Developmental and therapeutic implications of IL4ra expression for rhabdomyosarcoma.

Rhabdomyosarcoma (RMS) is a solid tumor whose metastatic progression can be accelerated through interleukin-4 receptor alpha (Il4ra) mediated interaction with normal muscle stem cells (satellite cells). To understand the function of Il4ra in this tumor initiation phase of RMS, we conditionally deleted Il4ra in genetically-engineered RMS mouse models. Nullizygosity of Il4ra altered the latency, site and/or stage distribution of RMS tumors compared to IL4RA intact models. Primary tumor cell cultures taken from the genetically-engineered models then used in orthotopic allografts further defined the interaction of satellite cells and RMS tumor cells in the context of tumor initiation: in alveolar rhabdomyosarcoma (ARMS), satellite cell co-injection was necessary for Il4ra null tumor cells engraftment, whereas in embryonal rhabdomyosarcoma (ERMS), satellite cell co-injection decreased latency of engraftment of Il4ra wildtype tumor cells but not Il4ra null tumor cells. When refocusing on Il4ra wildtype tumors by single cell sequencing and cytokine studies, we have uncovered a putative signaling interplay of Il4 from T-lymphocytes being received by Il4ra + rhabdomyosarcoma tumor cells, which in turn express Ccl2, the ligand for Ccr2 and Ccr5. Taken together, these results suggest that mutations imposed during tumor initiation have different effects than genetic or therapeutic intervention imposed once tumors are already formed. We also propose that CCL2 and its cognate receptors CCR2 and/or CCR5 are potential therapeutic targets in Il4ra mediated RMS progression.

Was it a HIIT? A process evaluation of a school-based high-intensity interval training intervention.

BACKGROUND: Despite a growing body of research investigating high-intensity interval training (HIIT) in schools, there are limited process evaluations investigating their implementation. This is concerning because process evaluations are important for appropriately interpreting outcome findings and augmenting intervention design. This manuscript presents a process evaluation of Making a HIIT, a school-based HIIT intervention. METHODS: The Making a HIIT intervention spanned 8 weeks and was completed at three schools in Greater Brisbane, Australia. Ten classes (intervention group) completed 10-min teacher-led HIIT workouts at the beginning of health and physical education (HPE) lessons, and five classes (control group) continued with regular HPE lessons. The mixed methods evaluation was guided by the Framework for Effective Implementation by Durlak and DuPre. RESULTS: Program reach: Ten schools were contacted to successfully recruit three schools, from which 79% of eligible students (n = 308, x ¯ age: 13.0 ± 0.6 years, 148 girls) provided consent. Dosage: The average number of HIIT workouts provided was 10 ± 3 and the average number attended by students was 6 ± 2. Fidelity: During HIIT workouts, the percentage of time students spent at ≥ 80% of maximum heart rate (HRmax) was 55% (interquartile range (IQR): 29%-76%). Monitoring of the control group: During lessons, the intervention and control groups spent 32% (IQR: 12%-54%) and 28% (IQR: 13%-46%) of their HPE lesson at ≥ 80% of HRmax, respectively. Responsiveness: On average, students rated their enjoyment of HIIT workouts as 3.3 ± 1.1 (neutral) on a 5-point scale. Quality: Teachers found the HIIT workouts simple to implement but provided insights into the time implications of integrating them into their lessons; elements that helped facilitate their implementation; and their use within the classroom. Differentiation: Making a HIIT involved students and teachers in the co-design of HIIT workouts. Adaption: Workouts were modified due to location and weather, the complexity of exercises, and time constraints. CONCLUSION: The comprehensive evaluation of Making a HIIT provides important insights into the implementation of school-based HIIT, including encouragings findings for student enjoyment and fidelity and recommendations for improving dosage that should be considered when developing future interventions. TRIAL REGISTRATION: ACTRN, ACTRN12622000534785 , Registered 5 April 2022 - Retrospectively registered.

Structure-activity relationship of dihydropyridines for rhabdomyosarcoma.

Childhood muscle-related cancer rhabdomyosarcoma is a rare disease with a 50-year unmet clinical need for the patients presented with advanced disease. The rarity of ∼350 cases per year in North America generally diminishes the viability of large-scale, pharmaceutical industry driven drug development efforts for rhabdomyosarcoma. In this study, we performed a large-scale screen of 640,000 compounds to identify the dihydropyridine (DHP) class of anti-hypertensives as a priority compound hit. A structure-activity relationship was uncovered with increasing cell growth inhibition as side chain length increases at the ortho and para positions of the parent DHP molecule. Growth inhibition was consistent across n = 21 rhabdomyosarcoma cell line models. Anti-tumor activity in vitro was paralleled by studies in vivo. The unexpected finding was that the action of DHPs appears to be other than on the DHP receptor (i.e., L-type voltage-gated calcium channel). These findings provide the basis of a medicinal chemistry program to develop dihydropyridine derivatives that retain anti-rhabdomyosarcoma activity without anti-hypertensive effects.

Making a HIIT: co-design of high-intensity interval training workouts with students & teachers within the curriculum.

BACKGROUND: High-intensity interval training (HIIT) interventions are becoming more common in schools. However, limited input has been sought from end-users, which can help design interventions that are more engaging and context appropriate, therefore increasing their potential for successful implementation. One method of engaging end-users is co-design, which involves an active collaboration to design solutions to pre-specified problems. This paper aimed to: (1) describe the methodology and results of the co-design process in Making a HIIT to develop HIIT workouts for a school-based intervention; and (2) evaluate the feasibility and impact of co-designing HIIT workouts with students and teachers within the health and physical education (HPE) curriculum. METHODS: The development of the HIIT workouts occurred during obligatory HPE lessons with year seven and eight students. The co-design process included: (1) identifying barriers and facilitators to exercise to create evaluation criteria for creating the HIIT workouts; (2) exploring HIIT; (3) defining HIIT parameters (intensity and interval length); (4) creating HIIT workouts using the parameters and evaluation criteria; (5) trialling and modifying the HIIT workouts based on class feedback and intensity data. To evaluate the feasibility and impact of the co-design process, a thematic analysis was completed using teacher interviews, student discussions, and student surveys. RESULTS: Five classes comprised of 121 students (12-14 years; 49% female) and five teachers were involved in the co-design process across three schools in Queensland, Australia. A total of 33 HIIT workouts were created aimed at satisfying the HIIT parameters and variations of the following evaluation criteria: (1) fun; (2) social; (3) achievable skill level; (4) feeling accomplished; and (5) beneficial for health. From the thematic analysis, three themes (acceptability; implementation; integration) and 12 codes contributed to the overarching understanding of the feasibility of the lessons within the curriculum and a further three themes (perceived changes to lessons; educative outcomes; personal and social capabilities) and three codes contributed towards understanding their impact. CONCLUSION: Overall, co-designing HIIT workouts was feasible within the HPE curriculum and may have contributed to positive educative outcomes. Using this methodology could improve the implementation of HIIT interventions within HPE while supporting educative benefits.

Making a HIIT: Methods for quantifying intensity in high-intensity interval training in schools and validity of session rating of perceived exertion.

Using the data from Making a HIIT, this paper aimed to: 1) investigate the different heart rate (HR) quantification methods reported in school-based high-intensity interval training (HIIT) studies; and 2) assess the criterion validity of session rating of perceived exertion (RPE). During an 8-week HIIT intervention, 213 students (13.1 (0.6) years; 46% female) completed 10-minute HIIT workouts during physical education lessons. In total, 1057 HR and RPE measurements were collected across 68 HIIT workouts. For aim 1, the average and peak HR across all participants and workouts were 79% (8%) and 92% (6%) of HRmax, respectively. The average RPE was 6 (2) points on a 10-point scale. An average of 51% of students in a class had an average HR ≥ 80% for each workout. The between-person variation for peak and average HR were 19% and 30% , respectively. Both average and peak HR decreased by 0.5% each week (p < 0.001). To assess aim 2, a within-participant correlation was calculated for the internal training load produced using HR and RPE data. The correlation was 0.39 (p < 0.001), which suggests utility of using RPE when HR is not a viable option.

Raw Acceleration from Wrist- and Hip-Worn Accelerometers Corresponds with Mechanical Loading in Children and Adolescents.

The purpose of this study was to investigate associations between peak magnitudes of raw acceleration (g) from wrist- and hip-worn accelerometers and ground reaction force (GRF) variables in a large sample of children and adolescents. A total of 269 participants (127 boys, 142 girls; age: 12.3 ± 2.0 yr) performed walking, running, jumping (<5 cm; >5 cm) and single-leg hopping on a force plate. A GENEActiv accelerometer was worn on the left wrist, and an Actigraph GT3X+ was worn on the right wrist and hip throughout. Mixed-effects linear regression was used to assess the relationships between peak magnitudes of raw acceleration and loading. Raw acceleration from both wrist and hip-worn accelerometers was strongly and significantly associated with loading (all p's < 0.05). Body mass and maturity status (pre/post-PHV) were also significantly associated with loading, whereas age, sex and height were not identified as significant predictors. The final models for the GENEActiv wrist, Actigraph wrist and Actigraph hip explained 81.1%, 81.9% and 79.9% of the variation in loading, respectively. This study demonstrates that wrist- and hip-worn accelerometers that output raw acceleration are appropriate for use to monitor the loading exerted on the skeleton and are able to detect short bursts of high-intensity activity that are pertinent to bone health.

Examination of Rickettsial Host Range for Shuttle Vectors Based on dnaA and parA Genes from the pRM Plasmid of Rickettsia monacensis.

The genus Rickettsia encompasses a diverse group of obligate intracellular bacteria that are highly virulent disease agents of mankind as well as symbionts of arthropods. Native plasmids of Rickettsia amblyommatis (AaR/SC) have been used as models to construct shuttle vectors for genetic manipulation of several Rickettsia species. Here, we report on the isolation of the complete plasmid (pRM658B) from Rickettsia monacensis IrR/Munich mutant Rmona658B and the construction of shuttle vectors based on pRM. To identify regions essential for replication, we made vectors containing the dnaA and parA genes of pRM with various portions of the region surrounding these genes and a selection reporter cassette conferring resistance to spectinomycin and expression of green fluorescent protein. Rickettsia amblyommatis (AaR/SC), R. monacensis (IrR/Munich), Rickettsia bellii (RML 369-C), Rickettsia parkeri (Tate's Hell), and Rickettsia montanensis (M5/6) were successfully transformed with shuttle vectors containing pRM parA and dnaA. PCR assays targeting pRM regions not included in the vectors revealed that native pRM was retained in R. monacensis transformants. Determination of native pRM copy number using a plasmid-carried gene (RM_p5) in comparison to chromosomally carried gltA indicated reduced copy numbers in R. monacensis transformants. In transformed R. monacensis strains, native pRM and shuttle vectors with homologous parA and dnaA formed native plasmid-shuttle vector complexes. These studies provide insight on the maintenance of plasmids and shuttle vectors in rickettsiae. IMPORTANCERickettsia spp. are found in a diverse array of organisms, from ticks, mites, and fleas to leeches and insects. Many are not pathogenic, but others, such as Rickettsia rickettsii and Rickettsia prowazeckii, can cause severe illness or death. Plasmids are found in a large percentage of nonpathogenic rickettsiae, but not in species that cause severe disease. Studying these plasmids can reveal their role in the biology of these bacteria, as well as the molecular mechanism whereby they are maintained and replicate in rickettsiae. Here, we describe a new series of shuttle plasmids for the transformation of rickettsiae based on parA and dnaA sequences of plasmid pRM from Rickettsia monacensis. These shuttle vectors support transformation of diverse rickettsiae, including the native host of pRM, and are useful for investigating genetic determinants that govern rickettsial virulence or their ability to function as symbionts.

A comparison of the associations between bone health and three different intensities of accelerometer-derived habitual physical activity in children and adolescents: a systematic review.

Positive associations have been identified between bone outcomes and accelerometer-derived moderate (MPA) and vigorous (VPA) physical activity (PA) in youth; however, it remains unclear which intensity is most beneficial. This systematic review aimed to summarise accelerometer-derived methods used to estimate habitual PA in children and adolescents and determine whether the magnitude of association was consistently stronger for a particular intensity (MPA/MVPA/VPA). Observational studies assessing associations between accelerometer-derived MPA and/or MVPA and VPA with bone outcomes in children and adolescents (≤ 18 years) were identified in MEDLINE, EMBASE, Web of Science, SPORTDiscus and the Cochrane Central Register of Controlled Trials. Thirty articles were included (total n = 20,613 (10,077 males), 4-18 years). Chi-square tests determined whether the proportion of significant associations and strongest within-study associations differed significantly between intensities. Results demonstrated that accelerometer methods were highly variable between studies. Of the 570 associations analysed, 186 were significant (p < 0.05). The proportion of within-study strongest associations differed by PA intensity (3 × 2 χ2 = 86.6, p < 0.001) and was significantly higher for VPA (39%) compared to MVPA (5%; 2 × 2 χ2 = 55.3, p < 0.001) and MPA (9%, 2 × 2 χ2 = 49.1, p < 0.001). Results indicated a greater benefit of VPA over MPA/MVPA; however, variability in accelerometer-derived methods used prevents the precise bone-benefitting amount of VPA from being identified. Long epochs and numerous intensity cut-point definitions mean that bone-relevant PA has likely been missed or misclassified in this population. Future research should explore the use of shorter epochs (1 s) and identify bone-specific activity intensities, rather than using pre-defined activity classifications more relevant to cardiovascular health.

A process evaluation, with mediation analysis, of a web-based intervention to augment primary care exercise referral schemes: the e-coachER randomised controlled trial.

BACKGROUND: The e-coachER trial aimed to determine whether adding web-based behavioural support to exercise referral schemes (ERS) increased long-term device-measured physical activity (PA) for patients with chronic conditions, compared to ERS alone, within a randomised controlled trial. This study explores the mechanisms of action of the e-coachER intervention using measures of the behaviour change processes integral to the intervention's logic model. METHODS: Four hundred fifty adults with obesity, diabetes, hypertension, osteoarthritis or history of depression referred to an ERS were recruited in Plymouth, Birmingham and Glasgow. The e-coachER intervention comprising 7-Steps to Health was aligned with Self-Determination Theory and mapped against evidence-based behaviour change techniques (BCTs). Participants completed questionnaires at 0, 4, and 12 months to assess PA and self-reported offline engagement with core BCTs in day-to-day life (including action planning and self-monitoring) and beliefs relating to PA (including perceived importance, confidence, competence, autonomy and support). We compared groups at 4 and 12 months, controlling for baseline measures and other covariates. Mediation analysis using the product of coefficients method was used to determine if changes in process variables mediated intervention effects on moderate to vigorous physical activity (MVPA) recorded by accelerometer and self-report at 4- and 12-months. RESULTS: The internal reliability (Cronbach's alpha) for all multi-item scales was > 0.77. At 4-months, those randomised to e-coachER reported higher levels of PA beliefs relating to importance (1.01, 95% confidence interval (CI): 0.42 to 1.61, p = 0.001), confidence (1.28, 95% CI: 0.57 to 1.98, p < 0.001), competence (1.61, 95% CI: .68 to 2.54, p = 0.001), availability of support (0.77, 95% CI: 0.07 to 1.48, p = 0.031), use of action planning (1.54, 95% CI: 0.23 to 2.85, p = 0.021) and use of self-monitoring (0.76, 95% CI: 0.19 to 1.32, p = 0.009) compared to ERS alone. There were no intervention effects on autonomous beliefs or perceived frequency of support, compared to ERS alone. At the 12-month follow-up, participants belief in the importance of PA was the only process measure to remain significantly higher in the e-coachER group when compared to ERS alone (0.75, 95% CI: 0.05 to 1.45). Intervention effects on perceived importance (2.52, 95% CI: 0.45 to 5.39), action planning (1.56, 95% CI: 0.10 to 3.54) and self-monitoring (1.92, 95% CI: 0.21 to 4.33) at 4-months significantly mediated change in accelerometer measured MVPA at 12-months (recorded in ≥ 10-min bouts). CONCLUSIONS: e-coachER led to some short-term changes in most process outcomes. Some of these processes also appeared to mediate e-coachER effects on changes in accelerometer measured MVPA. Further work should be carried out to understand how best to design and implement theoretically underpinned web-based physical activity promotion interventions within ERS. TRIAL REGISTRATION: ISRCTN, ISRCTN15644451 . Registered 12 February 2015.

Making a HIIT: study protocol for assessing the feasibility and effects of co-designing high-intensity interval training workouts with students and teachers.

BACKGROUND: High-intensity interval training (HIIT) is an effective strategy for improving a variety of health outcomes within the school setting. However, there is limited research on the implementation of school-based HIIT interventions and the integration of HIIT within the Health and Physical Education (HPE) curriculum. The aims of the Making a HIIT study are to: 1) describe the methodology and evaluate the feasibility of co-designing HIIT workouts with students and teachers in HPE; 2) determine the effect of co-designed HIIT workouts on cardiorespiratory and muscular fitness, and executive function; 3) understand the effect of co-design on students' motivation, enjoyment, and self-efficacy towards the workouts; and 4) evaluate the implementation of the intervention. METHODS: Three schools will participate. Within each school, three different groups will be formed from Year 7 and 8 classes: 1) Co-Designers; 2) HIIT Only; and 3) Control. The study will include two phases. In phase one, Group 1 will co-design HIIT workouts as part of the HPE curriculum using an iterative process with the researcher, teacher, and students as collaborators. This process will be evaluated using student discussions, student surveys, and teacher interviews. In phase two, Groups 1 and 2 will use the co-designed 10-minute HIIT workouts in HPE for 8-weeks. Group 3 (control) will continue their regular HPE lessons. All students will participate in cardiorespiratory fitness, muscular fitness, and executive function assessments before and after the HIIT program or control period. Students will complete questionnaires on their motivation, enjoyment, and self-efficacy of the workouts. Differences between groups will be assessed using linear regressions to account for covariates. Heart rate and rating of perceived exertion will be collected during each HIIT session. The implementation will be evaluated using the Framework for Effective Implementation. Ethical approval was granted by the University of Queensland Human Research Ethics Committee and other relevant bodies. DISCUSSION: This study will be the first to co-design HIIT workouts with teachers and students within the HPE curriculum. As this study relies on co-design, each HIIT workout will differ, which will add variability between HIIT workouts but increase the ecological validity of the study. TRIAL REGISTRATION: ACTRN, ACTRN12622000534785, Registered 5 April 2022 - Retrospectively registered, https://www.anzctr.org.au/ACTRN12622000534785.aspx.

Growth Dynamics and Antibiotic Elimination of Symbiotic Rickettsia buchneri in the Tick Ixodes scapularis (Acari: Ixodidae).

Rickettsia buchneri is the principal symbiotic bacterium of the medically significant tick Ixodes scapularis This species has been detected primarily in the ovaries of adult female ticks and is vertically transmitted, but its tissue tropism in other life stages and function with regard to tick physiology is unknown. In order to determine the function of R. buchneri, it may be necessary to produce ticks free from this symbiont. We quantified the growth dynamics of R. buchneri naturally occurring in I. scapularis ticks throughout their life cycle and compared it with bacterial growth in ticks in which symbiont numbers were experimentally reduced or eliminated. To eliminate the bacteria, we exposed ticks to antibiotics through injection and artificial membrane feeding. Both injection and membrane feeding of the antibiotic ciprofloxacin were effective at eliminating R. buchneri from most offspring of exposed females. Because of its effectiveness and ease of use, we have determined that injection of ciprofloxacin into engorged female ticks is an efficient means of clearing R. buchneri from the majority of progeny.IMPORTANCE This paper describes the growth of symbiotic Rickettsia buchneri within Ixodes scapularis through the life cycle of the tick and provides methods to eliminate R. buchneri from I. scapularis ticks.

Randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support for inactive adults with chronic health conditions: the e-coachER trial.

OBJECTIVE: To determine whether adding web-based support (e-coachER) to an exercise referral scheme (ERS) increases objectively assessed physical activity (PA). DESIGN: Multicentre trial with participants randomised to usual ERS alone (control) or usual ERS plus e-coachER (intervention). SETTING: Primary care and ERS in three UK sites from 2015 to 2018. PARTICIPANTS: 450 inactive ERS referees with chronic health conditions. INTERVENTIONS: Participants received a pedometer, PA recording sheets and a user guide for the web-based support. e-coachER interactively encouraged the use of the ERS and other PA options. MAIN OUTCOME MEASURES: Primary and key secondary outcomes were: objective moderate-to-vigorous PA (MVPA) minutes (in ≥10 min bouts and without bouts), respectively, after 12 months. Secondary outcomes were: other accelerometer-derived and self-reported PA measures, ERS attendance, EQ-5D-5L, Hospital Anxiety and Depression Scale and beliefs about PA. All outcomes were collected at baseline, 4 and 12 months. Primary analysis was an intention to treat comparison between intervention and control arms at 12-month follow-up. RESULTS: There was no significant effect of the intervention on weekly MVPA at 12 months between the groups recorded in ≥10 min bouts (mean difference 11.8 min of MVPA, 95% CI: -2.1 to 26.0; p=0.10) or without bouts (mean difference 13.7 min of MVPA, 95% CI: -26.8 to 54.2; p=0.51) for 232 participants with usable data. There was no difference in the primary or secondary PA outcomes at 4 or 12 months. CONCLUSION: Augmenting ERS referrals with web-based behavioural support had only a weak, non-significant effect on MVPA. TRIAL REGISTRATION NUMBER: ISRCTN15644451.

The Physical Activity Wearables in the Police Force (PAW-Force) study: acceptability and impact.

BACKGROUND: Policing is a highly stressful and increasingly sedentary occupation. The study aim was to assess the acceptability and impact of a mobile health (mHealth) technology intervention (Fitbit® activity monitor and 'Bupa Boost' smartphone app) to promote physical activity (PA) and reduce sedentary time in the police force. METHODS: Single-group, pre-post, mixed methods pilot study. Police officers and staff (n = 180) were recruited from two police forces in South West England. Participants used the technology for 12 weeks (an 'individual' then 'social' phase) followed by 5 months of optional use. Data sources included Fitbit®-recorded objective step count, questionnaire surveys and semi-structured interviews (n = 32). Outcome assessment points were baseline (week 0), mid-intervention (week 6), post-intervention (week 12) and follow-up (month 8). Paired t-tests were used to investigate changes in quantitative outcomes. Qualitative analysis involved framework and thematic analysis. RESULTS: Changes in mean daily step count were non-significant (p > 0.05), but self-reported PA increased in the short term (e.g. + 465.4 MET-minutes/week total PA baseline to week 12, p = 0.011) and longer term (e.g. + 420.5 MET-minutes/week moderate-to-vigorous PA baseline to month 8, p = 0.024). The greatest impact on behaviour was perceived by less active officers and staff. There were no significant changes in sedentary time; the qualitative findings highlighted the importance of context and external influences on behaviour. There were no statistically significant changes (all p-values > 0.05) in any secondary outcomes (physical and mental health-related quality of life, perceived stress and perceived productivity), with the exception of an improvement in mental health-related quality of life (SF-12 mental component score + 1.75 points, p = 0.020) from baseline to month 8. Engagement with and perceived acceptability of the intervention was high overall, but a small number of participants reported negative physical (skin irritation) and psychological (feelings of guilt and anxiety) consequences of technology use. Individual app features (such as goal-setting and self-monitoring) were generally preferred to social components (social comparison, competitions and support). CONCLUSIONS: mHealth technology is an acceptable and potentially impactful intervention for increasing PA in the police force. The intervention was less useful for reducing sedentary time and the impact on secondary outcomes is unclear. TRIAL REGISTRATION: NCT03169179 (registered 30th May 2017).

Personality factors and vulnerability to post-traumatic stress responses after childbirth.

OBJECTIVES: To investigate whether levels of perfectionism, organization, and intolerance of uncertainty predispose women to more negative birth experiences and post-partum post-traumatic stress symptoms (PTSS). Birth experience was also examined as a potential moderator of the relationship between levels of the personality traits and post-natal PTSS. DESIGN: Prospective survey. METHOD: First-time expectant mothers (N = 10,000) were contacted via Emma's Diary during the perinatal period. At 32-42 weeks' gestation, participants completed measures examining the three personality traits and prenatal mood. At 6-12 weeks' post-partum, instruments assessing childbirth experience, birth trauma, PTSS, and post-natal mood were completed. Data from 418 women were analysed. RESULTS: Higher perfectionism and intolerance of uncertainty were associated with more negative birth appraisals and PTSS. Organization was unrelated to birth experience or PTSS. In a regression, higher intolerance of uncertainty and perfectionism statistically predicted more negative birth appraisals. Only perfectionism predicted PTSS. Birth experience did not moderate the relationship between perfectionism or intolerance of uncertainty and PTSS. CONCLUSIONS: Personality risk factors for negative birth experiences and post-natal PTSS are identifiable prenatally. Maternity care providers could educate women about the unique roles of high perfectionism and intolerance of uncertainty during antenatal birth preparation. PRACTITIONER POINTS: Women who expect themselves to be more perfect or who find it more difficult to cope with uncertainty had more negative experiences of childbirth. Women with higher levels of perfectionism were more likely to experience more symptoms of post-traumatic stress during the early post-natal period. Being more perfectionistic continued to have a more negative effect on women's well-being after birth, regardless of whether they had a positive or negative experience of birth. Integrating these findings into antenatal discussion around birth preferences would increase women's awareness of predisposing and obstetric risk factors that partially explain experiences of unsatisfactory births and post-partum post-traumatic stress.

The community-based prevention of diabetes (ComPoD) study: a randomised, waiting list controlled trial of a voluntary sector-led diabetes prevention programme.

OBJECTIVE: This two-site randomised trial compared the effectiveness of a voluntary sector-led, community-based diabetes prevention programme to a waiting-list control group at 6 months, and included an observational follow-up of the intervention arm to 12 months. METHODS: Adults aged 18-75 years at increased risk of developing type 2 diabetes due to elevated blood glucose and being overweight were recruited from primary care practices at two UK sites, with data collected in participants' homes or community venues. Participants were randomised using an online central allocation service. The intervention, comprising the prototype "Living Well, Taking Control" (LWTC) programme, involved four weekly two-hour group sessions held in local community venues to promote changes in diet and physical activity, plus planned follow-up contacts at two, three, six, nine and 12 months alongside 5 hours of additional activities/classes. Waiting list controls received usual care for 6 months before accessing the programme. The primary outcome was weight loss at 6 months. Secondary outcomes included glycated haemoglobin (HbA1c), blood pressure, physical activity, diet, health status and well-being. Only researchers conducting analyses were blinded. RESULTS: The target sample of 314 participants (157 each arm) was largely representative of local populations, including 44% men, 26% from ethnic minorities and 33% living in deprived areas. Primary outcome data were available for 285 (91%) participants (141 intervention, 144 control). Between baseline and 6 months, intervention participants on average lost more weight than controls (- 1.7 kg, 95% CI - 2.59 to - 0.85). Higher attendance was associated with greater weight loss (- 3.0 kg, 95% CI - 4.5 to - 1.5). The prototype LWTC programme more than doubled the proportion of participants losing > 5% of their body weight (21% intervention vs. 8% control, OR 2.83, 95% CI 1.36 to 5.90) and improved self-reported dietary behaviour and health status. There were no impacts on HbA1c, blood pressure, physical activity and well-being at 6 months and, amongst intervention participants, few further changes from six to 12-months (e.g. average weight re-gain 0.36 kg, 95% CI - 0.20 to 0.91). There were no serious adverse events but four exercise-related injuries were reported in the intervention arm. CONCLUSIONS: This voluntary sector-led diabetes prevention programme reached a broad spectrum of the population and had modest effects on weight-related outcomes, but limited impacts on other diabetes risk factors. TRIAL REGISTRATION: Trial registration number: ISRCTN70221670, 5 September 2014 Funder (National Institute for Health Research School for Public Health Research) project reference number: SPHR-EXE-PES-COM.

Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

BACKGROUND: Physical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression. OBJECTIVE: The objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes. METHODS: Participants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes. RESULTS: Of the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference -3.6, 95% CI -6.1 to -1.1). CONCLUSIONS: It was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).

Children's Compliance With Wrist-Worn Accelerometry Within a Cluster-Randomized Controlled Trial: Findings From the Healthy Lifestyles Programme.

PURPOSE: The purpose of this study was to assess children's compliance with wrist-worn accelerometry during a randomized controlled trial and to examine whether compliance differed by allocated condition or gender. METHODS: A total of 886 children within the Healthy Lifestyles Programme trial were randomly allocated to wear a GENEActiv accelerometer at baseline and 18-month follow-up. Compliance with minimum wear-time criteria (≥10 h for 3 weekdays and 1 weekend day) was obtained for both time points. Chi-square tests were used to determine associations between compliance, group allocation, and gender. RESULTS: At baseline, 851 children had usable data, 830 (97.5%) met the minimum wear-time criteria, and 631 (74.1%) had data for 7 days at 24 hours per day. At follow-up, 789 children had usable data, 745 (94.4%) met the minimum wear-time criteria, and 528 (67%) had complete data. Compliance did not differ by gender (baseline: χ2 = 1.66, P = .2; follow-up: χ2 = 0.76, P = .4) or by group at follow-up (χ2 = 2.35, P = .13). CONCLUSION: The use of wrist-worn accelerometers and robust trial procedures resulted in high compliance at 2 time points regardless of group allocation, demonstrating the feasibility of using precise physical activity monitors to measure intervention effectiveness.

Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial.

BACKGROUND: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial. METHODS: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months. RESULTS: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day. CONCLUSION: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status. TRIAL REGISTRATION: ISRCTN15811706 (1/05/2012).

Associations Between Penetration Cognitions, Genital Pain, and Sexual Well-being in Women with Provoked Vestibulodynia.

INTRODUCTION: Provoked vestibulodynia (PVD) is a common vulvovaginal pain condition that negatively impacts women's psychological and sexual well-being. Controlled studies have found that women with PVD report greater negative and less positive cognitions about penetration; however, associations between these types of cognitions and women's pain and sexual well-being remain unknown. Further, researchers have yet to examine how interpersonal variables such as sexual communication may impact the association between women's penetration cognitions and PVD outcomes. AIM: We examined associations between vaginal penetration cognitions and sexual satisfaction, sexual function, and pain in women with PVD, as well as the moderating role of sexual communication. METHODS: Seventy-seven women (M age = 28.32, SD = 6.19) diagnosed with PVD completed the catastrophic and pain cognitions and positive cognitions subscales of the Vaginal Penetration Cognition Questionnaire, as well as the Dyadic Sexual Communication Scale. Participants also completed measures of sexual satisfaction, sexual function, and pain. MAIN OUTCOME MEASURES: Dependent measures were the (i) Global Measure of Sexual Satisfaction Scale; (ii) Female Sexual Function Index; and (iii) Present Pain Intensity scale of the McGill Pain Questionnaire, with reference to pain during vaginal intercourse. RESULTS: Women's lower catastrophic and pain cognitions, higher positive cognitions, and higher sexual communication were each uniquely associated with higher sexual satisfaction and sexual function. Lower catastrophic and pain cognitions also were associated with women's lower pain. For women who reported higher sexual communication, as positive cognitions increased, there was a significantly greater decrease in pain intensity during intercourse compared to women who reported lower levels of sexual communication. CONCLUSION: Findings may inform cognitive-behavioral interventions aimed at improving the pain and sexual well-being of women with PVD. Targeting the couple's sexual communication and women's penetration cognitions may improve women's sexual adjustment and reduce pain.