SMILE Study Research Articles

Erratum to: Standardised pre-competitive screening of athletes in some European and African countries: the SMILE study

Erratum to: Standardised pre-competitive screening of athletes in some European and African countries: the SMILE study

Successful Ingredients in the SMILE Study: Resident, Staff, and Management Factors Influence the Effects of Humor Therapy in Residential Aged Care

To test the hypothesis that individual and institutional-level factors influence the effects of a humor therapy intervention on aged care residents. Data were from the humor therapy group of the Sydney Multisite Intervention of LaughterBosses and ElderClowns, or SMILE, study, a single-blind cluster randomized controlled trial of humor therapy conducted over 12 weeks; assessments were performed at baseline, week 13, and week 26. One hundred eighty-nine individuals from 17 Sydney residential aged care facilities were randomly allocated to the humor therapy intervention. Professional performers called "ElderClowns" provided 9-12 weekly humor therapy 2-hour sessions, augmented by trained staff, called "LaughterBosses." Outcome measures were as follows: Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, Neuropsychiatric Inventory, the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and proxy-rated quality of life in dementia population scale. Facility-level measures were as follows: support of the management for the intervention, commitment levels of LaughterBosses, Environmental Audit Tool scores, and facility level of care provided (high/low). Resident-level measures were engagement, functional ability, disease severity, and time-in-care. Multilevel path analyses simultaneously modeled resident engagement at the individual level (repeated measures) and the effects of management support and staff commitment to humor therapy at the cluster level. Models indicated flow-on effects, whereby management support had positive effects on LaughterBoss commitment, and LaughterBoss commitment increased resident engagement. Higher resident engagement was associated with reduced depression, agitation, and neuropsychiatric scores. Effectiveness of psychosocial programs in residential aged care can be enhanced by management support, staff commitment, and active resident engagement.

Standardised pre-competitive screening of athletes in some European and African countries: the SMILE study

Most of the available data on the cardiovascular screening of athletes come from Italy, with fewer records being available outside of Italy and for non-Caucasian populations. The goals of the SMILE project (Sport Medicine Intervention to save Lives through ECG) are to evaluate the usefulness of 12-lead ECGs for the detection of cardiac diseases in athletes from three European countries and one African country and to estimate how many second-level examinations are needed subsequent to the initial screening in order to classify athletes with abnormal characteristics. A digital network consisting of Sport Centres and second and third opinion centres was set up in Greece, Germany, France and Algeria. Standard digital data input was carried out through the application of 12-lead ECGs, Bethesda questionnaires and physical examinations. Two hundred ninety-three of the 6,634 consecutive athletes required further evaluation, mostly (88.4%) as a consequence of abnormal ECGs. After careful evaluation, 237 were determined to be healthy or apparently healthy, while 56 athletes were found to have cardiac disorders and were thus disqualified from active participation in sports. There was a large difference in the prevalence of diseases detected in Europe as compared with Algeria (0.23 and 4.01%, respectively). Our data confirmed the noteworthy value of 12-lead resting ECGs as compared with other first-level evaluations, especially in athletes with asymptomatic cardiac diseases. Its value seems to have been even higher in Algeria than in the European countries. The establishment of a digital network of Sport Centres for second/third opinions in conjunction with the use of standard digital data input seems to be a valuable means for increasing the effectiveness of screening.

The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

BackgroundChronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children with limited evidence for treatment. The Phil Parker Lightning Process (LP) is a trademarked intervention, which >250 children use annually. There are no reported studies investigating the effectiveness or possible side effects of LP.MethodsThe trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service. The study was designed as a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process. Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment, randomization and interventions.ResultsA total of 56 children were recruited from 156 eligible children (1 October 2010 to 16 June 2012). Recruitment, randomization and both interventions were feasible and acceptable. Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol: stopped collecting 6-week outcomes; introduced a second reminder letter; used phone calls to collect primary outcomes from nonresponders; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability (SF-36 physical function subscale) and fatigue (Chalder Fatigue Scale).ConclusionsConducting randomized controlled trials (RCTs) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME. Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants. This is likely to improve recruitment rate and trial retention.Trial registrationFeasibility study first randomization: 29 September 2010.Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).Full trial first randomization: 19 September 2012.

Perceived unfairness and socioeconomic inequalities in functional decline: the Dutch SMILE prospective cohort study

BackgroundPeople in lower socioeconomic positions report worse health-related functioning. Only few examined whether perceptions of unfairness are particularly common in these people and whether this perceived unfairness relates to their subsequent poor health outcomes. We thus set out to examine the contribution of perceived unfairness to the higher risks of physical and mental dysfunction in men and women with a lower socioeconomic position.MethodsSeven-year prospective cohort data from the Dutch SMILE study among 1,282 persons, 55 years old and older, were used. Physical and mental health-related functioning was measured with the SF-36, socioeconomic status with income and education, and the perception of unfairness with an extended new measure asking for such perceptions in both work and non-work domains.ResultsPerceived unfairness was more common in lower socioeconomic positions. Such perpection was related to both physical (odds ratio = 1.57 (95% confidence interval: 1.17-2.11)) and mental (1.47 (1.07-2.03)) decline, while low socioeconomic position was only related to mental decline (1.33 (1.06-1.67)). When socioeconomic position and perceived unfairness were simultaneously controlled, odds ratios for both determinants decreased only very little. Socioeconomic position and perceived unfairness were for the largest part independently related to longitudinal health-related decline.ConclusionsThe general perception of unfairness, at work and beyond work, might have implications for functional decline in middle and older age. We recommend that – rather than addressing and changing individual perceptions of unfairness – more research is needed to find out whether specific environments can be defined as unfair and whether such environments can be effectively tackled in an attempt to truly improve public health.

Periodontal disease: a potential modifiable risk factor limiting conception

Periodontal disease (PD) is a common chronic infectious and inflammatory disease of the gums and its supporting tissues, associated with several adverse health outcomes including significant obstetric consequences. PD is treatable with good oral hygiene and dental care, and consequently is a modifiable variable that may lead to improvements in adult health. To date, there are no published studies describing the influence of PD on a woman's time to conceive (TTC). This study formed part of the Smile study, which was a multi-centre randomized controlled trial of treatment for PD in mid-pregnancy. PD was defined as the presence of pockets ≥4-mm deep at ≥12 probing sites in fully erupted teeth. At the time of recruitment, women were asked about their TTC and whether they had required fertility treatment. Of 3737 pregnant women recruited to the study, information was available from 3416 spontaneous conceptions, including 1014 cases with PD (29.7%). Planned pregnancies accounted for 1956 of the 3416 pregnancies available for study. For 146 women, the TTC was >12 months and PD was more prevalent in this group (34.9% versus 25.7%, P = 0.015). The mean TTC in women with PD was 7.1 months [confidence interval (CI): 5.7-8.6] compared with 5.0 months (CI: 4.4-5.5, P = 0.019) in those without PD. PD was present in 23.8% of Caucasian women and 41.4% of non-Caucasian women. Compared with Caucasian women without PD, non-Caucasian women with PD had an increased likelihood of TTC >12 months [13.9% versus 6.2%, odds ratio (OR): 2.88 (CI: 1.62-5.12), P < 0.001], but there was no difference for Caucasians with PD (8.6% versus 6.2%, OR: 1.15, CI: 0.74-1.79, P = 0.534). Other simultaneous predictors of TTC >1 year included age, BMI >25 and smoking. In the non-Caucasian population, PD was associated with an increased TTC, but whether this is related to PD, or some other factor also present within this population, should be further investigated.

Exercise and Pharmacotherapy in Patients With Major Depression: One-Year Follow-Up of the SMILE Study

To examine a 1-year follow-up of a 4-month, controlled clinical trial of exercise and antidepressant medication in patients with major depressive disorder (MDD). In the original study, 202 sedentary adults with MDD were randomized to: a) supervised exercise; b) home-based exercise; c) sertraline; or d) placebo pill. We examined two outcomes measured at 1-year follow-up (i.e., 16 months post randomization): 1) continuous Hamilton Depression Rating Scale score; and 2) MDD status (depressed; partial remission; full remission) in 172 available participants (85% of the original cohort). Regression analyses were performed to examine the effects of treatment group assignment, as well as follow-up antidepressant medication use and self-reported exercise (Godin Leisure-Time Exercise Questionnaire), on the two outcomes. In the original study, patients receiving exercise achieved similar benefits compared with those receiving sertraline. At the time of the 1-year follow-up, rates of MDD remission increased from 46% at post treatment to 66% for participants available for follow-up. Neither initial treatment group assignment nor antidepressant medication use during the follow-up period were significant predictors of MDD remission at 1 year. However, regular exercise during the follow-up period predicted both Hamilton Depression Rating Scale scores and MDD diagnosis at 1 year. This relationship was curvilinear, with the association concentrated between 0 minute and 180 minutes of weekly exercise. The effects of aerobic exercise on MDD remission seem to be similar to sertraline after 4 months of treatment; exercise during the follow-up period seems to extend the short-term benefits of exercise and may augment the benefits of antidepressant use. clinicaltrials.gov Identifier: NCT00331305.

Pretreatment EBV-DNA Copy Number Is Predictive for Response to SMILE Chemotherapy for Newly-Diagnosed Stage IV, Relapsed or Refractory Extranodal NK/T-Cell Lymphoma, Nasal Type: Results of NKTSG Phase II Study

AbstractAbstract 2873 Background:Extranodal NK/T-cell lymphoma, nasal type (ENKL) is a rare subtype of lymphoma and its standard therapy is not established. Because of the expression of multi-drug resistance associated P-glycoprotein, CHOP (-like) chemotherapy has limited efficacy in ENKL, with an overall response rate (ORR) of 36% for newly-diagnosed stage IV diseases and less than 10% for relapsed or refractory diseases. Our previous phase I trial of a new chemotherapeutic regimen, SMILE (Steroid=dexamethasone, Methotrexate, Ifosfamide, L-asparaginase and Etoposide) showed promising results (Cancer Sci, 2008). ENKL is invariably associated with clonal episomal infection of Epstein-Barr virus (EBV) in the lymphoma cells. The peripheral blood of these patients contains fragmented EBV-DNA, which can be used as a quantitative surrogate tumor marker for disease diagnosis, monitoring and prognostication. Methods:A phase II study of SMILE chemotherapy was conducted. Patients (Pts) with newly-diagnosed stage IV, or relapsed/refractory disease after first-line chemotherapy, between 15–69 years old and with a PS of 0–2 were eligible. Primary endpoint was ORR after 2 cycles of SMILE chemotherapy, and target enrollment was 38 pts. To ameliorate myelotoxicity and based on the results of phase I study, G-CSF was started from day 6. A part of this study (anti-tumor effect of the SMILE chemotherapy) has been presented in ASCO 2010 (abstract #8044) and EHA 2010 (abstract #299) meetings. EBV-DNA copy number before treatment was analyzed by using quantitative polymerase chain reaction. In Japan, the EBV-DNA was measured at the central laboratory (Nagoya Univ.). In Hong Kong and Korea, it was measured in each country, and was converted using coefficients. The association of converted EBV-DNA and anti-tumor effect of SMILE chemotherapy was investigated. Results:From July 2007 to October 2009, a total of 39 pts were enrolled in the phase II SMILE study. The median age was 47 years (range: 16–67), and male/female ratio was 21/18. There were newly-diagnosed stage IV disease in 21, first relapse in 13, and primary refractory disease in 5 pts. EBV-DNA before treatment was measured in 38 patients using whole blood (N=34) or plasma/serum (N=33). In 29 patients the EBV-DNA was examined in both samples. The median EBV-DNA was 2,850 copies/mL (range: 0–1.14×10^7) in whole blood and 1,101 copies/mL (range: 0–1.27×10^7). Results of these 2 measurement of EBV-DNA well correlated (r = 0.8706, P < 0.0001). EBV-DNA was undetectable (below the cutoff level) in 7 of 34 patients using whole blood and 14 of 33 patients using plasma/serum. 29 pts (74%) completed the planned treatment. The responses were complete remission (CR) in 15, partial remission (PR) in 14, no response in 4, progressive disease in 3, and early death in 3. ORR and %CR were 74% (90% confidence interval, 60–85) and 38%, respectively. Grade 4 neutropenia occurred in 36 of 39 patients (92%), and 2 patients died of infection during neutropenia. Grade 4 non-hematologic toxicities were infection (n=5), hyperbilirubinemia (n=1), ALT elevation (n=2) and encephalopathy (n=1). The grade 4 non-hematologic toxicity was only experienced in the 1st course of SMILE. No patient developed grade 4 non-hematologic toxicity in the 2nd course. The most common grade 3 non-hematologic toxicity was infection (41%). The whole blood EBV-DNA copy number was associated with ORR (r=0.71) and %CR (r=0.78). ORR was 88% in patients with less than 10^5 copies/mL EBV-DNA in whole blood, but was 44% in patients with more than 10^5 copies/mL (P=0.02). Six of 7 patients without detectable EBV-DNA in whole blood attained CR. In contrast, none of the 8 patients with more than 10^5 copies/mL EBV-DNA could achieve CR. Grade 4 non-hematologic toxicity was significantly higher in patients with more than 10^4 copies/mL of EBV-DNA in plasma (55% vs. 14%, P=0.03). Conclusion:Our results indicate that SMILE chemotherapy is an effective treatment for newly-diagnosed stage IV, relapsed or refractory ENKL. Myelosuppression and infection during the treatment should carefully be managed. EBV-DNA copy number is also predictive for response and adverse events of SMILE chemotherapy for newly-diagnosed stage IV, relapsed or refractory ENKL. Disclosures:Suzuki:Kyowa Kirin Company: Honoraria. Oshimi:Eisai Pharmaceutical Co Ltd: Employment.

Degree of solidarity with lifestyle and old age among citizens in the Netherlands: cross-sectional results from the longitudinal SMILE study

Background and aimWith the increasing interest in lifestyle, health and consequences of unhealthy lifestyles for the healthcare system, a new kind of solidarity is gaining importance: lifestyle solidarity. While it...

Increased attendance rate: BMI matters, lifestyles don't. Results from the Dutch SMILE study

a small group of frequent attenders is responsible for a disproportional large percentage of all daytime consultations in general practice. High attendance rates are related to demographic and psychological characteristics. Differences in attendance rates are only partly explained by chronic diseases. Furthermore, lifestyles might be relevant too. The aim of this study was to examine the effect of lifestyle on attendance rates. this study is part of the Study of Medical Information and Lifestyles in Eindhoven, the Netherlands (SMILE). Generalized estimated equations were used to determine the relation between attendance rate and the different lifestyle factors (N = 4444). a higher body mass index was related to increased attendance rate in both male [relative risk (RR) 1.02; 95% confidence interval (CI) 1.01-1.03] and female patients (RR 1.01; 95% CI 1.01-1.02). Lifestyles were not related to the attendance rate, except for a sedentary lifestyle in women (RR 1.08; 95% CI 1.04-1.12). since half of the Dutch population suffers from overweight or obesity and this number is still increasing, attendance rates will rise further. In order to relieve the GPs, nurse practitioners could play a more prominent role in lifestyle interventions concerning overweight and obesity and its related diseases.

Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: The SMILE study

Despite the high prevalence of pain, sexual dysfunction, and depression in patients on chronic hemodialysis, these symptoms are often unrecognized and under-treated by renal providers. This report describes the rationale and methodology of the SMILE study ( Symptom Management Invo lving End-Stage Renal Disease), a multi-center, randomized clinical trial comparing the effectiveness of two strategies for implementing treatment for these symptoms in patients receiving chronic hemodialysis. Approximately 250 patients from nine outpatient dialysis units will participate. Over a 2–12 month observational phase, participants complete monthly surveys characterizing their pain, sexual dysfunction, and depression. Following this observational period, subjects are randomized to one of two study arms to receive a 12-month intervention. In one study arm (feedback intervention), patients continue to complete the same three symptom surveys, and the presence and severity of the symptoms reported on these surveys is mailed to the patient's renal provider along with evidence-based algorithms outlining treatment options for these symptoms. Decisions on treatment are left at the discretion of the provider. Patients randomized to the other study arm (management intervention) also continue to complete the same monthly symptom surveys and are evaluated by a symptom management nurse trained in the management of these symptoms. This nurse then discusses the patient's symptoms with the renal provider, provides specific recommendations for treatment, and facilitates the implementation of treatment. The primary endpoints are changes in scores on pain, erectile dysfunction, and depression surveys. This report describes the rationale and methodology of this clinical trial.

Personality and parenting style in parents of adolescents

Since parental personality traits are assumed to play a role in parenting behaviors, the current study examined the relation between parental personality and parenting style among 688 Dutch parents of adolescents in the SMILE study. The study assessed Big Five personality traits and derived parenting styles (authoritative, authoritarian, indulgent, and uninvolved) from scores on the underlying dimensions of support and strict control. Regression analyses were used to determine which personality traits were associated with parenting dimensions and styles. As regards dimensions, the two aspects of personality reflecting interpersonal interactions (extraversion and agreeableness) were related to supportiveness. Emotional stability was associated with lower strict control. As regards parenting styles, extraverted, agreeable, and less emotionally stable individuals were most likely to be authoritative parents. Conscientiousness and openness did not relate to general parenting, but might be associated with more content-specific acts of parenting.

Anxiety, Stress and Coping Behaviours in Primary Care Migraine Patients: Results of the SMILE Study

The objectives of the SMILE study were to assess anxiety, stress, depression, functional impact and coping behaviours in migraine patients consulting in primary care in France. General practitioners (n = 1467) and 83 neurologists included 5417 consulting migraine patients. Of these patients, 67% were found anxious, of whom 59% were also depressive. Patients with both anxiety and depressive dimensions showed a profile similar to that of chronic migraine patients (severe attacks, poor treatment effectiveness and pronounced stress, functional impact and maladaptive behaviours). A quantitative progression in the levels of stress, maladaptive coping behaviours and functional impact was noted from patients with neither dimension to those with both anxious and depressive dimensions. Stress and maladaptive coping strategies were found to be major determinants of anxiety. Anxious and depressive dimensions were associated with elevated consumption of acute treatments for migraine and low treatment effectiveness. Stress and anxiety should be looked for carefully in migraine patients.

Material deprivation and health-related dysfunction in older Dutch people: findings from the SMILE study

Even in generally wealthy Western countries material deprivation and poverty are not uncommon. There is, however, little data on the prevalence of material deprivation and its associations with health-related dysfunction in older people. Cross-sectional data from the SMILE study were used to examine the prevalence of material deprivation and the associations between material deprivation and health-related dysfunction in persons aged 55 years and older (n > 4000). Material deprivation was measured with a comprehensive questionnaire assessing seven subdomains referring to current and anticipated financial problems and poverty in childhood. Health-related dysfunction was measured using the SF36-based physical and mental components. In addition, self-reported heart disease was examined as an indicator of health-related dysfunction as well. Almost 29% of subjects experienced at least one financial problem. Those reporting material deprivation had more than twice the risk of physical (OR = 2.22; 95% CI: 1.72-2.86) and mental (OR = 2.34; 95% CI: 1.84-2.97) dysfunction compared with non-deprived persons. A slightly weaker association was found when self-reported heart disease was used as an outcome variable (OR = 1.74; 95% CI: 1.40-2.15). Although odds ratios were generally higher for diseased older persons, no significant interaction effect between chronic disease and material deprivation subscales was found. Material deprivation in the Netherlands is not uncommon and is strongly related to both mental and physical dysfunction, and therefore needs further attention in public health policy. Longitudinal research is necessary to clarify the causal nature of our results and to develop appropriate interventions.

The SMILE study: a study of medical information and lifestyles in Eindhoven, the rationale and contents of a large prospective dynamic cohort study

BackgroundHealth problems, health behavior, and the consequences of bad health are often intertwined. There is a growing need among physicians, researchers and policy makers to obtain a comprehensive insight into the mutual influences of different health related, institutional and environmental concepts and their collective developmental processes over time.Methods/DesignSMILE is a large prospective cohort study, focusing on a broad range of aspects of disease, health and lifestyles of people living in Eindhoven, the Netherlands. This study is unique in its kind, because two data collection strategies are combined: first data on morbidity, mortality, medication prescriptions, and use of care facilities are continuously registered using electronic medical records in nine primary health care centers. Data are extracted regularly on an anonymous basis. Secondly, information about lifestyles and the determinants of (ill) health, sociodemographic, psychological and sociological characteristics and consequences of chronic disease are gathered on a regular basis by means of extensive patient questionnaires. The target population consisted of over 30,000 patients aged 12 years and older enrolled in the participating primary health care centers.DiscussionDespite our relatively low response rates, we trust that, because of the longitudinal character of the study and the high absolute number of participants, our database contains a valuable set of information.SMILE is a longitudinal cohort with a long follow-up period (15 years). The long follow-up and the unique combination of the two data collection strategies will enable us to disentangle causal relationships. Furthermore, patient-reported characteristics can be related to self-reported health, as well as to more validated physician registered morbidity. Finally, this population can be used as a sampling frame for intervention studies. Sampling can either be based on the presence of certain diseases, or on specific lifestyles or other patient characteristics.

Smile: First Observational Prospective Cohort Study of Migraine in Primary Care in France. Description of Methods and Study Population

The SMILE study was conducted among migraine patients consulting in primary care in France. The first phase aimed to describe the study sample of patients at entry to the study, especially emotional dimension (Hospital Anxiety and Depression scale), functional impact (abridged Migraine Specific Questionnaire), stress (Perceived Stress Scale) and coping behaviours (brief COPE inventory avoidance subscale, Coping Strategies Questionnaire catastrophizing subscale), as well as treatments used and their effectiveness and treatments prescribed at end of consultation. Results indicate that consulting migraine patients suffer frequent migraine attacks, exhibit substantial levels of anxiety, functional impact and stress, and often use maladaptive coping strategies. Abortive treatments appear ineffective in most patients (74%). Patients with more affected psychometric variables and treatment ineffectiveness are more likely to be deemed eligible for prophylactic treatment. These data highlight the seriousness of migraine and maladjustment of patients consulting in primary care.

Exercise and Pharmacotherapy in the Treatment of Major Depressive Disorder

To assess whether patients receiving aerobic exercise training performed either at home or in a supervised group setting achieve reductions in depression comparable to standard antidepressant medication (sertraline) and greater reductions in depression compared to placebo controls. Between October 2000 and November 2005, we performed a prospective, randomized controlled trial (SMILE study) with allocation concealment and blinded outcome assessment in a tertiary care teaching hospital. A total of 202 adults (153 women; 49 men) diagnosed with major depression were assigned randomly to one of four conditions: supervised exercise in a group setting; home-based exercise; antidepressant medication (sertraline, 50-200 mg daily); or placebo pill for 16 weeks. Patients underwent the structured clinical interview for depression and completed the Hamilton Depression Rating Scale (HAM-D). After 4 months of treatment, 41% of the participants achieved remission, defined as no longer meeting the criteria for major depressive disorder (MDD) and a HAM-D score of <8. Patients receiving active treatments tended to have higher remission rates than the placebo controls: supervised exercise = 45%; home-based exercise = 40%; medication = 47%; placebo = 31% (p = .057). All treatment groups had lower HAM-D scores after treatment; scores for the active treatment groups were not significantly different from the placebo group (p = .23). The efficacy of exercise in patients seems generally comparable with patients receiving antidepressant medication and both tend to be better than the placebo in patients with MDD. Placebo response rates were high, suggesting that a considerable portion of the therapeutic response is determined by patient expectations, ongoing symptom monitoring, attention, and other nonspecific factors.

Clusters of lifestyle behaviors: Results from the Dutch SMILE study

Objective.This study aimed to identify differences and similarities in health behavior clusters for respondents with different educational backgrounds. Methods.A total of 9449 respondents from the 2002 wave of the Dutch SMILE cohort study participated. Latent class analyses were used to identify clusters of people based on their adherence to Dutch recommendations for five important preventive health behaviors: non-smoking, alcohol use, fruit consumption, vegetable consumption and physical exercise. Results.The distribution of these groups of behaviors resulted in three clusters of people: a healthy, an unhealthy and poor nutrition cluster. This pattern was replicated in groups with low, moderate and high educational background. The high educational group scored much better on all health behaviors, whereas the lowest educational group scored the worst on the health behaviors. Conclusion.The same three patterns of health behavior can be found in different educational groups (high, moderate, low). The high educational group scored much better on all health behaviors, whereas the lowest educational group scored the worst on the health behaviors. Tailoring health education messages using a cluster-based approach may be a promising new approach to address multiple behavior change more effectively.

Effects of early angiotensin-converting enzyme inhibition in patients with non–ST-elevation acute anterior myocardial infarction

No data are available on the clinical efficacy of the early administration (<24 hours from onset of chest pain) of angiotensin-converting enzyme inhibitors in non-thrombolysed patients with non-ST-elevation myocardial infarction (NSTEMI). We have addressed this issue in a subgroup of NSTEMI patients enrolled in the SMILE trial. Of the overall population of 1556 patients, 526 (33.8%) had an anterior wall NSTEMI, defined as an ST elevation <1 mm or an ST depression in at least two contiguous precordial leads with or without new abnormal Q waves. No patient of the SMILE Study received thrombolytic therapy or was reperfused. Patients were randomized, double-blind, to zofenopril (n = 253) or placebo (n = 273) for 6 weeks. The primary end point was the effect of treatment on the 6-week combined occurrence of death and severe congestive heart failure (CHF). Secondary end points included the evaluation of the 6-week rate of severe CHF as well as the 1-year mortality rate. After 6 weeks of treatment, zofenopril significantly reduced both the incidence of the primary end point (risk reduction 65%, 95% CI 20-80, 2P = .003) and the 6-week incidence of severe CHF (84%, 95% CI 33-97, 2P = .006) in NSTEMI patients. One-year mortality was also significantly reduced by zofenopril treatment (43%, 95% CI 14-57, 2P = .036). Results of this post hoc analysis of the SMILE Study strongly suggest the benefit of the early administration of zofenopril even in patients with an anterior wall NSTEMI.

Associations of social-environmental and individual-level factors with adolescent soft drink consumption: results from the SMILE study

Adolescent obesity is positively associated with soft drink consumption. We investigated the association of social-environmental and individual-level factors with soft drink consumption in a Dutch adolescent sample. Data were gathered in a longitudinal Dutch adolescent sample (n = 208, 62% girls). Soft drink consumption, social cognitions from the Theory of Planned Behaviour and parenting practices towards limited soft drink intake, and Big Five personality dimensions were assessed. Data were analyzed using three-step linear regression analyses. Effect sizes were used as the informational source for the explanatory value of the model. Interaction terms were computed to test the individual-environment interaction. Attitude and subjective norm were significantly associated with soft drink consumption. When controlling for social cognitions, the distal variables parenting practices and the personality dimension Agreeableness remained significantly associated with soft drink consumption. Agreeableness moderated the association of parenting practices with adolescent soft drink consumption. Standardized regression coefficients ranged from 0.16 to 0.24 and explained 14% of the variance in soft drink consumption, indicating a medium effect size. Stricter parenting practices were associated with less soft drink consumption and these effects were moderated by adolescent personality. The direct effects of practices and personality are noteworthy from a theoretical perspective. Implications for obesity prevention interventions are discussed.