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To investigate if a 12-week community-based exercise program (FitSkills) fostered positive attitudes towards disability among university student mentors. A stepped-wedge cluster randomised trial was completed with 4 clusters. Students were eligible to be a mentor if enrolled in an entry-level health degree (any discipline, any year) at one of three universities. Each mentor was matched with a young person with a disability and the pair exercised together at the gym twice a week for an hour (24 sessions total). At 7 times over 18 months, mentors completed the Disability Discomfort Scale to indicate their level of discomfort when interacting with people with disability. Data were analysed according to the intention to treat principles using linear mixed-effects models to estimate changes in scores over time. A total of 207 mentors completed the Disability Discomfort Scale at least once, of whom 123 participated in FitSkills. Analysis found an estimated reduction of 32.8% (95% confidence interval (CI) −36.8 to −28.4) in discomfort scores immediately after exposure to FitSkills across all four clusters. These decreases were sustained throughout the remainder of the trial. Mentors reported more positive attitudes towards interacting with people with disability after completing FitSkills with changes retained for up to 15 months. Participating in a 12-week community physical activity program fostered lower levels of discomfort in interacting with young people with disability among university student mentors. Student mentor's positive attitudes to disability were sustained for up to 15 months following the program. Mentors with no previous experience of disability had a larger reduction in discomfort scores than mentors who had previous disability experience. We recommend short-duration (24 hours over 12 weeks) community-based experiences such as FitSkills to positively impact how entry-level health professional students relate to young people with disability. [ABSTRACT FROM AUTHOR]

Olive oil (OO) polyphenols have been shown to improve HDL anti-atherogenic function, thus demonstrating beneficial effects against cardiovascular risk factors. The aim of the present study was to investigate the effect of extra virgin high polyphenol olive oil (HPOO) v. low polyphenol olive oil (LPOO) on the capacity of HDL to promote cholesterol efflux in healthy adults. In a double-blind, randomised cross-over trial, fifty participants (aged 38·5 (sd 13·9) years, 66 % females) were supplemented with a daily dose (60 ml) of HPOO (320 mg/kg polyphenols) or LPOO (86 mg/kg polyphenols) for 3 weeks. Following a 2-week washout period, participants crossed over to the alternate treatment. Serum HDL-cholesterol efflux capacity, circulating lipids (i.e. total cholesterol, TAG, HDL, LDL) and anthropometrics were measured at baseline and follow-up. No significant between-group differences were observed. Furthermore, no significant changes in HDL-cholesterol efflux were found within either the LPOO and HPOO treatment arms; mean changes were 0·54 % (95 % CI (0·29, 1·37)) and 0·10 % (95 % CI (0·74, 0·94)), respectively. Serum HDL increased significantly after LPOO and HPOO intake by 0·13 mmol/l (95 % CI (0·04, 0·22)) and 0·10 mmol/l (95 % CI (0·02, 0·19)), respectively. A small but significant increase in LDL of 0·14 mmol/l (95 % CI (0·001, 0·28)) was observed following the HPOO intervention. Our results suggest that additional research is warranted to further understand the effect of OO with different phenolic content on mechanisms of cholesterol efflux via different pathways in multi-ethnic populations with diverse diets. [ABSTRACT FROM AUTHOR]

To evaluate feasibility of scaling up a 12-week community-based exercise program (FitSkills) in which young people with disability exercise with a student mentor. Within a stepped wedge cluster randomised trial, seven domains of feasibility were assessed: demand, implementation, acceptability, practicality, adaptation, integration, and expansion. Of the 163 participants with disability (61 females; 20.8 ± 5 y) and 226 mentors who enrolled, 123 participants and mentors completed FitSkills. Population demand was estimated at 9% of members of participating organisations. Most participants (76%) completed the twice-weekly program within 12 weeks, attending 79% of sessions (mean 18.9 ± 4.7). Key program elements valued by participants were the mentor, tailored exercise, and regular program schedule. Majority (87%) of mentors were recruited from physiotherapy, occupational therapy, and exercise science courses. Positives for participants were perceived benefits and organisational support, and for mentors, understanding disability. Communication and scheduling were burdens. Three serious and 28 non-serious adverse events occurred. Adaptations (additional screening, risk analysis, extra mentor support, or in-person consultation) enabled 29 young people with complexity to participate. The number of trial sites was expanded to 11 to accommodate participants. Scaling-up FitSkills is feasible, but with caveats related to communication, scheduling, and efficiency of recruitment. Key elements valued by participants as part of the successful scale-up of a community-based exercise program (FitSkills) across a large metropolitan city included a peer-mentor, tailored exercise, and organisational support structure. FitSkills can be adapted to include young people with complex disability with additional supports including screening, risk analysis, and professional support for the peer-mentor. The benefits of FitSkills, including social connectedness for young people with a disability and normalisation of disability for mentors, outweigh the burdens of participation. Communication with program organisers and scheduling logistics between the young person, their family/carers and peer mentors are important factors to manage for the successful implementation of FitSkills. [ABSTRACT FROM AUTHOR]

Background: Public health advocates have highlighted internalising problems as a leading cause of global burden of disease. Internalising problems (anxiety/depression) affect up to 20% of school‐age children and can impact peer relations, school engagement and later employment and mortality. This translational trial aimed to determine whether a selective/indicated parenting group programme to prevent internalising distress in shy/inhibited preschool children had sustained effects in middle childhood. Translational design aspects were a brief parent‐report screening tool for child inhibition offered universally across the population via preschools in the year before school, followed by an invitation to parents of all inhibited children to attend the parenting programme at venues in their local community. Methods: Design of the study was a randomised controlled trial. The setting was 307 preschool services across eight socioeconomically diverse government areas in Melbourne, Australia. Participants were 545 parents of inhibited four‐year‐old children of which 456 (84%) were retained during middle childhood (age of seven to 10 years). Early intervention was the Cool Little Kids parenting group programme, and control was 'usual care' access to available support services in the community. Primary outcomes were child anxiety and depression symptoms (parent and child report) and DSM‐IV anxiety disorders (assessor masked). Secondary outcomes were parenting practices and parent mental health. Results: There was no significant difference in anxiety disorders between the intervention and control group during the three annual follow‐ups of the cohort in middle childhood (2015 43% vs. 41%, 2016 40% vs. 36%, 2017 27% vs. 30%, respectively; p's >.05). There were also no significant differences in child anxiety or depression symptoms (by child or parent report), parenting practices or parent mental health, between the intervention and control group during middle childhood. However, a priori interaction tests suggested that for children with anxious parents, early intervention attenuated risk for middle childhood internalising problems. Conclusions: An issue for population translation is low levels of parent engagement in preventive interventions. Initial effects of the Cool Little Kids parenting group programme in reducing shy/inhibited preschool children's internalising distress at school entry dissipated over time, perhaps due to low engagement. Future translational research on early prevention of internalising problems could benefit from screening preschool children in the population at higher risk (combining temperamental inhibition and parent distress) and incorporating motivational techniques to facilitate family engagement. Trial registration ISRCTN30996662 http://www.isrctn.com/ISRCTN30996662. [ABSTRACT FROM AUTHOR]

Background: The aim was to determine outcomes in the first year of school of a population‐delivered parenting program to prevent internalising problems in temperamentally inhibited preschool children and predictors of engagement in parenting groups. Method: Design: Randomised controlled trial. Setting: 307 preschool services across eight socio‐economically diverse government areas in Melbourne, Australia. Participants: 545 parents of inhibited 4‐year‐old children; 469 (86%) retained at two‐year follow‐up. Intervention: Cool Little Kids program. Primary outcomes were child internalising symptoms and anxiety disorders. Secondary outcomes were parenting, parent well‐being and engagement. Trial registration ISRCTN30996662 http://www.isrctn.com/ISRCTN30996662. Results: In the first year of school (M (SD) age 6.7 (0.4) years), child anxiety symptoms were reduced in the intervention versus control arm (PAS‐R M (SD): total 36.2 (17.2) versus 39.4 (18.5); adjusted difference −3.26, 95% CI −6.46 to −0.05, p =.047; specific fears 9.1 (6.2) versus 10.7 (6.8), adjusted difference −1.53; 95% CI −2.69 to −0.38, p =.009). However, there was little difference in broader child internalising (CMFWQ M (SD): 2.2 (0.5) versus 2.3 (0.6); adjusted difference −0.03, 95% CI −0.13 to 0.06, p =.489) or anxiety disorders (37.6% vs. 42.6%; adjusted OR 0.79, 95% CI 0.53 to 1.18, p =.242). Lower income, younger mothers, less educated and more culturally diverse fathers engaged less with the intervention. Continued skills practice was less frequent for parents of girls and in advantaged neighbourhoods. Conclusions: There were population effects of Cool Little Kids in the first year of school for anxiety symptoms but not disorders. Considering motivation techniques to engage subgroups of families would be helpful in translation research. [ABSTRACT FROM AUTHOR]

Objective: This study examined the effectiveness of a nonsurgical, preconception weight loss intervention on pregnancy outcomes in women with obesity.Methods: This was a two-arm, parallel-group randomized controlled trial. A total of 164 women with BMI 30 to 55 kg/m2 who were aged 18 to 38 years and planning pregnancy were randomized to a 12-week standard dietary intervention (SDI; n = 79) or a modified very low-energy diet (VLED; n = 85). Participants were observed for ≤48 weeks while trying for pregnancy and then during pregnancy. The primary outcome was maternal fasting plasma glucose at 26 to 28 weeks' gestation. Exploratory outcomes were individual and composite obesity-related adverse pregnancy outcomes.Results: Weight loss was greater in the VLED group (SDI 3.2 [0.6] kg vs. VLED 13.0 [0.5] kg, p < 0.01). In completers who had a singleton live birth (SDI 22/79 vs. VLED 35/85, p = 0.10), there was no difference in fasting glucose at 26 to 28 weeks' gestation (SDI 4.8[0.2] mmol/L vs. VLED 4.6 [0.1] mmol/L, p = 0.42). However, the composite of adverse pregnancy outcomes was significantly lower in the VLED group (p < 0.001).Conclusions: Substantial prepregnancy weight loss in women with obesity does not alter fasting glucose at 26 to 28 weeks' gestation but does reduce a composite of adverse pregnancy outcomes. A better understanding of metabolic changes in pregnancy after preconception weight loss may assist in improving maternal and neonatal health outcomes. [ABSTRACT FROM AUTHOR]

Abstract Question Does adding weekly, physiotherapist-delivered motivational interviewing to outpatient oncology rehabilitation for cancer survivors increase physical activity levels and improve physical and psychosocial outcomes that are typically impaired in this cohort? Design Randomised controlled trial with blinded outcome assessment, concealed allocation and intention-to-treat analysis. Participants A heterogeneous sample of 46 cancer survivors (n = 29 female; mean age 59 years) participating in a public outpatient oncology rehabilitation program. Intervention Participants were randomly allocated to receive oncology rehabilitation (n = 24) or oncology rehabilitation with motivational interviewing delivered once weekly for 7 weeks via telephone by a physiotherapist (n = 22). Outcome measures The primary outcome was amount of physical activity of at least moderate intensity completed in 10-minute bouts, measured by an accelerometer worn continuously for 1 week. Secondary outcomes included other measures of physical activity, sedentary behaviour, physical function, psychosocial function, and quality of life. Results When added to oncology rehabilitation, motivational interviewing caused no appreciable increase in the amount of moderate-intensity physical activity (MD –1.2 minutes/day, 95% CI –2.5 to 0.02). Among many secondary outcomes, the only statistically significant result was a small effect on nausea, which probably represents a Type I error. However, several secondary outcomes related to lower-intensity physical activity had non-significant confidence intervals that included large effects such as: sedentary time (SMD –0.67, 95% CI –1.32 to 0.02), light-intensity physical activity (SMD 0.56, 95% CI –0.12 to 1.21) and daily step count (SMD 0.37, 95% CI –0.30 to 1.02). Conclusion Adding motivational interviewing to oncology rehabilitation did not increase moderate-intensity physical activity. Favourable trends on measures of lower-intensity physical activity suggest that motivational interviewing should be further investigated for its effects on reducing sedentary time and improving light-intensity physical activity for cancer survivors participating in rehabilitation. Trial registration ANZCTR 12616001079437. [Dennett AM, Shields N, Peiris CL, Prendergast LA, O'Halloran PD, Parente P, Taylor NF (2018) Motivational interviewing added to oncology rehabilitation did not improve moderate-intensity physical activity in cancer survivors: a randomised trial. Journal of Physiotherapy 64: 255–263] [ABSTRACT FROM AUTHOR]

Objective: To determine whether a population-delivered parenting programme assists in preventing internalising problems at school entry for preschool children at-risk with temperamental inhibition. Methods: Design: a randomised controlled trial was used. Setting: the setting was 307 preschool services across eight socioeconomically diverse government areas in Melbourne, Australia. Participants: a total of 545 parents of inhibited 4-year-old children: 498 retained at 1-year follow up. Early intervention: Cool Little Kids parenting group programme was implemented. Primary outcomes: the primary outcomes were child DSM-IV anxiety disorders (assessor blind) and internalising problems. Secondary outcomes: the secondary outcomes were parenting practices and parent mental health. Results: At 1-year follow up (mean (standard deviation) age = 5.8 (0.4) years), there was little difference in anxiety disorders between the intervention and control arms (44.2% vs 50.2%; adjusted odds ratio = 0.86, 95% confidence interval = [0.60, 1.25], p = 0.427). Internalising problems were reduced in the intervention arm (Strengths and Difficulties Questionnaire: abnormal - 24.2% vs 33.0%; adjusted odds ratio = 0.56, 95% confidence interval = [0.35, 0.89], p = 0.014; symptoms - mean (standard deviation) = 2.5 (2.0) vs 2.9 (2.2); adjusted mean difference = -0.47, 95% confidence interval = [-0.81, -0.13], p = 0.006). Parents' participation in the intervention was modest (29.4% attended most groups, 20.5% used skills most of the time during the year). A priori interaction tests suggested that for children with anxious parents, the intervention reduced anxiety disorders and internalising symptoms after 1 year. Conclusion: Offering Cool Little Kids across the population for inhibited preschoolers does not impact population outcomes after 1 year. Effects may be emerging for inhibited children at highest risk with parent anxiety. Trial outcomes will continue into mid-childhood. [ABSTRACT FROM AUTHOR]

Background: Obesity contributes to disability in older adults, and this is offset by weight loss and exercise. Very Low Calorie Diets (VLCDs) achieve rapid weight loss; however, these have not been rigorously evaluated in older people.Methods: A randomized trial was conducted from August 2012 through December 2015. The intervention was 12 weeks of thrice weekly exercise combined with either healthy eating advice (Ex/HE), hypocaloric diet (Ex/Diet), or VLCD (Ex/VLCD). Outcomes were physical function, measured by 6-minute walk test (6MWT) and De Morton Mobility Index (DEMMI). Other measures were body composition measured by Dual Energy X-Ray Absorptiometry, and nutritional parameters (albumin, vitamins B12 and D, ferritin and folate).Results: 36, 40, and 41 participants were randomized to Ex/HE, Ex/Diet, and Ex/VLCD, respectively. At 12 weeks, weight was reduced by 3.7, 5.1, and 11.1% (p < .01), respectively. Ex/VLCD had significant reduction in fat (16.8%), lean mass (4.8%), and bone mineral density (1.2%), but increased relative lean mass (3.8%). DEMMI improved by 14.25, 14.25, and 13.75 points in Ex/HE, Ex/Diet, and Ex/VLCD, respectively; however, there was no between-group difference (p = .30). 6MWT improved by 53.1, 64.7, and 84.4 meters in Ex/HE, Ex/Diet, and Ex/VLCD (p = .18). Post hoc stratification for gender and adjustment for initial physical function and type 2 diabetes only revealed significant between-group differences for men in the 6MWT, with improvement by 57.8, 77.8, and 140.3 meters in Ex/HE, Ex/Diet, and Ex/VLCD, respectively (p = .01). Improvements in nutritional parameters were seen in Ex/VLCD, but not in Ex/HE and Ex/Diet. The VLCD was well tolerated.Conclusions: VLCDs have potential in the treatment of obesity in older persons; of particular benefit is improvement in nutritional status. The gait speed improvement observed in men warrants further investigation. [ABSTRACT FROM AUTHOR]

Background: Whether testosterone treatment has benefits on body composition over and above caloric restriction in men is unknown. We hypothesised that testosterone treatment augments diet-induced loss of fat mass and prevents loss of muscle mass. Methods: We conducted a randomised double-blind, parallel, placebo controlled trial at a tertiary referral centre. A total of 100 obese men (body mass index ≥ 30 kg/m2) with a total testosterone level of or below 12 nmol/L and a median age of 53 years (interquartile range 47-60) receiving 10 weeks of a very low energy diet (VLED) followed by 46 weeks of weight maintenance were randomly assigned at baseline to 56 weeks of 10-weekly intramuscular testosterone undecanoate (n = 49, cases) or matching placebo (n = 51, controls). The main outcome measures were the between-group difference in fat and lean mass by dual-energy X-ray absorptiometry, and visceral fat area (computed tomography). Results: A total of 82 men completed the study. At study end, compared to controls, cases had greater reductions in fat mass, with a mean adjusted between-group difference (MAD) of -2.9 kg (-5.7 to -0.2; P = 0.04), and in visceral fat (MAD -2678 mm2; -5180 to -176; P = 0.04). Although both groups lost the same lean mass following VLED (cases -3.9 kg (-5.3 to -2.6); controls -4.8 kg (-6.2 to -3.5), P = 0.36), cases regained lean mass (3.3 kg (1.9 to 4.7), P < 0.001) during weight maintenance, in contrast to controls (0.8 kg (-0.7 to 2.3), P = 0.29) so that, at study end, cases had an attenuated reduction in lean mass compared to controls (MAD 3.4 kg (1.3 to 5.5), P = 0.002). Conclusions: While dieting men receiving placebo lost both fat and lean mass, the weight loss with testosterone treatment was almost exclusively due to loss of body fat. [ABSTRACT FROM AUTHOR]

Objective: To examine the impact of a prepregnancy very-low-energy diet (VLED) program on time to pregnancy in women with obesity.Design: Substudy of a two-arm parallel group randomized controlled trial.Setting: Multiple tertiary care centers.Patient(s): Women 18-38 years old with obesity (body mass index 30-55 kg/m2) and planning conception.Intervention(s): One hundred sixty-four normoglycemic women with body mass index 30-55 kg/m2, aged 18-38 years, and planning pregnancy were recruited through a social media platform for a two-arm randomized controlled trial. Women were allocated to a 12-week standard dietary intervention (SDI) or modified VLED. Completers of the intervention were observed for up to 48 weeks, and time to pregnancy was recorded.Main Outcome Measure(s): The prespecified exploratory outcome for this substudy was time to pregnancy between the completion of the 12-week intervention and the date of conception.Result(s): Maternal weight loss at the end of the 12-week intervention was 3.1% in the SDI group and 11.9% in the VLED group. In completers of the 12-week intervention, time to pregnancy was significantly shorter in the women allocated to the VLED group than in the SDI group. Post hoc analysis showed that this difference in time to conception was particularly overt within 90 days of the intervention.Conclusion(s): A VLED program that achieves substantial weight loss before conception reduces time to pregnancy compared with an SDI in women with obesity.Trial Registration Number: ACTRN12614001160628. [ABSTRACT FROM AUTHOR]