Early MOnitoring of REsponse (MORE) to Golimumab Therapy: Results of a Multicentre, Prospective Observational Trial.

BACKGROUND: The therapeutic goal of clinical remission in patients with moderate to severe ulcerative colitis (UC) is achieved after biological therapy only in 16-39%. Individualization of therapeutic intervention would benefit from prediction of early response. STUDY OBJECTIVE: The primary objective of our study was to assess golimumab (GLM) trough serum level of ≥2.5 µg/mL in combination with a reduction of faecal calprotectin (FC) of ≥50% at week 6 compared to baseline to predict clinical response at week 26 after regular GLM intake. METHODS: Patients with moderate to severe active UC and planned GLM treatment were recruited for a prospective, multicentre, observational study in Germany. Prediction of clinical response was assessed by FC and GLM trough level. Missing data were imputed as therapy failure according to the last observation carried forward method. RESULTS: Fifty nine patients have been enrolled. 54% of patients were anti-TNF naïve. Clinical response at week 6 was a significant predictor for achieving clinical response at week 26 (odds ratio [OR] 10.97, confidence interval [CI], 2.96-40.68; p < 0.001). Moreover, patients with a GLM trough level of ≥2.5 µg/mL and a ≥50% reduction of FC at week 6 had an OR of 5.33 (95% CI, 0.59-47.84) to achieve clinical response at week 26. CONCLUSION: Clinical response at week 6 is the best predictive marker for achieving clinical response at week 26. Consideration of significant reduction of FC and trough GLM serum levels could improve prediction of response.

Prevalence of Itch in German Schoolchildren: A Population-based Study.

Itch is a common symptom, but there is limited evidence on the prevalence of itch in children. The aim of this study was to assess the prevalence of itch in schoolchildren. A questionnaire was developed by experts in the field and based on a literature search. The questionnaire was applied in a pilot study of 25 consecutively selected paediatric patients and their parents. It confirmed the high content validity of the questionnaire, and the questionnaire was comparable to hospital records regarding chronic itch (n = 19, mean consistency 89.47%). The questionnaire was distributed among German schoolchildren in 9/12 randomly selected primary schools in Kiel, Germany. Of 1,722 invited students, 443 schoolchildren aged 6-10 years participated, and 26.2% (n = 116) reported itch. The prevalence of acute itch was 20.0% (n = 87), and 14.7% (n = 65) reported chronic itch. Reduced sleep and mood were often related to chronic itch. This study demonstrated that itch is a common symptom in German schoolchildren.

Profile of patients with inflammatory bowel disease in conjunction with unmet needs and decision-making for choosing a new biologic therapy: a baseline analysis of the VEDOIBD-Study.

PURPOSE: We characterized the profile of Crohn's disease (CD) or ulcerative colitis (UC) biologic-naïve patients (starting a new therapy with vedolizumab or TNFα-antagonists), their baseline disease activity predictors, and their perception of the quality of life (HRQoL). METHODS: The VEDOIBD-Study is a real-world study on the effectiveness of vedolizumab vs other biologics as induction and maintenance therapy for CD and UC. A total of 627 CD and 546 UC patients were enrolled from IBD-experienced centers across Germany. In both biologic-naïve vedolizumab (n=397) and anti-TNF (n=359) patients, CD and UC disease severity and HRQoL predictors were analyzed with logistic regression. The results were reported as odds ratio (OR) and 95% confidence interval (CI). RESULTS: When compared to biologic-naïve anti-TNF patients, a first biological therapy with vedolizumab was considered for older CD patients, with a less complicated though longer disease course, and with a history of comorbidities. No differences in (unmet) needs were observed among patients with UC. The presence of extra-intestinal manifestations in biologic-naïve anti-TNF patients with CD (OR (95% CI): 3.83 (1.69-8.68)) and, in both biologic-naïve groups of patients with UC, stool frequency (2.00 (1.25-3.19); 1.82 (1.10-3.02), respectively) and rectal bleeding (2.24 (1.20-4.18); 1.92 (1.19-3.11), respectively) emerged as the most important predictors of disease severity, which in turn were also significantly associated with a worse HRQoL. CONCLUSION: This study highlights the existence of unmet medical needs of patients with CD or UC, for whom a new biological therapy is planned as part of the VEDOIBD-Study, which considerably impacts their HRQoL.

Dietary pattern associated with selenoprotein P and MRI-derived body fat volumes, liver signal intensity, and metabolic disorders.

PURPOSE: The association of complex dietary patterns with circulating selenoprotein P (SELENOP) levels in humans is unknown. In a general population sample, we aimed to identify a dietary pattern explaining inter-individual variation in circulating SELENOP concentrations and to study this pattern in relation to prevalent diabetes, metabolic syndrome (MetS), MRI-determined total volumes of visceral (VAT) and subcutaneous (SAT) abdominal adipose tissue, and liver signal intensity/fatty liver disease. METHODS: In this cross-sectional study, serum SELENOP levels were measured in 853 individuals. In a subsample of 553 participants, whole-body MRI was performed to assess body fat distribution and liver fat. Dietary intake was assessed by a self-administered food frequency questionnaire and the dietary pattern identified using reduced-rank regression (RRR). Multivariable linear and logistic regressions were used to investigate associations between dietary pattern score and metabolic traits. RESULTS: Characterized by high intake of fruit, vegetables and antioxidant beverages, the RRR-derived dietary pattern displayed inverse associations with VAT, SAT, MetS, and prevalent diabetes in multivariable-adjusted restricted cubic splines. Each unit increase in dietary pattern score was associated with 31% higher SELENOP levels, 12% lower VAT (95% CI: - 19%; - 5%), 13% (95% CI: - 20%; - 6%) lower SAT values and 46% (95% CI: 27%; 60%) and 53% (95% CI: 22%; 72%) lower odds of having MetS or diabetes, respectively. No meaningful relations were observed between the dietary pattern and liver traits. CONCLUSIONS: Our observations propose diet-related regulation in SELENOP levels and that the identified dietary pattern is inversely related to VAT, SAT, MetS, and prevalent diabetes.

Postdiagnostic Mediterranean and Healthy Nordic Dietary Patterns Are Inversely Associated with All-Cause Mortality in Long-Term Colorectal Cancer Survivors.

Background: Dietary factors are known to affect the risk of new-onset colorectal cancer (CRC), but information on the extent to which postdiagnostic diet affects mortality in long-term CRC survivors is scarce.Objective: We investigated the association of 2 a priori-defined postdiagnostic dietary patterns [Modified Mediterranean Diet Score (MMDS) and healthy Nordic Food Index (HNFI)] with all-cause mortality in long-term CRC survivors.Methods: Diet was assessed at a median time of 6 y after cancer diagnosis in 1404 CRC survivors (median age: 69 y; 56% men) in a prospective cohort study in Northern Germany by using a semiquantitative food-frequency questionnaire. Cox proportional hazard models, adjusting for clinical and sociodemographic characteristics, were used to assess associations of the MMDS and the HNFI with all-cause mortality.Results: A total of 204 patients died during a median follow-up time of 7 y after diet assessment. In multivariable-adjusted models, higher adherence to the modified Mediterranean diet was significantly associated with lower all-cause mortality (HR: 0.48; 95% CI: 0.32, 0.74 for highest compared with lowest score quartile and HR: 0.88; 95% CI: 0.81, 0.96 per 1-point increment in pattern score). Similarly, the HNFI was inversely associated with all-cause mortality when the highest was compared with the lowest index quartile (HR: 0.63; 95% CI: 0.39, 1.04) and when modeled as a continuous trait (HR: 0.90; 95% CI: 0.82, 0.99 per 1-point increment in the score).Conclusions: Our results suggest that higher adherences to the Mediterranean diet and to the healthy Nordic diet after CRC diagnosis are associated with better overall survival in long-term CRC survivors.

Postdiagnostic physical activity, sleep duration, and TV watching and all-cause mortality among long-term colorectal cancer survivors: a prospective cohort study.

BACKGROUND: Lifestyle recommendations for cancer survivors are warranted to improve survival. In this study, we aimed to examine the association of total physical activity, different types of physical activity, hours of sleeping at day and night, and hours spent watching television (TV) with all-cause mortality in long-term colorectal cancer (CRC) survivors. METHODS: We assessed physical activity in 1376 CRC survivors (44% women; median age, 69 years) at median 6 years after CRC diagnosis using a validated questionnaire. Multivariable-adjusted Cox regression models were used to estimate hazard ratios (HRs) for all-cause mortality according to categories of physical activities, sleep duration, and TV watching. RESULTS: During a median follow-up time of 7 years, 200 participants had died. Higher total physical activity was significantly associated with lower all-cause mortality (HR: 0.53; 95% CI: 0.36-0.80, 4th vs. 1st quartile). Specifically, sports, walking, and gardening showed a significant inverse association with all-cause mortality (HR: 0.34; 95% CI: 0.20-0.59, HR: 0.65; 95% CI: 0.43-1.00, and HR: 0.62; 95% CI: 0.42-0.91, respectively for highest versus lowest category). Individuals with ≥2 h of sleep during the day had a significantly increased risk of all-cause mortality compared to individuals with no sleep at day (HR: 2.22; 95% CI: 1.43-3.44). TV viewing of ≥4 h per day displayed a significant 45% (95% CI: 1.02-2.06) higher risk of dying compared to ≤2 h per day of watching TV. CONCLUSIONS: Physical activity was inversely related to all-cause mortality; specific activity types might be primarily responsible for this association. More hours of sleep during the day and a higher amount of TV viewing were each associated with higher all-cause mortality. Based on available evidence, it is reasonable to recommend CRC survivors to engage in regular physical activity.

Inflammatory bowel disease (IBD) patients with impaired quality of life on biologic therapy benefit from the support of an IBD nurse specialist: Results of a randomised controlled trial in Germany (IBDBIO-ASSIST study).

BACKGROUND: IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by IBD nurse specialists in Germany in improving health-related quality of life (QoL) in IBD patients on biologic therapy. AIM: To evaluate patient-related outcomes and economic consequences associated with integrating IBD nurses into usual care. METHODS: We randomly assigned 1086 patients with IBD on biologic therapy to a control group (CG) receiving usual care or an intervention group (IG) receiving additional care from an IBD nurse specialist. The primary outcome was disease-specific QoL (sIBDQ) assessed at 6, 12 and 18 months. RESULTS: At baseline, patients in both groups were highly satisfied with their treatment situation and had relatively high sIBDQ values (range: 1-7; CG: 5.12; IG: 4.92). In the intention-to-treat (ITT) analysis of the overall sample, there was no significant difference in sIBDQ between groups at the assessment time points. However, a per-protocol analysis of patients with impaired QoL at baseline (EQ-VAS < 75 [median]), showed improvement in sIBDQ over 6 months that became significant at month 12 and remained significant through month 18 (baseline: IG 4.24; CG 4.31; 18 months: IG 5.02; CG 4.76; p = 0.017). CONCLUSION: High baseline satisfaction of IBD patients with treatment and the relatively high baseline sIBDQ values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired QoL derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term.

Health Status, Quality of Life, Psychosocial Well-being, and Wearables Data of Patients With Active Ulcerative Colitis Receiving Filgotinib Therapy (FilgoColitis Study): Protocol for a Real-world Observational Study.

BACKGROUND: Filgotinib was approved in Germany for treating patients with moderate to severe active ulcerative colitis in November 2021. It represents a preferential Janus kinase 1 inhibitor. The FilgoColitis study began recruiting immediately after approval and aims to assess filgotinib effectiveness under real-world conditions with a particular focus on patient-reported outcomes (PROs). The novelty of the study design is the optional inclusion of 2 innovative wearables, which could provide a new layer of patient-derived data. OBJECTIVE: The study investigates quality of life (QoL) and psychosocial well-being of patients with active ulcerative colitis during long-term exposure to filgotinib. PROs related to QoL and psychometric profiles (fatigue and depression) are collected alongside with disease activity symptom scores. We aim to evaluate physical activity patterns collected by wearables as an addition to traditional PROs, patient-reported health status, and QoL in different phases of disease activity. METHODS: This is a prospective, single-arm, multicentric, noninterventional, observational study with a sample size of 250 patients. QoL is assessed with validated questionnaires: the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) for the disease-specific QoL, the EQ-5D for the general QoL, and the fatigue questionnaire (Inflammatory Bowel Disease-Fatigue [IBD-F]). Physical activity data are collected from patients using wearables (SENS motion leg sensor [accelerometry] and smartwatch, GARMIN vívosmart 4). RESULTS: The enrollment started in December 2021 and was still open at the date of submission. After 6 months of study initiation, 69 patients were enrolled. The study is expected to be completed in June 2026. CONCLUSIONS: Real-world data for novel drugs are important to assess effectiveness outside of highly selected populations represented by randomized controlled trials. We examine whether patients' QoL and other PROs can be supplemented with physical activity patterns measured objectively. Use of wearables with newly defined outcomes represents an additional observational tool for monitoring disease activity in patients with inflammatory bowel disease. TRIAL REGISTRATION: German Clinical Trials Register DRKS00027327; https://drks.de/search/en/trial/DRKS00027327. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42574.

Evaluation of a downstaging, bidirectional version of the Montreal classification of Crohn's disease: Analysis of 5-year follow-up data from the prospective BioCrohn study.

OBJECTIVE: Under the assumption of irreversibility, the Montreal classification provides a unidirectional assessment of the complications and behaviour of Crohn's disease (CD) that does not allow for downstaging. We examined the use of a bidirectional Montreal classification system that can capture disease regression. DESIGN: From the BioCrohn Registry, an inception cohort of patients with CD for ≤12 months duration was defined and followed up for 5-years. Cumulative probabilities for developing complications were estimated using the Kaplan-Meier method. Potential associations of explanatory variables with disease progression were estimated with Cox regression. RESULTS: Among 393 incident CD patients (of whom 255 completed the entire follow-up), the 5-year cumulative probability of developing complications was 41.5% (15.6% and 25.9% for stricturing and penetrating complications respectively). Perianal disease (hazard ratio [95% confidence interval]: 8.45 [4.74-15.07]) and surgical resection of the intestine (2.71 [1.50-4.92]) in the very early phase of the disease were associated with a higher risk of developing a penetrating complication within the 5-year follow-up. The use of a bidirectional Montreal classification system which can account for disease regression demonstrated that 90% of patients exhibited inflammatory disease behaviour at 5 years, in contrast to 58%, if the hierarchical, unidirectional Montreal classification system was used. CONCLUSION: An additional bidirectional disease behaviour assessment capturing reversed or fully controlled complications may provide a more realistic appraisal of the complexity and unmet needs of patients treated with advanced therapies.

Real-world Comparative Effectiveness of Ustekinumab vs Anti-TNF in Crohn's Disease With Propensity Score Adjustment: Induction Phase Results From the Prospective, Observational RUN-CD Study.

BACKGROUND: In addition to randomized controlled trials (RCTs), real-world studies on the effectiveness of ustekinumab (UST) in Crohn's disease (CD) are required inasmuch as RCTs are usually confined to selected patients, which may not represent everyday clinical practice. Within the framework of the prospective real-world RUN-CD registry, a total of approximately 900 CD patients from 44 inflammatory bowel disease centers from all over Germany starting a new therapy with UST or other biologics were screened for a real-world evidence (RWE) comparison of CD patients with UST vs antitumor necrosis factor (TNF). METHODS: A total of 618 CD patients with a nonrandomized biological therapy were qualified for this induction phase effectiveness RUN-CD study of UST vs anti-TNF. To reduce selection bias in estimations of treatment effects, the propensity score with inverse probability of treatment weighting was implemented. The results were reported as odds ratio (OR) and 95% confidence interval (CI). RESULTS: A total of 339 UST and 279 anti-TNF patients were analyzed. The effectiveness of UST vs anti-TNF in terms of clinical remission (UST 65.4% vs anti-TNF 63.0%; OR, 1.11; 95% CI, 0.71-1.74) and steroid-free remission (UST 51.0% vs anti-TNF 53.8%; OR, 0.94; 95% CI, 0.60-1.47) was comparable at the end of induction therapy. Similar results were observed in the bio-naïve and bio-experienced UST vs anti-TNF groups. For both, the remission rates were higher in the bio-naïve than in the bio-experienced groups (P < .05). CONCLUSIONS: In this prospective, observational RUN-CD study, the RWE head-to-head comparison of UST vs anti-TNF showed similar induction effectiveness in both groups, remarkably higher than those found in prior RCTs.

The higher effectiveness outcome rates observed in patients treated with UST compared with pivotal studies in combination with its known favorable safety profile and an improved HRQoL support UST use as a first-line, advanced therapy in CD.

Real-World Effectiveness of Vedolizumab vs Anti-TNF in Biologic-naïve Crohn's Disease Patients: A 2-year Propensity-score-adjusted Analysis from the VEDOIBD-Study.

BACKGROUND: The aim of this observational, real-world evidence, modified intention-to-treat (mITT) study based on prospectively collected data from the VEDOIBD registry was to compare the effectiveness of vedolizumab (VEDO) vs antitumor necrosis factor (anti-TNF) in biologic-naïve Crohn's disease (CD) patients. METHODS: Between 2017 and 2020, 557 CD patients starting therapy with VEDO or anti-TNF were consecutively enrolled in 45 IBD centers across Germany. Per study protocol, the analysis excluded biologic-experienced patients and those with a missing Harvey-Bradshaw Index score, resulting in a final sample of 327 biologic-naïve CD patients. Clinical remission was measured using the Harvey-Bradshaw Index at the end of induction therapy and after 1 and 2 years. Switching to a different therapy was considered an outcome failure. Propensity score adjustment with inverse probability of treatment weighting was used to correct for confounding. RESULTS: The effectiveness of both VEDO (n = 86) and anti-TNF (n = 241) was remarkably high for induction treatment, but VEDO performed significantly less well than anti-TNF (clinical remission: 56.3% vs 73.9%, P < .05). In contrast, clinical remission after 2 years was significantly better for VEDO compared with anti-TNF (74.2% vs 44.7%; P < .05; odds ratio, 0.45; 95% CI, 0.22-0.94). Remarkably, only 17% of patients switched from VEDO to another biologic vs 44% who received anti-TNF. CONCLUSIONS: The results of this prospective, 2-year, real-world evidence study suggest that the choice of VEDO led to higher remission rates after 2 years compared with anti-TNF. This could support the role of VEDO as a first-line biologic therapy in CD.

Real-world effectiveness of vedolizumab compared to anti-TNF agents in biologic-naïve patients with ulcerative colitis: A two-year propensity-score-adjusted analysis from the prospective, observational VEDOIBD -study.

BACKGROUND: This observational real-world evidence (RWE) study is based on prospectively collected data from the VEDOIBD registry study. AIM: To compare the effectiveness of vedolizumab and anti-TNF agents in biologic-naïve patients with ulcerative colitis (UC) at the end of induction and during maintenance treatment. METHODS: Between 2017 and 2020, we enrolled 512 patients with UC starting therapy with vedolizumab or an anti-TNF agent in 45 IBD centres across Germany. We excluded biologic-experienced patients and those with missing partial Mayo (pMayo) outcomes; this resulted in a final sample of 314 (182 on vedolizumab and 132 on an anti-TNF agent). The primary outcome was clinical remission measured using pMayo score; any switch to a different biologic agent was considered an outcome failure (modified ITT analysis). We used propensity score adjustment with inverse probability of treatment weighting to correct for confounding. RESULTS: During induction therapy, clinical remission was relatively low and similar in vedolizumab- and anti-TNF-treated patients (23% vs. 30.4%, p = 0.204). However, clinical remission rates after two years were significantly higher for vedolizumab-treated patients than those treated with an anti-TNF agent (43.2% vs. 25.8%, p < 0.011). Among patients treated with vedolzumab, 29% switched to other biologics, versus 54% who had received an anti-TNF agent. CONCLUSION: After two years of treatment, vedolizumab resulted in higher remission rates than anti-TNF agents.

Relationship between Birth Weight, Early Growth Rate, and Body Composition in 5- to 7-Year-Old Children.

BACKGROUND: Programing of body composition during intrauterine growth may contribute to the higher risk for cardio-metabolic disease in individuals born small or large for gestational age (SGA, LGA). Compensations of intrauterine growth by catch-up or catch-down postnatal growth may lead to adverse consequences like a thin-fat phenotype. METHODS: The impact of (i) birth weight as well as (ii) the interaction between birth weight and catch-up or catch-down growth during the first 2 years of life on fat-free mass index (FFMI) and fat mass index (FMI) in 3,204 5-7-year-old children were investigated using Hattori's body composition chart. Body composition results were compared to appropriate for gestational age (AGA) birth weight with the same body mass index (BMI). RESULTS: In total, 299 children at age 5-7 years were categorized as SGA, 2,583 as AGA, and 322 as LGA. When compared to AGA-children, BMI at 5-7 years of age was higher in LGA-children (15.5 vs. 16.2 kg/m2; p < 0.001) but not different in SGA-children. Compared to AGA with the same BMI, LGA was associated with higher FMI and a lower FFMI in 5-7-year-old girls. This phenotype was also seen for both sexes with catch-down growth during the first 2 years of life whereas catch-up growth prevented the higher FMI and lower FFMI per BMI. By contrast, SGA was associated with a higher FFMI and lower FMI in 5-7-year-old boys compared to AGA boys with the same BMI. This phenotype was also seen with catch-down growth in both genders whereas catch-up growth in girls led to more gain in FMI per BMI. CONCLUSION: LGA with a compensatory catch-down postnatal growth may be a risk factor for the development of disproportionate gain in fat over lean mass whereas SGA with a catch-down postnatal growth seems to favor the subsequent accretion of lean over fat mass. A higher propensity of lean mass accretion during postnatal growth in boys compared to girls explains sex differences in these phenotypes.

Body Composition Characteristics of a Load-Capacity Model: Age-Dependent and Sex-Specific Percentiles in 5- to 17-Year-Old Children.

INTRODUCTION: Body composition assessment is superior to the use of body mass index (BMI) to characterize the nutritional status in pediatric populations. For data interpretation, suitable reference data are needed; hence, we aimed to generate age-dependent and sex-specific body composition reference data in a larger population of children and adolescents in Germany. METHODS: This is a cross-sectional study on a representative group of 15,392 5- to 17-year-old children and adolescents. Body composition was assessed by bioelectrical impedance analysis using a population-specific algorithm validated against air displacement plethysmography. Age- and sex-specific percentiles for BMI, fat mass index (FMI), fat-free mass index (FFMI), and a "load-capacity model" (characterized by the ratios of fat mass [FM]/ fatt-free mass [FFM] and FM/FFM2) were modeled using the LMS method. RESULTS: BMI, FMI, FFMI, FM/FFM, and FM/FFM2 curves showed similar shapes between boys and girls with steady increases in BMI, FMI, and FFMI, while FM/FFM2-centiles decreased during early childhood and adolescence. Sex differences were observed in FMI and FM/FFM percentiles with increases in FMI up to age 9 years followed by a steady decrease in FM/FFM during and after puberty with a fast-growing FFMI up to age 17 in boys. The prevalence of low FFM relative to FM reached more than 60% in overweight children and adolescents. CONCLUSION: These pediatric body composition reference data enable physicians and public health scientists to monitor body composition during growth and development and to interpret individual data. The data point out to an early risk of sarcopenia in overweight children and adolescents.

Clustering of lifestyle factors and association with overweight in adolescents of the Kiel Obesity Prevention Study.

OBJECTIVE: To identify lifestyle clusters in adolescents and to characterize their association with overweight and obesity. DESIGN: Cross-sectional and longitudinal data of the Kiel Obesity Prevention Study. SETTING: Schools in Kiel, Germany. SUBJECTS AND METHODS: Cross-sectional data of 1894 adolescents aged 14 years and 4-year longitudinal data of a subsample of 389 children aged 10 and 14 years. Self-reported data of physical activity, modes of commuting to school, media time, nutrition, alcohol consumption and smoking were used to identify lifestyle clusters with two-step cluster analysis. Obesity indices (height, weight, waist circumference and fat mass (FM)) were measured. RESULTS: Three lifestyle clusters were identified: a 'low activity and low-risk behaviour' cluster (cluster 1: n 740, 39·1 %); a 'high media time and high-risk behaviour' cluster (cluster 2: n 498, 26·3 %); and a 'high activity and medium-risk behaviour' cluster (cluster 3: n 656, 34·6 %). Strictly speaking, none of these clusters was considered to be markedly healthy. The prevalence of overweight and obesity tended to be lower in cluster 3 (15·9 %) than in clusters 1 (20·4 %) and 2 (20·5 %; P = 0·053). Longitudinally, 4-year changes in FM were found to be lowest in cluster 2, but the 4-year incidence rate of obesity was lowest in cluster 3. CONCLUSIONS: Explicit healthy lifestyles do not exist, but an active lifestyle reduces the incidence of obesity. In adolescents, health promotion should take into account the diversity of lifestyles and address specific lifestyle clusters.

Determinants of the prevalence and incidence of overweight in children and adolescents.

OBJECTIVE: To systematically analyse determinants of overweight prevalence and incidence in children and adolescents, as a basis of treatment and prevention. DESIGN: Cross-sectional and longitudinal data of the Kiel Obesity Prevention Study (KOPS). SETTING: Schools in Kiel, Germany. SUBJECTS: Cross-sectional data from 6249 students aged 5-16 years and 4-year longitudinal data from 1087 children aged 5-11 years. Weight status of students was assessed and familial factors (weight status of parents and siblings, smoking habits), social factors (socio-economic status, nationality, single parenting), birth weight as well as lifestyle variables (physical activity, media time, nutrition) were considered as independent variables in multivariate logistic regression analyses to predict the likelihood of the student being overweight. RESULTS: The cross-sectional data revealed the prevalence of overweight as 18·3 % in boys and 19·2 % in girls. In both sexes determinants of overweight prevalence were overweight and obese parents, overweight siblings, parental smoking, single parenthood and non-German nationality. High birth weight and low physical activity additionally increased the risk in boys. High media time and low parental education were significant determinants in girls. Effect of media time was mediated by maternal weight status in boys as well as by socio-economic status and age in girls. From the longitudinal data, the 4-year cumulative incidence of overweight was 10·0 % in boys and 8·2 % in girls. Parental obesity, parental smoking and low physical activity were determinants of overweight incidence in boys, whereas paternal obesity increased the risk in girls. CONCLUSIONS: Treatment and prevention should address family and social determinants with a focus on physical activity and media use.

Health-related behaviour, knowledge, attitudes, communication and social status in school children in Eastern Germany.

Enhancing health literacy is a keystone in health promotion. Yet, most studies on health literacy are limited to functional literacy levels. Furthermore, little evidence is available from children. Based on Nutbeam's outcome model for health promotion, this study aims (i) to elaborate a set of short scales to measure important health literacy domains in children and (ii) to analyse their associations among each other, with health behaviour as an intermediate health outcome, subjective health, social status and gender. The sample comprised 852 school children in fifth grade, aged 9-13 years, in Western Pomerania, Germany. Items were taken from the child's questionnaire to form short scales for health-related knowledge, attitudes, communication and behaviour. The internal consistencies of the communication and attitude scales were 0.73 and 0.57, respectively. Unidimensional scalability of the knowledge and behaviour scales was supported by item response models. Associations between health scales were modest. In regression analyses, social status and gender predicted only health knowledge and communication but not health behaviours, attitudes and self-efficacy. Health knowledge was not associated with any other scale. Our results suggest that targeting one specific component of health literacy in children is likely to exert only small effects on health status and health behaviour.

Family and Lifestyle Factors Mediate the Relationship between Socioeconomic Status and Fat Mass in Children and Adolescents.

Socioeconomic status (SES) is strongly associated with childhood overweight. The underlying mechanism and the role of family and lifestyle factors as potential mediators of this relationship remain, however, unclear. Cross-sectional data of 4,772 girls and boys aged 5-16 years from the Kiel Obesity Prevention Study were considered in mediation analyses. Fat mass (FM) was assessed by bioelectrical impedance analysis and converted into a percent FM SD score (FM%-SDS). SES was defined by the parental educational level, classified as low, middle, or high. Characteristics of family and lifestyle factors were obtained via validated questionnaires and considered as mediators. In 3 different age groups, the product-of-coefficients method was used to examine age-specific mediator effects on the relationship between SES and FM%-SDS (c = total effects) and their ratio to total effects, adjusted for age, sex, puberty, and nationality. The prevalence of overweight was 6.9%. In all age groups, SES was inversely associated with FM%-SDS as follows: 5-7 years, c1 = -0.11 (95% CI -0.19 to -0.03); 9-11 years, c2 = -0.21 (95% CI -0.27 to -0.14); and 13-16 years, c3 = -0.23 (95% CI -0.28 to -0.17). The relationship between SES and FM%-SDS was fully (5-7 and 9-11 years) and partly (13-16 years) mediated by similar and age-specific mediators, including parental BMI, parental smoking habits, media consumption, physical activity, and shared meals. Overall, these variables resulted in a total mediating effect of 77.8% (5-7 years), 82.4% (9-11 years), and 70.6% (13-16 years). Consistent for both sexes, the relationship between SES and FM%-SDS was therefore mediated by parental weight status, risk-related behavior within families, and children's and adolescents' lifestyle factors. Strategies for obesity prevention, which are predominantly targeted at socially disadvantaged groups, should therefore address the family environment and lifestyle factors.

Short stature and obesity: positive association in adults but inverse association in children and adolescents.

Shorter than average adults are at a higher risk for obesity and are also more susceptible to diabetes and CVD, independent of BMI. In contrast, taller children have a higher risk of obesity. We hypothesised that short stature is related to adverse body composition and that the association between stature and obesity differs between generations. In a cross-sectional German database of 213 804 adults and 12 411 children and adolescents, the prevalence of overweight and obesity was compared between percentiles of height. The association between stature and percentage of fat mass (%FM), lean BMI (LBMI; kg/m2) or waist:hip ratio (in children only) was analysed within BMI groups. In adults, the prevalence of BMI >30 kg/m2 gradually increased with decreasing percentile of height whereas in children and adolescents, a positive association between height and weight status was observed. Short-stature women and girls had a 0.8-3.2 % lower %FM than tall subjects (P < 0.05), whereas no trend for %FM was observed in males. When compared with tall subjects, LBMI was 0.2-0.6 kg/m2 lower in short-stature men, as well as obese women (P < 0.05). There was a non-significant trend for a lower LBMI and a higher waist:hip ratio in shorter children. In conclusion, short stature is associated with an increased risk of obesity in adults. Cardiometabolic risk in short stature is not explained by an adverse body composition.

Quercetin reduces systolic blood pressure and plasma oxidised low-density lipoprotein concentrations in overweight subjects with a high-cardiovascular disease risk phenotype: a double-blinded, placebo-controlled cross-over study.

Regular consumption of flavonoids may reduce the risk for CVD. However, the effects of individual flavonoids, for example, quercetin, remain unclear. The present study was undertaken to examine the effects of quercetin supplementation on blood pressure, lipid metabolism, markers of oxidative stress, inflammation, and body composition in an at-risk population of ninety-three overweight or obese subjects aged 25-65 years with metabolic syndrome traits. Subjects were randomised to receive 150 mg quercetin/d in a double-blinded, placebo-controlled cross-over trial with 6-week treatment periods separated by a 5-week washout period. Mean fasting plasma quercetin concentrations increased from 71 to 269 nmol/l (P < 0.001) during quercetin treatment. In contrast to placebo, quercetin decreased systolic blood pressure (SBP) by 2.6 mmHg (P < 0.01) in the entire study group, by 2.9 mmHg (P < 0.01) in the subgroup of hypertensive subjects and by 3.7 mmHg (P < 0.001) in the subgroup of younger adults aged 25-50 years. Quercetin decreased serum HDL-cholesterol concentrations (P < 0.001), while total cholesterol, TAG and the LDL:HDL-cholesterol and TAG:HDL-cholesterol ratios were unaltered. Quercetin significantly decreased plasma concentrations of atherogenic oxidised LDL, but did not affect TNF-alpha and C-reactive protein when compared with placebo. Quercetin supplementation had no effects on nutritional status. Blood parameters of liver and kidney function, haematology and serum electrolytes did not reveal any adverse effects of quercetin. In conclusion, quercetin reduced SBP and plasma oxidised LDL concentrations in overweight subjects with a high-CVD risk phenotype. Our findings provide further evidence that quercetin may provide protection against CVD.