cross-sectional survey was carried out in 2014 in five refugee camps near Tindouf, Algeria. A total of 180 women and 175 men were included. PA was measured using the international physical activity questionnaire short form (IPAQ-SF).Results: There was a large amount of variance in reported PA for both genders, ranging from 10 min of total PA per week to above 40 hours. Forty-three percent of the participants had a low PA level (defined as not meeting the PA recommendations of 150 min of moderate to vigorous PA per day). The chi-square test of independence showed that males, those aged ≥ 60 years and people with higher education were more likely to be in the low PA level category. No significant relationship was found between PA level and BMI status. Most of the participants thought that engaging in PA would be wise, valuable, right and good but thought to a lesser degree that PA would be easy, comfortable and interesting.Conclusions: Almost half of the participants were categorised as insufficiently physically active, however, most of the Sahrawi refugees express a positive attitude towards PA. PA is a low-cost approach to reducing deaths and NCDs, government initiatives to increase PA levels in refugee camps are advised.

ObjectiveThis study aimed to compare the effects of two aerobic exercise programs of different intensities on energy expenditure.MethodsThis was a single‐center randomized controlled trial of patients with severe obesity allocated to a 24‐week moderate‐intensity continuous training (MICT) program or a combined MICT with high‐intensity interval training (HIIT/MICT) program. The primary outcome was energy expenditure during exercise (EEDE). Secondary outcomes included resting metabolic rate, cardiorespiratory fitness, and body composition.ResultsA total of 82 (56% females) patients were screened, and 71 (55% females) patients were allocated to HIIT/MICT (n = 37) or MICT (n = 34). Per‐protocol analysis showed that EEDE increased by 10% (95% CI: 3%‐17%) in the HIIT/MICT group (n = 16) and 7.5% (95% CI: 4%‐10%) in the MICT group (n = 24), with no differences between groups. In the 8‐ to 16‐ week per‐protocol analysis, the HIIT/MICT group had a significantly larger increase in EEDE compared with the MICT group. Resting metabolic rate remained unchanged in both groups. HIIT/MICT and MICT were associated with significant weight loss of 5 kg and 2 kg, respectively.ConclusionsPatients completing a 24‐week combined HIIT/MICT program did not achieve a higher EEDE compared with those who completed a 24‐week MICT program. The HIIT/MICT group experienced, on average, a 3‐kg‐larger weight loss than the MICT group.

This study mapped existing health-promotion provisions targeting adults in professional football clubs across England, the Netherlands, Norway, and Portugal, and explored motives behind the clubs’ adoption of the European Fans in Training (EuroFIT) programme. We surveyed top-tier football clubs in the four countries and interviewed representatives from football clubs and the clubs’ charitable foundation who delivered EuroFIT. The findings showed large between-country differences, with football clubs in England reporting far greater healthy lifestyle provision than other countries. Relatively few health-promotion programmes targeted adults, particularly in the Netherlands, Portugal, and Norway. Club representatives reported that the motives for adopting the EuroFIT programme often involved adhering to both the social objectives of the football club or club’s foundation and business-related objectives. They viewed the scientific evidence and evaluation underpinning EuroFIT as helpful in demonstrating the value and potential future impact of both the programme and the clubs’ wider corporate social responsibility provision.

Increased physical activity (PA), reduced time spent sedentary (SED), healthier diet and reduced body weight may all have a positive impact on cardiometabolic risk. The relative importance of change in each of these variables on cardiometabolic risk, however, is unclear. We therefore sought to investigate the relative contributions of changes in PA, SED, diet and body weight on cardiometabolic risk. This is a secondary analysis of data collected from the EuroFIT randomised controlled trial, which was a 12-week group-based lifestyle intervention for overweight middle-aged men delivered by coaches in football club stadia aiming to improve PA, SED, diet, and body weight. PA and SED were assessed by accelerometry, diet using the Dietary Instrument for Nutrition Education (DINE). An overall cardiometabolic risk score was derived from combining z-scores for glucose, HbA1c, insulin, lipids and blood pressure. In total, 707 men (from the overall cohort of 1113) with complete data for these variables at baseline and 12-month follow-up were included in the multivariable linear regression analyses. In multivariable analyses, change in number of steps (explaining 5.1% of R2) and dietary factors (less alcohol, fatty and sugary food, and more fruit and vegetables) (together explaining 4.5% of R2), but not changes in standing time or SED, were significantly associated with change in body weight. Changes in number of steps (R2 = 1.7%), fatty food score (R2 = 2.4%), and sugary food score (R2 = 0.4%) were significantly associated with change in cardiometabolic risk score in univariable models. However, in multivariable models which included changes in weight as well as changes in steps and dietary variables, change in weight explained a substantially larger proportion of the change in cardiometabolic risk score, explaining 14.1% of R2 (out of an overall model R2 of 19.0%). When baseline (as well as change) values were also included in the model, 38.8% of R2 for change in cardiometabolic risk score was explained overall, with 14.1% of R2 still explained by change in weight. Change in body weight, together with baseline cardiometabolic risk explained most of the change in cardiometabolic risk. Thus, the benefits of increasing physical activity and improving diet on cardiometabolic risk appear to act largely via an effect on changes in body weight. International Standard Randomised Controlled Trials, ISRCTN-81935608. Registered 06052015. https://www.isrctn.com/ISRCTN81935608?q=&filters=recruitmentCountry:Portugal&sort=&offset=7&totalResults=92&page=1&pageSize=10&searchType=basic-search

Background There is evidence of increased low grade inflammation (LGI) in schizophrenia patients. However, the inter-individual variation is large and the association with demographic, somatic and psychiatric factors remains unclear. Our aim was to explore whether levels of the novel LGI marker soluble urokinase plasminogen activator receptor (suPAR) were associated with clinical factors in schizophrenia and if such associations were sex-dependent. Method In this observational study a total of 187 participants with schizophrenia (108 males, 79 females) underwent physical examination and assessment with clinical interviews (Positive and Negative Syndrome Scale (PANSS), Calgary Depression Scale for Schizophrenia (CDSS), Alcohol Use Disorder Identification Test (AUDIT), and Drug Use Disorder Identification Test (DUDIT)). Blood levels of suPAR, glucose, lipids, and high sensitivity C-reactive protein (hsCRP) were determined and body mass index (BMI) calculated. Multivariable linear regression analyses were used adjusting for confounders, and sex interaction tested in significant variables. Results Adjusting for sex, age, current tobacco smoking and BMI, we found that levels of hsCRP and depressive symptoms (CDSS) were positively associated with levels of suPAR ( p < 0.001). The association between suPAR and CDSS score was significant in females ( p < 0.001) but not in males. Immune activation measured by hsCRP was not associated with depressive symptoms after adjusting for BMI. Conclusion Our findings indicate that increased suPAR levels are associated with depressive symptoms in females with schizophrenia, suggesting aberrant immune activation in this subgroup. Our results warrant further studies, including longitudinal follow-up of suPAR levels in schizophrenia and experimental studies of mechanisms.