Biography

Research

Research interests

Research projects

My publications

Publications

Hodgkins CE, Raats MM, Fife-Schaw CR, Peacock M, Groeppel-Klein A, Koenigstorfer J, Wasowicz G, Stysko-Kunkowska M, Gulcan Y, Kustepeli Y, Gibbs M, Shepherd R, Grunert K (2015) Guiding healthier food choice: systematic comparison of four front-of-pack labelling systems and their effect on judgements of product healthiness, British Journal of Nutrition 113 (10) pp. 1652-1663 Cambridge University Press
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.
Egan MB, Hodgkins C, Fragodt A, Krines C, Raats MM (2009) User-centred food composition data-analysis of user needs through the Use Case approach, FOOD CHEMISTRY 113 (3) pp. 804-807 ELSEVIER SCI LTD
BMRB Social Research, Food, Consumer Behaviour and Health Research Centre at the University of Surrey (2008) Comprehension and use of UK nutrition signpost labelling schemes: Scientific Rationale and Design, Food Standards Agency
Egan B, Hodgkins C, Fragodt A, Raats MM (2011) Compilation of food composition data sets: an analysis of user needs through the Use Case approach., European Journal of Clinical Nutrition 65 (6) pp. 757-760 Nature Publishing Group
Background/Objectives:The objective of this study was to identify the common requirements of users involved in the compilation of food composition data sets with a view to informing the development of a common access system to food composition data, within the European Food Information Resource (EuroFIR) project.Subjects/Methods:A number of examples of food composition data set compilation have been examined using the Use Case approach, namely the compilation of a data set for a national nutrition survey, for a cross-national nutrition study and for a nutritional software programme.Results:The key user requirement identified from the compilation step analysed by the Use Case approach is the increased availability of and access to more detailed food composition data on a wider range of foods and nutrients.Conclusions:Food composition data serve a variety of purposes, and different user groups will often have both common needs and more individual or specific needs of their data sets. The development of Use Cases for specific processes effectively identifies the needs of users, highlighting any similarities and/or differences in those needs. The application of the Use Case approach to support the software development activities within EuroFIR will ensure that user needs are effectively identified and captured in a systematic and documented way.
Hodgkins C, Raats MM, Egan MB, Fragodt A, Buttriss J, McKevith B (2010) Optimising food composition data flow within the UK food supply chain and to external stakeholders, JOURNAL OF FOOD COMPOSITION AND ANALYSIS 23 (7) pp. 749-752 ACADEMIC PRESS INC ELSEVIER SCIENCE
Klepacz NA, Nash RA, Egan MB, Hodgkins CE, Raats MM (2015) When Is an Image a Health Claim? A False-Recollection Method to Detect Implicit Inferences About Products' Health Benefits, HEALTH PSYCHOLOGY 35 (8) pp. 898-907 AMER PSYCHOLOGICAL ASSOC
Raats MM, Malcolm RN, Lahteenmaki L, Pravst I, Gage H, Cleary A, Karatzia A, Kusar A, Yang W, Jackson DL, Hodgkins CE, Klopcic M (2016) Understanding the impact of legislation on 'reduction of disease risk' claims on food and drinks: the REDICLAIM project, AGRO FOOD INDUSTRY HI-TECH 27 (3) pp. 30-32 TEKNOSCIENZE PUBL
Egan B, Hodgkins C, Shepherd R, Timotijevic L, Raats MM (2011) An overview of consumer attitudes and beliefs about plant food supplements., Food and Function 2 (12) pp. 747-752 Royal Society of Chemistry
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.
Raats MM, Hieke S, Jola C, Hodgkins C, Kennedy J, Wills J (2014) Reference amounts utilised in front of package nutrition labelling; impact on product healthfulness evaluations., Eur J Clin Nutr 69 (5) pp. 619-625
BACKGROUND/OBJECTIVES: The research question addressed in this paper is how different reference amounts utilised in front of package nutrition labelling influence evaluation of product healthfulness. SUBJECTS/METHODS: A total of 13,117 participants from six European countries (Germany, UK, Spain, France, Poland and Sweden) were recruited via online panels. A mixed between/within-subject factorial design was employed with food (biscuits, sandwiches, yogurts), healthfulness and presence of Guideline Daily Amounts as within-subjects factors and reference amount ('per 100 g', 'typical portion', 'half portion') and country as between-subjects factors. RESULTS: Overall, people correctly ranked foods according to their objective healthfulness as defined by risk nutrients alone, and could distinguish between more and less healthful variants of foods. General healthfulness associations with the three product categories do not appear to have had a strong influence on product ratings. This study shows that where the reference amount of 'per 100 g' is very different from the 'typical' portion size, as was the case for biscuits, products with a 'per 100 g' label are rated significantly less healthful than the 'typical' or 'half typical' portions. CONCLUSION: The results indicate that across the three food categories, consumers do factor the reference amount, that is, the quantity of food for which the nutritional information is being presented, into their judgements of healthfulness. Therefore, appropriate reference amounts are also of importance for the effective presentation of nutritional information.
Bonsmann SSG, Celemin LF, Larranaga A, Egger S, Wills JM, Hodgkins C, Raats MM (2010) Penetration of nutrition information on food labels across the EU-27 plus Turkey, EUROPEAN JOURNAL OF CLINICAL NUTRITION 64 (12) pp. 1379-1385 NATURE PUBLISHING GROUP
Egan MB, Fragodt A, Raats M, Hodgkins C, Lumbers M (2007) The importance of harmonizing food composition data across Europe, European Journal of Clinical Nutrition 61 (7) pp. 813-821
Objective: To examine the role of food composition data in Europe in four sectors, namely health, trade regulation and legislation, agriculture and the environment. Results: The need for further harmonization of data across Europe is clearly identified and evidenced from a number of previous successful European collaborations. Conclusions: Data on the nutritional composition of foods are essential for a broad spectrum of activities, including public health nutrition, research, the food industry and government policy development and implementation. With the expansion of the European Union and the concomitant increase in cross border trade and cooperation harmonizing food composition data becomes a more important issue than ever. Harmonization is not solely a technical issue, but also involves creating durable and sustainable structures to maintain the viability of the data. These are some of the issues currently being addressed by the European Food Information Resource Network of Excellence.
Aschemann-Witzel J, Grunert KG, van Trijp H, Bialkova S, Raats MM, Hodgkins C, Wasowicz-Kirylo G, Koenigstorfer J (2013) Effects of nutrition label format and product assortment on the healthfulness of food choice, Appetite 71 pp. 63-74
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. © 2013 Elsevier Ltd.
Peacock M, Hodgkins C, Shepherd R, Raats M (2011) Articulating health through food labelling: encouraging healthier choices, ANNALS OF NUTRITION AND METABOLISM 58 pp. 206-206
Dean M, Spence M, Hodgkins C, Raats MM (2015) Front-of-pack (FOP) labelling of foods and beverages, In: Berryman P (eds.), Advances in Food and Beverage Labelling Information and Regulations 7 pp. 113-131 Woodhead Publishing Limited
Many food and drink products now display nutritional information on the front of the food package, so called front-of-pack (FOP) nutrition labels or nutrition signpost labels, which serve to provide a simple and visible summary of the products nutritional quality. This chapter reviews FOP labelling in the EU. It covers the history of FOP development, the different types of FOP labelling, the underpinnings of the different FOP schemes as well as ways of classifying FOP schemes. The impact FOP labels have on consumers and the food industry are discussed with a useful section on future trends. A list of review papers are presented for further reading.
Hodgkins C, Barnett J, Wasowicz-Kirylo G, Stysko-Kunkowska M, Gulcan Y, Kustepeli Y, Akgungor S, Chryssochoidis G, Fernández-Celemin L, Storcksdieck Genannt Bonsmann S, Gibbs M, Raats MM (2012) Understanding how consumers categorise nutritional labels: A consumer derived typology for front-of-pack nutrition labelling., Appetite 59 (3) pp. 806-817 Elsevier
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.
Scarborough P, Hodgkins CE, Raats MM, Harrington R, Cowburn G, Dean M, Doherty A, Foster C, Juszczak E, Matthews A, Mizdrak A, Ni Mhurchu C, Shepherd R, Tiomotijevic L, Winstone N, Rayner M (2015) Protocol for a pilot randomised controlled trial of an intervention to increase the use of traffic light food labelling in UK shoppers (the FLICC trial), Pilot and Feasibility Studies 1 (21) 21 BioMed Central

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 webcite

Scarborough P, Matthews A, Eyles H, Kaur A, Hodgkins CE, Raats MM, Rayner M (2015) Reds are more important than greens: how UK supermarket shoppers use the different information on a traffic light nutrition label in a choice experiment, International Journal of Behavioral Nutrition and Physical Activity 12 ARTN 1 BioMed Central

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.

Garcia-Alvarez A, Egan MB, de Klein S, Dima L, Maggi F, Isoniemi M, Ribas-Barba L, Raats MM, Meissner E, Badea M, Bruno F, Salmenhaara M, Mila-Villarroel R, Knaze V, Hodgkins CE, Marculescu A, Uusitalo L, Restani P, Serra-Majem L (2014) Usage of Plant Food Supplements across Six European Countries: Findings from the PlantLIBRA Consumer Survey, PLoS ONE 9 (3) Public Library of Science

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.

Klepacz N, Nash R, Egan MB, Raats MM, Hodgkins CE (2015) When Is an Image a Health Claim? A False-Recollection Method to Detect Implicit Inferences About Products? Health Benefits, Health Psychology 35 (8) pp. 898-907 American Psychological Association
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 memories 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.
Pravst I, Hodgkins C, Lähteenmäki L, Malcolm R, Kuaar A, Kulikovskaja V, }mitek K, Miklavec K, Raats M, Lavriaa } (2017) Recommendations for successful substantiation of new health claims in the European Union, Trends in Food Science & Technology 71 pp. 259-263 Elsevier

Background:

While functional foods offer promise for public health and innovation in the food industry, the efficiency of such foods should be assured to protect consumers from misleading claims. Globally, many countries regulate the communication of the health effects of such foods to final consumers.

Scope and approach:

In the European Union (EU), the use of health claims was harmonized in 2006. All claims need to be scientifically assessed by the European Food Safety Authority (EFSA) and pre-approved. Implementing the regulation has involved a steep learning curve for stakeholders, resulting in many health claims being rejected. The EU-funded REDICLAIM project used existing guidance documents, analyses of Scientific Opinions on new health claim applications, and a series of interviews with experts involved in such applications to identify key points in the process of authorizing new health claims.

Key findings and conclusions:

Recommendations for the successful substantiation of new health claims in the EU were prepared. The substantiation of health claims is primarily based on human efficacy studies, and greater resources are required to authorize more innovative claims. The reported recommendations should be seen as a starting point for researchers in the area of nutrition and food technology, and for those dealing with functional foods, including the food industry.

Background: Food composition data, front-of-pack nutrition labelling and nutrition and health claims have an important role to play in the development of appropriate policy, regulation and public health interventions ultimately aimed at reducing the burden of diet-related chronic disease. The overarching aim of this thesis is to explore whether the communication of healthier food choice through front-of-pack (FOP) nutrition labelling and health claims can be enhanced by the development of consumer derived frameworks (typologies) of these domains, a greater understanding of the degree to which the different FOP labelling schemes impact on consumer health inferences and an improved approach to the sharing of food composition data between stakeholders.
Method: The potential for more effective approaches to the transfer of food composition data on processed foods, was explored via a survey conducted within the UK food industry (Study 1). To facilitate the development of a consumer derived typology of FOP nutrition labelling schemes in Europe, a free-sorting study utilising the ?Multiple Sort Procedure? (MSP) was performed in four countries; France, Poland, Turkey and the United Kingdom (Study 2). Building on the MSP methodology utilised in Study 2, a further study on nutrition and health claims was performed in five countries; Germany, the Netherlands, Slovenia, Spain and the United Kingdom. (Study 3). The final study in this thesis sought to quantify the extent to which consumer perceptions of healthiness are impacted by the interpretative elements of the prevalent FOP labelling schemes in four countries; Germany, Poland, Turkey and the United Kingdom (Study 4).
Conclusion: The outcomes of this research propose an optimised approach to the sharing of food composition data, an optimised approach to FOP labelling and consumer derived typologies for both the FOP labelling and nutrition and health claims domains.
Banks Adrian P., Egan Bernadette, Hodgkins Charo E., Peacock Matthew, Raats Monique M. (2018) The role of causal models and beliefs in interpreting health claims, British Journal of Health Psychology 23 (4) pp. 933-948 Wiley

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 is to elicit the causal beliefs and causal models about food and health held by consumers, i.e. 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: 400 participants from Germany, the Netherlands, Spain, Slovenia, and the UK were presented with 7 authorised 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 were 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.

Touray Morro, Antonini A, Gentile G, Giglio M, Marcante A, Gage Heather, Fotiadis D, Gatsios D, Konitsiotis S, Timotijevic Lada, Egan B, Hodgkins Charo, Biundo R, Pellicano C (2018) Acceptability to patients, carers and clinicians of a mHealth platform for the management of Parkinson's disease (PD_Manager): study protocol for a pilot randomised controlled trial, Trials 19 (492) BioMed Central
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 d 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.