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OBJECTIVES: We evaluated the frequency of moderate and severe adverse events following coadministration of seasonal influenza vaccine (SIV) versus placebo with COVID-19 vaccines among adults to support practice guidelines. METHODS: FluVID is a participant-blinded, phase IV, randomised control trial. On the same day as the participant's scheduled COVID-19 vaccine, participants were randomised to receive SIV or saline placebo; those assigned placebo at visit one then received SIV a week later, and vice versa. Self-reported adverse events were collected daily for seven days following each visit. The primary endpoint was any solicited adverse event of at least moderate severity occurring up to seven days following receipt of SIV or placebo. This was modelled using a Bayesian logistic regression model. Analyses were performed by COVID-19 vaccine type and dose number. RESULTS: Overall, 248 participants were enrolled; of these, 195 had received BNT162b2 and 53 had received mRNA1273 COVID-19 vaccines according to national guidelines. After randomisation, 119 were assigned to receive SIV and 129 were assigned to receive placebo at visit one. Adverse events were most frequently reported as mild (grade 1) in nature. Among 142 BNT162b2 booster dose one and 43 BNT162b2 booster dose two recipients, the posterior median risk difference for moderate/severe adverse events following SIV versus placebo was 13% (95% credible interval [CrI] -0.03 to 0.27) and 13% (95%CrI -0.37 to 0.12), respectively. Among 18 mRNA1273 booster dose one and 35 mRNA1273 booster dose two recipients, the posterior median risk difference of moderate/severe adverse events following influenza vaccine versus placebo was 6% (95%CrI -0.29 to 0.41) and -4% (95%CrI -0.30 to 0.23), respectively. CONCLUSION: Adverse events following SIV and COVID-19 co-administration were generally mild and occurred with similar frequency to events following COVID-19 vaccine alone. We found no evidence to justify routine separation of SIV and COVID-19 vaccine doses. CLINICAL TRIAL REGISTRATION: ACTRN12621001063808.
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COVID-19 , Vacunas contra la Influenza , Gripe Humana , Adulto , Humanos , Vacunas contra la COVID-19/efectos adversos , Gripe Humana/prevención & control , COVID-19/prevención & control , Vacuna BNT162 , Teorema de Bayes , Estaciones del Año , Método Doble CiegoRESUMEN
The aim of this study is to examine the feasibility of a brief intervention to reduce instances of indulgent energy intake. Forty-five participants with a body mass index (BMI) ≥25 kg m-2 were randomized to one of three groups for 8 weeks. The control group was asked to complete a questionnaire every 4 days, the self-monitoring group was given the same instructions but also asked to 'say no' to indulgences. The self-monitoring and feedback group was asked to do the same but in addition to send a photograph or description of that to which they had 'said no' and were then provided with feedback. All participants reported on indulgences for 7 days prospectively at baseline and 8-week follow-up. The follow-up rate was 80%; completion of questionnaires was 63% and 87 text messages were sent. The control group reduced their indulgences by 4.1 (SD 10.0), the self-monitoring group by 13.8 (SD 16.8) and self-monitoring and feedback group by 9.0 (SD 11.7) per week. All bar one, feasibility progression criteria were met and this was the return of the indulgence diaries during the intervention period. The study demonstrates the feasibility of a brief intervention to reduce the number of indulgences people ate. The progression criteria were met and areas of improvement are highlighted.
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Ingestión de Alimentos/psicología , Ingestión de Energía , Conducta Alimentaria , Humanos , Masculino , Estudios Prospectivos , Bocadillos/psicologíaRESUMEN
We aimed to describe the current state of specialist obesity services for adults with clinically severe obesity in public hospitals in Australia, and to analyse the gap in resources based on expert consensus. We conducted two surveys to collect information about current and required specialist obesity services and resources using open-ended questionnaires. Organizational level data were sought from clinician expert representatives of specialist obesity services across Australia in 2017. Fifteen of 16 representatives of current services in New South Wales (n = 8), Queensland (n = 1), Victoria (n = 2), South Australia (n = 3), and the Australian Capital Territory (n = 1) provided data. The composition of services varied substantially between hospitals, and patient access to services and effective treatments were limited by strict entry criteria (e.g. body mass index 40 kg/m2 or higher with specific complication/s), prolonged wait times, geographical location (major cities only) and out-of-pocket costs. Of these services, 47% had a multidisciplinary team (MDT), 53% had an exercise physiologist/physiotherapist, 53% had a bariatric surgeon and 33% had pharmacotherapy resources. Key gaps included staffing components of the MDT (psychologist, exercise physiologist/physiotherapist) and access to publicly funded weight loss pharmacotherapy and bariatric surgery. There was consensus on the need for significant improvements in staff, physical infrastructure, access to services, education/training in obesity medicine and targeted research funding. Based on the small number of existing, often under-resourced specialist obesity services that are located only in a few major cities, the vast majority of Australians with clinically severe obesity cannot access the specialist evidence based treatments needed.
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Accesibilidad a los Servicios de Salud , Servicios de Salud , Hospitales Públicos , Obesidad Mórbida/terapia , Especialización , Programas de Reducción de Peso , Adulto , Actitud del Personal de Salud , Australia , Cirugía Bariátrica , Índice de Masa Corporal , Mantenimiento del Peso Corporal , Ciudades , Consenso , Ejercicio Físico , Personal de Salud , Recursos en Salud , Humanos , Grupo de Atención al Paciente , Fisioterapeutas , Encuestas y Cuestionarios , Pérdida de PesoRESUMEN
The cardiovascular safety of liraglutide, a glucagon-like peptide-1 receptor agonist approved for weight management at a dose of 3.0 mg, was evaluated post hoc using data from 5908 participants in 5 randomized, double-blind, placebo-controlled clinical trials. Participants were randomized to liraglutide or a comparator group (placebo or orlistat). The objective was to evaluate whether cardiovascular risk was increased with liraglutide treatment. The primary composite outcome of this time-to-event analysis was the first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke. These cardiovascular events were adjudicated prospectively for three of the trials and retrospectively for two trials by an event adjudication committee. The primary outcome was analyzed using a Cox proportional hazards model, stratified by trial. With liraglutide 3.0 mg, 8 participants had positively adjudicated cardiovascular events (1.54 events/1000 person-years) compared to 10 participants in the comparators group (3.65 events/1000 person-years). The hazard ratio for liraglutide 3.0 mg compared to comparators was 0.42 (95% confidence interval, 0.17-1.08). In this analysis, liraglutide 3.0 mg treatment was not associated with excess cardiovascular risk. However, the wide confidence intervals and retrospective adjudication of events in two of the trials are limitations of the analysis.
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Fármacos Antiobesidad/efectos adversos , Enfermedades Cardiovasculares/inducido químicamente , Liraglutida/efectos adversos , Obesidad/tratamiento farmacológico , Sobrepeso/tratamiento farmacológico , Fármacos Antiobesidad/administración & dosificación , Método Doble Ciego , Humanos , Liraglutida/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de RiesgoRESUMEN
The prevalence of depression in those with obesity is reported to be as high as double that in individuals of normal weight. There is potentially a bi-directional relationship between obesity and depression. Some research has suggested that depression results in weight gain and obesity, and other studies have suggested that those with obesity are more likely to develop depression at a later stage. The aim of this study was to investigate the association of depression symptoms with weight change over a 12-month study. Seventy participants undertook a 3-month lifestyle (diet and exercise) weight loss intervention, and were followed up as part of a 12-month study. Participants completed the Beck Depression Inventory-II (BDI-II) and had their body weight measured throughout the study. Baseline body mass index (BMI) of participants (mean ± standard deviation [SD]) was 31.1 ± 3.9 kg m-2 , body weight was 89.4 ± 16.1 kg, and age was 45.4 ± 11.1 years; 63% of the cohort were female. The mean weight change from baseline to 3 months was -5.2% (±SD 4.3%), and from baseline to 12 months was -4.2% (±SD 6.1%). There was a significant decrease in BDI-II scores over the 12-month study, and a 1-unit decrease in BDI-II score was associated with a further decrease in body weight of -0.4%. The current study indicated that weight loss was associated with improvements in mood for non-clinically depressed individuals with obesity, and these improvements persisted during a period of 3-12 months of follow-up.
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Depresión/etiología , Obesidad/complicaciones , Adolescente , Adulto , Anciano , Índice de Masa Corporal , Depresión/psicología , Femenino , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Obesidad/fisiopatología , Obesidad/psicología , Manejo de la Obesidad , Estudios Prospectivos , Escalas de Valoración Psiquiátrica , Adulto JovenRESUMEN
OBJECTIVE: Obesity is an established risk factor for cardiovascular disease. The mechanisms by which obesity affects cardiovascular risk have not been fully elucidated. This paper reports a comprehensive systematic review and meta-analysis on obesity and two key aspects of vascular health using gold-standard non-invasive measures - arterial endothelial function (brachial flow-mediated dilatation) and subclinical atherosclerosis (carotid intima-media thickness). METHODS: Electronic searches for 'Obesity and flow-mediated dilatation' and 'Obesity and intima-media thickness' were performed using Ovid Medline and Embase databases. A meta-analysis was undertaken for brachial flow-mediated dilatation and carotid intima-media thickness to obtain pooled estimates for adults with obesity and those with healthy weight. RESULTS: Of the 5,810 articles retrieved, 19 studies on flow-mediated dilatation and 19 studies on intima-media thickness were included. Meta-analysis demonstrated that obesity was associated with lower flow-mediated dilatation (-1.92 % [95% CI -2.92, -0.92], P = 0.0002) and greater carotid intima-media thickness (0.07 mm [95% CI 0.05, 0.08], P < 0.0001). CONCLUSIONS: Obesity is associated with poorer arterial endothelial function and increased subclinical atherosclerosis, consistent with these aspects of vascular health at least partially contributing to the increased risk of cardiovascular events in adults with obesity. These estimated effect sizes will enable vascular health benefits in response to weight loss treatment to be put in greater perspective, both in the research setting and potentially also clinical practice.
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Much healthcare expenditure is on pharmaceutical drugs. Expenditure on medications has increased both in absolute terms, and as a proportion of total health expenditure. No previous studies have investigated the prescribing costs by general practitioners when managing patients during a weight loss intervention. This study evaluated the medication costs by individual class during a 1-year study in which 268 participants were randomized to one of two weight loss programmes, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP). The baseline body mass index of participants (mean ± standard deviation) was 32.0 ± 2.5 kg m-2 , their body weight was 87.5 ± 11.8 kg, and age 47.4 ± 11.7 years. Weight loss for the SC and CP groups was -2.6 and -6.1 kg, respectively (between group difference; P < 0.0001). The greater weight loss in the CP group compared to SC was accompanied by larger reductions in waist circumference and fat mass. The CP group also had significantly greater improvements than SC in high-density lipoprotein cholesterol. Despite SC participants being prescribed and spending more on medications than the CP group with no better weight or metabolic outcomes, this was not of statistical significance. For both groups the highest proportion of prescriptions (≥30% of medications) was for control of risk factors for cardiovascular disease. In conclusion, this study indicates that obesity treatment via a shared care approach with a CP results in greater weight loss and some better clinical outcomes, but despite lower medication costs overall, this was not significant when compared to SC treatment.
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Médicos Generales , Pautas de la Práctica en Medicina , Programas de Reducción de Peso , Adulto , Australia , Índice de Masa Corporal , Femenino , Humanos , Masculino , Persona de Mediana Edad , Obesidad/terapia , Pérdida de PesoRESUMEN
OBJECTIVE AND METHODS: Finding effective solutions to curb the obesity epidemic is a great global public health challenge. The need for long-term follow-up necessitates weight loss trials conducted in real-world settings, outside the confines of tightly controlled laboratory or clinic conditions. Given the complexity of eating behaviour and the food supply, this makes the process of designing a practical dietary intervention that stands up to scientific rigor difficult. Detailed information about the dietary intervention itself, as well as the process of developing the final intervention and its underlying rationale, is rarely reported in scientific weight management publications but is valuable and essential for translating research into practice. Thus, this paper describes the design process and underlying rationale behind the dietary interventions in an exemplar weight loss trial - the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity). This trial assesses the long-term effects of fast versus slow weight loss on adiposity, fat free mass, muscle strength and bone density in women with obesity (body mass index 30-40 kg m-2) that are 45-65 years of age, postmenopausal and sedentary. RESULTS AND CONCLUSIONS: This paper is intended as a resource for researchers and/or clinicians to illustrate how theoretical values based on a hypothesis can be translated into a dietary weight loss intervention to be used in free-living women of varying sizes.
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UNLABELLED: Incorporating meal replacements has been shown to produce a significantly greater weight loss than a conventional reduced calorie diet. Ready-to-eat conventional foods may also be effective in this role and provide additional benefit because of their palatability, acceptance and enjoyment and thus increase dietary compliance. This trial investigated the efficacy of a ready-to-eat food product (Vita-Weat biscuit) that is both high in carbohydrate and high in protein as part of a diet prescription for weight loss in an overweight and obese population group. A total of 76 participants were randomized to a 6-week weight loss intervention including the ready-to-eat food product (intervention group) or advice on the 'Australian Guide to Healthy Eating' (control group). Both groups lost approximately 2 kg weight which equated to a reduction in body mass index of 0.70 kg m(-2) . There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups; mean difference for the intervention vs. CONTROL GROUP: -0.20% (95% confidence interval: -0.96, 1.36); P = 0.73. Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period. This may have benefit when incorporated into an individual's meal plan intermittently to assist weight control. It also provides support for current public health nutritional guidelines as the participants in this study following such advice were also successful in achieving a clinically meaningful weight loss.
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Carbohidratos de la Dieta/administración & dosificación , Proteínas en la Dieta/administración & dosificación , Alimentos Especializados , Obesidad/dietoterapia , Adulto , Índice de Masa Corporal , Ingestión de Energía , Femenino , Humanos , Masculino , Estudios Prospectivos , Pérdida de PesoRESUMEN
Very-low-energy diets (VLEDs) and ketogenic low-carbohydrate diets (KLCDs) are two dietary strategies that have been associated with a suppression of appetite. However, the results of clinical trials investigating the effect of ketogenic diets on appetite are inconsistent. To evaluate quantitatively the effect of ketogenic diets on subjective appetite ratings, we conducted a systematic literature search and meta-analysis of studies that assessed appetite with visual analogue scales before (in energy balance) and during (while in ketosis) adherence to VLED or KLCD. Individuals were less hungry and exhibited greater fullness/satiety while adhering to VLED, and individuals adhering to KLCD were less hungry and had a reduced desire to eat. Although these absolute changes in appetite were small, they occurred within the context of energy restriction, which is known to increase appetite in obese people. Thus, the clinical benefit of a ketogenic diet is in preventing an increase in appetite, despite weight loss, although individuals may indeed feel slightly less hungry (or more full or satisfied). Ketosis appears to provide a plausible explanation for this suppression of appetite. Future studies should investigate the minimum level of ketosis required to achieve appetite suppression during ketogenic weight loss diets, as this could enable inclusion of a greater variety of healthy carbohydrate-containing foods into the diet.
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Regulación del Apetito , Dieta Cetogénica , Dieta Reductora , Hambre , Cetosis/fisiopatología , Obesidad/dietoterapia , Pérdida de Peso , Dieta Baja en Carbohidratos , Ingestión de Energía , Humanos , Cetosis/metabolismo , Obesidad/fisiopatología , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND/OBJECTIVES: The Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed a significantly increased relative risk of nonfatal cardiovascular events, but not mortality, in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise. We examined the relationship between early changes (both increases and decreases) in pulse rate, and the impact of these changes on subsequent cardiovascular outcome events in both the placebo and sibutramine groups. SUBJECTS/METHODS: 9804 males and females, aged ⩾55 years, with a body mass index of 27-45 kg m(-)(2) were included in this current subanalysis of the SCOUT trial. Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor, to assess cardiovascular outcomes. The primary outcome event (POE) was a composite of nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest or cardiovascular death. Time-to-event analyses of the POE were performed using Cox regression models. RESULTS: During the initial 6-week sibutramine treatment period, the induced pulse rate increase was related to weight change (1.9±7.7 beats per minute (bpm) with weight increase; 1.4±7.3 bpm, 0-5 kg weight loss; 0.6±7.4 bpm, ⩾5 kg weight loss). Throughout the subsequent treatment period, those continuing on sibutramine showed a consistently higher mean pulse rate than the placebo group. There was no difference in POE rates with either an increase or decrease in pulse rate over the lead-in period, or during lead-in baseline to 12 months post randomization. There was also no relationship between pulse rate at lead-in baseline and subsequent cardiovascular events in subjects with or without a cardiac arrhythmia. CONCLUSION: Baseline pulse rate and changes in pulse rate may not be an important modifier nor a clinically useful predictor of outcome in an individual elderly cardiovascular obese subject exposed to weight management.
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Depresores del Apetito/administración & dosificación , Enfermedades Cardiovasculares/prevención & control , Ciclobutanos/administración & dosificación , Angiopatías Diabéticas/prevención & control , Frecuencia Cardíaca/efectos de los fármacos , Obesidad/fisiopatología , Anciano , Índice de Masa Corporal , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/epidemiología , Angiopatías Diabéticas/tratamiento farmacológico , Angiopatías Diabéticas/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Obesidad/complicaciones , Obesidad/epidemiología , Valor Predictivo de las Pruebas , Factores de Riesgo , Resultado del Tratamiento , Reino Unido/epidemiología , Pérdida de PesoRESUMEN
BACKGROUND AND AIMS: An inverse relationship between (serum) total bilirubin and risk of cardiovascular disease has been reported previously, but longitudinal data on overweight and obese patients are lacking. We have investigated the relationship between total bilirubin and cardiovascular adverse events in a large group of patients with risk factors for cardiovascular disease who were enrolled in a large weight loss trial. METHODS AND RESULTS: Data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, including almost 10.000 overweight/obese high cardiovascular risk patients, were used. The relationship between total bilirubin level at screening and the primary outcome (i.e. non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death) for the entire study period was investigated using Cox proportional hazards models. The population was divided into four groups based on total bilirubin levels (normal range 5-25 µmol/L). Time-dependent Cox analyses were also performed to adjust for weight loss over time. Initial analyses adjusted for sex, age and treatment allocation showed significantly reduced hazard ratios of 0.80 (95% confidence interval 0.68-0.94), 0.73 (0.62-0.86) and 0.77 (0.65-0.91), for the three higher total bilirubin groups: >8 and ≤10 µmol/L, >10 and ≤13 µmol/L and >13 µmol/L (5-95 interpercentile range for total bilirubin at screening; 6-19 µmol/L), compared to the lowest total bilirubin group ≤8 µmol/L. When adjusting for classical cardiovascular risk factors, estimates increased towards unity. Additional adjustment for indicators of liver function did not alter the results. A time-dependent Cox model, adjusted for weight loss, demonstrated a similar trend. CONCLUSION: Bilirubin was not a risk-factor independent from other traditional cardiovascular risk-factors in our population.
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Bilirrubina/sangre , Enfermedades Cardiovasculares/etiología , Obesidad/fisiopatología , Sobrepeso/fisiopatología , Anciano , Índice de Masa Corporal , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/prevención & control , Estudios de Cohortes , Método Doble Ciego , Femenino , Paro Cardíaco/epidemiología , Paro Cardíaco/etiología , Paro Cardíaco/prevención & control , Paro Cardíaco/terapia , Humanos , Incidencia , Estilo de Vida , Masculino , Persona de Mediana Edad , Mortalidad , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Infarto del Miocardio/prevención & control , Obesidad/sangre , Obesidad/terapia , Sobrepeso/sangre , Sobrepeso/terapia , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/prevención & control , Regulación hacia Arriba , Pérdida de PesoRESUMEN
BACKGROUND/OBJECTIVES: The Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed a significantly increased relative risk of nonfatal cardiovascular events, but not mortality, in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise. We examined the relationship between early changes (both increases and decreases) in body weight and blood pressure, and the impact of these changes on subsequent cardiovascular outcome events. SUBJECTS/METHODS: A total of 9804 male and female subjects, aged 55 years or older, with a body mass index of 27-45 kg m(-2) were included in this current subanalysis of the SCOUT trial. Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor (hypertension, dyslipidemia, current smoking or diabetic nephropathy) to assess cardiovascular outcomes. Post hoc subgroup analyses of weight change (categories) and blood pressure were performed overall and by treatment group (6-week sibutramine followed by randomized placebo or continued sibutramine). The primary outcome event (POE) was a composite of nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest or cardiovascular death. Time-to-event analyses of the POE were performed using Cox regression models with factors for treatment, subgroups and interactions. RESULTS: During the initial 6-week sibutramine treatment period, systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects (-8.1±10.5 mm Hg with <5 kg weight loss to -10.8±11.0 mm Hg with ⩾5 kg weight loss). The highest POE incidence occurred mainly in groups with increases in both weight and blood pressure. However, with long-term sibutramine treatment, a markedly lower blood pressure tended to increase POEs. CONCLUSION: Modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events, as expected. However, the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population.
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Depresores del Apetito/uso terapéutico , Presión Sanguínea , Enfermedades Cardiovasculares/complicaciones , Ciclobutanos/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Angiopatías Diabéticas/prevención & control , Obesidad/tratamiento farmacológico , Pérdida de Peso , Índice de Masa Corporal , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/fisiopatología , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/fisiopatología , Diabetes Mellitus Tipo 2/prevención & control , Diabetes Mellitus Tipo 2/terapia , Angiopatías Diabéticas/fisiopatología , Angiopatías Diabéticas/terapia , Método Doble Ciego , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Obesidad/fisiopatología , Obesidad/prevención & control , Sobrepeso/tratamiento farmacológico , Estudios Prospectivos , Factores de Riesgo , Conducta de Reducción del Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Because of the high prevalence of overweight and obesity, there is a need to identify cost-effective approaches for weight loss in primary care and community settings. OBJECTIVE: To evaluate the long-term cost effectiveness of a commercial weight loss programme (Weight Watchers) (CP) compared with standard care (SC), as defined by national guidelines. METHODS: A Markov model was developed to calculate the incremental cost-effectiveness ratio (ICER), expressed as the cost per quality-adjusted life year (QALY) over the lifetime. The probabilities and quality-of-life utilities of outcomes were extrapolated from trial data using estimates from the published literature. A health sector perspective was adopted. RESULTS: Over a patient's lifetime, the CP resulted in an incremental cost saving of AUD 70 per patient, and an incremental 0.03 QALYs gained per patient. As such, the CP was found to be the dominant treatment, being more effective and less costly than SC (95% confidence interval: dominant to 6225 per QALY). Despite the CP delaying the onset of diabetes by â¼10 months, there was no significant difference in the incidence of type 2 diabetes, with the CP achieving <0.1% fewer cases than SC over the lifetime. CONCLUSION: The modelled results suggest that referral to community-based interventions may provide a highly cost-effective approach for those at high risk of weight-related comorbidities.
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Diabetes Mellitus Tipo 2/prevención & control , Obesidad/terapia , Derivación y Consulta , Pérdida de Peso , Programas de Reducción de Peso , Australia/epidemiología , Análisis Costo-Beneficio , Femenino , Alemania/epidemiología , Humanos , Masculino , Cadenas de Markov , Obesidad/economía , Obesidad/epidemiología , Atención Primaria de Salud/economía , Años de Vida Ajustados por Calidad de Vida , Factores de Riesgo , Factores de Tiempo , Reino Unido/epidemiología , Programas de Reducción de Peso/economíaRESUMEN
BACKGROUND: Many weight loss programmes show short-term success, but long-term data in larger studies are scarce, especially in community settings. Attrition is common and complicates the interpretation of long-term outcomes. OBJECTIVE: To investigate 2-year outcomes and explore issues of attrition and missing data. SUBJECTS: A total of 772 overweight and obese adults recruited by primary care practices in Australia, Germany and the UK and randomised to a 12-month weight loss intervention delivered in a commercial programme (CP) or in standard care (SC). MEASUREMENT: Weight change from 0-24 and 12-24 months including measured weights only and measured and self-reported weights, using last observation carried forward (LOCF), baseline observation carried forward (BOCF), completers-only and missing-at-random (MAR) analyses. RESULTS: A total of 203 participants completed the 24-month visit. Using measured weights only, there was a trend for greater 24-month weight loss in CP than in SC, but the difference was only statistically significant in the LOCF and BOCF analyses: LOCF: -4.14 vs -1.99 kg, difference adjusted for centre -2.08 kg, P<0.001; BOCF: -1.33 vs -0.74 kg, adjusted difference -0.60 kg, P=0.032; completers: -4.76 vs -2.99 kg, adjusted difference -1.53 kg, P=0.113; missing at random: -3.00 vs -1.94 kg, adjusted difference -1.04 kg, P=0.150. Both groups gained weight from 12-24 months and weight regain was significantly (P<0.001) greater for CP than for SC in all analysis approaches. Inclusion of self-reported weights from a further 138 participants did not change the interpretation of the findings. CONCLUSION: Initial weight loss was poorly maintained during the no-intervention follow-up, but both groups did have lower weight over the 24 months. Attrition was high in both groups, and assumptions about missing data had considerable impact on the magnitude and statistical significance of treatment effects. It is vital that trials on weight loss interventions consider the plausibility of these differences in an analytical approach when interpreting research findings and comparing data between studies.
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Obesidad/prevención & control , Atención Primaria de Salud , Aumento de Peso , Pérdida de Peso , Programas de Reducción de Peso , Adulto , Australia/epidemiología , Recolección de Datos , Femenino , Estudios de Seguimiento , Alemania/epidemiología , Humanos , Perdida de Seguimiento , Masculino , Persona de Mediana Edad , Obesidad/epidemiología , Obesidad/psicología , Cooperación del Paciente/psicología , Cooperación del Paciente/estadística & datos numéricos , Resultado del Tratamiento , Reino Unido/epidemiologíaRESUMEN
For women attempting pregnancy, obesity reduces fertility and is an independent risk factor for obstetric and neonatal complications. The aim of this evaluator-blinded, randomized controlled trial was to evaluate a weight loss intervention on pregnancy rates in obese women undertaking fertility treatment. Forty-nine obese women, aged ≤ 37 years, presenting for fertility treatment were randomized to either a 12-week intervention (n = 27) consisting of a very-low-energy diet for the initial 6 weeks followed by a hypocaloric diet, combined with a weekly group multidisciplinary programme; or a control group (n = 22) who received recommendations for weight loss and the same printed material as the intervention. Anthropometric and reproductive parameters were measured at baseline and at 12 weeks. The 22 women who completed the intervention had greater anthropometric changes (-6.6 ± 4.6 kg and -8.7 ± 5.6 cm vs. -1.6 ± 3.6 kg and -0.6 ± 6.3 cm) compared with the control group (n = 17; P < 0.001). The intervention group achieved a pregnancy rate of 48% compared with 14% (P = 0.007), took a mean two fertility treatment cycles to achieve each pregnancy compared with four in the control group (P = 0.002), and had a marked increase in the number of live births (44% vs. 14%; P = 0.02). A group weight loss programme, incorporating dietary, exercise and behavioural components, is associated with a significant improvement in pregnancy rates and live births in a group of obese women undergoing fertility treatment.
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Infertilidad Femenina/terapia , Obesidad/terapia , Técnicas Reproductivas Asistidas , Pérdida de Peso , Adulto , Femenino , Humanos , EmbarazoRESUMEN
The well-documented finding that obese adults have a high likelihood of weight regain following participation in behavioural weight loss programmes highlights the importance of developing more effective approaches for weight loss maintenance. One promising approach is to improve the quality of social support for effective weight control available to an obese individual by including support people in behavioural weight loss programmes. This paper describes the rationale and design of a randomized controlled trial that evaluates the effectiveness of training support people to assist obese adults in their weight management. The study entails a two-arm randomized controlled trial in which obese participants take part in a 1-year (26-session) cognitive behaviour therapy group weight management programme, including motivational interviewing strategies (CBT-MI). In one arm, participants receive CBT-MI alone, while in the second arm (CBT-MI-SP), participants also have a support person who attends 10 group sessions designed to teach effective skills for supporting an individual in healthy weight control. More specifically, support people will be trained in skills that aim to promote self-motivation for weight management. Assessments of anthropometric, medical, behavioural, motivational, psychological and social functioning take place at pre-treatment, post-treatment and a 1-year follow-up. By helping obese participants to increase and sustain their motivation and skills for weight control both during treatment and in the crucial period after treatment cessation through the ongoing input of support people, the CBT-MI-SP approach of the current study has the potential to effectively help patients to achieve sustained weight loss while minimizing the patient's need for ongoing, intensive weight control treatment with its attendant costs.
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Terapia Cognitivo-Conductual , Obesidad/psicología , Obesidad/terapia , Apoyo Social , Adulto , Femenino , Humanos , MasculinoRESUMEN
Physical activity is an important component in weight loss treatment and weight maintenance. We evaluated the physical activity component of two weight loss programmes, either standard care (SC) as defined by national guidelines, or a commercial programme (CP; Weight Watchers) over the period of weight loss and follow-up. 772 adults (mean body mass index: 31.4 ± 2.6 kg m(-2)) were recruited by primary care practices in Australia, the United Kingdom, and Germany, and randomly assigned to 12 months SC, or the CP. They were then followed up at 24 months. Change in physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ)-short form, and pedometer recordings. Both groups reported increases in physical activity using the IPAQ from baseline to 12 months and 24 months (within groups P < 0.0001) and in pedometer steps from baseline to 12 months only (within groups P < 0.0001). Differences between groups with both methods of assessment were not significant. There was a significant difference in weight loss between the groups at 12 months favouring the CP group; however, this statistical difference was not maintained at 24 months. In conclusion, despite similar increases in reported activity, there were significant differences in weight loss and regain between groups. Therefore, greater weight loss seen with the CP is unlikely to be due to increases in physical activity. Trends in pedometer steps mirrored changes in weight over time more closely than the IPAQ; however, both assessment tools have limitations. Better activity assessment measures are needed to more accurately gauge changes in physical activity during weight loss interventions.
Asunto(s)
Terapia por Ejercicio , Obesidad/terapia , Pérdida de Peso , Adulto , Índice de Masa Corporal , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Actividad Motora , Obesidad/metabolismo , Obesidad/fisiopatología , Adulto JovenRESUMEN
BACKGROUND: Obesity is commonly assessed by body mass index (BMI) of which limitations come from an inability to distinguish body fat mass from lean mass. Several anthropometric measurements, including BMI, waist circumference, waist-to-height ratio and waist-to-hip ratio have been used to predict metabolic syndrome. The purpose of this study was to evaluate the utility of FMI or BF% combined with previous known anthropometric indices to assess the risk of metabolic syndrome in clinical practice. METHODS: In 5534 men visiting a hospital for health check-ups, blood tests, anthropometric measurements and body composition analysis using BIA were performed. Logistic regression analysis was performed to compare the odds ratios for metabolic syndrome and each component of metabolic syndrome among BMI, waist-to-height ratio, waist-to-hip ratio, FMI and BF%. The area under the curve (AUC) of the receiver operating characteristic curve (ROC) for metabolic syndrome was compared between several measurements. The net reclassification improvement with integrated discrimination improvement was used for assessing value of body composition measurement. RESULTS: The adjusted odds ratios of metabolic syndrome was 1.80 (95% CI, 1.71-1.89) for FMI and 1.15 (95% CI, 1.13-1.17) for BF%. Odds ratio of each metabolic component was highest for FMI among several anthropometric and body composition measurements. AUCs using the ROC curve for metabolic syndrome was highest for waist-to-height ratio, 0.823 (95% CI, 0.808-0.837) by National Cholesterol Education Program criteria. FMI caused a mild increase in integrated discrimination improvement when combined with waist-to-height ratio. CONCLUSIONS: Waist-to-height ratio seems to be the best screening tool for evaluating metabolic syndrome in Korean men, and adding FMI could result in a modest increase in integrated discrimination improvement.
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Antropometría/métodos , Composición Corporal/fisiología , Síndrome Metabólico/diagnóstico , Obesidad/diagnóstico , Adulto , Estatura/etnología , Estatura/fisiología , Índice de Masa Corporal , Métodos Epidemiológicos , Humanos , Masculino , Síndrome Metabólico/etnología , Persona de Mediana Edad , Obesidad/etnología , República de Corea/etnología , Circunferencia de la Cintura/etnología , Circunferencia de la Cintura/fisiología , Relación Cintura-Cadera/métodosRESUMEN
BACKGROUND: Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings. OBJECTIVE: We evaluated the cost effectiveness of two weight loss programmes of 1-year duration, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP). DESIGN: This analysis was based on a randomised controlled trial of 772 adults (87% female; age 47.4±12.9 years; body mass index 31.4±2.6 kg m(-2)) recruited by health professionals in primary care in Australia, United Kingdom and Germany. Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER, expressed as the cost per quality adjusted life year (QALY). RESULTS: The cost per kilogram of weight loss was USD122, 90 and 180 for the CP in Australia, the United Kingdom and Germany, respectively. For SC the cost was USD138, 151 and 133, respectively. From a health-sector perspective, the ICER for the CP relative to SC was USD18 266, 12 100 and 40 933 for Australia, the United Kingdom and Germany, respectively. Corresponding societal ICER figures were USD31,663, 24,996 and 51,571. CONCLUSION: The CP was a cost-effective approach from a health funder and societal perspective. Despite participants in the CP group attending two to three times more meetings than the SC group, the CP was still cost effective even including these added patient travel costs. This study indicates that it is cost effective for general practitioners (GPs) to refer overweight and obese patients to a CP, which may be better value than expending public funds on GP visits to manage this problem.