Abstract Background Lifestyle interventions can increase the probability of remission of prediabetes to normal glucose tolerance, but their economic value remains unclear. We assessed the within-trial and lifetime-horizon modeled cost-effectiveness of intensive and conventional lifestyle interventions in risk-stratified participants with prediabetes. Methods A health economic evaluation was conducted alongside the 12-month multicenter PLIS trial (n=1,105). High-risk participants were randomized to intensive (HR-INT) or conventional (HR-CONV); low-risk participants to conventional lifestyle intervention (LR-CONV) or control (only short single consultation; LR-CTRL) with risk stratification based on insulin secretion, insulin sensitivity, and liver fat content. Within-trial analyses estimated incremental costs per additional remission to normoglycemia and per quality-adjusted life year (QALY). Lifetime cost-effectiveness was modelled using a four-state Markov Model. Findings At 12 months, HR-INT and LR-CONV increased remission compared with their respective comparators. The incremental cost per additional remission was €7,081 (95% CI: dominated-47,277) for HR-INT and €4,278 (1,312–11,793) for LR-CONV from a health insurance perspective. A willingness-to-pay of €22,000 (HR-INT) and €7,500 (LR-CONV) per additional remission corresponded to 90% probability of cost-effectiveness. Neither intervention was cost-effective in terms of QALYs gained within the 12-months period. Lifetime modelling suggested that both HR-INT and LR-CONV are not only cost-effective, but also cost-saving, relative to HR-CONV and LR-CTRL, respectively. Also in the probabilistic sensitivity analysis, most simulations indicated dominance (71.7% for HR and 88% for LR). Interpretation Based on short-term economic evaluation, the interventions assessed were cost-effective regarding additional participants with remission, not for incremental QALYs gained. Lifetime modelling suggests cost savings for both risk groups. Targeting populations with lifestyle interventions to achieve prediabetes remission seems to generate good value for money in the long term. Trial registration number: NCT01947595 Research in context What is already known about this subject? Lifestyle modification is pivotal for type 2 diabetes prevention in individuals with prediabetes; improvements are needed to overcome nonresponse to preventive interventions. The 12-month Prediabetes Lifestyle Intervention Study (PLIS) was the first multicenter study, which involved eight study sites in university hospitals in Germany, where investigators prospectively tested different intensities of lifestyle intervention in a risk-stratified manner. PLIS achieved higher remission rates of prediabetes with an intensive lifestyle intervention (16 counseling sessions) in high-risk participants and a conventional lifestyle intervention (8 counselling sessions) in low-risk participants, relative to a conventional (8 counselling sessions) and control lifestyle intervention (single short counselling session), respectively. As risk-stratified diabetes prevention has not been implemented so far and more intense lifestyle interventions are usually associated with higher healthcare utilization, it remains unclear whether these interventions are cost-effective. What is the key question? Are intensive and conventional lifestyle interventions of the Prediabetes Lifestyle Intervention Study cost-effective after 12 months and over the lifetime horizon? What are the new findings? Intensive lifestyle intervention in high-risk participants and the conventional lifestyle intervention in low-risk participants are both likely to be cost-effective at a willingness-to-pay threshold between €10,000 and €20,000 per additional person with prediabetes remission. Neither intensive lifestyle intervention nor conventional lifestyle intervention are cost-effective in terms of quality adjusted life years gained in the 12-month trial period; however, this was not unexpected, given the limited scope for short-term improvement in health-related quality of life in a largely asymptomatic population with high baseline utility values. Simulation modeling with a lifetime horizon thereby shows that intensive lifestyle intervention in high-risk participants and conventional lifestyle intervention in low-risk participants may be not only cost-effective but also cost-saving. How might this impact on clinical practice in the foreseeable future? Individualized, risk phenotype-based lifestyle intervention in prediabetes may be cost-effective regarding remission to normal glucose regulation in the short- and regarding quality-adjusted life years gained the long-term. When evaluating lifestyle-based type 2 diabetes prevention, a long-term perspective is essential, as the intervention may translate into clinically meaningful and economically relevant benefits only over time through delayed diabetes onset, fewer diabetes-related complications, and reduced healthcare utilization.

Postoperative follow-up care after metabolic bariatric surgery (MBS) is considered essential to achieve optimal outcomes. These follow-up care pathways were partially disrupted during the COVID-19 pandemic. Our objective was to investigate whether the COVID-19 pandemic and in particular the first (spring 2020) and the second wave (winter 2020/2021) had an impact on short-term outcomes of MBS in Germany. We analyzed data of 5,859 patients from 154 bariatric centers across Germany. Our predefined endpoints were percentage total weight loss (

Background: Metabolic and bariatric surgery (MBS) improves the health and quality of life of patients with severe obesity. Interdisciplinary, structured postoperative follow-ups are recommended. Evidence of structured, close-to-home, standardized, non–center-based follow-up programs is limited. Methods: This multicenter, prospective, non-randomized study examined the effects of a non–center-based structured, close-to-home, cross-sectoral, 18-month follow-up program that included trained outpatient physicians, electronic health records, an app, and bariatric case managers. The early intervention group (IG1) started immediately, and the late intervention group (IG2) started 18 months after surgery and were compared to two control groups (CGs) receiving usual center-based follow-ups. The primary endpoint was general health [measured by the modified composite King’s Score (KS)], and secondary endpoints included various quality-of-life measures. The endpoint assessment was conducted 18 months (IG1 vs CG1) and 36 months (IG2 vs CG2) after MBS. Results: MBS substantially reduced body weight and improved comorbidities in all groups. After 18 months, the health status of IG1 ( n = 72) was significantly better than that of CG1 ( n = 180) [KS: 5.79 (95% confidence interval 4.70–6.89) vs 7.22 (6.33–8.10); P = 0.030], while IG2 ( n = 128) and CG2 ( n = 168) did not differ [KS: 7.80 (6.62–8.98) vs KS: 8.03 (6.96–9.11)]. The quality of life of IG1 was also better than that of CG1 (EQ-5D-5L Index: 0.93 vs 0.89, P < 0.05; Short Form-36 Physical Component Score (SF-36 PCS): 53.16 vs 50.32, P < 0.05; Bariatric Quality of Life Index (BQL): 4.20 vs 3.92, P < 0.01), and symptoms of anxiety were reduced [Generalized Anxiety Disorder 7 (GAD-7): 10.32 vs 11.47, P < 0.05]. Conclusions: A qualified non-center-based follow-up program after MBS seems superior in the short term and not inferior in the mid-term to the usual center-based care. Therefore, structured postoperative outpatient care could become a viable option to improve patient care and relieve the workload on specialized obesity centers.

Introduction: Almost 25% of German adults have obesity and numbers are rising, making it an important health issue. Bariatric-metabolic surgery reduces body weight and complications for persons with obesity, but therapeutic success requires long-term postoperative care. Since no German standards for follow-up by family physicians exist, follow-up is provided by surgical obesity centers, but they are reaching their limits. The ACHT study, funded by the German Innovation Fund, is designed to establish and evaluate the follow-up program, with local physicians following patients supported remotely by obesity centers. Methods: ACHT is a multicenter, prospective, non-randomized control group study. The 18-month ACHT follow-up program is a digitally supported, structured, cross-sectoral, and close-to-home program to improve success after bariatric-metabolic surgery. Four groups are compared: intervention group 1 starts the program immediately (3 weeks) after Roux-en-Y gastric bypass or sleeve gastrectomy (months 1-18 postoperatively), intervention group 2 begins the program 18 months after surgery (months 19-36 postoperatively). Intervention groups are compared to respective control groups that had surgery 18 and 36 months previously. In total, 250 patients, enrolled in the intervention groups, are compared with 360 patients in the control groups, who only receive standard care. Results: The primary endpoint to compare intervention and control groups is the adapted King's score, a composite tool evaluating physical, psychological, socioeconomic, and functional health status. Secondary endpoints include changes in care structures and care processes for the intervention groups. Multivariate regression analyses adjusting for confounders (including the type of surgery) are used to compare intervention and control groups and evaluate determinants in longitudinal analyses. The effect of the intervention on healthcare costs will be evaluated based on health insurance billing data of patients who had bariatric-metabolic surgery in the 3 years prior to the start of the study and of patients who undergo bariatric-metabolic surgery during the study period. Conclusions: ACHT will be the one of the first evaluated structured, close-to-home follow-up programs for bariatric surgery in Germany. It will evaluate the effectiveness of the implemented program regarding improvements in health status, mental health, quality of life, and the feasibility of such a program outside of specialized obesity centers.

Passive alveolar molding (PAM) and nasoalveolar molding (NAM) are established presurgical infant orthodontic (PSIO) therapies for cleft lip palate (CLP) patients. PAM guides maxillary growth with a modified Hotz appliance, while NAM also uses extraoral taping and includes nasal stents. The effects of these techniques on alveolar arch growth have rarely been compared. We retrospectively compared 3D-scanned maxillary models obtained before and after PSIO from infants with unilateral, non-syndromic CLP treated with PAM (n = 16) versus NAM (n = 13). Nine anatomical points were set digitally by four raters and transversal/sagittal distances and rotations of the maxilla were measured. Both appliances reduced the anterior cleft, but NAM percentage wise more. NAM decreased the anterior and medial transversal width compared to PAM, which led to no change. With both appliances, the posterior width increased. The alveolar arch length of the great and small segments and the sagittal length of the maxilla increased with PAM but only partially with NAM. However, NAM induced a significant greater medial rotation of the larger and smaller segment compared to PAM with respect to the lateral angle. NAM and PAM presented some significant differences regarding maxillary growth. While NAM reduced the anterior cleft and effectively rotated the segments medially, PAM allowed more transversal and sagittal growth. The results of this study should be taken into consideration when to decide whether to use PAM or NAM, since they show a different outcome within the first few months. Further studies are necessary regarding long-term differences.

Our analysis shows that metabolic-bariatric surgery leads to a relevant reduction in antidiabetic medications and their costs in everyday care. However, 3-year follow-up data is limited in this data set leading to wide confidence intervals. Mixed models help estimate mean costs and number of medications, but a higher number of patients would be preferable for estimates. With the introduction of the structured ACHT-program, other important aspects of care, such as access to local medical follow-up, psychological support and quality of life, will be evaluated.

Abstract Background The COVID-19 pandemic induced restrictions in daily life and anxiety especially in vulnerable parts of the population. We investigated the psycho-social burden of the pandemic and self-perceived risk and harm in a large IBD cohort. Methods In this monocentric prospective observational study, pediatric (pIBD) and adult patients completed questionnaires related to their IBD (phenotype, disease activity, treatment), comorbidities, demographic and socioeconomic factors, validated tools on Perceived Stress (PSQ) and quality of life (sIBDQ). They judged perception of harm in case of acquiring COVID-19 using ratings from 1 to 7. We used number and type of established conditions for severe COVID-19 outcome to categorize patients in 5 risk groups. SARS-CoV2 antibodies were determined by Elecsys Roche anti-N pan-Ig. All comparisons were made by using t-test, Mann-Whitney-U-test or Chi-square-test where applicable with 2-sided significance levels of 5%. Univariate and multiple logistic regression was performed to determine associations between factors and perceived harm. Results Between mid-July to mid-October, 504 (62%) of 820 invited IBD patients and 86 pIBD parents completed the survey. Age ranged from 6-85 years, 80% received mono- or combo-therapy with immunomodulator, biologic, JAK-inhibitor or corticosteroids. Remission, mild, moderate and severe disease activity were reported by 46, 39, 12 and 3%, respectively. High harm of potential COVID-19 (>3) was perceived by 75.4%, rates increased with age (p=0.0019). After adjusting for age and gender, high perceived harm was significantly associated with immunosuppressive drugs, number/type of comorbidities, sleep disturbance, unintended gain or loss of weight, higher PSQ and lower sIBDQ scores. PSQ scored lower in males >60 years vs age matched females or younger adults, and in patients in remission vs active disease. PIBD mothers’ total PSQ was similar with even higher subscores for demands (P=0.0004) as adults with moderate/severe disease. Compared to pre-pandemic, 58-93% of pIBD decreased physical activities (at home, sports, outdoor) with minor changes in adults. SARS-CoV-2 serology was positive in 0.4% of IBD patients compared to 2% of our city population. Conclusion Prior to 2nd infection wave, even IBD patients aged <40 years suffer from a high degree of worries, stress and perceived harm for potential COVID-19. Most elderly patients and those with comorbidities adequately estimate their risks. In pIBD, pandemic restrictions substantially impacted on physical activity. The low seropositivity rate indicates high adherence to social distancing or altered immune response due to IBD drugs. Results of the follow up survey in March 21 are underway.

Background: COVID-19-associated restrictions impact societies. We investigated the impact in a large cohort of inflammatory bowel disease (IBD) patients. Methods: Pediatric (pIBD) and adult patients and pIBD parents completed validated questionnaires for self-perceived stress (Perceived Stress Questionnaire, PSQ) and quality of life from July to October 2020 (1st survey) and March to April 2021 (2nd survey). Analyses were stratified by age groups (6–20, >20–40, >40–60, >60 years). Perceived risk of infection and harm from COVID-19 were rated on a 1–7 scale. An index for severe outcome (SIRSCO) was calculated. Multivariable logistic regression analysis was performed. Results: Of 820 invited patients, 504 (62%, 6–85 years) patients and 86 pIBD parents completed the 1st, thereof 403 (80.4%) the 2nd survey. COVID-19 restrictions resulted in cancelled doctoral appointments (26.7%), decreased physical activity, increased food intake, unintended weight gain and sleep disturbance. PSQ increased with disease activity. Elderly males rated lower compared to females or younger adults. PSQ in pIBD mothers were comparable to moderate/severe IBD adults. Infection risk and harm were perceived high in 36% and 75.4%. Multivariable logistic models revealed associations of higher perceived risk with >3 household members, job conditions and female gender, and of perceived harm with higher SIRSCO, unintended weight change, but not with gender or age. Cancelled clinic-visits were associated with both. SARS-CoV-2 antibodies prior 2nd infection wave were positive in 2/472 (0.4%). Conclusions: IBD patients report a high degree of stress and self-perceived risk of complications from COVID-19 with major differences related to gender and age. Low seroprevalence may indicate altered immune response.

Background Obesity can significantly reduce health-related quality of life (HRQoL) and may lead to numerous health problems even in youths. This study aimed to investigate whether HRQoL varies among youths with obesity depending on grade of obesity and other factors. Methods For the Youths with Extreme obesity Study (YES) (2012–2014), a prospective multicenter cohort study, a baseline sample of 431 obese and extremely obese adolescents and young adults (age 14 to 24 years, BMI ≥30 kg/m 2 ) was recruited at four German university medical centers and one job center. Obesity grade groups (OGG) were defined according to BMI (OGG I: 30–34.9 kg/m 2 , OGG II: 35–39.9 kg/m 2 , OGG III (extreme obesity): ≥40 kg/m 2 ). HRQoL was measured with the Euroqol-5D-3 L (EQ-5D-3 L), DISABKIDS chronic generic (DCGM-31) and the KINDL R obesity module. Differences between OGGs were assessed with logistic and linear regression models, adjusting for age, sex, and study center in the base model. In a second regression analysis, we included other characteristics to identify possible determinants of HRQoL. Results Three hundred fifty-two adolescents (mean age: 16.6 (±2.4), mean BMI: 39.1 (±7.5) kg/ m 2 ) with available HRQoL data were analysed. HRQoL of youths in all OGGs was markedly lower than reference values of non-obese adolescents. Adjusting for age and sex, HRQoL of youths in OGG III significantly impaired compared to OGG I. Youths in OGG III were 2.15 times more likely to report problems with mobility in the EQ-5D-3 L than youths in OGG I. A mean difference of 9.7 and 6.6 points between OGG III and I were found for DCGM-31 and KINDL respectively and 5.1 points between OGG II and I for DCGM-31. Including further variables into the regression models, showed that HRQoL measured by DCGM-31 was significantly different between OGGs. Otherwise, female sex and having more than 4 h of daily screen time were also associated with lower HRQoL measured by DCGM-31 and KINDL. Conclusion HRQoL of adolescents with obesity is reduced, but HRQoL of adolescents with extreme obesity is particularly affected. Larger and longitudinal studies are necessary to understand the relation of extreme obesity and HRQoL, and the impact of other lifestyle or socioeconomic factors. Trial Registration Clinicaltrials.gov NCT01625325 ; German Clinical Trials Register (DRKS) DRKS00004172.

Aim This cross-sectional study used a large nationwide claims data set to assess the excess medical costs of people with type 2 diabetes according to age group in 2015. Methods Data from 291 709 people with diabetes and 291 709 age- and sex-matched controls were analysed. Total costs (expressed as 2015 euros) of outpatient and inpatient services, medication, rehabilitation, and the provision of aids and appliances were examined. Overall and age-stratified excess costs of people with diabetes were estimated using gamma regression with a log-link. Results Overall, the estimated total direct costs of a person with type 2 diabetes are approximately double those of a person without diabetes: euro4727 vs. euro2196, respectively. Absolute excess costs were approximately the same in all age groups (around euro2500), however, relative excess costs of persons with diabetes were much higher in younger (similar to 334% for < 50 years) than in older age groups (similar to 156% for >= 80 years). Regional costs, both absolute and excess, partly differed from the national level. Conclusions This study complements and updates previous studies on the excess medical costs of people with diabetes in Germany. The results indicate the importance of preventing the development of type 2 diabetes, especially in younger age groups. Longitudinal and regional studies examining changes in prevalence and the development of excess costs in groups with different types of diabetes, and according to age, would be of interest to validate our findings and better understand the avoidable burden of having diabetes.

CONTEXT In recent decades, obesity and type 2 diabetes mellitus (T2DM) have both become global epidemics associated with substantial healthcare needs and costs. OBJECTIVE The aim of this review was to critically assess nutritional interventions for their impact on healthcare costs to community-dwelling individuals regarding T2DM or obesity or both, specifically using CHEERS (Consolidated Health Economic Evaluation Reporting Standards) criteria to assess the economic components of the evidence. DATA SOURCES Searches were executed in Embase, EconLit, AgEcon, PubMed, and Web of Science databases. STUDY SELECTION Studies were included if they had a nutritional perspective, reported an economic evaluation that included healthcare costs, and focused on obesity or T2DM or both. Studies were excluded if they examined clinical nutritional preparations, dietary supplements, industrially modified dietary components, micronutrient deficiencies, or undernutrition; if they did not report the isolated impact of nutrition in complex or lifestyle interventions; or if they were conducted in animals or attempted to transfer findings from animals to humans. DATA EXTRACTION A systematic review was performed according to PRISMA guidelines. Using predefined search terms, 21 studies evaluating food habit interventions or taxation of unhealthy foods and beverages were extracted and evaluated using CHEERS criteria. RESULTS Overall, these studies showed that nutrition interventions and taxation approaches could lead to cost savings and improved health outcomes when compared with current practice. All of the included studies used external sources and economic modeling or risk estimations with population-attributable risks to calculate economic outcomes. CONCLUSIONS Most evidence supported taxation approaches. The effect of nutritional interventions has not been adequately assessed. Controlled studies to directly measure economic impacts are warranted.

Objectives Adolescent extreme obesity is associated with somatic and psychiatric comorbidity, low quality of life, and social dysfunction. Nevertheless, few adolescents seek obesity treatment, thus many may elope appropriate care. We examine whether previous treatment seeking relates to disease burden, and whether previously non-treatment seeking adolescents accept diagnostic and therapeutic offers. This information is important to inform intervention strategies. Methods The Youth with Extreme obesity Study (YES) is a prospective, multicenter cohort study. We developed a novel recruitment strategy to span medical and vocational ascertainment settings and directly compare previously treatment seeking and non-treatment seeking youth. Participants aged 14–24 years; BMI ≥ 30 kg/m 2 were enrolled at four medical- and one job centers. We present comorbidity and psycho-social baseline data by sex, obesity WHO grade I-III, and treatment-seeking status, defined as self-reported previous participation in a weight-loss program. Results Of 431 participants, 47% were male; mean age 16.6 (standard deviation 2.3) years, BMI 39.2 (7.5) kg/m 2 . Somatic comorbidity increased with obesity grade, p < 0.05: hypertension (42, 55, 64%), dyslipidemia (28, 24, 37%,), dysglycemia (9, 19, 20%,), elevated transaminases (15, 26, 30%). Quality of life (EQ5 D) decreased (74, 71, 70). Rates of psychiatric disorders were stable: depression 11%, attention deficit disorder 6%, substance use disorder 2%, self-injurious behavior 5%, suicide attempt 3%. Only 63% (56, 64, 69%) reported previous treatment seeking. Acceptance of the diagnostic (89%) or therapeutic (28%) program, medical or psychosocial situation did not differ by treatment seeking status. Acceptance of the therapeutic program was generally low, but high at the job center (92%). Conclusion Irrespective of previous treatment seeking, adolescent extreme obesity was associated with high comorbidity and psychosocial burden. Acceptance of the diagnostic program overall and the therapeutic program at the job center were high. This underscores the need of innovative, accessible programs beyond the currently offered care.

Regular walnut consumption is associated with better health. We have previously shown that eight weeks of walnut consumption (43 g/day) significantly improves lipids in healthy subjects. In the same study, gut microbiome was evaluated. We included 194 healthy subjects (134 females, 63 ± 7 years, BMI 25.1 ± 4.0 kg/m2) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (eight weeks each); 96 subjects first followed a walnut-enriched diet (43 g/day) and then switched to a nut-free diet, while 98 subjects followed the diets in reverse order. While consuming the walnut-enriched diet, subjects were advised to either reduce fat or carbohydrates or both to account for the additional calories. Fecal samples were collected from 135 subjects at the end of the walnut-diet and the control-diet period for microbiome analyses. The 16S rRNA gene sequencing data was clustered with a 97% similarity into Operational Taxonomic Units (OTUs). UniFrac distances were used to determine diversity between groups. Differential abundance was evaluated using the Kruskal–Wallis rank sum test. All analyses were performed using Rhea. Generalized UniFrac distance shows that walnut consumption significantly affects microbiome composition and diversity. Multidimensional scaling (metric and non-metric) indicates dissimilarities of approximately 5% between walnut and control (p = 0.02). The abundance of Ruminococcaceae and Bifidobacteria increased significantly (p < 0.02) while Clostridium sp. cluster XIVa species (Blautia; Anaerostipes) decreased significantly (p < 0.05) during walnut consumption. The effect of walnut consumption on the microbiome only marginally depended on whether subjects replaced fat, carbohydrates or both while on walnuts. Daily intake of 43 g walnuts over eight weeks significantly affects the gut microbiome by enhancing probiotic- and butyric acid-producing species in healthy individuals. Further evaluation is required to establish whether these changes are preserved during longer walnut consumption and how these are linked to the observed changes in lipid metabolism.

Background: PCSK9 inhibitors (PCSK9i) decrease LDL-cholesterol by ∼50% in hypercholesterolemia. However, it is unclear whether PCSK9i decrease all LDL-subfractions equally. Methods: We evaluated the effect of PCSK9i on LDL-subfractions in 16 patients (63±11y, BMI 29.9±5.0kg/m2) with coronary

This study aims to analyse the non-linear relationship between Body Mass Index (BMI) and direct health care costs, and to quantify the resulting cost fraction attributable to obesity in Germany. Five cross-sectional surveys of cohort studies in southern Germany were pooled, resulting in data of 6757 individuals (31–96 years old). Self-reported information on health care utilisation was used to estimate direct health care costs for the year 2011. The relationship between measured BMI and annual costs was analysed using generalised additive models, and the cost fraction attributable to obesity was calculated. We found a non-linear association of BMI and health care costs with a continuously increasing slope for increasing BMI without any clear threshold. Under the consideration of the non-linear BMI-cost relationship, a shift in the BMI distribution so that the BMI of each individual is lowered by one point is associated with a 2.1% reduction of mean direct costs in the population. If obesity was eliminated, and the BMI of all obese individuals were lowered to 29.9 kg/m2, this would reduce the mean direct costs by 4.0% in the population. Results show a non-linear relationship between BMI and health care costs, with very high costs for a few individuals with high BMI. This indicates that population-based interventions in combination with selective measures for very obese individuals might be the preferred strategy.