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Background: The articulatory accuracy of patients with dysarthria is one of the most affected speech dimensions with a high impact on speech intelligibility. Behavioural treatments of articulation can either involve direct or indirect approaches. The latter have been thoroughly investigated and are generally appreciated for their almost immediate effects on articulation and intelligibility. The number of studies on (short‐term) direct articulation therapy is limited. Aims: To investigate the effects of short‐term, boost articulation therapy (BArT) on speech intelligibility in patients with chronic or progressive dysarthria and the effect of severity of dysarthria on the outcome. Methods & Procedures: The study consists of a two‐group pre‐/post‐test design to assess speech intelligibility at phoneme and sentence level and during spontaneous speech, automatic speech and reading a phonetically balanced text. A total of 17 subjects with mild to severe dysarthria participated in the study and were randomly assigned to either a patient‐tailored, intensive articulatory drill programme or an intensive minimal pair training. Both training programmes were based on the principles of motor learning. Each training programme consisted of five sessions of 45 min completed within one week. Outcomes & Results: Following treatment, a statistically significant increase of mean group intelligibility was shown at phoneme and sentence level, and in automatic sequences. This was supported by an acoustic analysis that revealed a reduction in formant centralization ratio. Within specific groups of severity, large and moderate positive effect sizes with Cohen's d were demonstrated. Conclusions & Implications: BArT successfully improves speech intelligibility in patients with chronic or progressive dysarthria at different levels of the impairment. What this paper addsWhat is already known on the subjectBehavioural treatment of articulation in patients with dysarthria mainly involves indirect strategies, which have shown positive effects on speech intelligibility. However, there is limited evidence on the short‐term effects of direct articulation therapy at the segmental level of speech. This study investigates the effectiveness of BArT on speech intelligibility in patients with chronic or progressive dysarthria at all severity levels.What this paper adds to existing knowledgeThe intensive and direct articulatory therapy programmes developed and applied in this study intend to reduce the impairment instead of compensating it. This approach results in a significant improvement of speech intelligibility at different dysarthria severity levels in a short period of time while contributing to exploit and develop all available residual motor skills in persons with dysarthria.What are the potential or actual clinical implications of this work?The improvements in intelligibility demonstrate the effectiveness of a BArT at the segmental level of speech. This makes it to be considered a suitable approach in the treatment of patients with chronic or progressive dysarthria. [ABSTRACT FROM AUTHOR]

Background: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [ABSTRACT FROM AUTHOR]

Given the widespread use of touch screen devices, the effect of the users' fingers on information processing and learning is of growing interest. The present study drew on cognitive load theory and embodied cognition perspectives to investigate the effects of pointing and tracing gestures on the surface of a multimedia learning instruction. Learning performance, cognitive load and visual attention were examined in a one‐factorial experimental design with the between‐subject factor pointing and tracing gestures. The pointing and tracing group were instructed to use their fingers during the learning phase to make connections between corresponding text and picture information, whereas the control group was instructed not to use their hands for learning. The results showed a beneficial effect of pointing and tracing gestures on learning performance, a significant shift in visual attention and deeper processing of information by the pointing and tracing group, but no effect on subjective ratings of cognitive load. Implications for future research and practice are discussed. Lay Description: What is currently known about the subject matter? Pointing and tracing gestures enhance learning with multimediaThe effect is true for paper based and digital learning instructionsLess is known about the cause of this effect with regard to complex learningDifferent theoretical explanations are currently discussed What our paper adds to this A detailed analysis of the effect using eye‐tracking and touch screen dataEvidence that the effect of pointing and tracing is mediated by eye‐movementsRelevant information concerning the discussion about theoretical explanations The implications of study findings for practitioners Pointing and tracing gestures can guide the learners' visual focus of attentionPointing and tracing gestures can increase the learners' visual attentionPointing and tracing gestures foster information processing when learning with multimediaLearners can or even should use pointing and tracing gestures to support learning [ABSTRACT FROM AUTHOR]

Background/aim Engagement in desired occupations can promote health and wellbeing in older adults. Assessments of engagement often measure frequency, amount or importance of specific activities. This study aimed to develop a scale to measure older adults' evaluation of the extent to which their everyday activities are contributing to their health and wellness. Methods Eighteen items, each scored with a seven-point rating scale, were initially developed by content experts, covering perceptions of how daily activities contribute to physical and mental health, as well as satisfaction and activity participation in the last six months. Rasch analysis methods were used to refine the scale using the pencil and paper responses of 460 community-living older adults. Results Initial Rasch analysis indicated three unlabelled rating scale categories were seldom used, reducing measurement precision. Five items were conceptually different by misfit statistics and principal component analysis. Subsequently, those items were removed and the number of rating scale steps reduced to 4. The remaining 13-item, 4-step scale, termed the Activity Significance Personal Evaluation ( ASPEn), formed a unidimensional hierarchy with good fit statistics and targeting. Person separation reliability (2.7) and internal consistency (.91) indicated the tool is appropriate for individual person measurement. Relative validity indicated equivalence between Rasch measures and total raw scores. Conclusions ASPEn is a brief, easily administered assessment of older adults' perception of the contribution of everyday activities to personal health and wellness. ASPEn may facilitate occupational therapy practice by enabling clinicians to assess change in meaning of an older adult's activity over time. [ABSTRACT FROM AUTHOR]

Prenatal iron supplementation improves children's health and cognitive performance, but few studies explore behavioural development. This study assessed the effects of adjusting prenatal iron supplementation to maternal iron stores during early pregnancy on children's behavioural problems. Randomized controlled trial conducted in Tarragona (Spain) involving 230 nonanaemic pregnant women and their children after a 4‐year follow‐up. Based on haemoglobin (Hb) levels before gestational week (GW) 12, women receive different iron doses: those with Hb = 110–130 g/L were randomized to receive 80 or 40 mg/day and those with Hb > 130 g/L were randomized to receive 20 or 40 mg/day. Maternal iron stores at GW12 were classified using serum ferritin (SF) as low (SF < 15 µg/L), normal (SF = 15–65 µg/L), and normal‐high (SF > 65 µg/L). Children's behaviour was assessed by parents using the Child Behaviour Checklist for ages 1.5–5 years and the Behaviour Rating Inventory of Executive Function‐Preschool Version, and by teachers using the Teacher's Report Form for ages 1.5–5 years. Multivariable regression models were performed. Taking 80 mg/day of iron improved child behaviour when women had low iron stores but worsened it when mothers had normal–high iron stores, except for depressive and attention/hyperactivity problems. Taking 20 mg/day of iron improved behaviour only in those children whose mothers had SF > 65 µg/L in early pregnancy. Additionally, executive functioning improved at high doses of prenatal iron when maternal baseline SF < 15 µg/L. Adjusting prenatal iron supplementation to both maternal baseline Hb levels and iron stores reduces behavioural problems in 4‐year‐old children. Key messages: Prenatal iron supplementation succeeds in improving maternal haematological outcomes and cognitive performance of children, but few studies have focused on behavioural development.Prenatal iron supplementation adjusted to maternal iron stores reduces behavioural problems in 4‐year‐old children.Maternal iron stores early in pregnancy should be measured in addition to haemoglobin concentration.These findings contribute greatly to the advancement of public health by giving physicians the tools to prescribe the most appropriate dose of iron supplementation to contribute to better child development. [ABSTRACT FROM AUTHOR]

Aims To update the existing scientific evidence on the efficacy of local antimicrobials as adjuncts to subgingival debridement in the treatment of chronic periodontitis. Material and Methods Fifty-six papers were selected, reporting data from 52 different investigations. All the studies reported changes in probing pocket depth ( PPD) and clinical attachment level ( CAL) and most in plaque index (PlI) and/or bleeding on probing ( BOP). Meta-analyses were performed with the data retrieved from the studies fulfilling the inclusion criteria. Results The overall effect of the subgingival application of antimicrobials was statistically significant ( p = 0.000) for both changes in PPD and CAL with a weighted mean difference ( WMD) of −0.407 and −0.310 mm respectively. No significant differences occurred for changes in BOP and PlI. Subgingival application of tetracycline fibres, sustained released doxycycline and minocycline demonstrated a significant benefit in PPD reduction ( WMD between 0.5 and 0.7 mm). The rest of the tested outcomes demonstrated a high heterogeneity. The local application of chlorhexidine and metronidazole showed a minimal effect when compared with placebo ( WMD between 0.1 and 0.4 mm). Conclusions The scientific evidence supports the adjunctive use of local antimicrobials to debridement in deep or recurrent periodontal sites, mostly when using vehicles with proven sustained release of the antimicrobial. [ABSTRACT FROM AUTHOR]

Background: Sensitive responsiveness is an important aspect in affect‐regulation of people with severe to profound intellectual disabilities. Aim: This randomized controlled trial evaluated the Attune & Stimulate‐checklist, a tool for detecting subtle and idiosyncratic communicative behaviours and responding adequately. Methods: Effects on the sensitive responsiveness of professional caregivers and the arousal and valence of adults with severe to profound intellectual disabilities were investigated. Video recordings of 102 interactions were analysed with several observation instruments. Results: Although no significant effect was found on the checklist‐suggestions of responsive behaviours (d = 0.33, p =.052), the intervention increased caregivers' sensitive responsive and affective behaviour (d = 0.94 – 1.10, p <.001) and clients' optimal arousal (d = 0.48, p =.019) and interactive engagement (d = 0.40 – 0.48, p =.018 ‐.050). Conclusion: This low‐intensity intervention had a medium to large immediate effect on the interaction. Future research should investigate medium‐ and long‐term effects. [ABSTRACT FROM AUTHOR]

Child undernutrition in Cambodia is a persistent public health problem requiring low‐cost and scalable solutions. Rising cellphone use in low‐resource settings represents an opportunity to replace in‐person counselling visits with phone calls; however, questions remain on relative effectiveness. Our objective was to evaluate the impact of two options for delivering a World Vision infant and young child feeding (IYCF) counselling programme: (1) traditional Positive Deviance/Hearth (PDH) programme with in‐person visits or (2) PDH with Interactive Voice Calling (PDH‐IVC) which integrates phone calls to replace 62.5% of face‐to‐face interaction between caregivers and volunteers, compared to the standard of care (SOC). We conducted a longitudinal cluster‐randomised controlled trial in 361 children 6–23 months. We used an adjusted difference‐in‐difference approach using baseline, midline (3 months) and endline (12 months) surveys to evaluate the impact on child growth among the three groups. At baseline, nearly a third of children were underweight, and over half were food insecure. At midline the PDH group and the PDH‐IVC groups had improved weight‐for‐age z‐scores (0.13 DID, p = 0.011; 0.13 DID, p = 0.02, respectively) and weight‐for‐height z‐score (0.16 DID, p = 0.038; 0.24 DID, p = 0.002), relative to SOC. There were no differences in child height‐for‐age z‐scores. At endline, the impact was sustained only in the PDH‐IVC group for weight‐for‐age z‐score (0.14 DID, p = 0.049), and the prevalence of underweight declined by 12.8 percentage points (p = 0.036), relative to SOC. Integration of phone‐based IYCF counselling is a potentially promising solution to reduce the burden of in‐person visits; however, the modest improvements suggest the need to combine it with other strategies to improve child nutrition. [ABSTRACT FROM AUTHOR]

Cardiac disease and type 2 diabetes are prevalent diseases globally. Cardiac rehabilitation and diabetes self-management programs empower patients' self-management to improve their health outcomes. However, inappropriate delivery modes and continuing low participation rates indicate some programs are less than optimal. A previous study demonstrated the feasibility of incorporating telephone and text messages into a cardiac-diabetes self-management program in Australia; however, the program did not specifically address patients' cultural backgrounds. This current study used a randomized blocked design to evaluate short-term efficacy of the cardiac-diabetes self-management program incorporating telephone and text-messaging across different cultural contexts in Australia and Taiwan in comparison to usual care. No significant differences between groups were observed for outcomes of self-care behavior, self efficacy, knowledge and health-related quality of life, with patients in both groups demonstrating improvements. Patient-reported outcomes indicated some evidence of an interaction effect between country of origin and group allocation. Findings indicated an improved tendency of outcome measures between the baseline and follow-up assessments within usual care and intervention groups. Further research is required to clarify components of the program work for each cultural group. [ABSTRACT FROM AUTHOR]

Prenatal supplementation with protein-energy (PE) and/or multiple-micronutrients (MMNs) may improve fetal growth, but trials of lipid-based nutritional supplements (LNSs) have reported inconsistent results. We conducted a post-hoc analysis of non-primary outcomes in a trial in Gambia, with the aim to test the associations of LNS with fetal growth and explore how efficacy varies depending on nutritional status. The sample comprised 620 pregnant women in an individually randomized, partially blinded trial with four arms: (a) iron and folic acid (FeFol) tablet (usual care, referent group), (b) MMN tablet, (c) PE LNS, and (d) PE + MMN LNS. Analysis of variance examined unadjusted differences in fetal biometry z-scores at 20 and 30 weeks and neonatal anthropometry z-scores, while regression tested for modification of intervention-outcome associations by season and maternal height, body mass index, and weight gain. Despite evidence of between-arm differences in some fetal biometry, z-scores at birth were not greater in the intervention arms than the FeFol arm (e.g., birth weight z-scores: FeFol −0.71, MMN −0.63, PE −0.64, PE + MMN −0.62; group-wise p = .796). In regression analyses, intervention associations with birth weight and head circumference were modified by maternal weight gain between booking and 30 weeks gestation (e.g., PE + MMN associations with birth weight were +0.462 z-scores (95% CI [0.097, 0.826]) in the highest quartile of weight gain but -0.099 z-scores (−0.459, 0.260) in the lowest). In conclusion, we found no strong evidence that a prenatal LNS intervention was associated with better fetal growth in the whole sample. [ABSTRACT FROM AUTHOR]

Aim To assess the impact on fear of hypoglycaemia and treatment satisfaction with an artificial pancreas system used for 2 consecutive months, as well as participant acceptance of the artificial pancreas system. Methods In a randomized crossover trial patient-related outcomes associated with an evening-and-night artificial pancreas and sensor-augmented pump therapy were compared. Both intervention periods lasted 8 weeks. The artificial pancreas acceptance questionnaire (range 0-90, higher scores better), Hypoglycaemia Fear Survey II (range 0-72, higher scores worse) and Diabetes Treatment Satisfaction Questionnaire (range 0-36, higher scores better) were completed by 32 participants. Semi-structured interviews were conducted after study completion in a subset of six participants. Outcomes were compared using a repeated-measures anova model or paired t-test when appropriate. Results The total artificial pancreas acceptance questionnaire score at the end of the artificial pancreas period was 69.1 ( sd 14.7; 95% CI 63.5, 74.7), indicating a positive attitude towards the artificial pancreas. No significant differences were found among the scores at baseline, end of sensor-augmented pump therapy period or end of the artificial pancreas period with regard to fear of hypoglycaemia [28.2 ( sd 17.5), 23.5 ( sd 16.6) and 23.5 ( sd 16.7), respectively; P = 0.099] or diabetes treatment satisfaction [29.0 ( sd 3.9), 28.2 ( sd 5.2) and 28.0 ( sd 7.1), respectively; P = 0.43]. Themes frequently mentioned in the interviews were 'positive effects at work', 'improved blood glucose', 'fewer worries about blood glucose', but also 'frequent alarms', 'technological issues' and 'demand for an all-in-one device'. Conclusions The psychological outcomes of artificial pancreas and sensor-augmented pump therapy were similar. Current artificial pancreas technology is promising but user concerns should be taken into account to ensure utility of these systems. [ABSTRACT FROM AUTHOR]

Background: The extant literature demonstrates that children with autism spectrum disorder (ASD) often have difficulty interacting and socially connecting with typically developing classmates. However, some children with ASD have social outcomes that are consistent with their typically developing counterparts. Little is known about this subgroup of children with ASD. This study examined the stable (unlikely to change) and malleable (changeable) characteristics of socially successful children with ASD. Methods: This study used baseline data from three intervention studies performed in public schools in the Southwestern United States. A total of 148 elementary-aged children with ASD in 130 classrooms in 47 public schools participated. Measures of playground peer engagement and social network salience (inclusion in informal peer groups) were obtained. Results: The results demonstrated that a number of malleable factors significantly predicted playground peer engagement (class size, autism symptom severity, peer connections) and social network salience (autism symptom severity, peer connections, received friendships). In addition, age was the only stable factor that significantly predicted social network salience. Interestingly, two malleable (i.e., peer connections and received friendships) and no stable factors (i.e., age, IQ, sex) predicted overall social success (e.g., high playground peer engagement and social network salience) in children with ASD. Conclusions: School-based interventions should address malleable factors such as the number of peer connections and received friendships that predict the best social outcomes for children with ASD. [ABSTRACT FROM AUTHOR]

Objectives To compare the use of sonic powered or manual toothbrush in patients with intellectual disability ( ID) in terms of plaque (PlI) and gingival ( GI) indices and adverse effects. Material and Methods Subjects with ID were recruited for this cluster-randomized, single blinded (examiner), 6-month clinical trial, comparing powered versus manual toothbrushing. Outcome variables included PlI and GI, evaluated at baseline and 3 months after supervised toothbrushing and after 3 additional months of unsupervised used. Clinical outcome variables were analysed by repeated measures ANCOVA considering time and group as factors and respective baseline values as covariates (generalized linear model). Results Sixty-four patients (34 male, mean age 34.5) in six clusters were included in the study. No statistically significant effect of toothbrushing group was observed for PlI or GI. A significant effect of time was identified ( p < 0.001) with mean reductions ranging 0.44-0.45 for PlI and 0.30-0.36 for GI from baseline to 3-6 months. No relevant adverse effect or technical problems were observed. Conclusion The tested sonic powered toothbrush was as effective and safe as the manual toothbrush. The use of powered or manual toothbrushes, together with fluoride toothpaste, may improve plaque and gingivitis levels, in patients with mild to limit ID. [ABSTRACT FROM AUTHOR]

Objective Evaluate the immediate and cumulative optical whitening efficacy of a blue covarine toothpaste. Materials and Methods 180 bovine tooth specimens with similar shade (Δ E < 3.5) were staining of different beverage: black tea(BT), green tea (GT), red wine (RW), orange soda (OS), and brazilian açai juice (AJ), and then submitted to tooth brushing with a blue covarine toothpaste (Op) or a control abrasive toothpaste (Ab). The whitening effect was evaluated at baseline (B), after staining (S), after 1 day (1D) and 7 days of cumulative use of toothpastes (7D). The color shade chances were assessment by Vita Easyshade reflectance spectroscope and the data of CIELab color coordinates (L*, a*, and b*), color difference (Δ E) and the whiteness index optimized (WIO), were analyzed by two-way mixed analysis of variance (ANOVA) for repeated measures and Bonferroni-corrected t-tests (α = 0.05). Results The analysis showed statistically significant differences before and after staining by colored beverages ( p < 0.05), but no differences were found due to the action of toothpaste ( p > 0.05), in the CIELab coordinates, Δ E and WIO index. Conclusions The use of toothpastes (Op or Ab) reduced the dental staining caused by different colored beverage, but the whitening effect of blue covarine toothpaste could not be confirmed ( p > 0.05). [ABSTRACT FROM AUTHOR]

Background An increased plasma lipopolysaccharide ( LPS) concentration may favour metabolic disorders such as insulin resistance. The meal composition influences plasma LPS concentrations. The present study aimed to investigate the effect of the acute consumption of a high-fat meal (49% of energy from fat) containing conventional or high-oleic peanuts on post-prandial LPS concentrations and its relationship with lipaemia and insulinaemia in overweight and obese men. Methods The test meal consisted of a shake containing conventional peanuts ( CVP; n = 21), high-oleic peanuts ( HOP; n = 23) or a control biscuit ( CT; n = 21). Blood samples were collected in the fasting state and 1, 2 and 3 h post-prandially. LPS, insulin, lipids and glucose concentrations were assessed. Results LPS concentrations were lower in CVP [mean (SE) 0.7 (0.5) EU mL−1] and HOP [1.0 (0.9) EU mL−1] groups compared to CT [1.6 (1.2) EU mL−1] at 3 h post-prandially. Triacylglycerol and insulin concentrations increased in all groups. Triacylglycerol started to increase only after 2 h in the CVP and HOP groups. LPS correlated positively with triacylglycerol. Insulin returned to basal concentrations at 3 h only in the CVP and HOP groups. Conclusions The acute consumption of peanuts delayed the increase in serum triacylglycerol and favoured the quicker return of insulin to basal concentrations, especially in the CVP group. Our results suggest that the consumption of conventional or high-oleic peanuts may help to reduce the risk of endotoxaemia and metabolic disorders. [ABSTRACT FROM AUTHOR]

As pregnancy may trigger overweight in women, new means for its prevention are being sought. The aim here was to investigate the effect of individual dietary counselling during and after pregnancy on post‐partum weight and waist circumference up to 4 years post‐partum. A cohort of women (n = 256) were randomized to receive repeated individual dietary counselling by a nutritionist during and after pregnancy, or as controls not receiving dietary counselling, from the first trimester of pregnancy until 6 months after delivery. Counselling aimed to bring dietary intake into line with recommendations, with particular focus on the increase in the intake of unsaturated fatty acids instead of saturated. Pre‐pregnancy weight was taken from welfare clinic records. Weight and waist circumference were measured at 4 years after delivery. The proportion of overweight women increased from 26% prior to pregnancy to 30% at 4 years after delivery among women receiving dietary counselling, as against considerably more, from 32% to 57%, among controls. The prevalence of central adiposity was 31% in women receiving dietary counselling, 64% in controls. Likewise, both the risk of overweight (odds ratio: 0.23, 0.08–0.63, P = 0.005) and central adiposity (odds ratio: 0.18, 0.06–0.52, P = 0.002) were lower in women receiving dietary counselling compared with controls. Repeated dietary counselling initiated in early pregnancy can be beneficial in long‐term weight control after delivery. [ABSTRACT FROM AUTHOR]

What is already known about this subject Obesity-related insulin resistance is highly prevalent in children and adolescents, and contributes to an increased lifetime risk of type 2 diabetes mellitus and cardiovascular disease., Intensive exercise training may improve insulin sensitivity., What this study adds Three monitored exercise training sessions per week for 8 weeks can improve fitness-related insulin sensitivity in obese, insulin resistant children., Insulin sensitivity and skeletal muscle oxidative phosphorylation may be dissociable in this population., Improvements in fitness may be accompanied by a rise in intramyocellular lipid content and an associated increase in resting energy expenditure., Background Obesity is associated with poor fitness and adverse metabolic consequences in children. Objective To investigate how exercise and lifestyle modification may improve fitness and insulin sensitivity in this population. Design and subjects Randomized controlled trial, 21 obese (body mass index ≥ 95% percentile) subjects, ages 10 to 17 years. Methods Subjects were given standardized healthful lifestyle advice for 8 weeks. In addition, they were randomized to an in-home supervised exercise intervention ( n = 10) or control group ( n = 11). Measurements Fasting laboratory studies (insulin, glucose, lipid profile) and assessments of fitness, body composition, skeletal muscle oxidative phosphorylation and intramyocellular lipid content ( IMCL), were performed at baseline and study completion. Results Subjects were 13.0 ± 1.9 (standard deviation) years old, 72% female and 44% non-white. Exercise improved fitness ( P = 0.03) and power ( P = 0.01), and increased IMCL ( P = 0.02). HOMA-IR decreased among all subjects in response to lifestyle modification advice ( P = 0.01), regardless of exercise training assignment. In univariate analysis in all subjects, change in cardiovascular fitness was associated with change in HOMA-IR. In exploratory analyses, increased IMCL was associated with greater resting energy expenditure (r = 0.78, P = 0.005) and a decrease in fasting respiratory quotient (r = −0.70, P = 0.02) ( n = 11). Conclusions Change in fitness was found to be related to change in insulin resistance in response to lifestyle modification and exercise in obese children. IMCL increased with exercise in these obese children, which may reflect greater muscle lipid oxidative capacity. [ABSTRACT FROM AUTHOR]

Aim To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease ( COPD) patients with chronic periodontitis ( CP). Materials and Methods In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing ( SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Results Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p < 0.05). Overall, the means of forced expiratory volume in the first second/forced vital capacity ( FEV1/ FVC) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up ( p < 0.05). In addition, the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up ( p < 0.05). Conclusions Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. [ABSTRACT FROM AUTHOR]

Objective The purpose of this ongoing randomized study was to assess differences in bone level changes and success rates using implants supporting single crowns in the posterior mandible either with platform matched or platform switched abutments. Material and Methods Patients aged 18 and above, missing at least two teeth in the posterior mandible and with a natural tooth mesial to the most proximal implant site were enrolled. Randomization followed implant placement. Definitive restorations were placed after a minimum transgingival healing period of 8 weeks. Changes in crestal bone level from surgery and loading (baseline) to 12-month post-loading were radiographically measured. Implant survival and success were determined. Results Sixty-eight patients received 74 implants in the platform switching group and 72 in the other one. The difference of mean marginal bone level change from surgery to 12 months was significant between groups ( p < 0.004). Radiographical mean bone gain or no bone loss from loading was noted for 67.1% of the platform switching and 49.2% of the platform matching implants. Implant success rates were 97.3% and 100%, respectively. Conclusions Within the same implant system the platform switching concept showed a positive effect on marginal bone levels when compared with restorations with platform matching. [ABSTRACT FROM AUTHOR]

Background To date, there are no dietary intervention studies available jointly examining the changes produced in cardiometabolic risk indices and diet quality assessed with the Healthy Eating Index 2005 (HEI-2005). The present study aimed to evaluate the effect of a 3-month multicomponent lifestyle intervention on several cardiometabolic risk indices, physical activity levels and diet quality. Methods A total sample of 108 hypercholesterolaemic adults (40-60 years old) were randomised to two intervention groups provided with and instructed to consume daily: (i) plain milk ( n = 37) or (ii) enriched milk ( n = 40) respectively; both groups were attending a 3-month dietary counselling programme. For the needs of the present study both intervention groups were analysed together IG: n = 77) and were compared against a control group following usual diet ( CG: n = 31). Results Regarding diet quality HEI scores for 'milk' ( P = 0.021), 'dark green/orange vegetables and legumes' ( P = 0.050) and 'total HEI score' ( P = 0.045) were improved in the IG compared to the CG. The IG also improved 'whole grains' and 'calories from solid fats, alcoholic beverages and added sugars' scores compared to their baseline values. Both groups improved the 'total vegetable' HEI score. Regarding physical activity levels and cardiometabolic risk indices, the IG significantly increased the daily number of steps ( P = 0.005) and decreased body weight ( P = 0.021), body mass index ( P = 0.019) and waist circumference ( P = 0.027) to a higher extent compared to the changes observed in the CG. Moreover, the IG significantly decreased systolic ( P = 0.001) and diastolic blood pressure ( P = 0.050) compared to baseline values. Conclusions The present study revealed that this 3-month lifestyle and nutrition counselling intervention programme appears to have favourable effects on diet quality, physical activity levels, anthropometric and certain cardiometabolic risk indices. [ABSTRACT FROM AUTHOR]

Voclosporin (VCS) is a novel calcineurin (CN) inhibitor intended for prevention of organ graft rejection and treatment of lupus nephritis. These studies evaluated the single ascending dose pharmacokinetics (PK) and pharmacodynamics (PD, CN activity) of VCS and the effect of food. VCS was administered orally in single doses of 0.25 through 4.5 mg/kg in 62 subjects in the single ascending dose study and as a single oral 1.5 mg/kg dose to 18 subjects after fasting, consumption of a low-fat and high-fat meal. Non-compartmental PK, PD, and PKPD correlation were evaluated. Following single oral doses, systemic exposure increased in a linear manner and demonstrated 1:1 dose-proportional, first-order linear PK above 1.5 mg/kg. VCS inhibited CN activity in a dose-related fashion with maximal inhibition peaking at 3.0 mg/kg. PKPD correlation indicated an EC50 of 78.3 ± 6.8 ng/mL. Administration of VCS with a low-fat and high-fat meal decreased Cmax by 29% and 53%, respectively, and AUCinf by 15% and 25%, respectively. Following ascending single doses of VCS, exposure increased in a linear fashion. A food effect on exposure was demonstrated, with a more pronounced effect following a high-fat meal. VCS concentrations were also found to correlate with CN activity. [ABSTRACT FROM AUTHOR]

Aims To assess the efficacy of methylphenidate as a substitution therapy for amphetamine/methamphetamine dependence in Finland and New Zealand. Design Parallel-group, double-blind, randomized placebo-controlled trial. Setting Out-patient care. Participants Amphetamine-/methamphetamine-dependent, aged 16-65 years. Measurements The primary outcome measure was presence/absence of amphetamine/methamphetamine in urine samples collected twice weekly. Secondary measures included treatment adherence, alterations in craving scores and self-reported use. Primary analysis was by intention-to-treat ( ITT). The study drug, methylphenidate (as Concerta®), was up-titrated over 2 weeks to a maximum dose of 54 mg daily and continued for a further 20 weeks. Doses were given under daily supervision at the clinics. Findings Seventy-nine participants were randomized (40 methylphenidate; 39 placebo); 76 received allocated treatment and 27 completed the trial. ITT analysis ( n = 78) showed no statistically significant difference in the percentage of positive urines between the methylphenidate and placebo arms (odds ratio: 0.95, 95% confidence interval: 0.83-1.08). However, there was a significant difference ( P < 0.05) between the active and placebo arms in retention, the placebo arm displaying a significantly lower retention from 6 weeks that persisted until the end of the trial. Conclusions The trial failed to replicate earlier findings suggesting that methylphenidate was superior to placebo. The low retention rate confounded the ability to draw firm conclusions about efficacy. The higher retention rate was observed in the methylphenidate arm. Any replication of this work would need to consider alternatives to the rigid clinic attendance criteria, and consider an increased dose. [ABSTRACT FROM AUTHOR]

Previous research has shown clinical effectiveness of dermal substitution; however, in burn wounds, only limited effect has been shown. A problem in burn wounds is the reduced take of the autograft, when the substitute and graft are applied in one procedure. Recently, application of topical negative pressure ( TNP) was shown to improve graft take. The aim of this study was to investigate if application of a dermal substitute in combination with TNP improves scar quality after burns. In a four-armed multicenter randomized controlled trial, a split-skin graft with or without a dermal substitute and with or without TNP was compared in patients with deep dermal or full-thickness burns requiring skin transplantation. Graft take and rate of wound epithelialization were evaluated. Three and 12 months postoperatively, scar parameters were measured. The results of 86 patients showed that graft take and epithelialization did not reveal significant differences. Significantly fewer wounds in the TNP group showed postoperative contamination, compared to other groups. Highest elasticity was measured in scars treated with the substitute and TNP, which was significantly better compared to scars treated with the substitute alone. Concluding, this randomized controlled trial shows the effectiveness of dermal substitution combined with TNP in burns, based on extensive wound and scar measurements. [ABSTRACT FROM AUTHOR]

Two open-label, randomized, multiple-dose clinical studies evaluated the potential for pharmacokinetic interaction between the antiepileptic drugs lacosamide and valproic acid. The influence of lacosamide on valproic acid pharmacokinetics (trial A) and valproic acid on lacosamide pharmacokinetics (trial B) was investigated in 32 healthy male volunteers, 16 in each trial. Volunteers in trial A received valproic acid (300 mg bid) with randomization to either early or late addition of lacosamide (200 mg bid). Those in trial B received lacosamide (200 mg bid) with randomization to either early or late addition of valproic acid (300 mg bid). Area under the concentration-time curve during a 12-hour dosing interval at steady state (AUCτ,ss) and maximum steady-state plasma drug concentration (Cmax,ss) were measured for each drug alone and together and tested for equivalence. The point estimates (90% confidence intervals) for AUCτ,ss and Cmax,ss were 104% (99%-109%) and 101% (97%-107%), respectively, for valproic acid and 100% (98%-103%) and 101% (96%-107%), respectively, for lacosamide, which were within the generally accepted equivalence range of 80% to 125%. No changes in the rate or extent of absorption, terminal half-life, or time to maximum concentration were observed. These results suggest that lacosamide and valproic acid have no relevant pharmacokinetic drug-drug interaction. [ABSTRACT FROM PUBLISHER]

Aims To characterize infections and compare obstetric outcomes in opioid-dependent pregnant women who participated in a randomized clinical trial comparing agonist medications, methadone and buprenorphine. Design Incidence of infections was identified as part of the screening medical assessment. As part of a planned secondary analysis, analysis of variance and polytomous logistic regressions were conducted on obstetric outcome variables using treatment randomization condition (maternal maintenance with either methadone or buprenorphine) as the predictor variable, controlling for differences between study sites. Setting Six United States sites and one European site that provided comprehensive treatment to opioid-dependent pregnant women. Participants Pregnant opioid-dependent women ( n = 131) who delivered while participating in the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study. Measurements Obstetric, infectious and other maternal medical complications captured by medical records, physical examination, blood tests and self-report. Neonatal medical complications captured by medical records. Findings Hepatitis C was the most common infection (32.3%), followed by hepatitis B (7.6%) and chlamydia (6.1%) among participants at study enrollment. Maternal methadone versus buprenorphine maintenance was associated with a higher incidence of preterm labor ( P = 0.04) and a significantly higher percentage of signs of respiratory distress in neonates at delivery ( P = 0.05). Other medical and obstetric complications were infrequent in the total sample, as well as in both methadone and buprenorphine conditions. Conclusions Buprenorphine appears to have an acceptable safety profile for use during pregnancy. [ABSTRACT FROM AUTHOR]

Background Behavioural change interventions for persons with chronic illness draw on a variety of theoretical approaches including motivational interviewing and shared decision making. Health literacy provides an additional, potentially powerful explanatory framework to guide research and practice. Objective To examine the changes in the depth and detail of diabetes-related knowledge and confidence for persons with type 2 diabetes. Design Two-year, prospective, observational study, using questionnaire data at two time points (baseline and 2 years later) and in-depth interviews with a theoretically selected subsample. Setting and participants A total of 319 patients initially recruited from a deprived urban area in north-west England Intervention Dedicated tele-carer education and support, tailored to the individual circumstances of the patient. Main outcome measures Perceptions of confidence, levels of empowerment, learning for self-care and most helpful aspects of the intervention. Results Over 90% expressed confidence in keeping their blood sugar controlled, and high levels of perceived empowerment (mean = 4.25; 95% CI, 4.17-4.33) were found. Changes in the depth and detail of diabetes-related knowledge and confidence, from the specific to the more general, were observed and enhanced competence in translating knowledge into practice. Discussion and conclusions The intervention, built within a developed working partnership between tele-carer and patient, operated at two levels: health literacy, enhancing knowledge, developing personal skills and enabling self-control; and socio-psychological behavioural change, tailored to individuals within their socio-economic environments, enabling increased motivation and supportive problem-solving. Both approaches find reflection in the findings and provide powerful explanatory lenses to interrogate the data. [ABSTRACT FROM AUTHOR]

Medical Education 2012: 46: 807-814 Context Little is known about best practices for teaching and learning reflection. We hypothesised that reflective ability scores on written reflections would be higher in students using critical reflection guidelines, or receiving feedback on reflective skill in addition to reflection content, or both, compared with those in students who received only a definition of reflection or feedback on reflection content alone. Methods Using a 2 (guidelines) × 2 (feedback) × 2 (time) design, we randomly assigned half of our sample of 149 Year 3 medical students to receive critical reflection guidelines and the other half to receive only a definition of critical reflection. We then randomly divided both groups in half again so that one half of each group received feedback on both the content and reflective ability in their reflections, and the other received content feedback alone. The learners' performance was measured on the first and third written reflections of the academic year using a previously validated scoring rubric. We calculated descriptive statistics for the reflection scores and conducted a repeated-measures analysis of variance with two between-groups factors, guidelines and feedback, and one within-group factor, occasion, using the measure of reflective ability as the dependent variable. Results We failed to find a significant interaction between guidelines and feedback ( F = 0.51, d.f. = 1, 145, p = 0.48). However, the provision of critical reflection guidelines improved reflective ability compared with the provision of a definition of critical reflection only ( F = 147.1, d.f. = 1, 145, p < 0.001). Feedback also improved reflective ability, but only when it covered reflective skill in addition to content ( F = 6.5, d.f. = 1, 145, p = 0.012). Conclusions We found that the provision of critical reflection guidelines improved performance and that feedback on both content and reflective ability also improved performance. Our study demonstrates that teaching learners the characteristics of deeper, more effective reflection and helping them to acquire the skills they need to reflect well improves their reflective ability as measured by performance on reflective exercises. [ABSTRACT FROM AUTHOR]

Endogenous opioids and µ-opioid receptors have been linked to hedonic and rewarding aspects of palatable food intake. The authors examined the safety, pharmacokinetic, and pharmacodynamic profile of GSK1521498, a µ-opioid receptor inverse agonist that is being investigated primarily for the treatment of overeating behavior in obesity. In healthy participants, GSK1521498 oral solution and capsule formulations were well tolerated up to a dose of 100 mg. After single doses (10-150 mg), the maximum concentration (Cmax) and area under the curve (AUC) in plasma increased in a dose-proportional manner. GSK1521498 selectively reduced sensory hedonic ratings of high-sugar and high-fat dairy products and caloric intake of high-fat/high-sucrose snack foods. These findings provide encouraging data in support of the development of GSK1521498 for the treatment of disorders of maladaptive ingestive behavior or compulsive consumption. [ABSTRACT FROM PUBLISHER]

Background: Brief interventions have the potential to reduce heavy drinking in young adults who present to the emergency department (ED), but require time and resources rarely available. Text-messaging (TM) may provide an effective way to collect drinking data from young adults after ED discharge as well as to provide immediate feedback and ongoing support for behavior change. The feasibility of screening young adults in the ED, recruiting them for a TM-based interventional trial, collecting weekly drinking data through TM, and the variance in drinking outcomes remains unknown. Methods: Young adults in 3 urban EDs ( n = 45; aged 18 to 24 years, 54% women) identified as hazardous drinkers by the Alcohol Use Disorders Identification Test-Consumption score were randomly assigned to weekly TM-based feedback with goal setting (Intervention), weekly TM-based drinking assessments without feedback (Assessment), or control. Participants in the Intervention group who reported ≥5 (for men) and ≥4 (for women) maximum drinks during any one 24-hour period were asked whether they would set a goal to reduce their drinking the following week. We describe the interaction with TM and goal setting. We also describe the heavy drinking days (HDDs), drinks per drinking day (DPDD) using timeline follow-back procedure at baseline and 3 months. Results: We screened 109 young adults over 157 hours across 24 unique days and 52 (48%; 95% CI 38 to 50) screened positive for hazardous drinking. Of these, 45 (87%; 95% CI 74 to 94) met inclusion criteria, were enrolled and randomized, and 6 (13%; 95% CI 5 to 27) did not complete 3-month web-based follow-up; 88% (95% CI 84 to 91) of weekly TM-based drinking assessments were answered, with 77% (95% CI 58 to 90) of participants responding to all 12 weeks. Agreeing to set a goal was associated with a repeat HDD 36% (95% CI 17 to 55) of the time compared with 63% (95% CI 44 to 81) when not willing to set a goal. At 3 months, participants that were exposed to the TM-based intervention had 3.4 (SD 5.4) fewer HDDs in the last month and 2.1 (SD 1.5) fewer DPDD when compared to baseline. Conclusions: TM can be used to assess drinking in young adults and can deliver brief interventions to young adults discharged from the ED. TM-based interventions have the potential to reduce heavy drinking among young adults but larger studies are needed to establish efficacy. [ABSTRACT FROM AUTHOR]

Background The Cochrane Collaboration is strongly encouraging the use of a newly developed tool, the Cochrane Collaboration Risk of Bias Tool (CCRBT), for all review groups. However, the psychometric properties of this tool to date have yet to be described. Thus, the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity, in comparison with the Effective Public Health Practice Project Quality Assessment Tool (EPHPP). Methods Both tools were used to assess the methodological quality of 20 randomized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain. Each study assessment was completed independently by two reviewers using each tool. We analysed the inter-rater reliability of each tool's individual domains, as well as final grade assigned to each study. Results The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade. In contrast, the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade. Of interest, no agreement between the two tools was evident in their final grade assigned to each study. Although both tools were developed to assess 'quality of the evidence', they appear to measure different constructs. Conclusions Both tools performed quite differently when evaluating the risk of bias or methodological quality of studies in knowledge translation interventions for cancer pain. The newly introduced CCRBT assigned these studies a higher risk of bias. Its psychometric properties need to be more thoroughly validated, in a range of research fields, to understand fully how to interpret results from its application. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To review and analyse in experimentally controlled studies the impact of alcohol consumption on intentions to engage in unprotected sex. To draw conclusions with respect to the question of whether alcohol has an independent effect on the incidence of human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Methods A systematic review and meta-analysis of randomized controlled studies examined the association between blood alcohol content (BAC) and self-perceived likelihood of using a condom during intercourse. The systematic review and meta-analysis were conducted according to internationally standardized protocols (Preferred Reporting Items for Systematic Reviews and Meta-Analyses: PRISMA). The meta-analysis included an estimate of the dose-response effect, tests for publication bias and sensitivity analyses. Results Of the 12 studies included in the quantitative synthesis, our pooled analysis indicated that an increase in BAC of 0.1 mg/ml resulted in an increase of 5.0% (95% CI: 2.8-7.1%) in the indicated likelihood (indicated by a Likert scale) of engaging in unprotected sex. After adjusting for potential publication bias, this estimate dropped to 2.9% (95% CI: 2.0-3.9%). Thus, the larger the alcohol intake and the subsequent level of BAC, the higher the intentions to engage in unsafe sex. The main results were homogeneous, persisted in sensitivity analyses and after correction for publication bias. Conclusions Alcohol use is an independent risk factor for intentions to engage in unprotected sex, and as risky sex intentions have been shown to be linked to actual risk behavior, the role of alcohol consumption in the transmission of HIV and other STIs may be of public health importance. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study aimed to assess the effectiveness of the Örebro prevention programme (ÖPP), an alcohol misuse prevention programme that aims to reduce youth drinking by changing parental behaviour. Design Cluster-randomized trial, with schools assigned randomly to the ÖPP or no intervention. Setting Forty municipal schools in 13 counties in Sweden. Participants A total of 1752 students in the 7th grade and 1314 parents were assessed at baseline. Students' follow-up rates in the 8th and 9th grades were 92.1% and 88.4%, respectively. Measurements Classroom questionnaires to students and postal questionnaires to parents were administered before randomization and 12 and 30 months post-baseline. Findings Two-level logistic regression models, under four different methods of addressing the problem of loss to follow-up, revealed a statistically significant programme effect for only one of three drinking outcomes under one loss-to-follow-up method, and that effect was observed only at the 12-month follow-up. Conclusions The Örebro prevention programme as currently delivered in Sweden does not appear to reduce or delay youth drunkenness. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smoking cessation trials generally record information on daily smoking behavior, but base analyses on measures of smoking status at the end of treatment (EOT). We present an alternative approach that analyzes the entire sequence of daily smoking status observations. Methods We analyzed daily abstinence data from a smoking cessation trial, using two longitudinal logistic regression methods: a mixed-effects (ME) model and a generalized estimating equations (GEE) model. We compared results to a standard analysis that takes abstinence status at EOT as outcome. We evaluated time-varying covariates (smoking history and time-varying drug effect) in the longitudinal analysis and compared ME and GEE approaches. Results We observed some differences in the estimated treatment effect odds ratios across models, with narrower confidence intervals under the longitudinal models. GEE yields similar results to ME when only baseline factors appear in the model, but gives biased results when one includes time-varying covariates. The longitudinal models indicate that the quit probability declines and the drug effect varies over time. Both the previous day's smoking status and recent smoking history predict quit probability, independently of the drug effect. Conclusion When analysing outcomes of studies from smoking cessation interventions, longitudinal models with multiple outcome data points, rather than just end of treatment, can makes efficient use of the data and incorporate time-varying covariates. The generalized estimating equations approach should be avoided when using time-varying predictors. [ABSTRACT FROM AUTHOR]

Diabet. Med. 29, e126-e132 (2012) Abstract Aims To assess the effect of lifestyle intervention on depressive symptoms during a 36-month randomized clinical trial designed to prevent Type 2 diabetes. Methods A total of 522 middle-aged participants, who were overweight or obese and had impaired glucose tolerance, were randomized to the lifestyle intervention or control group in the Finnish Diabetes Prevention Study. The intervention group received individualized counselling aimed at reducing weight and increasing physical activity. Depressive symptoms were measured using the Beck Depression Inventory among a subgroup of 140 participants. Results On study entry, the mean Beck Depression Inventory scores ± sd were 6.8 ± 5.6 in the intervention group and 6.7 ± 5.5 in the control group. Beck Depression Inventory scores reduced during the intervention study: the mean ± sd (95% CI) reduction was 0.90 ± 4.54 (−1.99 to −0.19) scores in the intervention group and 0.75 ± 4.47 (−1.80 to 0.31) in the control group, with no difference between the groups. In a stepwise linear multivariate regression analysis, the variables with the strongest associations with the change in Beck Depression Inventory scores were baseline Beck Depression Inventory scores, marital status, weight change and change of total energy intake ( R2 = 0.209, P < 0.001). Conclusions Participation in the study lowered depression scores, with no specific group effect. Among the lifestyle changes, particularly successful reduction of body weight was associated with the greater reduction of depressive symptoms. Thus, regardless of the intensity of the treatment, the success in executing alterations in one's lifestyle and behaviour is associated with beneficial changes in mood. [ABSTRACT FROM AUTHOR]