Health Economic Evaluation of a Controlled Lifestyle Intervention: The Healthy Lifestyle Community Program (Cohort 2; HLCP-2).

Non-communicable diseases (NCD) are associated with high costs for healthcare systems. We evaluated changes in total costs, comprising direct and indirect costs, due to a 24-month non-randomized, controlled lifestyle intervention trial with six measurement time points aiming to improve the risk profile for NCDs. Overall, 187 individuals from the general population aged ≥18 years were assigned to either the intervention group (IG; n = 112), receiving a 10-week intensive lifestyle intervention focusing on a healthy, plant-based diet; physical activity; stress management; and community support, followed by a 22-month follow-up phase including monthly seminars, or a control group (CG; n = 75) without intervention. The complete data sets of 118 participants (IG: n = 79; CG: n = 39) were analyzed. At baseline, total costs per person amounted to 67.80 ± 69.17 EUR in the IG and 48.73 ± 54.41 EUR in the CG per week. The reduction in total costs was significantly greater in the IG compared to the CG after 10 weeks (p = 0.012) and 6 months (p = 0.004), whereas direct costs differed significantly after 10 weeks (p = 0.017), 6 months (p = 0.041) and 12 months (p = 0.012) between the groups. The HLCP-2 was able to reduce health-related economic costs, primarily due to the reduction in direct costs.

The healthful plant-based diet index as a tool for obesity prevention-The healthy lifestyle community program cohort 3 study.

Background: World-wide the prevalence of obesity is high, and promoting a shift toward more healthful and more plant-based dietary patterns appears to be one promising strategy to address this issue. A dietary score to assess adherence to a healthy plant-based diet is the healthful plant-based diet index. While there is evidence from cohort studies that an increased healthful plant-based diet index is associated with improved risk markers, evidence from intervention studies is still lacking. Methods: A lifestyle intervention was conducted with mostly middle-aged and elderly participants from the general population (n = 115). The intervention consisted of a 16-month lifestyle program focusing on a healthy plant-based diet, physical activity, stress management, and community support. Results: After 10 weeks, significant improvements were seen in dietary quality, body weight, body mass index, waist circumference, total cholesterol, measured and calculated low-density lipoprotein (LDL) cholesterol, oxidized LDL particles, non-high-density lipoprotein cholesterol, remnant cholesterol, glucose, insulin, blood pressure, and pulse pressure. After 16 months, significant decreases were seen in body weight (-1.8 kg), body mass index (-0.6 kg/m2), and measured LDL cholesterol (-12 mg/dl). Increases in the healthful plant-based diet index were associated with risk marker improvements. Conclusions: The recommendation of moving toward a plant-based diet appears acceptable and actionable and may improve body weight. The healthful plant-based diet index can be a useful parameter for intervention studies.

Effects of the healthy lifestyle community program (cohort 1) on stress-eating and weight change after 8 weeks: a controlled study.

Stress-eating (eating more or more unhealthily in order to accommodate to stress), contributes to the development and maintenance of obesity. The effect of comprehensive weight loss interventions on changes in stress-eating as well as the contributing role of stress-eating on weight reduction has not been examined. The impact of the 8-week intensive phase of the Healthy Lifestyle Community Programme (HLCP, cohort 1) on emotional, external and restrained eating, as expressions of stress-eating was evaluated in a non-randomized controlled trial. Intervention: 14 seminars (twice per week, including practical units), complemented by stress-regulation and cooking workshops and coaching sessions empowering participants to change their behaviour towards a healthy plant-based diet (ad libitum), stress regulation, regular exercise and to focus on social support. Participants were recruited from the general population. In the intervention group, 91 participants (IG; age: 56 ± 10, 77% female) and in the control group, 52 (CG; age: 62 ± 14, 57% female) were enrolled. At baseline, participants of the IG reported higher levels of stress (9.7 ± 5.4 points [P] vs. 7.6 ± 6.2; p < 0.011), and of emotional eating (27.9 ± 9.4 vs. 20.0 ± 7.1; p < 0.001) and external eating (29.1 ± 4.9 vs. 25.5 ± 5.6; p < 0.001) than participants of the CG. Within 8 weeks, in the IG, scores of emotional eating (- 3.5 ± 5.4 P) and external eating significantly decreased (= - 2.0 ± 3.8 P), while restrained eating increased (2.7 ± 5.0 P; p for all < 0.001). Weight change was negatively correlated with change of external eating (R2 = 0.045; CC = - 0.285; p = 0.014), indicating that a greater weight change was associated with a smaller change of external eating. This is the first study to prospectively investigate the role of stress-eating on the weight reduction effect of comprehensive lifestyle interventions. Our data confirm that overweight is associated with EE and external eating and suggest that the HLCP is capable to reduce both, weight and stress-eating.Trial registration: German Clinical Trials Register (DRKS; reference: DRKS00018821; September 18th 2019; retrospectively registered).

Effect of a controlled lifestyle intervention on medication use and costs: The Healthy Lifestyle Community Program (cohort 2).

TRIAL REGISTRATION: German Clinical Trials Register DRKS (www.drks.de; reference: DRKS00018775).

Effects of a lifestyle intervention on the biomarkers of oxidative stress in non-communicable diseases: A systematic review.

Oxidative stress plays a critical role in the pathogenesis of chronic diseases. Therefore, improvement of oxidative stress status through lifestyle intervention can play a vital role in preventing and treating chronic diseases. This systematic review aims to provide an overview of articles published in the last decade examining the association between lifestyle intervention and oxidative stress biomarkers in the context of non-communicable diseases. The electronic databases PubMed and Web of Science were searched for relevant studies, following the PRISMA (Preferred Reporting of Systematic Reviews and Meta-Analyses) guidelines. This systematic review focused on the four important oxidative stress biomarkers; glutathione (GSH), superoxide dismutase (SOD), catalase, and malondialdehyde. 671 articles were identified, of which nine met the inclusion criteria. A trend emerged, showing that lifestyle modifications that focus on diet and physical health can improve oxidative stress in the form of an increase in superoxide dismutase and CAT levels and a decrease in Malondialdehyde levels in participants with non-communicable diseases (NCDs), GSH levels were not affected. However, the results are difficult to compare because of the heterogeneity of the methods of the biomarkers studied. Our review indicates that oxidative stress can be influenced by lifestyle modifications and may be an effective tool for the prevention and management of non-communicable diseases. This review also elucidated the importance of analyzing multiple oxidative stress biomarkers to evaluate oxidative stress, it further highlights the need to conduct long-term lifestyle intervention studies on oxidative stress biomarkers to understand the connection between oxidative stress biomarkers, NCDs and Lifestyle intervention.

Exploratory analysis of the effect of a controlled lifestyle intervention on inflammatory markers - the Healthy Lifestyle Community Programme (cohort 2).

BACKGROUND: Chronic low-grade inflammation is associated with an increased risk of chronic disease and mortality. The objective of the study was to test the effect of a healthy lifestyle intervention on biomarkers of inflammation (among other risk markers). METHODS: We conducted a non-randomized controlled trial with mostly middle-aged and elderly participants from the general population in rural northwest Germany (intervention: n = 114; control: n = 87). The intervention consisted of a 1-year lifestyle programme focusing on diet (largely plant-based; strongest emphasis), physical activity, stress management, and social support. High-sensitivity C-reactive protein (hs-CRP) was assessed at baseline, 10 weeks, 6 months, and 1 year. Homocysteine (Hcy) was assessed at baseline, 10 weeks, and 1 year. Adiponectin (Apn) was assessed at baseline and 10 weeks. An exploratory analysis of these inflammatory markers assessing the between-group differences with ANCOVA was conducted. RESULTS: The 1-year trajectory of hs-CRP was significantly lower in the intervention group compared to control (between-group difference: -0.8 (95% CI -1.2, -0.3) mg/l; p = 0.001; adjusted for baseline). The 1-year trajectory of Hcy was non-significantly higher in the intervention compared to control (between-group difference: 0.2 (95% CI -0.3, 0.7) µmol/l; p = 0.439; adjusted for baseline). From baseline to 10 weeks, Apn decreased significantly more in the intervention group compared to control (between-group difference: -1.6 (95% CI -2.7, -0.5) µg/ml; p = 0.004; adjusted for baseline). CONCLUSIONS: Our study shows that healthy lifestyle changes can lower hs-CRP and Apn levels and are unlikely to significantly affect Hcy levels within 1 year. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; reference: DRKS00018775 , registered 12 Sept 2019; retrospectively registered; www.drks.de ).

Eight Weeks of Lifestyle Change: What are the Effects of the Healthy Lifestyle Community Programme (Cohort 1) on Cortisol Awakening Response (CAR) and Perceived Stress?

Background: Stress and cortisol dysregulation are linked to NCDs. Moreover, stress favours unhealthy lifestyle patterns, which increase the risk for NCDs. The role of the Cortisol Awakening Response (CAR) and the effect of lifestyle interventions on the same remain unclear. Methods: The impact of the intensive 8-week phase of the Healthy Lifestyle Community Programme (HLCP, cohort 1) on parameters of the CAR, ie cortisol values 0 (sample [S]1), 30), 45 and 60 minutes post-awakening, average peak, S1-peak delta and area under the increase curve (AUCI), and perceived stress levels (PSL) was evaluated in a non-randomized, controlled trial. Covariates of the CAR (eg sleep measures) and irregularities in sampling were assessed. The intervention focussed on stress management, a healthy diet, regular exercise, and social support. Participants were recruited from the general population. Multiple linear regression analyses were conducted. Results: 97 participants (age: 56 ± 10 years; 71% female), with 68 in the intervention group (IG; age: 55 ± 8, 77% female) and 29 participants in the control group (CG; age: 59 ± 12, 59% female), were included in the analysis. The baseline characteristics of both groups were comparable, except participants of IG were younger. On average, the PSL at baseline was low in both groups (IG: 9.7 ± 5.4 points; CG: 8.5 ± 6.9 points; p = .165), but 22% (n = 15) in the IG and 20% (n = 6) in the CG reported a high PSL. Most participants reported irregularities in CAR sampling, eg interruption of sleep (IG: 80% CG: 81%). After 8 weeks, most CAR parameters and the PSL decreased in the IG and CG, resulting in no differences of change between the groups. In the IG only, a decrease of PSL was linked to an increase of CAR parameters, eg AUCI (correlation coefficient = -0.307; p = .017). Conclusion: The HLCP may potentially reduce PSL and change the CAR, but results cannot be clearly attributed to the programme. Methodological challenges and multiple confounders, limit suitability of the CAR in the context of lifestyle interventions. Other measures (eg hair-cortisol) may give further insights. Trial registration: German Clinical Trials Register (DRKS); DRKS00018821; www.drks.de.

Bridging the gap between science and society: long-term effects of the Healthy Lifestyle Community Programme (HLCP, cohort 1) on weight and the metabolic risk profile: a controlled study.

Background: The potential of adopting a healthy lifestyle to fight non-communicable diseases (NCDs) is not fully used. We hypothesised that the Healthy Lifestyle Community Programme (HLCP, cohort 1) reduces weight and other risk markers compared with baseline and control. Methods: 24-month, non-randomised, controlled intervention trial. Intervention: intensive 8-week phase with seminars, workshops and coaching focusing on a healthy lifestyle (eg, plant-based diet, physical activity, stress management) and group support followed by a 22-month alumni phase. Weight reduction as the primary outcome and other NCD risk parameters were assessed at six time points. Participants were recruited from the general population. Multiple linear regression analyses were conducted. Results: 143 participants (58±12 years, 71% female) were enrolled (91 in the intervention (IG) and 52 in the control group (CG)). Groups' baseline characteristics were comparable, except participants of IG were younger, more often females, overweight and reported lower energy intake (kcal/day). Weight significantly decreased in IG at all follow-ups by -1.5 ± 1.9 kg after 8 weeks to -1.9 ± 4.0 kg after 24 months and more than in CG (except after 24 months). Being male, in the IG or overweight at baseline and having a university degree predicted more weight loss. After the intervention, there were more participants in the IG with a 'high' adherence (+12%) to plant-based food patterns. The change of other risk parameters was most distinct after 8 weeks and in people at elevated risk. Diabetes-related risk parameters did not improve. Conclusion: The HLCP was able to reduce weight and to improve aspects of the NCD risk profile. Weight loss in the IG was moderate but maintained for 24 months. Participants of lower educational status might benefit from even more practical units. Future interventions should aim to include more participants at higher risk. Trial registration number: DRKS00018821.

Healthy lifestyle changes favourably affect common carotid intima-media thickness: the Healthy Lifestyle Community Programme (cohort 2).

Common carotid intima-media thickness (ccIMT) progression is a risk marker for cardiovascular disease (CVD), whereas healthy lifestyle habits are associated with lower ccIMT. The objective of the present study was to test whether a healthy lifestyle intervention can beneficially affect ccIMT progression. A community-based non-randomised, controlled lifestyle intervention was conducted, focusing on a predominantly plant-based diet (strongest emphasis), physical activity, stress management and social health. Assessments of ccIMT were made at baseline, 6 months and 1 year. Participants had an average age of 57 years and were recruited from the general population in rural northwest Germany (intervention: n 114; control: n 87). From baseline to 1 year, mean ccIMT significantly increased in both the intervention (0⋅026 [95 % CI 0⋅012, 0⋅039] mm) and control group (0⋅045 [95 % CI 0⋅033, 0⋅056] mm). The 1-year trajectory of mean ccIMT was lower in the intervention group (P = 0⋅022; adjusted for baseline). In a subgroup analysis with participants with high baseline mean ccIMT (≥0⋅800 mm), mean ccIMT non-significantly decreased in the intervention group (-0⋅016 [95 % CI -0⋅050, 0⋅017] mm; n 18) and significantly increased in the control group (0⋅065 [95 % CI 0⋅033, 0⋅096] mm; n 12). In the subgroup, the 1-year trajectory of mean ccIMT was significantly lower in the intervention group (between-group difference: -0⋅051 [95 % CI -0⋅075, -0⋅027] mm; P < 0⋅001; adjusted for baseline). The results indicate that healthy lifestyle changes may beneficially affect ccIMT within 1 year, particularly if baseline ccIMT is high.

Effect of a 1-Year Controlled Lifestyle Intervention on Body Weight and Other Risk Markers (the Healthy Lifestyle Community Programme, Cohort 2).

INTRODUCTION: The prevalence of obesity is high and increasing worldwide. Obesity is generally associated with an increased risk of chronic disease and mortality. The objective of the study was to test the effect of a lifestyle intervention on body weight and other chronic disease risk markers. METHODS: A non-randomized controlled trial was conducted, including mostly middle-aged and elderly participants recruited from the general population in rural northwest Germany (intervention: n = 114; control: n = 87). The intervention consisted of a 1-year lifestyle programme, focussing on four key areas: a largely plant-based diet (strongest emphasis), physical activity, stress management, and community support. Parameters were assessed at baseline, 10 weeks, 6 months, and 1 year. The control group received no intervention. RESULTS: Compared to the control, in the intervention group, significantly lower 1-year trajectories were observed for body weight, body mass index (BMI), waist circumference (WC), total cholesterol, calculated LDL cholesterol, non-HDL cholesterol, remnant cholesterol (REM-C), glucose, HbA1c, and resting heart rate (RHR). However, between-group differences at 1 year were small for glucose, HbA1c, and cholesterol (apart from REM-C). No significant between-group differences were found for 1-year trajectories of measured LDL cholesterol, HDL cholesterol, triglycerides, insulin, blood pressure, and pulse pressure. CONCLUSION: The intervention successfully reduced body weight, BMI, WC, REM-C, and RHR. However, at 1 year, effectiveness of the intervention regarding other risk markers was either very modest or could not be shown.

A Comprehensive Lifestyle Intervention to Prevent Type 2 Diabetes and Cardiovascular Diseases: the German CHIP Trial.

The prevalence of type 2 diabetes is continuously increasing. This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system. In view of the fact that type 2 diabetes is primarily caused by behavioral factors, effective preventive strategies are urgently needed. We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes. We conducted a randomized controlled trial in a primary care setting in Hannover, Germany, with 83 patients diagnosed as (pre)diabetic or at risk for diabetes. CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases. The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach. The primary outcome parameter was the body mass index (BMI). Secondary outcome parameters included body weight, blood pressure, fasting glucose, HbA1c, blood lipids, and the FINDRISK score, which assesses long-term diabetes risk. At the final measurement after 12 months, in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m(2) in controls (p = .119). The mean sustained weight loss after 12 months was -4.1 kg in the intervention group versus -0.8 kg in controls. Furthermore, we found a trend toward a stronger reduction in blood pressure, fasting glucose, and HbA1c as well as an improved FINDRISK score in the intervention group, compared to controls. Although failing to reach statistical significance at the final assessment, this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes.

Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial.

OBJECTIVE: We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. METHOD: Secondary analysis of a randomized controlled trial: In 2002-2004, 8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6months during the 3-year follow-up. RESULTS: In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 15.3% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group×time: P=0.005). The effect was largest after 6 and 12months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24months. CONCLUSION: A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. TRIAL REGISTRATION: ClinicalTrials.gov (www.clinicaltrials.gov): NCT00379249.

Effects of an HIV-Care-Program on immunological parameters in HIV-positive patients in Yaoundé, Cameroon: a cluster-randomized trial.

OBJECTIVES: To measure the effects of an HIV-Care-Program, focusing on nutrition and lifestyle, which can be provided at scale to HIV-infected patients, on clinical and anthropometrical parameters, and health status. METHODS: A cluster-randomized trial, including 5 health facilities randomized to intervention n = 100 (HIV-Care-Program) or control n = 101 (Usual-Care). The HIV-Care-Program consisted of counseling lessons for 6 months, on: nutrition, hygiene, coping with stigma and discrimination, embedded in practical activities. Outcome variables were CD4 count after 6 months and time to antiretroviral therapy (ARV) initiation, using analysis of covariance and Kaplan-Meier method, respectively. RESULTS: After 6 months, CD4 count dropped by 46.3 cells (7.7%) (intervention) and 129 (23%) (control) (p = 0.003). Mean time to ARV; 5.9 months 95% CI (5.9, 6.0) (intervention); 4.9 months 95% CI (4.7, 5.2) (control) (p < 0.004). There was a partial correlation between CD4 count and initial viral load (r = -0.190, p = 0.017). CONCLUSIONS: The intervention provides a low-cost alternative improving health status, slowing down CD4 cell decline, delaying initiation of ARV and thus freeing local ARV capacities for patients in urgent need.

Longitudinal association between body mass index and health-related quality of life.

OBJECTIVE: Health-related quality of life (HRQoL) is an important outcome in individuals with a high risk for cardiovascular diseases. We investigated the association of HRQoL and body mass index (BMI) as an indicator for obesity. DESIGN: Secondary longitudinal analysis of the ORBITAL study, an intervention study which included high-risk cardiovascular primary care patients with hypercholesterolemia and an indication for statin therapy. METHODS: HRQoL was determined with the generic Short Form (SF)-12 health status instrument. Body weight and height were assessed at baseline and at months 6, 12, 18, 24, 30, and 36. We used a linear and a linear mixed-effects regression model to investigate the association between BMI and SF-12 summary scores at baseline as well as between change in BMI and SF-12 summary scores over 3 years. We adjusted for age, sex, smoking status, and in the longitudinal analysis also for the study arm and its interaction term with time. RESULTS: Of the 7640 participants who completed the baseline questionnaire, 6726 participants (mean age: 61 years) were analyzed. The baseline BMI was inversely associated with physical and mental SF-12 summary scores (ß [95% CI] per 1 kg/m2: -0.36 [-0.41; -0.30] and -0.05 [-0.11; -0.00], respectively). A significant association between the change in BMI and physical SF-12 summary scores over time was only present in women (-0.18 [-0.27; -0.09]) and only in obese participants (-0.19 [-0.29; -0.10]). A change in BMI was directly associated with mental SF-12 summary scores (0.12 [0.06; 0.19]) in the total population. CONCLUSION: Increases in BMI were associated with decreases in physical HRQoL, particularly in obese individuals and in women. In contrast, the mental HRQoL seemed to increase with increasing BMI over time. Thus, body weight management with respect to the HRQoL should be evaluated differentially by sex and body weight status. TRIAL REGISTRATION: ClinicalTrials.gov NCT00379249.

Effects of antioxidants on CD4 and viral load in HIV-infected women in sub-Saharan Africa - dietary supplements vs. local diet.

In sub-Sahara Africa, micronutrient deficiency, especially of antioxidant micronutrients including vitamins A, C, and E, beta-carotene, selenium, zinc, and polyphenols is very common in HIV-positive patients. Amongst adults, women are the most vulnerable. Antioxidants are known to play a vital role in the immune system, reducing oxidative stress. Oxidative stress is induced by excess production of reactive oxygen species (ROS), due to the HIV infection. Such damage may be prevented or moderated through adequate oral intake of antioxidants, scavenging ROS, as well as protecting cells and tissues against oxidative stress. Antioxidants can be provided to the body through locally available antioxidant rich-diets such as fruit-and-vegetable-based diets and/or dietary supplements. Provision of antioxidants through local diets or dietary supplements exercise beneficial effects on biological markers of the immune system (CD4 and viral load). However, while dietary supplements represent a costly and short-term strategy to limiting antioxidant deficiency, local diets, combined with adequate nutritional education, can provide a low-cost and long-term strategy to reduce oxidative stress, prevent micronutrient deficiency, and slow down HIV disease progression. The former can be applicable in countries around the West, Central, and South coast of Africa, which are rich in natural food resources. In contrast with significant evidence that dietary supplements confer benefits in HIV patients, fewer data are available relating to the benefits of local diets. Thus the need to do more research in this area arises. This review compares available data on effects of antioxidants on CD4 and viral load in HIV-positive women noneligible for antiretroviral therapy. Intake of antioxidants though dietary supplements and local diet, associated with nutritional education, is compared. Studies conducted in sub-Sahara Africa are considered.

The Coronary Health Improvement Project (CHIP) for lowering weight and improving psychosocial health.

This study extends previous research evaluating the association between the CHIP intervention, change in body weight, and change in psychological health. A randomized controlled health intervention study lasting 4 wk. was used with 348 participants from metropolitan Rockford, Illinois; ages ranged from 24 to 81 yr. Participants were assessed at baseline, 6 wk., and 6 mo. The Beck Depression Inventory (BDI) and three selected psychosocial measures from the SF-36 Health Survey were used. Significantly greater decreases in Body Mass Index (BMI) occurred after 6 wk. and 6 mo. follow-up for the intervention group compared with the control group, with greater decreases for participants in the overweight and obese categories. Significantly greater improvements were observed in BDI scores, role-emotional and social functioning, and mental health throughout follow-up for the intervention group. The greater the decrease in BMI through 6 wk., the better the chance of improved BDI score, role-emotional score, social functioning score, and mental health score, with odds ratios of 1.3 to 1.9. Similar results occurred through 6 mo., except the mental health variable became nonsignificant. These results indicate that the CHIP intervention significantly improved psychological health for at least six months afterwards, in part through its influence on lowering BMI.

How unusual are the contents of paraphilias? Paraphilia-associated sexual arousal patterns in a community-based sample of men.

INTRODUCTION: This is a report of a cross-sectional study on paraphilia-associated sexual arousal patterns (PASAP) among men in a metropolitan city in Germany, EU. AIM: To determine the prevalence of PASAP during sexual fantasies, fantasies accompanying masturbation, and real-life sociosexual behavior. METHODS: In a cross-sectional study, self-reported sexual history data were collected by questionnaire from 367 volunteers recruited from a community sample of 1,915 men aged 40-79 years. MAIN OUTCOME MEASURES: The Derogatis Symptom Checklist-Revised (SCL-90-R) and the Life Satisfaction Questionnaire (LSQ; German original, Fragebogen zur Lebenszufriedenheit, [FLZ]) were administered to obtain a general subjective health measure and a measure of general as well as sex life satisfaction. The Questionnaire on Sexual Experiences and Behaviour was administered to comprehensively assess all relevant sexo-medical data. Results. The percent of men that reported at least one PASAP was 62.4%. In 1.7% of cases, PASAP were reported to have caused distress. The presence of PASAP was associated with a higher likelihood of being single (odds ratio [OR] 2.6; 95%; confidence interval [CI] 1.047-6.640), masturbating at least once per week (OR 4.4; 95%; CI 1.773-10.914), or having a low general subjective health score (OR 11.9; 95%; CI 2.601-54.553). Pedophilic PASAP in sexual fantasies and in real-life sociosexual behavior was reported by 9.5% and 3.8% of participants, respectively. CONCLUSION: The findings suggest that paraphilia-related experience can not be regarded as unusual from a normative perspective. At the same time, many men experience PASAP without accompanying problem awareness or distress, even when PASAP contents are associated with potentially causing harm to others. In view of the relevance for sex life and relationship satisfaction, presence of PASAP should be assessed in all sexual medicine consultations. Future research should focus on conditions in which PASAP reach clinical significance in the sense of mental disorders.

Is patient self-report an adequate tool for monitoring cardiovascular conditions in patients with hypercholesterolemia?

BACKGROUND: To determine the accuracy of patient self-reports of specific cardiovascular diagnoses and to identify individual patient characteristics that influence the accuracy. METHODS: This investigation was conducted as a part of the randomized controlled ORBITAL study. Patients with hypercholesterolemia were enrolled in 1961 primary-care centers all over Germany. Self-reported questionnaire data of 7640 patients were compared with patients' case report forms (CRFs) and medical records on cardiovascular diseases, using kappa statistics and binomial logit models. RESULTS: kappa values ranged from 0.89 for diabetes to 0.04 for angina. The percentage of overreporting varied from 1% for diabetes to 17% for angina, whereas the percentage of underreporting varied from 8.0% for myocardial infarction to 57% for heart failure. Individual characteristics such as choice of individual general practitioner, male gender and age were associated with the accuracy of self-report data. CONCLUSION: Since the agreement between patient self-report and CRFs/medical records varies with specific cardiovascular diagnoses in patients with hypercholesterolemia, the adequacy of this tool seems to be limited. However, the authors recommend additional data validation for certain patient groups and consideration of individual patient characteristics associated with over- and underreporting.

Impact of a compliance program on cholesterol control: results of the randomized ORBITAL study in 8108 patients treated with rosuvastatin.

AIM: To determine whether a compliance-enhancing program could increase the level of lipid control in patients treated with rosuvastatin. METHODS AND RESULTS: A total of 8108 patients (56% men, mean age 59 years; 44% women, mean age 63 years) with low-density lipoprotein cholesterol (LDL-C) >or=115 mg/dl if statin-naive or else >or=125 mg/dl were randomized to rosuvastatin 10 mg daily either with or without a compliance-enhancing program for 12 months. Patients not achieving the goal after 3 months were uptitrated to rosuvastatin 20 mg daily thereafter. At 3, 6, and 12 months, rosuvastatin plus compliance initiatives were similarly effective to rosuvastatin alone in terms of 1998 European LDL-C goal of less than 115 mg/dl achievement (72 vs. 70%, 71 vs. 69%, 68 vs. 68%) and changes in the lipid profile. Significant differences were observed in the subgroup of statin-naive patients at 3 and 6 months (80 vs. 76% and 78 vs. 73%, P<0.01). The frequency of adverse events and relevant changes in laboratory data were consistent with the known safety profile of rosuvastatin. CONCLUSION: Rosuvastatin 10/20 mg daily enables the majority of patients to achieve LDL-C less than 115 mg/dl within 3 months. The compliance-enhancing program was only effective in statin-naive patients at early time points, but had no overall effect over 12 months.

Can newly acquired healthy behaviors persist? An analysis of health behavior decay.

INTRODUCTION: We evaluated data from the Coronary Health Improvement Project (CHIP) to determine whether improved health behaviors associated with this intervention persisted or decayed during 18 months of follow-up. METHODS: Participants were 348 volunteers aged 24 to 81 years from the Rockford, Illinois, metropolitan area enrolled in CHIP, a 4-week educational course delivered as lectures. The intervention taught the importance of making better lifestyle choices and improving dietary and physical activity behaviors. Physical activity and dietary behaviors were assessed at baseline, and changes in behaviors were assessed at 6 weeks and 18 months. Changes were evaluated according to quartile groupings of each variable at baseline. RESULTS: No baseline differences were found between participants who dropped out and participants who provided data through 18 months. Mean changes significantly improved through 6 weeks for each of the 21 selected physical activity and dietary behavior variables except percentage of daily calories from carbohydrates. Mean changes significantly improved through 18 months for each of the 21 variables except calories from protein, alcohol, and whole grain servings. The percentage of participants who improved their physical or dietary behavior at 6 weeks ranged from 49% for percentage of daily calories from carbohydrates (64% at 18 months) to 91% for intake of dietary cholesterol per day (84% at 18 months). The level of change through 18 months for all variables was significantly influenced by quartile groupings at baseline. Physical activity improved significantly through 18 months only for participants in the lowest two quartiles of physical activity at baseline. Exercise decreased significantly through 18 months for participants in the highest quartile of physical activity at baseline. CONCLUSION: During an 18-month period, participants' physical activity and dietary behaviors improved significantly. Even though behavior improvement tended to be greater at 6 weeks, most healthy behaviors did not return to baseline levels after 18 months.