Dependency of fentanyl analogue protomer ratios on solvent conditions as measured by ion mobility-mass spectrometry.

Recently, our group has shown that fentanyl and many of its analogues form prototropic isomers ("protomers") during electrospray ionization. These different protomers can be resolved using ion mobility spectrometry and annotated using mobility-aligned tandem mass spectrometry fragmentation. However, their formation and the extent to which experimental variables contribute to their relative ratio remain poorly understood. In the present study, we systematically investigated the effects of mixtures of common chromatographic solvents (water, methanol, and acetonitrile) and pH on the ratio of previously observed protomers for 23 fentanyl analogues. Interestingly, these ratios (N-piperidine protonation vs. secondary amine/O = protonation) decreased significantly for many analogues (e.g., despropionyl ortho-, meta-, and para-methyl fentanyl), increased significantly for others (e.g., cis-isofentanyl), and remained relatively constant for the others as solvent conditions changed from 100% organic solvent (methanol or acetonitrile) to 100% water. Interestingly, pH also had significant effects on this ratio, causing the change in ratio to switch in many cases. Lastly, increasing conditions to pH ≥ 4.0 also prompted the appearance of new mobility peaks for ortho- and para-methyl acetyl fentanyl, where all previous studies had only showed one single distribution. Because these ratios have promise to be used qualitatively for identification of these (and emerging) fentanyl analogues, understanding how various conditions (i.e., mobile phase selection and/or chromatographic gradient) affect their ratios is critically important to the development of advanced ion mobility and mass spectrometry methodologies to identify fentanyl analogues.

Co-designed weight management intervention for women recovering from oestrogen-receptor positive breast cancer.

BACKGROUND: Weight gain is commonly observed during and after breast cancer treatment and is associated with poorer survival outcomes, particularly in women with oestrogen receptor-positive (ER +) disease. The aim of this study was to co-design (with patients) a programme of tailored, personalised support (intervention), including high-quality support materials, to help female breast cancer patients (BCPs) with ER + disease to develop the skills and confidence needed for sustainable weight loss.  METHODS: ER + BCPs were recruited from two UK National Health Service (NHS) Trusts. The selection criteria included (i) recent experience of breast cancer treatment (within 36 months of completing primary treatment); (ii) participation in a recent focus group study investigating weight management perceptions and experiences; (iii) willingness to share experiences and contribute to discussions on the support structures needed for sustainable dietary and physical activity behaviour change. Co-design workshops included presentations and interactive activities and were facilitated by an experienced co-design researcher (HH), assisted by other members of the research team (KP, SW and JS). RESULTS: Two groups of BCPs from the North of England (N = 4) and South Yorkshire (N = 5) participated in a two-stage co-design process. The stage 1 and stage 2 co-design workshops were held two weeks apart and took place between Jan-March 2019, with each workshop being approximately 2 h in duration. Guided by the Behaviour Change Wheel, a theoretically-informed weight management intervention was developed on the basis of co-designed strategies to overcome physical and emotional barriers to dietary and physical activity behaviour change. BCPs were instrumental in designing all key features of the intervention, in terms of Capability (e.g., evidence-based information, peer-support and shared experiences), Opportunity (e.g., flexible approach to weight management based on core principles) and Motivation (e.g., appropriate use of goal-setting and high-quality resources, including motivational factsheets) for behaviour change. CONCLUSION: This co-design approach enabled the development of a theoretically-informed intervention with a content, structure and delivery model that has the potential to address the weight management challenges faced by BCPs diagnosed with ER + disease. Future research is required to evaluate the effectiveness of the intervention for eliciting clinically-important and sustainable weight loss in this population.

A modifiable factors-based model for detecting inactive individuals: are the European assessment tools fit for purpose?

BACKGROUND: The lack of systematic factors affecting physical inactivity (PIA) challenges policymakers to implement evidence-based solutions at a population level. The study utilizes the Eurobarometer to analyse PIA-modifiable variables. METHODS: Special Eurobarometer 412 physical activity (PA) data were analysed (n = 18 336), including 40 variables along with the International PA Questionnaire. PIA was used as the dependent variable. Variables considered were alternatives to car, places, reasons and barriers to engaging in PA, memberships to clubs and categorical responses about the agreement extent with the area, provision of activities and local governance statements. Logistic regression was used to identify variables contributing to PIA. Beta values (ß), standard errors, 95% confidence intervals, the exponentiation for odds ratio and Cox & Snell and Nagelkerke R2 were indicated. RESULTS: The resulting model correctly identified 10.7% inactives and 96.9% of actives (R2 of Nagelkerke: 0.153). Variables contributing to the detection of PIA were (P ≤ 0.01): having a disability or an illness, not having friends to do sport with, lacking motivation or interest in and being afraid of injury risk. Additionally, totally agreeing, tend to agree and tend to disagree regarding the extent of local providers offering enough opportunities to be more active also contributed to the model. CONCLUSIONS: The model reported a limited ability to detect modifiable factors affecting PIA, identifying a small percentage of inactive individuals correctly. New questions focused on understanding inactive behaviour are needed to support the European PA public health agenda.

Spectral and polarization based imaging in deep-ultraviolet excited photoelectron microscopy.

Using photoelectron emission microscopy, nanoscale spectral imaging of atomically thin MoS2 buried between Al2O3 and SiO2 is achieved by monitoring the wavelength and polarization dependence of the photoelectron signal excited by deep-ultraviolet light. Although photons induce the photoemission, images can exhibit resolutions below the photon wavelength as electrons sense the response. To validate this concept, the dependence of photoemission yield on the wavelength and polarization of the exciting light was first measured and then compared to simulations of the optical response quantified with classical optical theory. A close correlation between experiment and theory indicates that photoemission probes the optical interaction of UV-light with the material stack directly. The utility of this probe is then demonstrated when both the spectral and polarization dependence of photoemission observe spatial variation consistent with grains and defects in buried MoS2. Taken together, these new modalities of photoelectron microscopy allow mapping of optical property variation at length scales unobtainable with conventional light-based microscopy.

No changes in adolescent's sedentary behaviour across Europe between 2002 and 2017.

BACKGROUND: Public health organizations have been alerted to the high levels of sedentary behaviour (SB) among adolescents as well as to the health and social consequences of excess sedentary time. However, SB changes of the European Union (EU) adolescents over time have not been reported yet. This study aimed to identify SB of the EU adolescents (15-17 years) in four-time points (2002, 2005, 2013 and 2017) and to analyse the prevalence of SB according to the sex. METHODS: SB of 2542 adolescents (1335 boys and 1207 girls) as a whole sample and country-by-country was analysed in 2002, 2005, 2013, and 2017 using the Sport and Physical Activity EU Special Eurobarometers' data. SB was measured using the sitting time question from the short version of the International Physical Activity Questionnaire (IPAQ), such that 4h30min of daily sitting time was the delineating point to determine excess SB behaviour (≥4h30min of sitting time) or not (≤4h30min of sitting time). A χ2 test was used to compare the prevalence of SB between survey years. Furthermore, SB prevalence between sexes was analysed using a Z-Score test for two population proportions. RESULTS: The prevalence of SB among EU adolescents across each of the four survey years ranged from 74.2 and 76.8%, rates that are considered high. High levels of SB were also displayed by both sexes (girls: 76.8 to 81.2%; boys: 71.7 to 76.7%). No significant differences in the prevalence of SB among years (p > 0.05) were found for the whole sample, and for either girls or boys. Also, no significant differences in the prevalence of SB between girls and boys were found. CONCLUSION: The SB prevalence in European adolescents is extremely high (76.8% in 2017) with no differences between girls and boys. No significant improvements have been seen between 2002 and 2017. Eurobarometer should increase the adolescents' sample to make possible benchmarking comparisons among the EU countries and extend the survey to the younger children population.

Integration of a vertebral fracture identification service into a fracture liaison service: a quality improvement project.

Integration of a vertebral fracture identification service into a Fracture Liaison Service is possible. Almost one-fifth of computerised tomography scans performed identified an individual with a fracture. This increase in workload needs to be considered by any FLS that wants to utilise such a service. INTRODUCTION: This service improvement project aimed to improve detection of incidental vertebral fractures on routine imaging. It embedded a vertebral fracture identification service (Optasia Medical, OM) on routine computerised tomography (CT) scans performed in this hospital as part of its Fracture Liaison Service (FLS). METHODS: The service was integrated into the hospital's CT workstream. Scans of patients aged ≥ 50 years for 3 months were prospectively retrieved, alongside their clinical history and the CT report. Fractures were identified via OM's machine learning algorithm and cross-checked by the OM radiologist. Fractures identified were then added as an addendum to the original CT report and the hospital FLS informed. The FLS made recommendations based on an agreed algorithm. RESULTS: In total, 4461 patients with CT scans were retrieved over the 3-month period of which 850 patients had vertebra fractures identified (19.1%). Only 49% had the fractures described on hospital radiology report. On average, 61 patients were identified each week with a median of two fractures. Thirty-six percent were identified by the FLS for further action and recommendations were made to either primary care or the community osteoporosis team within 3 months of fracture detection. Of the 64% not identified for further action, almost half was because the CT was part of cancer assessment or treatment. The remaining were due to a combination of only ≤ 2 mild fractures; already known to a bone health specialist; in the terminal stages of any chronic illness; significant dependency for activities of daily living; or a life expectancy of less than 12 months CONCLUSION: It was feasible to integrate a commercial vertebral fracture identification service into the daily working of a FLS. There was a significant increase in workload which needs to be considered by any future FLS planning to incorporate such a service into their clinical practice.

Changes in sedentary behaviour in European Union adults between 2002 and 2017.

BACKGROUND: Sedentary behaviour (SB) has been identified as an important mortality risk factor. Health organizations have recognised SB as a public health challenge with major health, social, and economic consequences. Researchers have alerted the need to develop specific strategies, to monitor, prevent, and reduce SB. However, there is no systematic analysis of the SB changes in European Union adults. We aimed to examine SB changes between 2002 and 2017 in the European Union (EU) adult population. METHODS: SB prevalence (>4h30mins of sitting time/day) of 96,004 adults as a whole sample and country-by-country was analysed in 2002, 2005, 2013, and 2017 of the Sport and Physical Activity EU Special Eurobarometers' data. The SB question of a modified version of the International Physical Activity Questionnaire was considered. SB prevalence between countries and within years was analysed with a χ2 test, and SB between genders was analysed with the Z-Score test for two population proportions. RESULTS: An association between the SB prevalence and the years was found (p < 0.001), with increases for the whole sample (2002: 49.3%, 48.5-50.0 95% confidence interval (CI); 2017: 54.5%, 53.9-55.0 95% CI) and men (2002: 51.2%, 50.0-52.4 95% CI; 2017: 55.8%, 55.0-56.7 95% CI) and women (2002: 47.6%, 46.6-48.7 95% CI; 2017: 53.4%, 52.6-54.1 95% CI) separately. The adjusted standardised residuals showed an increase in the observed prevalence versus the expected during 2013 and 2017 for the whole sample and women and during 2017 for men. For all years, differences were observed in the SB prevalence between countries for the whole sample, and men and women separately (p < 0.001). Besides, the SB prevalence was always higher in men versus women in the overall EU sample (p < 0.001). CONCLUSIONS: SB prevalence increased between 2002 and 2017 for the EU as a whole and for both sexes separately. Additionally, differences in SB prevalence were observed for all years between EU countries in the whole sample and both sexes separately. Lastly, SB was consistently higher in men than women. These findings reveal a limited impact of current policies and interventions to tackle SB at the EU population level.

The active living gender's gap challenge: 2013-2017 Eurobarometers physical inactivity data show constant higher prevalence in women with no progress towards global reduction goals.

BACKGROUND: The World Health Organization (WHO) considers physical inactivity (PIA) as a critical noncommunicable factor for disease and mortality, affecting more women than men. In 2013, the WHO set a 10% reduction of the PIA prevalence, with the goal to be reached by 2025. Changes in the 2013-2017 period of physical inactivity prevalence in the 28 European Union (EU) countries were evaluated to track the progress in achieving WHO 2025 target. METHODS: In 2013 and 2017 EU Special Eurobarometers, the physical activity levels reported by the International Physical Activity Questionnaire of 53,607 adults were analyzed. Data were considered as a whole sample and country-by-country. A χ2 test was used to analyze the physical inactivity prevalence (%) between countries, analyzing women and men together and separately. Additionally, PIA prevalence was analyzed between years (2013-2017) for the overall EU sample and within-country using a Z-Score for two population proportions. RESULTS: The PIA prevalence increased between 2013 and 2017 for the overall EU sample (p <  0.001), and for women (p = 0.04) and men (p < 0.001) separately. Data showed a higher PIA prevalence in women versus men during both years (p <  0.001). When separately considering changes in PIA by gender, only Belgium's women and Luxembourg's men showed a reduction in PIA prevalence. Increases in PIA prevalence over time were observed in women from Austria, Croatia, Germany, Lithuania, Malta, Portugal, Romania, and Slovakia and in men from Bulgaria, Croatia, Czechia, Germany, Italy, Lithuania, Portugal, Romania, Slovakia, and Spain. CONCLUSIONS: PIA prevalence showed an overall increase across the EU and for both women and men between 2013 and 2017, with higher rates of PIA reported for women versus men during both years. PIA prevalence was reduced in only Belgium's women and Luxembourg's men. Our data indicate a limited gender-sensible approach while tacking PIA prevalence with no progress reaching global voluntary reductions of PIA for 2025.

Agnosia Interferes With Daily Hygiene in Patients With Dementia.

Patients with dementia, particularly Alzheimer's disease, may not recognize that their clothes are dirty. They may see the food stains and discoloration of the clothes and yet because of their agnosia are unable to integrate these observations and deduce that their clothes are dirty and need to be changed. They will, therefore, resist attempts to get them to change clothes, especially if these clothes happen to be their favorite ones. This often causes caregivers to become frustrated, especially, if it represents a change in the patient's previous habits of only wearing clean clothes. In this case study, we present a 72-year-old woman with moderate Alzheimer's disease who lives with her daughter, who adamantly refuses to change the clothes she has been wearing for a few days and which are now clearly dirty. We report the interaction, highlight what went wrong in the patient-daughter interaction, and discuss how the catastrophic ending could have been avoided or averted.

Insomnia and Mild Cognitive Impairment.

Insomnia is a common problem in older people, especially in patients with mild cognitive impairment (MCI) whose circadian rhythm is often compromised. Insomnia exerts such a toll on caregivers that it is frequently the primary reason for seeking to institutionalize their loved ones. Three different types of insomnia are recognized: sleep-onset or initial insomnia, sleep maintenance or middle insomnia, and early morning awakening or late insomnia. Nocturnal hypoglycemia, as a cause of middle insomnia, is the main focus of this case study. Other types of insomnia are also briefly reviewed. The management of insomnia is then discussed including sleep hygiene, the usefulness and potential drawbacks of dietary supplements, nonprescription over-the-counter preparations and prescription hypnotics. Sleep architecture is then briefly reviewed, emphasizing the importance of its integrity and the role of each sleep stage.

Visual Hallucinations and Paranoid Delusions.

Visual well-formed hallucinations, fluctuations in the level of cognition, and alertness and extrapyramidal signs are core features of dementia with Lewy bodies. Some patients realize that what they are seeing or hearing are just hallucinations and learn to accept them. Others, however experience these hallucinations as quite real and cannot be dissuaded from the firm belief that they are. In fact, efforts to dissuade them often serve only to confirm the often associated paranoid delusions and this may lead to a catastrophic ending. Hence, it is best not to contradict the patient. Instead, attempts should be made to distract the patient and change the focus of her or his attention. In this case scenario, we present a 68-year-old man who has been diagnosed with dementia with Lewy bodies. He lives with his daughter. He has visual hallucinations and paranoid delusions that worsen at night: He thinks there are people outside the house plotting to kill him. We discuss what went wrong in the patient/caregiver interaction and how the catastrophic ending could have been avoided or averted.

Repetitive Questioning II.

Repetitive questioning is a major problem for caregivers, particularly taxing if they are unable to recognize and understand the reasons why their loved one keeps asking the same question over and over again. Caregivers may be tempted to believe that the patient does not even try to remember the answer given or is just getting obnoxious. This is incorrect. Repetitive questioning is due to the underlying disease: The patient's short term memory is impaired and he is unable to register, encode, retain and retrieve the answer. If he is concerned about a particular topic, he will keep asking the same question over and over again. To the patient each time she asks the question, it is as if she asked it for the first time. Just answering repetitive questioning by providing repeatedly the same answer is not sufficient. Caregivers should try to identify the underlying cause for this repetitive questioning. In an earlier case study, the patient was concerned about her and her family's safety and kept asking whether the doors are locked. In this present case study, the patient does not know how to handle the awkward situation he finds himself in. He just does not know what to do. He is not able to adjust to the new unexpected situation. So he repeatedly wants to reassure himself that he is not intruding by asking the same question over and over again. We discuss how the patient's son-in-law could have avoided this situation and averted the catastrophic ending.

Repetitive Questioning Exasperates Caregivers.

Repetitive questioning is due to an impaired episodic memory and is a frequent, often presenting, problem in patients with Alzheimer's disease (amnestic type). It is due to the patients' difficulties learning new information, retaining it, and recalling it, and is often aggravated by a poor attention span and easy distractibility. A number of factors may trigger and maintain repetitive questioning. Caregivers should try to identify and address these triggers. In the case discussion presented, it is due to the patient's concerns about her and her family's safety triggered by watching a particularly violent movie aired on TV. What went wrong in the patient/caregiver interaction and how it could have been avoided or averted are explored. Also reviewed are the impact of repetitive questioning, the challenges it raises for caregivers, and some effective intervention strategies that may be useful to diffuse the angst that caregivers experience with repetitive questioning.

Intragastric balloon as an adjunct to lifestyle programme in severely obese adolescents: impact on biomedical outcomes and skeletal health.

Intragastric Balloons are a temporary, reversible and safer option compared to bariatric surgery to promote significant weight loss, leading to improved metabolic outcomes. However, due to subsequent weight regain, alternative procedures are now preferred in adults. In adolescents, more amenable to lifestyle change, balloons may be an alternative to less reversible procedures. Our aim was to assess the tolerability and efficacy of the intragastric balloon in severely obese adolescents and the impact of associated weight loss on biomedical outcomes (glucose metabolism, blood pressure, lipid profiles) and bone density. A 2-year cohort study of 12 adolescents (BMI >3.5 s.d., Tanner stage >4) following 6 months intragastric balloon placement was carried out. Subjects underwent anthropometry, oral glucose tolerance test, and DEXA scans at 0, 6 and 24 months. The results showed clinically relevant improvements in blood pressure, insulin: glucose metabolism, liver function and sleep apnoea at 6 months. Changes were not sustained at 2 years though some parameters (Diastolic BP, HBA1c, insulin AUC) demonstrated longer-term improvement despite weight regain. Despite weight loss, bone mass accrual showed age appropriate increases. In conclusion, the intragastric balloon was safe, well tolerated and effective in supporting short-term weight loss and clinically relevant improvement in obesity-related complications, which resolved in some individuals. Benefits were not sustained in the majority at 2 years.

Structural effects of intra-articular TGF-ß1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial.

BACKGROUND: To determine effects of allogeneic human chondrocytes expressing TGF-ß1 (TG-C) on structural progression of MRI features of knee osteoarthritis over a 1 year period. METHODS: This phase II randomized controlled trial of TG-C included patients with moderate to advanced osteoarthritis. Patients were randomized to receive an intraarticular 3:1 mixture of non-transduced allogeneic human chondrocytes and TG-C or placebo. 3 T MRI was acquired for all patients at baseline and follow-up (3, 6 and 12 months). MRIs were assessed using the WORMS system including cartilage damage, bone marrow lesions (BMLs), meniscal damage/extrusion, Hoffa-, effusion-synovitis, and osteophytes. Analyses were performed on a whole knee level, compartmental level, and subregional level. Binary logistic regression with Generalized Estimating Equation was used to compare risks of progression, adjusting for baseline age and gender. Mann - Whitney - Wilcoxon tests were used to assess differences for continuous variables. RESULTS: Fifty-seven Patients were included in the TG-C group and 29 in the placebo group. At 12 months, knees in the TG-C group showed less progression of cartilage damage compared to placebo on a whole knee level (34.6% vs. 47.9%; adjusted RR 0.7, 95%CI [0.5-1.1], p = 0.077). Less progression of Hoffa-synovitis and effusion-synovitis was observed in the TG-C group compared to placebo (9.6% vs. 21.1%, adjusted RR 0.5, 95%CI [0.2,1.2], p = 0.115). No statistically significant differences were seen for BMLs, meniscal damage and osteophytes. CONCLUSIONS: Intraarticular treatment with TG-C showed fewer patients in the treated group with progression in structural OA features and other MRI-defined inflammatory markers such as Hoffa-synovitis and effusion-synovitis. However, no differences were observed in regard to progression of BMLs and meniscal damage, or hypertrophic osteophyte formation. TRIAL REGISTRATION: NCT01221441 .Registered 13th October, 2010.

Hallucinations Are Real to Patients With Dementia.

In this case study, we present a patient with preexistent posttraumatic stress disorder and psychosis who has been recently diagnosed with Dementia with Lewy Bodies. He is experiencing vivid hallucinations. What went wrong between him and his wife as a result of these hallucinations is presented. Alternative actions that could have been used are suggested. OBJECTIVES: At the end of this case study, readers will know the following:The characteristic clinical features of Dementia with Lewy Bodies (DLB).Patients experiencing hallucinations should not be contradicted, to them, these hallucinations are real.Easy distractibility and short attention span can be exploited to avert or defuse potentially catastrophic situations.Patients with dementia should not have access to loaded guns.

Patients With Dementia Are Easy Victims to Predators.

Patients with dementia, especially Alzheimer's disease and particularly those in early stages, are susceptible to become victims of predators: Their agnosia (see Case 1) prevents them from detecting and accurately interpreting subtle signals that otherwise would have alerted them that they are about to fall for a scam. Furthermore, their judgment is impaired very early in the disease process, often before other symptoms manifest themselves and usually before a diagnosis is made. Patients with early stages of dementia are therefore prime targets for unscrupulous predators, and it behooves caregivers and health care professionals to ensure the integrity of these patients. In this case study, we discuss how a man with mild Alzheimer's disease was about to fall for a scam were it not for his vigilant wife. We discuss what went wrong in the patient/caregiver interaction and how the catastrophic ending could have been avoided or averted.

Too Many Choices Confuse Patients With Dementia.

Choices are often difficult to make by patients with Alzheimer Dementia. They often become acutely confused when faced with too many options because they are not able to retain in their working memory enough information about the various individual choices available. In this case study, we describe how an essentially simple benign task (choosing a dress to wear) can rapidly escalate and result in a catastrophic outcome. We examine what went wrong in the patient/caregiver interaction and how that potentially catastrophic situation could have been avoided or defused.

A formative review of physical activity interventions for minority ethnic populations in England.

Background: Physical activity (PA) levels are lower among some UK Black and minority ethnic (BME) groups than the majority White British population and a variety of tailored interventions have emerged. This study documents the characteristics and logic of local adaptations, a vital first step in evaluating such innovations. Methods: An English PA data set was examined to identify and characterize PA programmes focussed on BME populations. Three case studies were conducted, employing documentary analysis and qualitative interviews. Netto et al.'s principles of adapting health promotion interventions for BME populations guided the analysis. Results: Out of 861 PA interventions, 57 focussed on BME populations. These were typically aimed to engage the most inactive groups, improve both health and social outcomes and were largely publically/charitably funded. Tailored approaches matched Netto et al.'s five principles: using community resources for publicity, identifying and addressing barriers, developing sensitive communication strategies, working with values and accommodating cultural identification. Another common principle was identified: building community capacity for sustainability. Conclusions: PA interventions tailored to the needs of BME groups reflect their largely disadvantaged position in society and focus on inactivity. The six principles could be used as a framework for developing, designing and evaluating tailored interventions for BME populations.

Intra-gastric balloon as an adjunct to lifestyle support in severely obese adolescents; impact on weight, physical activity, cardiorespiratory fitness and psychosocial well-being.

BACKGROUND: Severe adolescent obesity (body mass index (BMI) >99.6th centile) is a significant public health challenge. Current non-invasive treatments, including community-based lifestyle interventions, are often of limited effectiveness in this population, with NICE guidelines suggesting the use of bariatric surgery as the last line of treatment. Health professionals are understandably reluctant to commission bariatric surgery and as an alternative, the use of an intra-gastric balloon as an adjunct to a lifestyle programme might offer a reversible, potentially safer and less invasive option. OBJECTIVES: Explore the use of an intra-gastric balloon as an adjunct to a lifestyle support programme, to promote weight loss in severely obese adolescents. Outcomes included weight loss, waist and hip measurements, psychosocial outcomes including health-related quality of life (HRQoL) and physical self perceptions, physical activity and cardiorespiratory fitness. METHOD: Non-randomised pilot study. RESULTS: Twelve severely obese adolescents (5 males, 7 females; mean age 15 years; BMI >3.5 s.d.; puberty stage 4 or more) and their families were recruited. Mean weight loss at 12 months (n=9) was 3.05 kg±14.69; d=0.002, P=0.550, and a BMI Z-score (n=12) change of 0.2 s.d.; d=0.7, P=0.002 was observed at 6 months with a large effect, but was not sustained at 12 months (mean change 0.1 s.d.; d=0.3, P=0.146). At 24 months (n=10), there was a weight gain from baseline of +9.9 kg±1.21 (d=0.4; P=0.433). Adolescent and parent HRQoL scores exceeded the minimal clinical important difference between baseline and 12 months for all domains but showed some decline at 24 months. CONCLUSION: An intra-gastric balloon as an adjunct to a lifestyle support programme represents a safe and well-tolerated treatment approach in severely obese adolescents, with short-term effects on weight change. Improvements in psychosocial health, physical activity and cardiorespiratory fitness were maintained at 12 months, with varying results at 24 months.