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Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries.

ABSTRACT: Improving lifestyle behaviours has considerable potential for reducing the global burden of non-communicable diseases, promoting better health across the life-course and increasing well-being. However, realising this potential will require the development, testing and implementation of much more effective behaviour change interventions than are used conventionally. Therefore, the aim of this study was to conduct a multi-centre, web-based, proof-of-principle study of personalised nutrition (PN) to determine whether providing more personalised dietary advice leads to greater improvements in eating patterns and health outcomes compared to conventional population-based advice. A total of 5,562 volunteers were screened across seven European countries; the first 1,607 participants who fulfilled the inclusion criteria were recruited into the trial. Participants were randomly assigned to one of the following intervention groups for a 6-month period: Level 0-control group-receiving conventional, non-PN advice; Level 1-receiving PN advice based on dietary intake data alone; Level 2-receiving PN advice based on dietary intake and phenotypic data; and Level 3-receiving PN advice based on dietary intake, phenotypic and genotypic data. A total of 1,607 participants had a mean age of 39.8 years (ranging from 18 to 79 years). Of these participants, 60.9 % were women and 96.7 % were from white-European background. The mean BMI for all randomised participants was 25.5 kg m(-2), and 44.8 % of the participants had a BMI ? 25.0 kg m(-2). Food4Me is the first large multi-centre RCT of web-based PN. The main outcomes from the Food4Me study will be submitted for publication during 2015.

SUBMITTER: Celis-Morales C

PROVIDER: S-EPMC4261071 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries.

Celis-Morales Carlos C Livingstone Katherine M KM Marsaux Cyril F M CF Forster Hannah H O'Donovan Clare B CB Woolhead Clara C Macready Anna L AL Fallaize Rosalind R Navas-Carretero Santiago S San-Cristobal Rodrigo R Kolossa Silvia S Hartwig Kai K Tsirigoti Lydia L Lambrinou Christina P CP Moschonis George G Godlewska Magdalena M Surwiłło Agnieszka A Grimaldi Keith K Bouwman Jildau J Daly E J EJ Akujobi Victor V O'Riordan Rick R Hoonhout Jettie J Claassen Arjan A Hoeller Ulrich U Gundersen Thomas E TE Kaland Siv E SE Matthews John N S JN Manios Yannis Y Traczyk Iwona I Drevon Christian A CA Gibney Eileen R ER Brennan Lorraine L Walsh Marianne C MC Lovegrove Julie A JA Alfredo Martinez J J Saris Wim H M WH Daniel Hannelore H Gibney Mike M Mathers John C JC

Genes & nutrition 20141210 1

Improving lifestyle behaviours has considerable potential for reducing the global burden of non-communicable diseases, promoting better health across the life-course and increasing well-being. However, realising this potential will require the development, testing and implementation of much more effective behaviour change interventions than are used conventionally. Therefore, the aim of this study was to conduct a multi-centre, web-based, proof-of-principle study of personalised nutrition (PN) t ...[more]

PMID: 25491748

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Project description:BackgroundThe effect of personalised nutrition advice on discretionary foods intake is unknown. To date, two national classifications for discretionary foods have been derived. This study examined changes in intake of discretionary foods and beverages following a personalised nutrition intervention using these two classifications.MethodsParticipants were recruited into a 6-month RCT across seven European countries (Food4Me) and were randomised to receive generalised dietary advice (control) or one of three levels of personalised nutrition advice (based on diet [L1], phenotype [L2] and genotype [L3]). Dietary intake was derived from an FFQ. An analysis of covariance was used to determine intervention effects at month 6 between personalised nutrition (overall and by levels) and control on i) percentage energy from discretionary items and ii) percentage contribution of total fat, SFA, total sugars and salt to discretionary intake, defined by Food Standards Scotland (FSS) and Australian Dietary Guidelines (ADG) classifications.ResultsOf the 1607 adults at baseline, n = 1270 (57% female) completed the intervention. Percentage sugars from FSS discretionary items was lower in personalised nutrition vs control (19.0 ± 0.37 vs 21.1 ± 0.65; P = 0.005). Percentage energy (31.2 ± 0.59 vs 32.7 ± 0.59; P = 0.031), percentage total fat (31.5 ± 0.37 vs 33.3 ± 0.65; P = 0.021), SFA (36.0 ± 0.43 vs 37.8 ± 0.75; P = 0.034) and sugars (31.7 ± 0.44 vs 34.7 ± 0.78; P < 0.001) from ADG discretionary items were lower in personalised nutrition vs control. There were greater reductions in ADG percentage energy and percentage total fat, SFA and salt for those randomised to L3 vs L2.ConclusionsCompared with generalised dietary advice, personalised nutrition advice achieved greater reductions in discretionary foods intake when the classification included all foods high in fat, added sugars and salt. Future personalised nutrition approaches may be used to target intake of discretionary foods.Trial registrationClinicaltrials.gov NCT01530139 . Registered 9 February 2012.

Project description:National guidelines emphasize healthy eating to promote wellbeing and prevention of non-communicable diseases. The perceived healthiness of food is determined by many factors affecting food intake. A positive perception of healthy eating has been shown to be associated with greater diet quality. Internet-based methodologies allow contact with large populations. Our present study aims to design and evaluate a short nutritional perception questionnaire, to be used as a screening tool for assessing nutritional status, and to predict an optimal level of personalisation in nutritional advice delivered via the Internet.Data from all participants who were screened and then enrolled into the Food4Me proof-of-principle study (n?=?2369) were used to determine the optimal items for inclusion in a novel screening tool, the Nutritional Perception Screening Questionnaire-9 (NPSQ9). Exploratory and confirmatory factor analyses were performed on anthropometric and biochemical data and on dietary indices acquired from participants who had completed the Food4Me dietary intervention (n?=?1153). Baseline and intervention data were analysed using linear regression and linear mixed regression, respectively.A final model with 9 NPSQ items was validated against the dietary intervention data. NPSQ9 scores were inversely associated with BMI (??=?-0.181, p?<?0.001) and waist circumference (??=?-0.155, p?<?0.001), and positively associated with total carotenoids (??=?0.198, p?<?0.001), omega-3 fatty acid index (??=?0.155, p?<?0.001), Healthy Eating Index (HEI) (??=?0.299, p?<?0.001) and Mediterranean Diet Score (MDS) (??=?0. 279, p?<?0.001). Findings from the longitudinal intervention study showed a greater reduction in BMI and improved dietary indices among participants with lower NPSQ9 scores.Healthy eating perceptions and dietary habits captured by the NPSQ9 score, based on nine questionnaire items, were associated with reduced body weight and improved diet quality. Likewise, participants with a lower score achieved greater health improvements than those with higher scores, in response to personalised advice, suggesting that NPSQ9 may be used for early evaluation of nutritional status and to tailor nutritional advice.NCT01530139 .

Project description:INTRODUCTION:Economic evaluations of tobacco control policies targeting adolescents are scarce. Few take into account real-world, large-scale implementation costs; few compare cost-effectiveness of different policies across different countries. We assessed the cost-effectiveness of five tobacco control policies (nonschool bans, including bans on sales to minors, bans on smoking in public places, bans on advertising at points-of-sale, school smoke-free bans, and school education programs), implemented in 2016 in Finland, Ireland, the Netherlands, Belgium, Germany, Italy, and Portugal. METHODS:Cost-effectiveness estimates were calculated per country and per policy, from the State perspective. Costs were collected by combining quantitative questionnaires with semi-structured interviews on how policies were implemented in each setting, in real practice. Short-term effectiveness was based on the literature, and long-term effectiveness was modeled using the DYNAMO-HIA tool. Discount rates of 3.5% were used for costs and effectiveness. Sensitivity analyses considered 1%-50% short-term effectiveness estimates, highest cost estimates, and undiscounted effectiveness. FINDINGS:Nonschool bans cost up to €253.23 per healthy life year, school smoking bans up to €91.87 per healthy life year, and school education programs up to €481.35 per healthy life year. Cost-effectiveness depended on the costs of implementation, short-term effectiveness, initial smoking rates, dimension of the target population, and weight of smoking in overall mortality and morbidity. CONCLUSIONS:All five policies were highly cost-effective in all countries according to the World Health Organization thresholds for public health interventions. Cost-effectiveness was preserved even when using the highest costs and most conservative effectiveness estimates. IMPLICATIONS:Economic evaluations using real-world data on tobacco control policies implemented at a large scale are scarce, especially considering nonschool bans targeting adolescents. We assessed the cost-effectiveness of five tobacco control policies implemented in 2016 in Finland, Ireland, the Netherlands, Belgium, Germany, Italy, and Portugal. This study shows that all five policies were highly cost-effective considering the World Health Organization threshold, even when considering the highest costs and most conservative effectiveness estimates.

Project description:BackgroundDespite widespread age-of-sale restrictions on tobacco, adolescents continue to obtain cigarettes and experiment with smoking. This mixed-methods study aimed to understand how European adolescents access cigarettes and how the policy context may influence this process, using a realist evaluation approach. This is the first study to assess access to cigarettes across various European contexts.MethodsA survey of 4104 students was combined with qualitative data from focus groups among 319 adolescents aged 14-19 across seven European countries. Data were synthesized to explore mechanisms via which young people obtain cigarettes despite age-of-sale restrictions.ResultsWhile purchasing cigarettes from supermarkets was widely regarded as difficult, many participants purchased cigarettes from noncompliant retailers (often in smaller shops or cafes). Other contra-mechanisms included circumventing age checks, proxy purchases, and/or social sources. Dominant forms of access differed across the seven contexts, with direct purchases more common where perceived enforcement was low (eg, Belgium) and proxy purchases more important where perceived enforcement of age-of-sale laws was high (eg, Finland). The effectiveness of age-of-sale restrictions in reducing youth access appears to be influenced by a range of contextual factors including retailer compliance, the availability of vending machines, and the specific minimum age-of-sale.ConclusionsOur findings illustrate the relevance of programme theory in understanding the contra-mechanisms that undermine the effectiveness of age-of-sale laws in discouraging youth smoking. Young people's access to cigarettes could be further limited by addressing these contra-mechanisms, including an increase in the legal sales age (particularly in Belgium), banning vending machines, and strengthening enforcement.ImplicationsDespite widespread implementation of age-of-sale laws, a substantial proportion of minors continue to access cigarettes. Young people use a number of contra-mechanisms to circumvent age-of-sale restrictions. These include accessing cigarettes via social sources, proxy sales or by circumventing age checks. Our findings show that in contexts where perceived enforcement of age-of-sale restrictions is high, young people are more reliant on irregular forms of access such as proxy sales. Young people's access to cigarettes may be further reduced by policy interventions that address these contra-mechanisms-for example, banning vending machines, strengthening enforcement of age-of-sale laws, and increasing the minimum age-of-sale.

Project description:BackgroundTo determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation interventions undergo continuous development, and most are not adapted for Web-based delivery. The Food4Me study (N=1607) provided the opportunity to use existing frameworks to describe standardized Web-based techniques employed in a large-scale, internet-based intervention to change dietary behavior and physical activity.ObjectiveThe aims of this study were (1) to describe techniques embedded in the Food4Me study design and explain the selection rationale and (2) to demonstrate the use of behavior change technique taxonomies, develop standard operating procedures for training, and identify strengths and limitations of the Food4Me framework that will inform its use in future studies.MethodsThe 6-month randomized controlled trial took place simultaneously in seven European countries, with participants receiving one of four levels of personalized advice (generalized, intake-based, intake+phenotype-based, and intake+phenotype+gene-based). A three-phase approach was taken: (1) existing taxonomies were reviewed and techniques were identified a priori for possible inclusion in the Food4Me study, (2) a standard operating procedure was developed to maintain consistency in the use of methods and techniques across research centers, and (3) the Food4Me behavior change technique framework was reviewed and updated post intervention. An analysis of excluded techniques was also conducted.ResultsOf 46 techniques identified a priori as being applicable to Food4Me, 17 were embedded in the intervention design; 11 were from a dietary taxonomy, and 6 from a smoking cessation taxonomy. In addition, the four-category smoking cessation framework structure was adopted for clarity of communication. Smoking cessation texts were adapted for dietary use where necessary. A posteriori, a further 9 techniques were included. Examination of excluded items highlighted the distinction between techniques considered appropriate for face-to-face versus internet-based delivery.ConclusionsThe use of existing taxonomies facilitated the description and standardization of techniques used in Food4Me. We recommend that for complex studies of this nature, technique analysis should be conducted a priori to develop standardized procedures and training and reviewed a posteriori to audit the techniques actually adopted. The present framework description makes a valuable contribution to future systematic reviews and meta-analyses that explore technique efficacy and underlying psychological constructs. This was a novel application of the behavior change taxonomies and was the first internet-based personalized nutrition intervention to use such a framework remotely.Trial registrationClinicalTrials.gov NCT01530139; https://clinicaltrials.gov/ct2/show/NCT01530139 (Archived by WebCite at http://www.webcitation.org/6y8XYUft1).

Dataset Information

Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries.

Publications

Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries.

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