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Project SWEET examined the barriers and facilitators to the use of non-nutritive sweeteners and sweetness enhancers (hereafter "S&SE") alongside potential risks/benefits for health and sustainability. The Beverages trial was a double-blind multi-centre, randomised crossover trial within SWEET evaluating the acute impact of three S&SE blends (plant-based and alternatives) vs. a sucrose control on glycaemic response, food intake, appetite sensations and safety after a carbohydrate-rich breakfast meal. The blends were: mogroside V and stevia RebM; stevia RebA and thaumatin; and sucralose and acesulfame-potassium (ace-K). At each 4 h visit, 60 healthy volunteers (53% male; all with overweight/obesity) consumed a 330 mL beverage with either an S&SE blend (0 kJ) or 8% sucrose (26 g, 442 kJ), shortly followed by a standardised breakfast (â¼2600 or 1800 kJ with 77 or 51 g carbohydrates, depending on sex). All blends reduced the 2-h incremental area-under-the-curve (iAUC) for blood insulin (p < 0.001 in mixed-effects models), while the stevia RebA and sucralose blends reduced the glucose iAUC (p < 0.05) compared with sucrose. Post-prandial levels of triglycerides plus hepatic transaminases did not differ across conditions (p > 0.05 for all). Compared with sucrose, there was a 3% increase in LDL-cholesterol after stevia RebA-thaumatin (p < 0.001 in adjusted models); and a 2% decrease in HDL-cholesterol after sucralose-ace-K (p < 0.01). There was an impact of blend on fullness and desire to eat ratings (both p < 0.05) and sucralose-acesulfame K induced higher prospective intake vs sucrose (p < 0.001 in adjusted models), but changes were of a small magnitude and did not translate into energy intake differences over the next 24 h. Gastro-intestinal symptoms for all beverages were mostly mild. In general, responses to a carbohydrate-rich meal following consumption of S&SE blends with stevia or sucralose were similar to sucrose.
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Stevia , Edulcorantes , Humanos , Apetito , Bebidas , Glucemia , Colesterol , Estudios Cruzados , Ingestión de Alimentos , Estudios Prospectivos , Sacarosa/farmacología , Edulcorantes/farmacología , Método Doble CiegoRESUMEN
BACKGROUND: The rise in use of food supplements based on botanical ingredients (herbal supplements) is depicted as part of a trend empowering consumers to manage their day-to-day health needs, which presupposes access to clear and accurate information to make effective choices. Evidence regarding herbal supplement efficacy is extremely variable so recent regulations eliminating unsubstantiated claims about potential effects leave producers able to provide very little information about their products. Medical practitioners are rarely educated about herbal supplements and most users learn about them via word-of-mouth, allowing dangerous misconceptions to thrive, chief among them the assumption that natural products are inherently safe. Print media is prolific among the information channels still able to freely discuss herbal supplements. METHOD: This study thematically analyses how 76 newspaper/magazine articles from the UK, Romania and Italy portray the potential risks and benefits of herbal supplements. RESULTS: Most articles referenced both risks and benefits and were factually accurate but often lacked context and impartiality. More telling was how the risks and benefits were framed in service of a chosen narrative, the paucity of authoritative information allowing journalists leeway to recontextualise herbal supplements in ways that serviced the goals and values of their specific publications and readerships. CONCLUSION: Providing sufficient information to empower consumers should not be the responsibility of print media, instead an accessible source of objective information is required.
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Suplementos Dietéticos/estadística & datos numéricos , Comunicación , Informática Aplicada a la Salud de los Consumidores , Suplementos Dietéticos/análisis , Humanos , Italia , Publicaciones Periódicas como Asunto , Medición de Riesgo , Rumanía , Reino UnidoRESUMEN
BACKGROUND: Colour coded front-of-pack nutrition labelling ('traffic light labelling') has been recommended for use in the UK since 2006. The voluntary scheme is used by all the major retailers and some manufacturers. It is not clear how consumers use these labels to make a single decision about the relative healthiness of foods. Our research questions were: Which of the four nutrients on UK traffic light labels (total fat, saturated fat, sugar and salt) has the most influence on decisions? Do green lights or red lights have a greater influence? Are there age and gender differences in how people use the colour and nutrient information? METHODS: We recruited participants from a UK supermarket chain membership list to conduct an online choice experiment in May 2014. We analysed data using multilevel logisitic models with food choices (n = 3321) nested in individuals (n = 187) as the unit of analysis. RESULTS: A food with more reds was 11.4 (95% confidence intervals: 10.3, 12.5) times less likely to be chosen as healthy, whereas a food with more greens was 6.1 (5.6, 6.6) times more likely to be chosen as healthy. Foods with better colours on saturated fat and salt were 7.3 (6.7, 8.0) and 7.1 (6.5, 7.8) times more likely to be chosen as healthy - significantly greater than for total fat (odds ratio 4.8 (4.4, 5.3)) and sugar (5.2 (4.7, 5.6)). Results were broadly similar for different genders and age groups. CONCLUSIONS: We found that participants were more concerned with avoiding reds than choosing greens, and that saturated fat and salt had a greater influence on decisions regarding healthiness than total fat and sugar. This could influence decisions about food reformulation and guidance on using nutrition labelling.
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Conducta de Elección/fisiología , Color , Comercio , Etiquetado de Alimentos/métodos , Estimulación Luminosa/métodos , Adolescente , Adulto , Distribución por Edad , Anciano , Femenino , Etiquetado de Alimentos/estadística & datos numéricos , Preferencias Alimentarias/fisiología , Humanos , Masculino , Persona de Mediana Edad , Distribución por Sexo , Encuestas y Cuestionarios , Reino Unido , Adulto JovenRESUMEN
Different front-of-pack (FOP) labelling systems have been developed in Europe by industry and organisations concerned with health promotion. A study (n 2068) was performed to establish the extent to which inclusion of the most prevalent FOP systems--guideline daily amounts (GDA), traffic lights (TL), GDA+TL hybrid (HYB) and health logos (HL)--impact consumer perceptions of healthiness over and above the provision of a FOP basic label (BL) containing numerical nutritional information alone. The design included within- and between-subjects factors. The within-subjects factors were: food (pizzas, yogurts and biscuits), healthiness of the food (high health, medium health and low health) and the repeated measurements under BL and test FOP label conditions. The between-subjects factors were: the system (GDA, TL, GDA+TL hybrid, HL), portion size (typical portion size and a 50% reduction of a typical portion) and country (the UK, Germany, Poland and Turkey). Although the FOP systems tested did result in small improvements for objective understanding under some conditions, there was little difference between the provision of an FOP label containing basic numerical nutritional information alone or between the various systems. Thus, any structured and legible presentation of key nutrient and energy information on the FOP label is sufficient to enable consumers to detect a healthier alternative within a food category when provided with foods that have distinctly different levels of healthiness. Future research should focus on developing greater understanding of the psychological and contextual factors that impact motivation and the opportunity to use the various FOP systems in real-world shopping settings.
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Conducta de Elección , Comportamiento del Consumidor , Dieta/efectos adversos , Etiquetado de Alimentos , Conocimientos, Actitudes y Práctica en Salud , Política Nutricional , Adolescente , Adulto , Anciano , Escolaridad , Femenino , Alemania , Humanos , Internet , Masculino , Persona de Mediana Edad , Polonia , Ingesta Diaria Recomendada , Factores Socioeconómicos , Turquía , Reino Unido , Adulto JovenRESUMEN
This study aims to find out whether front-of-pack nutrition label formats influence the healthfulness of consumers' food choices and important predictors of healthful choices, depending on the size of the choice set that is made available to consumers. The predictors explored were health motivation and perceived capability of making healthful choices. One thousand German and Polish consumers participated in the study that manipulated the format of nutrition labels. All labels referred to the content of calories and four negative nutrients and were presented on savoury and sweet snacks. The different formats included the percentage of guideline daily amount, colour coding schemes, and text describing low, medium and high content of each nutrient. Participants first chose from a set of 10 products and then from a set of 20 products, which was, on average, more healthful than the first choice set. The results showed that food choices were more healthful in the extended 20-product (vs. 10-product) choice set and that this effect is stronger than a random choice would produce. The formats colour coding and texts, particularly colour coding in Germany, increased the healthfulness of product choices when consumers were asked to choose a healthful product, but not when they were asked to choose according to their preferences. The formats did not influence consumers' motivation to choose healthful foods. Colour coding, however, increased consumers' perceived capability of making healthful choices. While the results revealed no consistent differences in the effects between the formats, they indicate that manipulating choice sets by including healthier options is an effective strategy to increase the healthfulness of food choices.
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Conducta de Elección , Etiquetado de Alimentos/métodos , Preferencias Alimentarias , Alimentos Orgánicos , Adulto , Ingestión de Energía , Femenino , Alemania , Política de Salud , Humanos , Masculino , Persona de Mediana Edad , Motivación , Polonia , Factores SocioeconómicosRESUMEN
The Childhood Obesity Plan aimed to reduce sugar and energy in foods through a voluntary sugar-reduction programme. Our primary objective was to determine whether this implementation strategy had been successful, focusing on the out-of-home sector. We used a repeated cross-sectional design to evaluate nutritional changes in desserts served by leading chain restaurants. We extracted nutrition information from online menus in autumn/winter 2020, for comparison with baseline (2017) and interim (2018) values extracted from third-party datasets. We assessed compliance with the 20% sugar-reduction target and category-specific energy targets by product category and for pooled desserts. Overall, sugar/portion and energy/portion decreased by 11% and 4%, respectively. Policy targets were achieved in one of five categories (ice-cream: -38% sugar, p < 0.001; -30% energy, p < 0.001). Secondary outcomes were analysed for subgroups with the necessary data. Few chains significantly reduced sugar and/or energy across their dessert range. Energy/portion was positively associated with portion weight and sugar/portion but not with sugar/100 g. More than half of adults' desserts contained excessive sugar and/or saturated fat compared with dietary guidelines. Children's desserts less frequently exceeded guidelines. These results demonstrate that voluntary measures can drive substantial change when technical, commercial, and operational barriers can be overcome.
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Obesidad Infantil , Adulto , Humanos , Niño , Estudios Transversales , Obesidad Infantil/epidemiología , Obesidad Infantil/prevención & control , Alimentos , Política Nutricional , Azúcares , Valor Nutritivo , Ingestión de EnergíaRESUMEN
Significant ongoing debate exists amongst stakeholders as to the best front-of-pack labelling approach and emerging evidence suggests that the plethora of schemes may cause confusion for the consumer. To gain a better understanding of the relevant psychological phenomena and consumer perspectives surrounding FoP labelling schemes and their optimal development a Multiple Sort Procedure study involving free sorting of a range of nutritional labels presented on cards was performed in four countries (n=60). The underlying structure of the qualitative data generated was explored using Multiple Scalogram Analysis. Elicitation of categorisations from consumers has the potential to provide a very important perspective in this arena and results demonstrated that the amount of information contained within a nutrition label has high salience for consumers, as does the health utility of the label although a dichotomy exists in the affective evaluation of the labels containing varying degrees of information aggregation. Classification of exiting front-of-pack labelling systems on a proposed dimension of 'directiveness' leads to a better understanding of why some schemes may be more effective than others in particular situations or for particular consumers. Based on this research an enhanced hypothetical front-of-pack labelling scheme which combines both directive and non-directive elements is proposed.
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Comportamiento del Consumidor , Toma de Decisiones , Dieta , Etiquetado de Alimentos/clasificación , Conocimientos, Actitudes y Práctica en Salud , Promoción de la Salud/métodos , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Política Nutricional , Valor Nutritivo , Adulto JovenRESUMEN
INTRODUCTION: The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar. METHODS AND ANALYSIS: SWEET (S&SEs: prolonged effects on health, obesity and safety) is a 1-year multicentre RCT including at least 330 adults with overweight (18-65 years, body mass index (BMI) >25 kg/m2) and 40 children (6-12 years, BMI-for-age >85th percentile). In an initial 2-month period, adults will consume a low-energy diet with the aim to achieve ≥5% weight loss. Children are advised to consume a generally healthy diet to maintain body weight, thus reducing their BMI-for-age z-score. In the following 10 months, participants will be randomised to follow a healthy ad libitum diet with or without S&SE products. Clinical investigations are scheduled at baseline, after 2, 6 and 12 months. The primary outcomes are body weight for efficacy and gut microbiota composition (in relation to metabolic health) for safety, both in adults. Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity. ETHICS AND DISSEMINATION: The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed scientific journals regardless of whether the findings are positive, negative or inconclusive. TRIAL REGISTRATION NUMBER: NCT04226911 (Clinicaltrials.gov).
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Sobrepeso , Edulcorantes , Adulto , Peso Corporal , Niño , Humanos , Estudios Multicéntricos como Asunto , Obesidad/complicaciones , Sobrepeso/complicaciones , Ensayos Clínicos Controlados Aleatorios como Asunto , Azúcares , Pérdida de PesoRESUMEN
INTRODUCTION: Intake of free sugars in European countries is high and attempts to reduce sugar intake have been mostly ineffective. Non-nutritive sweeteners and sweetness enhancers (S&SEs) can maintain sweet taste in the absence of energy, but little is known about the impact of acute and repeated consumption of S&SE in foods on appetite. This study aims to evaluate the effect of acute and repeated consumption of two individual S&SEs and two S&SE blends in semisolid and solid foods on appetite and related behavioural, metabolic and health outcomes. METHODS AND ANALYSIS: A work package of the SWEET Project; this study consists of five double-blind randomised cross-over trials which will be carried out at five sites across four European countries, aiming to have n=213. Five food matrices will be tested across three formulations (sucrose-sweetened control vs two reformulated products with S&SE blends and no added sugar). Participants (body mass index 25-35 kg/m2; aged 18-60 years) will consume each formulation for 14 days. The primary endpoint is composite appetite score (hunger, inverse of fullness, desire to eat and prospective food consumption) over a 3-hour postprandial incremental area under the curve during clinical investigation days on days 1 and 14. ETHICS AND DISSEMINATION: The trial has been approved by national ethical committees and will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed open-access scientific journals. Research data from the trial will be deposited in an open-access online research data archive. TRIAL REGISTRATION NUMBER: NCT04633681.
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Apetito , Edulcorantes , Humanos , Sobrepeso , Gusto , Ingestión de Energía , Obesidad/metabolismo , Azúcares , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
The focus of the current paper is on a design of responsible governance of food consumer science e-infrastructure using the case study Determinants and Intake Data Platform (DI Data Platform). One of the key challenges for implementation of the DI Data Platform is how to develop responsible governance that observes the ethical and legal frameworks of big data research and innovation, whilst simultaneously capitalizing on huge opportunities offered by open science and the use of big data in food consumer science research. We address this challenge with a specific focus on four key governance considerations: data type and technology; data ownership and intellectual property; data privacy and security; and institutional arrangements for ethical governance. The paper concludes with a set of responsible research governance principles that can inform the implementation of DI Data Platform, and in particular: consider both individual and group privacy; monitor the power and control (e.g., between the scientist and the research participant) in the process of research; question the veracity of new knowledge based on big data analytics; understand the diverse interpretations of scientists' responsibility across different jurisdictions.
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BACKGROUND: Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely. OBJECTIVE: We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities. METHODS: PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored. RESULTS: Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers' burden. Motor Aspects of Experiences of Daily Living and patients' self-rated health status also influence the system's use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. CONCLUSIONS: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17396879; http://www.isrctn.com/ISRCTN17396879. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2767-4.
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Aplicaciones Móviles , Enfermedad de Parkinson , Telemedicina , Anciano , Estudios de Factibilidad , Femenino , Humanos , Masculino , Enfermedad de Parkinson/diagnóstico , Teléfono InteligenteRESUMEN
BACKGROUND: Most food in the United Kingdom is purchased in supermarkets, and many of these purchases are routinely tracked through supermarket loyalty card data. Using such data may be an effective way to develop remote public health interventions and to measure objectively their effectiveness at changing food purchasing behavior. OBJECTIVE: The Front-of-pack food Labels: Impact on Consumer Choice (FLICC) study is a pilot randomized controlled trial of a digital behavior change intervention. This pilot trial aimed to collect data on recruitment and retention rates and to provide estimates of effect sizes for the primary outcome (healthiness of ready meals and pizzas purchased) to inform a larger trial. METHODS: The intervention consisted of a website where participants could access tailored feedback on previous purchases of ready meals and pizzas, set goals for behavior change, and model and practice the recommended healthy shopping behavior using traffic light labels. The control consisted of Web-based information on traffic light labeling. Participants were recruited via email from a list of loyalty card holders held by the participating supermarket. All food and drink purchases for the participants for the 6 months before recruitment, during the 6-week intervention period, and during a 12-week washout period were transferred to the research team by the participating supermarket. Healthiness of ready meals and pizzas was measured using a predeveloped scale based solely on the traffic light colors on the foods. Questionnaires were completed at recruitment, end of the intervention, and end of washout to estimate the effect of the intervention on variables that mediate behavior change (eg, belief and intention formation). RESULTS: We recruited 496 participants from an initial email to 50,000 people. Only 3 people withdrew from the study, and purchase data were received for all other participants. A total of 208 participants completed all 3 questionnaires. There was no difference in the healthiness of purchased ready meals and pizzas between the intervention and control arms either during the intervention period (P=.32) or at washout (P=.59). CONCLUSIONS: Although the FLICC study did not find evidence of an impact of the intervention on food purchasing behavior, the unique methods used in this pilot trial are informative for future studies that plan to use supermarket loyalty card data in collaboration with supermarket partners. The experience of the trial showcases the possibilities and challenges associated with the use of loyalty card data in public health research. TRIAL REGISTRATION: ISRCTN Registry ISRCTN19316955; http://www.isrctn.com/ISRCTN19316955 (Archived by WebCite at http://www.webcitation.org/76IVZ9WjK). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40814-015-0015-1.
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The Nutrition and Health Claims Regulation (NHCR) EC No 1924/2006 aims to provide an appropriate level of consumer protection whilst supporting future innovation and fair competition within the EU food industry. However, consumers' interpretation of health claims is less well understood. There is a lack of evidence on the extent to which consumers are able to understand claims defined by this regulatory framework. Utilising the Multiple Sort Procedure (MSP), a study was performed (N = 100 participants across five countries: Germany, the Netherlands, Slovenia, Spain and the United Kingdom) to facilitate development of a framework of health-related claims encompassing dimensions derived from consumers. Our results provide useful insight into how consumers make sense of these claims and how claims may be optimised to enhance appropriate consumer understanding. They suggest consumers may not consciously differentiate between a nutrition claim and a health claim in the way that regulatory experts do and provide insight into where this might occur. A consumer-derived typology of health-related claims based on three key dimensions is proposed: (1) Familiarity with the nutrient, substance or food stated in the claim; (2) statement type in terms of simplicity/complexity; (3) relevance of the claim, either personally or for a stated population group.
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Conducta de Elección , Comprensión , Comportamiento del Consumidor , Industria de Alimentos , Preferencias Alimentarias/psicología , Adolescente , Adulto , Anciano , Unión Europea , Femenino , Etiquetado de Alimentos , Alemania , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Valor Nutritivo , Eslovenia , España , Encuestas y Cuestionarios , Reino Unido , Adulto JovenRESUMEN
OBJECTIVE: Health claims on food packaging are regulated to inform and protect consumers; however, many consumers do not accurately interpret the meaning of the claims. Whilst research has shown different types of misinterpretation, it is not clear how those interpretations are formed. The aim of this study was to elicit the causal beliefs and causal models about food and health held by consumers, that is their understanding of the causal relationships between nutrients, health outcomes, and the causal pathways connecting them, and investigate how well this knowledge explains the variation in inferences they draw about health benefits from health claims. METHOD: A total of 400 participants from Germany, the Netherlands, Spain, Slovenia, and the United Kingdom were presented with seven authorized health claims and drew inferences about the health benefits of consuming nutrients specified in the claim. Then, their personal causal models of health were elicited along with their belief in the truth and familiarity with the claims. RESULTS: The strength of inferences about health benefits that participants drew from the claims was predicted independently by the strength of the relevant causal pathways within the causal model, and belief in the truth of the claim, but not familiarity with the claim. Participants drew inferences about overall health benefits of the nutrients by extrapolating from their causal models of health. CONCLUSION: Consumers' interpretation of claims is associated with their belief in the claim and their causal models of health. This prior knowledge is used to interpret the claim and draw inferences about overall health benefits that go beyond the information in the claim. Therefore, efforts to improve consumers' understanding and interpretation of health claims must address both their wider causal models of health and their knowledge of specific claims. Statement of Contribution What is already known on this subject? Health claims influence the likelihood of buying a product. But consumers do not accurately understand or interpret health claims. What does this study add? Consumers' interpretation of health claims is mediated by their personal causal model of health. Consumers draw inferences that go beyond what is claimed by extrapolating from their personal causal model of health. Consumers are also influenced directly by their belief in the claim, but not frequency of exposure to it.
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Comportamiento del Consumidor/estadística & datos numéricos , Etiquetado de Alimentos/métodos , Conocimientos, Actitudes y Práctica en Salud , Modelos Psicológicos , Adolescente , Adulto , Anciano , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
BACKGROUND: Parkinson's disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD_Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD_Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD_Manager for clinical decision making and the acceptability of the system in clinical practice. METHODS/DESIGN: This trial is an unblinded, parallel, two-group, randomised controlled pilot study. A total of 200 persons with Parkinson's disease (Hoehn and Yahr stage 3, experiencing motor fluctuations at least 2 h per day), with primary family carers, in three countries (110 Rome, 50 Venice, Italy; 20 each in Ioannina, Greece and Surrey, England) will be recruited. Following informed consent, baseline information will be gathered, including the following: age, gender, education, attitudes to technology (patient and carer); time since Parkinson's diagnosis, symptom status and comorbidities (patient only). Randomisation will assign participants (1:1 in each country), to PD_Manager vs control, stratifying by age (1 ≤ 70 : 1 > 70) and gender (60% M: 40% F). The PD_Manager system captures continuous data on motor symptoms, sleep, activity, speech quality and emotional state using wearable devices (wristband, insoles) and a smartphone (with apps) for storing and transmitting the information. Control group participants will be asked to keep a symptom diary covering the same elements as PD_Manager records. After a minimum of two weeks, each participant will attend a consultation with a specialist doctor for review of the data gathered (by either means), and changes to management will be initiated as indicated. Patients, carers and clinicians will be asked for feedback on the acceptability and utility of the data collection methods. The PD_Manager intervention, compared to a symptom diary, will be evaluated in a cost-consequences framework. DISCUSSION: Information gathered will inform further development of the PD_Manager system and a larger effectiveness trial. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN17396879 . Registered on 15 March 2017.
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Actitud del Personal de Salud , Cuidadores/psicología , Prestación Integrada de Atención de Salud/métodos , Conocimientos, Actitudes y Práctica en Salud , Enfermedad de Parkinson/terapia , Aceptación de la Atención de Salud , Médicos/psicología , Telemedicina/métodos , Anciano , Toma de Decisiones Clínicas , Europa (Continente) , Femenino , Humanos , Masculino , Estudios Multicéntricos como Asunto , Enfermedad de Parkinson/diagnóstico , Enfermedad de Parkinson/fisiopatología , Enfermedad de Parkinson/psicología , Grupo de Atención al Paciente , Proyectos Piloto , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
OBJECTIVE: Images on food and dietary supplement packaging might lead people to infer (appropriately or inappropriately) certain health benefits of those products. Research on this issue largely involves direct questions, which could (a) elicit inferences that would not be made unprompted, and (b) fail to capture inferences made implicitly. Using a novel memory-based method, in the present research, we explored whether packaging imagery elicits health inferences without prompting, and the extent to which these inferences are made implicitly. METHOD: In 3 experiments, participants saw fictional product packages accompanied by written claims. Some packages contained an image that implied a health-related function (e.g., a brain), and some contained no image. Participants studied these packages and claims, and subsequently their memory for seen and unseen claims were tested. RESULTS: When a health image was featured on a package, participants often subsequently recognized health claims that-despite being implied by the image-were not truly presented. In Experiment 2, these recognition errors persisted despite an explicit warning against treating the images as informative. In Experiment 3, these findings were replicated in a large consumer sample from 5 European countries, and with a cued-recall test. CONCLUSION: These findings confirm that images can act as health claims, by leading people to infer health benefits without prompting. These inferences appear often to be implicit, and could therefore be highly pervasive. The data underscore the importance of regulating imagery on product packaging; memory-based methods represent innovative ways to measure how leading (or misleading) specific images can be. (PsycINFO Database Record
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Recuerdo Mental/fisiología , Estimulación Luminosa , Adolescente , Adulto , Publicidad , Señales (Psicología) , Femenino , Humanos , Masculino , Adulto JovenRESUMEN
BACKGROUND: Traffic light labelling of foods-a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods-has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions. METHODS/DESIGN: The objectives of this two-arm randomised controlled pilot trial are to assess recruitment, retention and data completion rates, to generate potential effect size estimates to inform sample size calculations for the main trial and to assess the feasibility of conducting such a trial. Participants will be recruited by email from a loyalty card database of a UK supermarket chain. Eligible participants will be over 18 and regular shoppers who frequently purchase ready meals or pizzas. The intervention is informed by a review of previous interventions encouraging the use of nutrition labelling and the broader behaviour change literature. It is designed to impact on mechanisms affecting belief and behavioural intention formation as well as those associated with planning and goal setting and the adoption and maintenance of the behaviour of interest, namely traffic light label use during purchases of ready meals and pizzas. Data will be collected using electronic sales data via supermarket loyalty cards and web-based questionnaires and will be used to estimate the effect of the intervention on the nutrition profile of purchased ready meals and pizzas and the behavioural mechanisms associated with label use. Data collection will take place over 48 weeks. A process evaluation including semi-structured interviews and web analytics will be conducted to assess feasibility of a full trial. DISCUSSION: The design of the pilot trial allows for efficient recruitment and data collection. The intervention could be generalised to a wider population if shown to be feasible in the main trial. TRIAL REGISTRATION: ISRCTN: ISRCTN19316955.
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BACKGROUND: The popularity of botanical products is on the rise in Europe, with consumers using them to complement their diets or to maintain health, and products are taken in many different forms (e.g. teas, juices, herbal medicinal products, plant food supplements (PFS)). However there is a scarcity of data on the usage of such products at European level. OBJECTIVE: To provide an overview of the characteristics and usage patterns of PFS consumers in six European countries. DESIGN: Data on PFS usage were collected in a cross-sectional, retrospective survey of PFS consumers using a bespoke frequency of PFS usage questionnaire. SUBJECTS/SETTING: A total sample of 2359 adult PFS consumers from Finland, Germany, Italy, Romania, Spain and the United Kingdom. DATA ANALYSES: Descriptive analyses were conducted, with all data stratified by gender, age, and country. Absolute frequencies, percentages and 95% confidence intervals are reported. RESULTS: Overall, an estimated 18.8% of screened survey respondents used at least one PFS. Characteristics of PFS consumers included being older, well-educated, never having smoked and self-reporting health status as "good or very good". Across countries, 491 different botanicals were identified in the PFS products used, with Ginkgo biloba (Ginkgo), Oenothera biennis (Evening primrose) and Cynara scolymus (Artichoke) being most frequently reported; the most popular dose forms were capsules and pills/tablets. Most consumers used one product and half of all users took single-botanical products. Some results varied across countries. CONCLUSIONS: The PlantLIBRA consumer survey is unique in reporting on usage patterns of PFS consumers in six European countries. The survey highlights the complexity of measuring the intake of such products, particularly at pan-European level. Incorporating measures of the intake of botanicals in national dietary surveys would provide much-needed data for comprehensive risk and benefit assessments at the European level.
Asunto(s)
Suplementos Dietéticos/estadística & datos numéricos , Extractos Vegetales/administración & dosificación , Adolescente , Adulto , Estudios Transversales , Encuestas sobre Dietas , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto JovenRESUMEN
The use of dietary supplements is increasing globally and this includes the use of plant food supplements (PFS). A variety of factors may be influencing this increased consumption including the increasing number of older people in society, mistrust in conventional medicine and the perception that natural is healthy. Consumer studies in this area are limited, with a focus on dietary supplements in general, and complicated by the use of certain plant food supplements as herbal medicines. Research indicates that higher use of dietary supplements has been associated with being female, being more educated, having a higher income, being white and being older, however the drivers for consumption of supplements are complex, being influenced by both demographic and health-related factors. The aim of this paper is to provide an overview of current knowledge about the users and the determinants of usage of plant food supplements. With growing consumption of these products, the need for effective risk-benefit assessment becomes ever more important and an insight into who uses these types of products and why is an important starting point for any future science-based decisions made by policy makers, PFS manufacturers and ultimately by consumers themselves.