Is the UN receiving ethical approval for its research with human participants?

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors' experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight?

Seasonality and the effects of weather on Campylobacter infections.

BACKGROUND: Campylobacteriosis is a major public health concern. The weather factors that influence spatial and seasonal distributions are not fully understood. METHODS: To investigate the impacts of temperature and rainfall on Campylobacter infections in England and Wales, cases of Campylobacter were linked to local temperature and rainfall at laboratory postcodes in the 30 days before the specimen date. Methods for investigation included a comparative conditional incidence, wavelet, clustering, and time series analyses. RESULTS: The increase of Campylobacter infections in the late spring was significantly linked to temperature two weeks before, with an increase in conditional incidence of 0.175 cases per 100,000 per week for weeks 17 to 24; the relationship to temperature was not linear. Generalized structural time series model revealed that changes in temperature accounted for 33.3% of the expected cases of Campylobacteriosis, with an indication of the direction and relevant temperature range. Wavelet analysis showed a strong annual cycle with additional harmonics at four and six months. Cluster analysis showed three clusters of seasonality with geographic similarities representing metropolitan, rural, and other areas. CONCLUSIONS: The association of Campylobacteriosis with temperature is likely to be indirect. High-resolution spatial temporal linkage of weather parameters and cases is important in improving weather associations with infectious diseases. The primary driver of Campylobacter incidence remains to be determined; other avenues, such as insect contamination of chicken flocks through poor biosecurity should be explored.

A comparison of weather variables linked to infectious disease patterns using laboratory addresses and patient residence addresses.

BACKGROUND: To understand the impact of weather on infectious diseases, information on weather parameters at patient locations is needed, but this is not always accessible due to confidentiality or data availability. Weather parameters at nearby locations are often used as a proxy, but the accuracy of this practice is not known. METHODS: Daily Campylobacter and Cryptosporidium cases across England and Wales were linked to local temperature and rainfall at the residence postcodes of the patients and at the corresponding postcodes of the laboratory where the patient's specimen was tested. The paired values of daily rainfall and temperature for the laboratory versus residence postcodes were interpolated from weather station data, and the results were analysed for agreement using linear regression. We also assessed potential dependency of the findings on the relative geographic distance between the patient's residence and the laboratory. RESULTS: There was significant and strong agreement between the daily values of rainfall and temperature at diagnostic laboratories with the values at the patient residence postcodes for samples containing the pathogens Campylobacter or Cryptosporidium. For rainfall, the R-squared was 0.96 for the former and 0.97 for the latter, and for maximum daily temperature, the R-squared was 0.99 for both. The overall mean distance between the patient residence and the laboratory was 11.9 km; however, the distribution of these distances exhibited a heavy tail, with some rare situations where the distance between the patient residence and the laboratory was larger than 500 km. These large distances impact the distributions of the weather variable discrepancies (i.e. the differences between weather parameters estimated at patient residence postcodes and those at laboratory postcodes), with discrepancies up to ±10 °C for the minimum and maximum temperature and 20 mm for rainfall. Nevertheless, the distributions of discrepancies (estimated separately for minimum and maximum temperature and rainfall), based on the cases where the distance between the patient residence and the laboratory was within 20 km, still exhibited tails somewhat longer than the corresponding exponential fits suggesting modest small scale variations in temperature and rainfall. CONCLUSION: The findings confirm that, for the purposes of studying the relationships between meteorological variables and infectious diseases using data based on laboratory postcodes, the weather results are sufficiently similar to justify the use of laboratory postcode as a surrogate for domestic postcode. Exclusion of the small percentage of cases where there is a large distance between the residence and the laboratory could increase the precision of estimates, but there are generally strong associations between daily weather parameters at residence and laboratory.

Knowledge and behaviors in relation to antibiotic use among rural residents in Anhui, China.

OBJECTIVES: To examine antibiotic-related knowledge and behaviors in rural Anhui, identify factors associated with knowledge, and explore the relationship between knowledge and antibiotic use. METHODS: Cross-sectional study of a random sample of 2760 residents of rural China using structured interviews. RESULTS: The response rate was 94.6%. A total of 2390 respondents (91.6%) believed that antibiotics can control viruses; 2007 (77.5%) respondents thought that a combination of antibiotics is more effective than a single class; and 590 (22.6%) were able to name at least one disbenefit of using antibiotics. Multivariate analysis revealed those with a higher educational level and younger age group had greater knowledge of antibiotics (OR 2.54 and 0.77, respectively). Self-medication was common with 1052 (out of 2274 responses, 46.3%) of participants use over the counter or leftover medicines for common infections. Greater knowledge was associated with buying drugs without prescription (aOR 2.02; 95% CI, 1.29-3.17) and using leftover medication (aOR 2.80; 95% CI, 1.55-5.06). CONCLUSION: Knowledge about antibiotics was low and reported use high. Worryingly those with greater knowledge had less desirable behaviors that highlights the urgent need for multifaceted interventions to change behavior.

Exploring the evidence base for national and regional policy interventions to combat resistance.

The effectiveness of existing policies to control antimicrobial resistance is not yet fully understood. A strengthened evidence base is needed to inform effective policy interventions across countries with different income levels and the human health and animal sectors. We examine three policy domains-responsible use, surveillance, and infection prevention and control-and consider which will be the most effective at national and regional levels. Many complexities exist in the implementation of such policies across sectors and in varying political and regulatory environments. Therefore, we make recommendations for policy action, calling for comprehensive policy assessments, using standardised frameworks, of cost-effectiveness and generalisability. Such assessments are especially important in low-income and middle-income countries, and in the animal and environmental sectors. We also advocate a One Health approach that will enable the development of sensitive policies, accommodating the needs of each sector involved, and addressing concerns of specific countries and regions.

Helping Aged Victims of Crime (the HAVoC Study): Common Crime, Older People and Mental Illness.

BACKGOUND: Limited data suggest that crime may have a devastating impact on older people. Although identification and treatment may be beneficial, no well-designed studies have investigated the prevalence of mental disorder and the potential benefits of individual manualized CBT in older victims of crime. AIMS: To identify mental health problems in older victims of common crime, provide preliminary data on its prevalence, and conduct a feasibility randomized controlled trial (RCT) using mixed methods. METHOD: Older victims, identified through police teams, were screened for symptoms of anxiety, depression or post-traumatic stress disorder (PTSD) one (n = 581) and 3 months (n = 486) after experiencing a crime. Screen positive participants were offered diagnostic interviews. Of these, 26 participants with DSM-IV diagnoses agreed to be randomized to Treatment As Usual (TAU) or TAU plus our manualized CBT informed Victim Improvement Package (VIP). The latter provided feedback on the VIP. RESULTS: Recruitment, assessment and intervention are feasible and acceptable. At 3 months 120/486 screened as cases, 33 had DSM-IV criteria for a psychiatric disorder; 26 agreed to be randomized to a pilot trial. There were trends in favour of the VIP in all measures except PTSD at 6 months post crime. CONCLUSIONS: This feasibility RCT is the first step towards improving the lives of older victims of common crime. Without intervention, distress at 3 and 6 months after a crime remains high. However, the well-received VIP appeared promising for depressive and anxiety symptoms, but possibly not posttraumatic stress disorder.

Adiposity and carotid-intima media thickness in children and adolescents: a systematic review.

BACKGROUND: Adiposity in childhood is associated with later cardiovascular disease (CVD), but it is unclear whether this relationship is independent of other risk factors experienced in later life, such as smoking and hypertension. Carotid-intima media thickness (cIMT) is a measure of subclinical atherosclerosis that may be used to assess CVD risk in young people. The aim of this study was to examine the relationship between adiposity and cIMT in children and adolescents. METHODS: We searched Medline, Embase, Global Health, and CINAHL Plus electronic databases (1980-2014). Population-based observational studies that reported a measure of association between objectively-measured adiposity and cIMT in childhood were included in this review. RESULTS: Twenty-two cross-sectional studies were included (n = 7,366 children and adolescents). Thirteen of nineteen studies conducted in adolescent populations (mean age ≥ 12 years, n = 5,986) reported positive associations between cIMT and adiposity measures (correlation coefficients 0.13 to 0.59). Three studies of pre-adolescent populations (n = 1,380) reported mixed evidence, two studies finding no evidence of a correlation, and one an inverse relationship between skinfolds and cIMT. Included studies did not report an adiposity threshold for subclinical atherosclerosis. CONCLUSIONS: Based on studies conducted mostly in Western Europe and the US, adiposity does not appear to be associated with cIMT in pre-adolescents, but may be associated in adolescents. If further studies confirm these findings, a focus on cardiovascular disease prevention efforts in pre-adolescence, before arterial changes have emerged, may be justified.

Predictors of health-related behaviour change in parents of overweight children in England.

OBJECTIVE: Providing parents with information about their child's overweight status (feedback) could prompt them to make lifestyle changes for their children. We assessed whether parents of overweight children intend to or change behaviours following feedback, and examined predictors of these transitions. METHODS: We analysed data from a cohort of parents of children aged 4-5 and 10-11 years participating in the National Child Measurement Programme in five areas of England, 2010-2011. Parents of overweight children (body mass index ≥91st centile) with data at one or six months after feedback were included (n=285). The outcomes of interest were intention to change health-related behaviours and positive behaviour change at follow-up. Associations between respondent characteristics and outcomes were assessed using logistic regression analysis. RESULTS: After feedback, 72.1% of parents reported an intention to change; 54.7% reported positive behaviour change. Intention was associated with recognition of child overweight status (OR 11.20, 95% CI 4.49, 27.93). Parents of older and non-white children were more likely to report behaviour changes than parents of younger or white children. Intention did not predict behaviour change. CONCLUSIONS: Parental recognition of child overweight predicts behavioural intentions. However, intentions do not necessarily translate into behaviours; interventions that aim to change intentions may have limited benefits.

The benefits and harms of providing parents with weight feedback as part of the national child measurement programme: a prospective cohort study.

BACKGROUND: Small-scale evaluations suggest that the provision of feedback to parents about their child's weight status may improve recognition of overweight, but the effects on lifestyle behaviour are unclear and there are concerns that informing parents that their child is overweight may have harmful effects. The aims of this study were to describe the benefits and harms of providing weight feedback to parents as part of a national school-based weight-screening programme in England. METHODS: We conducted a pre-post survey of 1,844 parents of children aged 4-5 and 10-11 years who received weight feedback as part of the 2010-2011 National Child Measurement Programme. Questionnaires assessed general knowledge about the health risks associated with child overweight, parental recognition of overweight and the associated health risks in their child, child lifestyle behaviour, child self-esteem and weight-related teasing, parental experience of the feedback, and parental help-seeking behaviour. Differences in the pre-post proportions of parents reporting each outcome were assessed using a McNemar's test. RESULTS: General knowledge about child overweight as a health issue was high at baseline and increased further after weight feedback. After feedback, the proportion of parents that correctly recognised their child was overweight increased from 21.9% to 37.7%, and more than a third of parents of overweight children sought further information regarding their child's weight. However, parent-reported changes in lifestyle behaviours among children were minimal, and limited to increases in physical activity in the obese children only. There was some suggestion that weight feedback had a greater impact upon changing parental recognition of the health risks associated with child overweight in non-white ethnic groups. CONCLUSIONS: In this population-based sample of parents of children participating in the National Child Measurement Programme, provision of weight feedback increased recognition of child overweight and encouraged some parents to seek help, without causing obvious unfavourable effects. The impact of weight feedback on behaviour change was limited; suggesting that further work is needed to identify ways to more effectively communicate health information to parents and to identify what information and support may encourage parents in making and maintaining lifestyle changes for their child.

Perceptions of health risk among parents of overweight children: a cross-sectional study within a cohort.

OBJECTIVE: To identify the socio-demographic and behavioural characteristics associated with perceptions of weight-related health risk among the parents of overweight children. METHODS: Baseline data from a cohort of parents of children aged 4-11 years in five areas in England in 2010-2011 were analysed; the sample was restricted to parents of overweight children (body mass index ≥ 91(st) centile of UK 1990 reference; n=579). Associations between respondent characteristics and parental perception of health risk associated with their child's weight were examined using logistic regression analyses. RESULTS: Most parents (79%) did not perceive their child's weight to be a health risk. Perception of a health risk was associated with recognition of the child's overweight status (OR 10.59, 95% CI 5.51 to 20.34), having an obese child (OR 4.21, 95% CI 2.28 to 7.77), and having an older child (OR 2.67, 95% CI 1.32 to 5.41). However, 41% of parents who considered their child to be overweight did not perceive a health risk. CONCLUSIONS: Parents that recognise their child's overweight status, and the parents of obese and older children, are more likely to perceive a risk. However, many parents that acknowledge their child is overweight do not perceive a related health risk.

'Once the stuff's left my body, it's not me': service users' views on unlinked anonymous testing of blood for HIV.

This paper reports on the qualitative component of a mixed-methods study on unlinked anonymous testing for HIV in genitourinary medicine (GUM) clinics in two English cities. Unlinked anonymous testing is a system of monitoring population prevalence by testing residual blood samples taken for diagnostic purposes after they have been unlinked and anonymised from their source. Little is known about how individuals feel about their blood being tested in this way without their explicit consent, nor is it clear whether the process of unlinking blood affects how people feel about the use of their bodily material for public health surveillance purposes. We report participants' views on these issues, drawing on in-depth interviews with 20 GUM clinic users. The majority thought it preferable for blood samples to be used for population surveillance rather than being discarded. For most, blood and bodily tissue were not seen to represent personal identity even though participants understood that information about them could be gleaned from their analysis. The provision of information, rather than a strict consent process, was advocated as many felt that transactions between health professionals and patients should be as transparent as possible.

Scoping the impact of the national child measurement programme feedback on the child obesity pathway: study protocol.

BACKGROUND: The National Child Measurement Programme was established to measure the height and weight of children at primary school in England and provides parents with feedback about their child's weight status. In this study we will evaluate the impact of the National Child Measurement Programme feedback on parental risk perceptions of overweight, lifestyle behaviour and health service use. METHODS: The study will be a prospective cohort study of parents of children enrolled in the National Child Measurement Programme and key service providers from 5 primary care trusts (administrative bodies responsible for providing primary and secondary care services). We will conduct baseline questionnaires, followed by provision of weight feedback and 3 follow up questionnaires over the course of a year. Questionnaires will measure change in parental risk perception of overweight, health behaviours and health service use. Qualitative interviews will be used to identify barriers and facilitators to change. This study will produce preliminary data on National Health Service costs associated with weight feedback and determine which feedback approach (letter and letter plus telephone) is more effective. DISCUSSION: This study will provide the first large scale evaluation of the National Child Measurement Programme feedback. Findings from this evaluation will inform future planning of the National Child Measurement Programme.

The views of genitourinary medicine (GUM) clinic users on unlinked anonymous testing for HIV: evidence from a pilot study of clinics in two English cities.

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood left over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT.

Fear of dying in an ethnically diverse society: cross-sectional studies of people aged 65+ in Britain.

AIM: To examine fears about dying in an ethnically diverse population sample, and a more homogeneous population sample, aged 65 and over. METHODS: Personal interviews with people aged 65+ living at home responding to two Office for National Statistics Omnibus Surveys in Britain, and two Ethnibus Surveys of ethnically diverse populations in Britain. RESULTS: Ethnically diverse respondents were more likely than British population respondents to express fears about dying on all measures used. Respondents in both samples with better, compared with worse, quality of life had significantly reduced odds of having extreme fears of dying (ethnically diverse sample, OR 0.924 (95% CI 0.898 to 0.951); British population sample, OR 0.981 (95% CI 0.966 to 0.996); both p<0.001). In the latter sample only, older age was protective (OR 0.957; 95% CI 0.930 to 0.985; p<0.001), whereas in the Ethnibus sample, having a longstanding illness (OR 2.024; 95% CI 1.158 to 3.535; p<0.05) and having more relatives to help them (OR 1.134; 95% CI 1.010 to 1.274; p<0.05) increased fears about dying. CONCLUSIONS: Enabling older people to express fears about dying is likely to be important when planning supportive end-of-life care. Practitioners should not assume that fears about dying are the same in different social groups, or that extensive family support is protective against such anxiety. Older people from ethnic minorities had more anxieties about dying than others, and were more likely to express fears the more extensive their family support. These findings have implications for commissioners and practitioners of primary and secondary care.

The clinical and cost-effectiveness of a Victim Improvement Package (VIP) for the reduction of chronic symptoms of depression or anxiety in older victims of common crime (the VIP trial): study protocol for a randomised controlled trial.

BACKGROUND: Older people are vulnerable to sustained high levels of psychosocial distress following a crime. A cognitive behavioural therapy (CBT)-informed psychological therapy, the Victim Improvement Package (VIP) may aid recovery. The VIP trial aims to test the clinical and cost-effectiveness of the VIP for alleviating depressive and anxiety symptoms in older victims of crime. METHODS/DESIGN: People aged 65 years or more who report being a victim of crime will be screened by Metropolitan Police Service Safer Neighbourhood Teams within a month of the crime for distress using the Patient Health Questionnaire-2 and the Generalised Anxiety Disorder-2. Those who screen positive will be signposted to their GP for assistance, and re-screened at 3 months. Participants who screen positive for depression and/or anxiety at re-screening are randomised to a CBT informed VIP added to treatment as usual (TAU) compared to TAU alone. The intervention consists of 10 individual 1-h sessions, delivered weekly by therapists from the mental health charity Mind. The primary outcome measure is the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI), used as a composite measure, assessed at 6 months after the crime (post therapy) with a 9-month post-crime follow-up. Secondary outcome measures include the EQ-5D, and a modified Client Service Receipt Inventory. A total of 226 participants will be randomised VIP:TAU with a ratio 1:1, in order to detect a standardised difference of at least 0.5 between groups, using a mixed-effects linear-regression model with 90% power and a 5% significance level (adjusting for therapist clustering and potential drop-out). A cost-effectiveness analysis will incorporate intervention costs to compare overall health care costs and quality of life years between treatment arms. An embedded study will examine the impact of past trauma and engagement in safety behaviours and distress on the main outcomes. DISCUSSION: This trial should provide data on the clinical and cost-effectiveness of a CBT-informed psychological therapy for older victims of crime with anxiety and/or depressive symptoms and should demonstrate a model of integrated cross-agency working. Our findings should provide evidence for policy-makers, commissioners and clinicians responding to the needs of older victims of crime. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number, ID: ISRCTN16929670. Registered on 3 August 2016.

Exploring perceptions of health and the environment: a qualitative study of Thames Chase Community Forest.

This paper explores perceptions of health, the environment, and the relationships between them, in a programme of community forestry. Drawing on qualitative data generated within a multi-disciplinary project, the paper discusses the difficulties of conceptualising the key variables utilised in research on the links between green space and health. Health and the environment were not discrete entities that could be mapped on to one another, but fluid and contested concepts. A simple model of the 'impact' of environment on health could not do justice to the ways in which 'use' of outdoor space is a process, not an event.

Cross-sectional study of the use of antimicrobials following common infections by rural residents in Anhui, China.

OBJECTIVE: To describe help seeking behaviour from a medical doctor and antimicrobial use for common infections among rural residents of Anhui province, China. DESIGN: A cross-sectional retrospective household survey. SETTING: 12 administrative villages from rural Anhui, China. PARTICIPANTS: 2760 rural residents selected through cluster-randomised sampling using an interviewer administered questionnaire. METHOD: Logistic regression models were used to estimate associations between exposures (health insurance and antimicrobial-related knowledge), adjusted for confounders (sex, age and education), and help-seeking behaviour from a medical doctor and antimicrobial use following common infections, including acute respiratory tract infections (ARTIs), gastrointestinal tract infections (GTIs) and urinary tract infections (UTIs). RESULTS: In total 2611 (94.6%) rural residents completed the questionnaire. Help seeking from a medical doctor was highest for ARTIs (59.4%) followed by GTIs (42.1%), and UTIs (27.8%). Around two-thirds (82.3% for ARTIs, 87.0% for GTIs and 66.0% for UTIs) of respondents sought help within 3 days following symptom onset and over three quarters (88% for ARTIs, 98% for GTIs and 77% for UTIs) reported complete recovery within 7 days. Of the help-seeking respondents, 94.5% with ARTI symptoms recalled being prescribed either oral or intravenous antimicrobials (GTIs 81.7% and UTIs 70.4%). Use of antimicrobials bought from medicine shops without prescriptions ranged from 8.8% for GTIs to 17.2% for ARTIs; while use of antimicrobials leftover from previous illnesses or given by a relative ranged from 7.6% for UTIs to 13.4% for ARTIs. Multivariate logistic regression analysis revealed that respondents with a higher antimicrobial-related knowledge score and lack of insurance were associated with lower levels of help-seeking for ARTIs; while respondents with a higher antimicrobial-related knowledge score were less likely to be prescribed either oral or intravenous antimicrobials. CONCLUSIONS: Excessive antimicrobial use in the studied primary care settings is still prevalent.

Burden of child and adolescent obesity on health services in England.

OBJECTIVE: To assess the numbers of obese children and young people (CYP) eligible for assessment and management at each stage of the childhood obesity pathway in England. DESIGN: Pathway modelling study, operationalising the UK National Institute for Health and Care Excellence guidance on childhood obesity management against national survey data. SETTING: Data on CYP aged 2-18 years from the Health Survey for England 2006 to 2013. MAIN OUTCOME MEASURES: Clinical obesity (body mass index (BMI) >98th centile), extreme obesity (BMI ≥99.86th centile); family history of cardiovascular disease or type 2 diabetes; obesity comorbidities defined as primary care detectable (hypertension, orthopaedic or mobility problems, bullying or psychological distress) or secondary care detectable (dyslipidaemia, hyperinsulinaemia, high glycated haemoglobin, abnormal liver function). RESULTS: 11.2% (1.22 million) of CYP in England were eligible for primary care assessment and for community lifestyle modification. 2.6% (n=283 500) CYP were estimated to be likely to attend primary care. 5.1% (n=556 000) were eligible for secondary care referral. Among those aged 13-18 years, 8.2% (n=309 000) were eligible for antiobesity drug therapy and 2.4% (90 500) of English CYP were eligible for bariatric surgery. CYP from the most deprived quintile were 1.5-fold to 3-fold more likely to be eligible for obesity management. CONCLUSIONS: There is a mismatch between population burden and available data on service use for obesity in CYP in England, particularly among deprived young people. There is a need for consistent evidence-based commissioning of services across the childhood obesity pathway based on population burden.

Cost-effectiveness of a community-delivered multicomponent intervention compared with enhanced standard care of obese adolescents: cost-utility analysis alongside a randomised controlled trial (the HELP trial).

OBJECTIVE: To undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care. DESIGN: Cost-utility analysis alongside a randomised controlled trial. SETTING: Community settings in Greater London, England. PARTICIPANTS: 174 young people with obesity aged 12-19 years. INTERVENTIONS: Intervention participants received 12 one-to-one sessions across 6 months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice. MAIN OUTCOME MEASURES: Mean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC). RESULTS: Mean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI -0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained. CONCLUSIONS: We did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective. TRIAL REGISTRATION NUMBER: ISRCTN9984011.